CME FOR MDs, DOs, PAs AND OTHER HEALTH CARE PROVIDERS

2020 PENNSYLVANIAMEDICAL LICENSURE PROGRAM

PROGRAM SATISFIES MANDATORY

CME REQUIREMENTS FOR:

2 HOURSCHILD ABUSE

2 HOURSPRESCRIBING OPIOIDS

12 HOURSPATIENT SAFETY

PA.CME.EDU

STATE SPECIFIC CONTINUING MEDICAL EDUCATION

AMA PRA CATEGORY 1 CREDITS™ MIPS MOC STATE LICENSURE CME FOR:

InforMed is Accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

ONLINE MAIL FAXPA.CME.EDU

1015 Atlantic Blvd #301Jacksonville, FL 32233 1.800.647.1356

2020 PENNSYLVANIACHILD ABUSE RECOGNITION AND REPORTING IN PENNSYLVANIACOURSE ONE | 2 CREDITS **Satisfies Mandatory Requirement for Two (2) Credit Hours in Child Abuse

PRESCRIBER EDUCATION FOR OPIOID ANALGESICSCOURSE TWO | 2 CREDITS ****Satisfies Mandatory Requirement for Two (2) Credit Hours inMandatory Opioid Education - Prescribing Opioids

SUICIDE ASSESSMENT & PREVENTIONCOURSE THREE | 6 CREDITS ++Completion of Courses 3 & 4 Satisfies Mandatory Requirement for Twelve (12) Credit Hours in Patient Safety

PREVENTING CLINICIAN BURNOUTCOURSE FOUR | 6 CREDITS++Completion of Courses 3 & 4 Satisfies Mandatory Requirement for Twelve (12) Credit Hours in Patient Safety

LEARNER RECORDS: ANSWER SHEET & EVALUATIONREQUIRED TO RECEIVE CREDIT

01

21

94

54

128

method and answers to the evaluation questions

after july 1st

$95 $145PRIOR TO july 1st

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INFORMED TRACKSWHAT YOU NEED,WHEN YOU NEED IT

Pennsylvania Professional License Requirements

Disclaimer: The above information is provided by InforMed and is intended to summarize state CE/CME license requirements for informational purposes only. This is not intended as a comprehensive statement of the law on this topic, nor to be relied upon as authoritative. All information should be verified independently.

PA State Board of MedicineOne Penn Center, 2601 N. 3rd Street

Harrisburg, PA 17110P. (717) 783 -1400 F. (717) 787-7769MDs

12/31/2020DOs

10/31/2020PA State Board of Osteopathic Medicine

One Penn Center, 2601 N. 3rd StreetHarrisburg, PA 17110

P. (717) 783 -4858 F. (717) 787-7769

LICENSE RENEWALWe are a nationally accredited CME provider. For all board-related inquiries please contact:

The Pennsylvania State Boards of Medicine and Osteopathic Medicine requires all physicians (MD/DOs) maintaining a current license to complete one-hundred (100) credits of continuing medical education during the current licensure cycle. For MDs at least twenty (20) of these credits shall be AMA PRA Category 1 Credits™ and for DOs at least twenty (20) of these credits shall be AOA Category 1.

CHILD ABUSE Act 31 of 2014 states that all health-related licensees applying for the renewal of a license are required to complete at least two (2) hours of Board-approved continuing education in child abuse recognition and reporting requirements as a condition of renewal.

OPIOID EDUCATION According to 9.1(a)(2) of ABC-MAP, in order for medical physicians and surgeons, medical physician assistants and nurse-midwives with prescriptive authority to renew their license or prescriptive authority approval for the next renewal period, prescribers with a DEA registration must complete at least two (2) hours of continuing education in pain management or the identification of addiction or the practices of prescribing or dispensing of opioids. The continuing education requirements of ABC-MAP will count towards the total number of continuing education credits required for renewal.

PATIENT SAFETY The Pennsylvania State Boards of Medicine and Osteopathic Medicine require at least twelve (12) credit hours to be completed in the area of patient safety/risk management.

MANDATORY CME REQUIREMENTS

CONTINUING MEDICAL EDUCATION REQUIREMENT FOR LICENSE RENEWAL

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Table 1. MOC Recognition StatementsSuccessful completion of certain enclosed CME activities, which includes participation in the evaluation component, enables the participant to earn up to the amounts and credit types shown in Table 2 below. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting MOC credit.

Board ProgramsABA American Board of Anesthesiology’s redesigned Maintenance of Certification in

AnesthesiologyTM (MOCA®) program, known as MOCA 2.0®ABIM American Board of Internal Medicine’s Maintenance of Certification (MOC) program

ABO American Board of Ophthalmology’s Maintenance of Certification (MOC) program

ABOHNS American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC)

ABPath American Board of Pathology’s Continuing Certification Program

ABP American Board of Pediatrics’ Maintenance of Certification (MOC) program.

Table 2. Credits and Type AwardedActivity Title AMA PRA Category 1

CreditsTMABA ABIM ABO ABOHNS ABPath ABP

Child Abuse Recognition & Reporting in PA

2 AMA PRA Category 1 CreditsTM

2 Credits LL

2 Credits MK

2 Credits LL & SA

2 Credits SA

2 Credits LL & SAM

2 Credits LL + SA

Suicide Assessment & Prevention

6 AMA PRA Category 1 CreditsTM

6 CreditsLL and PS

6 CreditsMK and PS

6 Credits LL, SA, & PS

6 Credits SA & PS

6 Credits LL & SAM

6 CreditsLL+SA

Preventing Clinician Burnout

6 AMA PRA Category 1 CreditsTM

6 CreditsLL and PS

6 CreditsMK and PS

6 Credits LL, SA, & PS

6 Credits SA & PS

6 Credits LL & SAM

6 CreditsLL+SA

Legend: LL = Lifelong Learning, MK = Medical Knowledge, SA = Self-Assessment, SAM = Self-Assessment Module, LL+SA = Lifelong Learning & Self-Assessment, PS = Patient Safety

Table 3. CME for MIPS StatementCompletion of each accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA PSPA_28) for the Merit-based Incentive Payment Program (MIPS). Participation in this Clinical Practice Improvement Activity (CPIA) is optional for eligible providers.

MOC/MIPS CREDIT INFORMATION

In addition to awarding AMA PRA Category 1 CreditsTM, the successful completion of enclosed activities may award the following MOC points and credit types. To be awarded MOC points, you must obtain a passing score and complete the corresponding Activity Evaluation.

v DATA REPORTING: Federal, State, and Regulatory Agencies require disclosure of data reporting to all course participants. InforMed abides by each entity’s requirements for data reporting to attest compliance on your behalf. Reported data is governed by each entity’s confidentiality policy. To report compliance on your behalf, it’s mandatory that you must achieve a passing score and accurately fill out the learner information, activity and program evaluation, and the 90-day follow up survey. Failure to accurately provide this information may result in your data being non-reportable and subject to actions by these entities.

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PA.CME.EDU

For more than 49 years InforMed has been providing high level education activities to physicians and other healthcare professionals. Through our level of engagement with a wide variety of stakeholders, including our physician association, we have become the foremost public health policy continuing medical education organization in the United States. We are recognized as the leading provider of mandatory CME activities to physicians as a means of updating knowledge, improving competencies and fulfilling requirements for federal, state, regulatory and license renewal

1015 Atlantic Blvd #301Jacksonville, FL 32233

Dear Pennsylvania Medical Professionals,

InforMed is pleased to offer this collection of CME activities for physicians who are licensed by the state of Pennsylvania. The uniquely tailored curriculum is customized to the educational needs of Pennsylvania medical professionals. Participants earn AMA PRA Category 1 Credits™ through these self-directed, on-demand courses.

This CME series is designed to streamline the education requirements of the Pennsylvania State Boards of Medicine and Osteopathic Medicine. Licensees who complete this program optimize their learning path while satisfying professional credentialing requirements for two (2) credit hours in opioid education, twelve (12) credit hours in patient safety, and two (2) credit hours in child abuse. All activities are independently sponsored by InforMed Continuing Medical Education without commercial support.

Thank you for choosing InforMed as your CME provider. Please do not hesitate to contact us with any questions.

-InforMed CME Team

Visit PA.CME.EDU, select NETPASS to begin.

1

Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required.

Return your customer information/answer sheet, evaluation, and payment to InforMed by mail, phone, fax or complete online at course website under NETPASS.

TARGET AUDIENCE

This course is designed for Pennsylvania health care professionals and other mandatory reporters licensed through the Pennsylvania Department of State who are required to participate in approved child abuse recognition and reporting training as a condition of licensure.

COURSE OBJECTIVEThe purpose of this course is to educate health care providers about child abuse prevention, recognition, and reporting in accordance with state statutory requirements.

Completion of this course will better enable the course participant to:1. Discuss the statutory requirements of mandatory reporters within the Commonwealth.2. Recognize specific signs of child abuse.3. Assess and document cases of suspected abuse.4. Describe the reporting procedure for mandatory reporters of child abuse.

LEARNING OBJECTIVES

Release Date: 03/2020

Expiration Date: 02/2023Enduring Material

(Self Study)

2 AMA PRA

Category 1 Credits™

ACCREDITATION STATEMENTInforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENTInforMed designates this enduring material for maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CHILD ABUSE RECOGNITION AND REPORTING IN PENNSYLVANIA

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Mitchell Goldstein, MD, MBAAssistant Professor of Pediatrics Johns Hopkins University School of Medicine

Medical Director, Urgent Care ServicesJohns Hopkins University School of Medicine

Medical Director, Johns Hopkins Child Protection TeamJohns Hopkins University School of Medicine

FACULTY

V. Silverstein, MDMedical Writer Eagle Creek Medical Communications

ACTIVITY PLANNERMichael BrooksDirector of CME, InforMed

DISCLOSURE OF INTEREST:In accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

STAFF AND CONTENT REVIEWERSInforMed staff and any content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

FACULTY/PLANNING COMMITTEE DISCLOSUREThe following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity:

• V. Silverstein, MD• Mitchell Goldstein, MD, MBA • Michael Brooks

DISCLAIMER*2020. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.

This course is approved by the Pennsylvania Department of Human Services and Department of State for two (2) hours of child abuse recognition and reporting training.

Completion of this course satisfies the education requirements for training in child abuse recognition and reporting for

license renewals.

All health-related licensees applying for the renewal of a license issued by the Board are required to complete at least two (2) hours of Board-approved continuing education in child abuse recognition and reporting requirements.

CHILD ABUSE RECOGNITION &

REPORTING

PENNSYLVANIA SPECIAL APPROVAL

Provider Number: CACE000042

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IntroductionThe problem of child abuse and victimization

is nationwide in scope but of particular interest in the Commonwealth of Pennsylvania. In 2018, Pennsylvania received 44,063 reports of suspected abuse or neglect, 5,102 of which were substantiated, which was the highest level on record.1 There were 47 substantiated child fatalities in 2018 and 89 near-fatalities.1

Sexual abuse remains the leading type of child abuse in Pennsylvania (47%), followed by physicalabuse (28%), and parents continue to be the persons most responsible for abusing children.1

Pennsylvania’s Child Protective Services Law (CPSL) continues to evolve, with the following legislative changes being approved by the Governor in 2018:1

• Expansion of the definition of child abuse to include when a person leaves a child unsuper-vised with an individual, other than the child’s parent, who they know or reasonably should have known, to be a sexually violent predator or to be subject to lifetime registration (Act 29)

• Involuntary termination of parental rights for parents required to register as sexual offend-ers (Act 29)

• Requirements that all schools display ap-proved posters with information for reporting suspected child abuse (Act 54)

• New policies to allow indefinite maintenance of child protective services reports (Act 54)

Health-care professionals play a crucial role in the health and well-being of children, youth, and families. Their contact with children and families during the different stages of a child's life gives them a unique opportunity to observe families' resilience and progress and to provide education and support.2 When necessary, health-care professionals must report suspected child abuse and neglect.

This CME monograph on recognizing and reporting child abuse will cover the most recent Pennsylvania state guidelines for reporting child abuse based on the most recently-available version of the CPSL. It will review signs and symptoms of child abuse as well as the prevalence of the problem in Pennsylvania. It will familiarize course participants with some of the characteristics of individuals who may be victims of, or perpetrators of, child abuse. Finally, it will describe current mandatory reporting requirements, processes, and penalties for physicians and other professionals practicing in Pennsylvania. This program offers state-defined mandatory reporters, including physicians and other healthcare personnel, training for meeting their responsibilities for protecting vulnerable children from child abuse.

What Is Child Welfare?Child welfare is an array of services designed to

ensure that children are safe and that families have the necessary support to care for their children successfully. Child welfare agencies typically:2

• Support or coordinate services to prevent child abuse and neglect

• Provide services to families that need help protecting and caring for their children

• Receive and investigate reports of possible child abuse and neglect and assess child and family needs, strengths, and resources

• Arrange for children to live with kin or with foster families when safety cannot be ensured at home

• Support the well-being of children living with relatives or foster families, including ensuring that their health and educational needs are addressed

• Work with the children, youth, and families to achieve family reunification, adoption, or other permanent family connections for children and youth leaving foster careEach state or locality has a public child welfare

agency responsible for receiving and investigating reports of child abuse and neglect and assessing child and family needs, however the child welfare system is not a single entity.

Figure 1. Trends in Child Abuse in Pennsylvania1

Figure 2. Relationship of Perpetrator to Victims in Substantiated Reports of Child Abuse in Pennsylvania1

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Public child welfare agencies often collaborate with private child welfare agencies, community-based organizations, and other public agencies to ensure that families receive the services they need, such as supportive child care, parenting programs, in-home family preservation services, health and mental health services, and substance abuse treatment.2

The administrative framework for child welfare services and programs varies from state to state. All states are responsible for compliance with federal and state requirements, however, they may differ in the way child welfare services are operated and delivered. The different types of administration determine the degree of centralization of authority and responsibility for child welfare funding, policymaking, licensing, and training for workers.

Federal Child Abuse Prevention and Treatment Act

The key federal legislation addressing child abuse and neglect is the Child Abuse Prevention and Treatment Act (CAPTA), originally enacted in 1974 (Public Law 93-247).3 This Act was amended several times and was most recently amended and reauthorized on December 20, 2010, by the CAPTA Reauthorization Act of 2010. It was amended in 2015, 2016, and 2018, and most recently, certain provisions of the act were amended on January 7, 2019, by the Victims of Child Abuse Act Reauthorization Act of 2018 (P.L. 115-424).3

CAPTA provides Federal funding and guidance to states in support of prevention, assessment, investigation, prosecution, and treatment activities and also provides grants to public agencies and nonprofit organizations, including Indian Tribes and Tribal organizations, for demonstration programs and projects. Additionally, CAPTA identifies the Federal role in supporting research, evaluation, technical assistance, and data collection activities; establishes the Office on Child Abuse and Neglect; and establishes a national clearinghouse of information relating to child abuse and neglect. CAPTA also sets forth a Federal definition of child abuse and neglect. In 2015, the Federal definitions of “child abuse and neglect” and “sexual abuse” were expanded by the Justice for Victims of Trafficking Act to include a child who is identified as a victim of sex trafficking or severe forms of trafficking in persons. Pennsylvania became CAPTA-compliant in 2006.

Structure of Pennsylvania Child Welfare SystemPennsylvania’s child welfare system is one of

12 that operates as state-supervised, but county-administered. In Pennsylvania, child welfare and juvenile justice services are organized, managed, and delivered by 67 County Children and Youth Agencies, with staff in these agencies hired as county employees.

The Department of Human Services’ Office of Children, Youth and Families is the state agency that plans, directs, and coordinates statewide children’s programs including social services provided directly by the county children and youth agencies. There are some intrinsic differences in operating a state-supervised and county-administered system, which impact statewide outcomes for children and families. Within this structure, Pennsylvania provides the statutory and policy framework for delivery of child welfare services and monitors local implementation.

Differential ResponseChild Welfare services in Pennsylvania are

divided into Child Protective Service (CPS) and General Protective Services (GPS). The use of two or more discrete responses of intervention such as CPS and GPS is known as Differential Response, which is the creation of multiple responses for reports of maltreatment that are screened for response. The pathway or response assignment depends on an array of factors, such as the presence of imminent danger, level of risk, number of previous reports, source of the report, and/or presenting case characteristics, such as the type of alleged maltreatment and the age of the alleged victims.

Referral InterventionEach referral is evaluated at ChildLine (the

state’s 24-hour hotline to accept reports of child abuse) by a trained caseworker who determines the most appropriate course of action. These actions include forwarding a report to a county agency for investigation as child abuse, a general protective services referral, or forwarding the referral to the appropriate law enforcement official(s).

A General Protective Services (GPS) referral is when the referral in question does not meet the criteria of suspected child abuse, as defined by the Pennsylvania CPSL. GPS referrals are provided to the appropriate county agency, who will in turn screen the referral to determine if an assessment of the situation is needed. In some cases, services may be offered to the child and family.

A referral is a Registered/CPS referral when the allegations are determined to meet the criteria of suspected Child Abuse, as defined by the CPSL. CPS referrals are investigated by the appropriate county or regional office, who will in turn render a decision as to the appropriate status of the referral.

Differentiating Child Protective Services from General Protective Services

Child Protective Services (CPS) are services and activities provided by each county agency for child abuse cases. These services are provided in child abuse cases, that is when the abuse constitutes child abuse as defined in the law. Services may include counseling, classes to strengthen parenting

skills, self-help groups, emergency medical services, and, as a last resort, placement outside the home. CPS cases require that the alleged abuse falls under the definition of child abuse as provided in the CPSL and such cases require an investigation.

General Protective Services (GPS) is a governmental structure that supports and provides services when protective services are required in non-abuse cases. GPS protects children under non-abuse circumstances that, nevertheless, may interfere with a child’s growth and development. Such cases may involve children in the following conditions:1. Lack of proper parental care or control,

subsistence, education as required by law, or other care or control necessary for his or her physical, mental, or emotional health, or morals.

2. Placement for care or adoption in violation of law.

3. Abandonment by parents, a guardian, or other custodian.

4. Lack of a parent, guardian, or legal custodian.5. Habitual truancy (without justification) while

subject to compulsory school attendance.6. Commission of a specific act of habitual dis-

obedience of the reasonable and lawful com-mands of a parent, guardian, or other custo-dian and who is ungovernable and found to be in need of care, treatment, or supervision.

7. Being under 10 years of age and having com-mitted a delinquent act.

8. Having been formerly adjudicated under section 6341 of the Juvenile Act (relating to adjudication), and being under the jurisdic-tion of the court, subject to its conditions or placements and who commits an act which is defined as ungovernable in subparagraph (6).

9. Referral under section 6323 of the Juvenile Act (relating to informal adjustment), and who commits an act which is defined as ungovern-able in subparagraph (6).

GPS services can help parents recognize and correct conditions that are harmful to their children. Reports that involve non-serious injury or neglect are treated by the agency as General Protective Service (GPS) cases and can include inadequate shelter, truancy, inappropriate discipline, hygiene issues, abandonment, lack of appropriate supervision, or other problems that threaten a child’s opportunity for healthy growth and development. These services can assist parents in being able to recognize and correct conditions that are harmful to their children.Child Protective Services (CPS) cases require that the alleged abuse falls under the definition of child abuse as provided in the Child Protective Services law.

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Key Terms Related to Child Abuse

Child: an individual under 18 years of age.

Act of abuse: something done to harm or cause potential harm to a child.

Failure to act: something that is not done to prevent harm or potential harm to a child.

Recent act or failure to act: any act or failure to act committed within two years of the date of the report to the department or county agency.

Perpetrator: a person who has committed child abuse as defined in this section. The current law broadens the definition of perpetrator and clarifies acts of abuse versus failures to act.

Potential perpetrators for committing an act4

• A parent of the child• A spouse or former spouse of the child’s par-

ent• A paramour or former paramour of the child’s

parent• A person 14 years or older who is responsi-

ble for the child’s welfare or has direct contact with children as an employee of child-care services, a school or through a program, ac-tivity or service

• A resident of the child’s home who is 14 years or older

• An individual 18 years or older who does not reside in the same house as the child but is related within the third degree of consanguin-ity or affinity by birth or adoption to the child

• An individual 18 years of age or older who engages a child in severe forms of trafficking in persons or sex trafficking, as those terms are defined under Section 103 of the Traffick-ing Victims Protection Act of 2000 (114 Stat. 1466, 22 U.S.C. § 7102)

Potential perpetrators for failing to act4

• A parent of the child• A spouse or former spouse of the child’s par-

ent• A paramour or former paramour of the child’s

parent• A person 18 or older responsible for the

child’s welfare• A person 18 or older who resides in the same

home as the child

Person responsible for the child’s welfare: a person who provides permanent or temporary care, supervision, mental health diagnosis or treatment, training or control of a child in lieu of parental care, supervision and control.

The term includes any such person who has direct regular contact with a child through any program, activity or service sponsored by a school, for profit organization or religious or other not-for-profit organization. Important note: “perpetrator” now includes any person responsible for the child’s welfare.

Direct Contact with Children: the care, supervision, guidance or control of children, or routine interaction with children.

Program, Activity or Service: a public or private educational, athletic or other pursuit in which children participate. The term includes, but is not limited to, the following:• A youth camp or program• A recreational camp or program• A sports or athletic program• A community or social outreach program• An enrichment program• A troop, club or similar organization

School Employee: an individual who is employed by a school or who provides a program, activity or service sponsored by a school. The term does not apply to administrative or other support personnel unless the administrative or other support personnel have direct contact with the children.

Important note: “perpetrator” now includes school employees and independent contractors. School employees and independent contractors are now included as persons responsible for a child’s welfare or having direct contact with children as an employee of childcare services, a school or through a program, activity or service. Prior to December 31, 2014, only incidents of sexual abuse or exploitation and serious bodily injury by a school employee were considered child abuse under the CPSL. There was a separate reporting and investigation process in place for other types of abuse. Now the current law allows for school employees to be considered perpetrators under the definition provided for “person responsible for the child’s welfare having direct contact with children as an employee of child-care services, a school or through a program, activity or service.”

Student: an individual enrolled in a public or private school, intermediate unit or area vocational-technical school who is under 18 years of age.

What is Child Abuse Under Pennsylvania CPSL Child Abuse Laws?

The CPSL (§ 6303. b.1) defines “child abuse” as intentionally, knowingly, or recklessly doing any of the following:4

• Causing bodily injury to a child through any recent act or failure to act.

• Fabricating, feigning or intentionally exag-gerating or inducing a medical symptom or disease which results in a potentially harmful medical evaluation or treatment to the child through any recent act.

• Causing or substantially contributing to seri-ous mental injury to a child through any act or failure to act or a series of such acts or failures to act.

• Causing sexual abuse or exploitation of a child through any act or failure to act.

• Creating a reasonable likelihood of bodily inju-ry to a child through any recent act or failure to act.

• Creating a likelihood of sexual abuse or ex-ploitation of a child through any recent act or failure to act.

• Causing serious physical neglect of a child.• Causing the death of the child through any act

or failure to act.• Engaging a child in a severe form of trafficking

in persons or sex trafficking, as those terms are defined under section 103 of the Traffick-ing Victims Protection Act of 2000 (114 Stat. 1466, 22 U.S.C. § 7102)

Child abuse also includes certain acts in which the act itself constitutes abuse without any resulting injury or condition. These acts include any of the following:4

• Kicking, biting, throwing, burning, stabbing, or cutting a child in a manner that endangers the child.

• Unreasonably restraining or confining a child, based on consideration of the method, loca-tion or the duration of the restraint or con-finement.

• Forcefully shaking a child under one year of age.

• Forcefully slapping or otherwise striking a child under one year of age.

• Interfering with the breathing of a child.• Causing a child to be present during the oper-

ation of a methamphetamine laboratory, pro-vided that the violation is being investigated by law enforcement.

• Leaving a child unsupervised with an individu-al, other than the child’s parent, who the par-ent knows or reasonably should have known was required to register as a Tier II or III sex-ual offender or has been determined to be a sexually violent predator or sexually violent delinquent.

Specific Acts of Child Abuse Defined in Detail:4

• Bodily Injury: impairment of a physical con-dition or substantial pain rather than severe pain or lasting impairment

• Serious bodily injury: bodily injury which creates a substantial risk of death or which causes serious permanent disfigurement or protracted loss or impairment of function of any bodily member or organ.

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• Serious mental injury: a psychological con-dition, as diagnosed by a physician or licensed psychologist, including the refusal of appro-priate treatment, that: ° Renders a child chronically and severely

anxious, agitated, depressed, socially with-drawn, psychotic or in reasonable fear that the child’s life or safety is threatened; or

° Seriously interferes with a child’s ability to accomplish age-appropriate developmental and social tasks.

• Serious physical neglect: any of the fol-lowing when committed by a perpetrator that endangers a child’s life or health, threatens a child’s well-being, causes bodily injury or impairs a child’s health, development or func-tioning: ° A repeated, prolonged or egregious failure

to supervise a child in a manner that is ap-propriate considering the child’s develop-mental age and abilities.

° The failure to provide a child with adequate essentials of life, including food, shelter or medical care.

• Sexual abuse or exploitation: any of the following: ° The employment, use, persuasion, induce-

ment, enticement or coercion of a child to engage in or assist another individual to engage in sexually explicit conduct, which includes, but is not limited to, the following:−Looking at the sexual or other intimate

parts of a child or another individual for the purpose of arousing or gratifying sex-ual desire in any individual.

−Participating in sexually explicit conver-sation either in person, by telephone, by computer, or by a computer-aided device for the purpose of sexual stimulation or gratification of any individual.

−Actual or simulated sexual activity or nudi-ty for the purpose of sexual stimulation or gratification of any individual.

−Actual or simulated sexual activity for the purpose of producing visual depiction, in-cluding photographing, videotaping, com-puter depicting or filming.

−Note: this paragraph does not include consensual activities between a child who is 14 years of age or older and another person who is 14 years of age or older and whose age is within four years of the child’s age.

° Any of the following offenses committed against a child:−Rape as defined in (18 Pa.C.S. § 3121)−Statutory sexual assault as defined in (18

Pa.C.S. § 3122.1)− Involuntary deviate sexual intercourse as

defined in (18 Pa.C.S. § 3123)−Sexual assault as defined in (18 Pa.C.S.

§ 3124.1)

− Institutional sexual assault as defined in (18 Pa.C.S. § 3124.2)

−Aggravated indecent assault as defined in (18 Pa.C.S. § 3125)

− Indecent assault as defined in (18 Pa.C.S. § 3126)

− Indecent exposure as defined in (18 Pa.C.S. § 3127)

− Incest as defined in (18 Pa.C.S. § 4302)−Prostitution as defined in (18 Pa.C.S. §

5902)−Sexual abuse as defined in (18 Pa.C.S. §

6312)−Unlawful contact with a minor as defined in

(18 Pa.C.S. § 6318)−Sexual exploitation as defined in (18

Pa.C.S. § 6320)

• Sexual Misconduct: any act, including but not limited to, any verbal, nonverbal, written, or electronic communication, or physical activ-ity, directed toward or with a child or a student regardless of the age of the child or student, that is designed to establish a romantic or sex-ual relationship with the child or student. Such prohibited acts include, but are not limited to:

1. Sexual or romantic invitations2. Dating or soliciting dates3. Engaging in sexualized or romantic dialogue4. Making sexually suggestive comments5. Self-disclosure or physical exposure of a

sexual, romantic or erotic nature6. Any sexual, indecent, romantic, or erotic

contact with the child or student

• Human Trafficking: defined as: 1. Sex trafficking in which a commercial sex act

is induced by force, fraud, or coercion, or in which the person induced to perform such act has not attained 18 years of age; or

2. The recruitment, harboring, transportation, provision, or obtaining of a person for labor or services, through the use of force, fraud, or coercion for the purpose of subjection to involuntary servitude, peonage, debt bond-age, or slavery.

3. Sex Trafficking: The term “sex trafficking” means the recruitment, harboring, transpor-tation, provision, or obtaining of a person for the purpose of a commercial sex act.

Important Changes Made to Specific Definitions of Child Abuse in Pennsylvania

Restatement of CulpabilityThe definition of child abuse has been amended

to require that acts or failures to act be committed intentionally, knowingly, or recklessly.

Conduct that causes injury or harm to a child or creates a risk of injury or harm to a child shall not be considered child abuse if there is no evidence that the person acted intentionally, knowingly, or recklessly when causing injury or harm to the child or creating a risk of injury or harm to the child.

Standards of Culpability• Intentionally: A person acts intentionally

with respect to a material element of an of-fense when: (i) if the element involves the nature of his conduct or a result thereof, it is his conscious object to engage in conduct of that nature or to cause such a result; and (ii) if the element involves the attendant cir-cumstances, he is aware of the existence of such circumstances or he believes or hopes that they exist.

• Knowingly: A person acts knowingly with respect to a material element of an offense when: (i) if the element involves the nature of his conduct or the attendant circumstances, he is aware that his conduct is of that nature or that such circumstances exist; and (ii) if the element involves a result of his conduct, he is aware that it is practically certain that his conduct will cause such a result.

• Recklessly: A person acts recklessly with respect to a material element of an offense when he consciously disregards a substantial and unjustifiable risk that the material element exists or will result from his conduct. The risk must be of such a nature and degree that, considering the nature and intent of the ac-tor’s conduct and the circumstances known to him, its disregard involves a gross deviation from the standard of conduct that a reason-able person would observe in the actor’s sit-uation.

Exclusions to the definition of “Child Abuse”Although there are legal exclusions to the

definition of child abuse, the investigating agency makes that determination when substantiating a report. These are not exclusions to reporting suspected child abuse. Only suspicion, not proof, is needed when making the report. A report should be made when a person has reasonable cause to suspect that a child is a victim of child abuse.

The term “child abuse” does not include any conduct for which an exclusion is provided in section 6304 including:

• Environmental Factors: no child shall be deemed to be physically or mentally abused based on injuries that result solely from envi-ronmental factors, such as inadequate hous-ing, furnishings, income, clothing and medical care, that are beyond the control of the parent or person responsible for the child’s welfare with whom the child resides.

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This subsection does not apply to any child-care service as defined in this chapter, excluding an adoptive parent.

• Practice of Religious Beliefs: if, upon inves-tigation, the county agency determines that a child has not been provided needed medical or surgical care because of sincerely held re-ligious beliefs of the child’s parents or relative within the third degree of consanguinity and with whom the child resides, which beliefs are consistent with those of a bona fide religion, the child shall not be deemed to be physically or mentally abused. In such cases the follow-ing shall apply:

1. The county agency shall closely monitor the child and the child’s family and shall seek court-ordered medical intervention when the lack of medical or surgical care threatens the child’s life or long-term health.

2. All correspondence with a subject of the re-port and the records of the department and the county agency shall not reference child abuse and shall acknowledge the religious ba-sis for the child’s condition.

3. The family shall be referred for general pro-tective services, if appropriate.

4. This subsection shall not apply if the failure to provide needed medical or surgical care caus-es the death of the child.

5. This subsection shall not apply to any child-care service as defined in this chapter, exclud-ing an adoptive parent.

• Use of Force For Supervision, Control and Safety Purposes: subject to subsection (d), the use of reasonable force on or against a child by the child’s own parent or person re-sponsible for the child’s welfare shall not be considered child abuse if any of the following conditions apply: ° The use of reasonable force constitutes

incidental, minor or reasonable physical contact with the child or other actions that are designed to maintain order and control.

° The use of reasonable force is necessary:− to quell a disturbance or remove the child

from the scene of a disturbance that threatens physical injury to persons or damage to property

− to prevent the child from self-inflicted physical harm

− for self-defense or the defense of another individual

− to obtain possession of weapons or other dangerous objects or controlled substanc-es or paraphernalia that are on the child or within the control of the child.

• Rights Of Parents: nothing in this chapter shall be construed to restrict the generally

recognized existing rights of parents to use reasonable force on or against their children for the purposes of supervision, control, and discipline of their children.Such reasonable force shall not constitute child abuse.

• Participation in Events that Involve Phys-ical Contact with Child: an individual par-ticipating in a practice or competition in an interscholastic sport, physical education, a recreational activity or an extracurricular ac-tivity that involves physical contact with a child does not, in itself, constitute contact that is subject to the reporting requirements of this chapter.

• Child-on-Child Contact: ° Harm or injury to a child that results from

the act of another child shall not constitute child abuse unless the child who caused the harm or injury is a perpetrator.

° Notwithstanding the previous paragraph, the following shall apply:

° Acts constituting any of the following crimes against a child shall be subject to the re-porting requirements of this chapter:

1. Rape as defined in 18 Pa.C.S. § 3121 (re-lating to rape);

2. Involuntary deviate sexual intercourse as defined in 18 Pa.C.S. § 3123 (relating to involuntary deviate sexual intercourse);

3. Sexual assault as defined in 18 Pa.C.S. § 3124.1 (relating to sexual assault);

4. Aggravated indecent assault as defined in 18 Pa.C.S. § 3125 (relating to aggravated indecent assault);

5. Indecent assault as defined in 18 Pa.C.S. § 3126 (relating to indecent assault); and

6. Indecent exposure as defined in 18 Pa.C.S. § 3127 (relating to indecent exposure).

° No child shall be deemed to be a perpetra-tor of child abuse based solely on physical or mental injuries caused to another child in the course of a dispute, fight or scuffle entered into by mutual consent.

° A law enforcement official who receives a report of suspected child abuse is not re-quired to make a report to the department under section 6334(a) (relating to disposi-tion of complaints received), if the person allegedly responsible for the child abuse is a non-perpetrator child.

• Defensive Force: reasonable force for self-defense or the defense of another indi-vidual, consistent with the provisions of 18 Pa.C.S. §§ 505 (relating to use of force in self- protection) and 506 (relating to use of force for the protection of other persons), shall not be considered child abuse.

Recognition of Child Abuse (i.e., indicators)In order to help abused children, clinicians

must first learn to recognize the symptoms of child abuse. Although child abuse is divided into four types — physical abuse, neglect, sexual abuse, and emotional maltreatment — the types often overlap. A physically abused child for example is often emotionally maltreated as well, and a sexually abused child may be also neglected. Any child at any age may experience any of the types of child abuse. Children over age five are more likely to be physically abused and to suffer moderate injury than are children under age five.5

Child Physical Abuse

What Is Physical Abuse?The physical abuse of children can include

physical injury knowingly, intentionally, or recklessly caused by the child’s caretaker. Physical abuse can vary greatly in frequency and severity. It may include injuries sustained from burning, beating, kicking, or punching. Physical abuse may result from punishment that is inappropriate to the child’s age, developmental level, or condition. Additionally, it may be caused by a parent’s recurrent lapses in self-control that are brought on by immaturity, stress, or the use of alcohol or illicit drugs. Caretakers may physically abuse children during discipline or as a way to “teach the child a lesson.”

What is Physical Abuse under Pennsylvania CPSL Child Abuse Laws?• Physical abuse rises to the level of child abuse

when an individual intentionally, knowingly, or recklessly: ° Causes bodily injury to a child through any

recent act or failure to act. ° Creating a reasonable likelihood of bodily

injury to a child through any recent act or failure to act

° Bodily injury: which requires impairment of a physical condition or substantial pain rather than severe pain or lasting impair-ment.

What are the Signs of Physical Abuse?Consider the possibility of physical abuse when

the child:5

• Has unexplained burns, bites, bruises, broken bones, or black eyes

• Has fading bruises or other marks noticeable after an absence from school

• Seems frightened of the parents and protests or cries when it is time to go home

• Shrinks at the approach of adults• Reports injury by a parent or another adult

caregiver• Abuses animals or pets

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Consider the possibility of physical abuse when the parent or other adult caregiver:5 • Offers conflicting, unconvincing, or no expla-

nation for the child’s injury, or provides an ex-planation that is not consistent with the injury

• Describes the child as “evil” or in some other very negative way

• Uses harsh physical discipline with the child• Has a history of abuse as a child• Has a history of abusing animals or pets

Additional signs of possible physical abuse may include:6

• Fractures unexpectedly discovered in the course of an otherwise routine medical ex-amination (e.g., discovering a broken rib while listening to the child’s heartbeat)

• Injuries that are inconsistent with, or out of proportion to, the history provided by the caretaker or with the child’s age or develop-mental stage (e.g., a 3-month old burning her-self by crawling on top of the stove)

• Multiple fractures, often symmetrical (e.g., in both arms or legs), or fractures at different stages of healing

• Fractures in children who are not able to walk• Skeletal trauma (e.g., fractures) combined

with other types of injuries, such as burns and subdural hematomas (bleeding between the brain and its outer lining caused by ruptured blood vessels)

• Burns on the buttocks, around the anogenital region, on the backs of the hands, or on both hands, as well as those that are severe.

• Bruises ° Color−Bruises go through a cycle of color. They

are initially red, violet, black, or blue and later turn brown, green, or yellow. The color is affected by the depth and the placement of the bruise, as well as by the skin color and the quality of the light at the location where the bruise is being viewed.

−Estimating the age of a bruise by its color is imprecise, but in general:−A bruise with any yellow is usually older

than 18 hours.−Red, blue, purple, or black colors in a

bruise may occur anytime from within 1 hour of bruising to resolution (i.e., when the bruise coloration disap-pears).

−A red color may be present at any stage of the bruise.

−Bruises of identical age and cause on the same person may not appear with the same coloration and may not change color in the same manner.

° Site−Ears and buttocks usually are not injured

accidentally.−Knees, shins, foreheads, and elbows are

normal bruising areas, particularly for toddlers.

° Shape−Bruises caused by pinching often have a

symmetrical pattern.−Loop-shaped marks can be caused by

whipping a child with a cord or belt; no disease or accident looks like a loop or belt mark.

−Cords or ropes tied around a child’s an-kles or neck may result in a bruise or a rope burn.

− If a child is slapped or hit, a mark in the shape of the offender’s fingers or hand may be left.

° Placement −Loose tissues, with little bony structure

underneath (e.g., eyelids, genitals), bruise most easily and retain bruises longest; injuries at those locations often are not accidental.

−Clinicians should be suspicious if a care-taker delays seeking treatment for a child with a genital injury. For example, the in-jury may have been caused by pinching a boy’s penis to punish him for touching himself or by using a string or rubber band around the penis (causing grooves) to prevent the child from wetting the bed.

−Some individuals mistake the presence of Mongolian spots (birthmarks) as an indi-cator of abuse. These spots usually are grayish-blue, clearly defined spots on the buttocks, back, or extremities. They are most common in African-American and American Indian babies.

• Lacerations ° In cases of abuse, lacerations often occur

on soft tissue areas, such as the abdomen, the throat, the buttocks, and the thighs.

° Some areas of the body are normally pro-tected from lacerations by being inside or covered by other body parts (e.g., the side of the arm that normally lies against the body when in a standing position). It is diffi-cult to fall and injure these areas.

° Lacerations of the ear, the nose, or the throat do not tend to occur accidentally.

° A torn frenulum of the upper lip (the tissue that connects the upper lip to the upper gum) may be an indicator of abuse if there is no reasonable explanation, especially in the case of infants.

• Bites ° Human bites appear as oval or horse-

shoe-shaped marks in which tooth impres-sions look like bruises facing each other.

° If the distance between the canines (the third tooth on each side) is greater than 3 centimeters, the bite is most likely from an adult. Adult bite marks are a sign of serious danger to a child.

° Depending on the location of the bite, the victim’s teeth should be examined and mea-sured to exclude the possibility of a self-in-flicted bite.

° A forensic odontologist or pathologist should evaluate the size, contour, and color of the bite marks, as well as make molds of the suspected abuser’s teeth and of the bite itself, if possible. Each individual has a characteristic bite pattern.

• Burns/Scalds ° Immersion burns have a “water line” or

sharp demarcation border. Symmetrical burns with sharp edges (e.g., sock-shaped burns of the same height on each leg) are very suspicious. Clinicians should document an absence of splash marks, which may indicate that the child did not fall into the liquid and try to get out.

° Doughnut-shaped burns can occur when a child is forced into a bathtub. This causes parts of the body, usually the buttocks, to rest on the bottom of the tub, where they will not burn.

° Splash burns can occur when the offender throws hot liquid at the child. Unintentional splash burns are usually on the head or top of the chest and run downward and may be caused by a child reaching upward to grab a pot handle. Liquids that are thrown at a child hit at a horizontal angle, causing the burns to be concentrated on the child’s face or chest and run toward the back of the body. Splash burns on the back or but-tocks are highly suspicious.

° Cigarette burns usually appear on the trunk, external genitalia, or extremities. They also often appear on the palms of the hands or soles of the feet. Cigarette burns usually are symmetrical in shape. Impetigo blisters (caused by a bacterial infection) are irregular and can be ruled out by testing for signs of strep. When there are intentional cigarette burns on a child, there often are multiple burns in various stages of healing (i.e., indicating that the burns occurred at various times).

° Chemical burns are caused by household products. Some parents or caretakers force children to drink lye derivatives (toilet bowl cleaner, detergents, or oils), which causes chemical burns of the mouth and throat, vomiting, and esophageal damage.

• Fractures and Dislocations ° Fractures usually are inflicted by an abuser

on non-ambulatory children. ° Ninety percent of all abusive fractures in

children 2 years of age or younger include the ribs.

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° The following types of fractures and dislo-cations may indicate abuse:−Metaphyseal fractures can only occur

when a jerking force is applied to the ex-tremities (e.g., by shaking or swinging a child by the arms or legs).

−Spiral fractures are common in children because they have more pliant bones. Spiral fractures can occur in small chil-dren by twisting their own leg or ankle in an accidental injury (e.g., getting their feet caught in the slats of a crib). Thus, spiral fractures are not always indicative of abuse.

−Periosteal elevation occurs when an in-fant’s extremities are twisted or shaken, causing the periosteum to be separated from the bone and blood to collect in the new space.

−Rib fractures can be caused by a caretaker forcefully squeezing the baby. Victims may present with signs of respiratory distress, but they are usually asymptomatic.

• Neurological Damage (Skull Fracture, Brain or Spinal Cord Damage, and Intra-cranial Hemorrhage) ° Serious life-threatening skull injuries, with

the exception of epidural hematomas, do not result from a child falling from a short height, such as a bed or crib.

° Skull fractures are more likely in young chil-dren. Any pressure from cerebritis or hem-orrhage can separate fontanelles.

° Brain injury in young children is more likely due to their having an increased subarach-noid space.

° Subgaleal hematoma is often a sign of skull fracture. Diagnostic images of the skull should be taken. It may be caused by jerk-ing or twisting a child’s hair —especially in girls with pigtails—and may be indicated by a bald spot.

° Alopecia (a partial or complete loss of hair) may be caused by neglect if the child lies on his back for long periods of time.

• Shaken Baby Syndrome ° This occurs when a child has been held

around the upper thorax (under the arms) and shaken back and forth with great force. It also occurs when the child is held upside down by the feet and is shaken up and down.

° Many infants die from shaken baby syn-drome, especially if there is a delay in getting treatment. Those who survive often have permanent brain damage and may be paralyzed, be developmentally delayed, or develop cerebral palsy.

° There is often an absence of externally visible injuries, but retinal bleeding may oc-cur. Subdural hematoma and metaphyseal lesions are common effects of shaken baby syndrome.

Consequences of Child Physical AbusePhysical abuse affects every aspect of a

victim’s development: cognitive, physical, social, and emotional.7 Victims are more likely to have suicidal thoughts, learning impairments, conduct disorder, a poor self-image, abuse drugs or alcohol, act out sexually, and/or show signs of depression.8 Adults who were physically abused as children often have problems establishing intimate personal relationships. They are at higher risk for anxiety, depression, substance abuse, medical abuse, medical illness, and problems with school or work.9 Adults abused as children may also end up repeating the pattern. Research suggests that adults abused as children are 26% more likely to abuse their own children compared to adults who were not abused.10

Physically abused children are also more likely to be arrested for a violent crime than children who suffered from other forms of maltreatment.11 One in four female prisoners and one in ten male prisoners were physically abused before the age of eighteen.11

Clinical Testing and Documentation of Physical Abuse

If a clinician suspects an injury may be the result of abuse, he or she may conduct tests to screen for other injuries and/or underlying medical causes to support the finding or be considered in the differential diagnosis.12 The extent and nature of the testing depends on the severity and type of injury, and the age and developmental level of the child—the younger the child and the more severe the injuries the more extensive and important are the diagnostic tests to be considered. Child abuse pediatricians and/or pediatric subspecialists can be consulted to help determine appropriate testing or procedures.

Whenever one child is identified as a suspected victim of abuse, siblings, other young children in the household, or other child contacts of the suspected abuser should be assessed, if possible, for injuries (particularly important for twins).12 Thorough medical documentation (written, photographic, or orally described) of suspected physical abuse can be critical for protecting and intervening early in cases of suspected abuse. Documentation that includes specific levels of concern, alternative diagnostic possibilities and the results of additional testing can be important for later review or to assist child protective services or legal investigations.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 1.

Questions for case study:

Case Study 113

Instructions: Review the case below and consider the questions that follow.

1. Is this a case of physical abuse?

2. Should this case be reported?

A 5-year-old boy is brought to your office for a well-child checkup, accompanied by his father, mother, and 2 older siblings. He was reported to be healthy, but upon examination, you discover a 2-centimeter linear bruise on his palm. When asked about the bruise, the father says that a few days earlier he had spanked the boy with a belt and the child had put his hand behind him, resulting in the injury. The child had no other bruises or signs of abuse.

Commentary: Spanking a child is a parenting behavior that can fall into a gray area of physical abuse. In this case, the child clearly suffered some bodily injury that involved significant pain and the injury resulted from the deliberate action of the parent, hence it would meet the legal definitions in Pennsylvania of physical abuse.

The fact that it can be difficult to decide whether to report suspected abuse does not negate one’s professional and legal responsibility to protect children by doing so. Physicians are not responsible for determining whether maltreatment occurred, only for reporting reasonable suspicion. Physicians may reduce the burden of deciding whether or not to report a suspected case by participating regularly in continuing education related to child maltreatment, familiarizing themselves with reporting laws and local child protective services staff, and consulting with colleagues.

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Child Sexual Abuse

What Is Child Sexual Abuse?At the extreme end of the spectrum, sexual

abuse includes sexual intercourse or its deviations. Yet all offenses that involve sexually touching a child, as well as non-touching offenses and sexual exploitation, are just as harmful and devastating to a child’s well-being.14

What is Sexual Abuse under Pennsylvania CPSL Child Abuse Laws?

Child abuse applies under Pennsylvania’s CPSL when intentionally, knowingly or recklessly:• Causing sexual abuse or exploitation of a child

through any act or failure to act• Creating a reasonable likelihood of bodily inju-

ry to a child through any recent act or failure to act

• See Sexual Abuse and Sexual Misconduct defi-nitions under the “Specific Acts of Child Abuse Defined in Detail” section

Who are the Victims?Sexual abuse can occur in all populations. It

happens to children in both rural and urban areas, in all socioeconomic and educational levels, and across all racial and cultural groups.14 Statistics indicate that girls are more frequently the victims of sexual abuse, but that the number of boys is also significant. Estimates suggest that males account for 25-35% of child sexual abuse victims.15 Factors that may increase a child’s risk of sexual abuse include being between the ages of 7 and 13, having an absent parent, and being isolated, depressed, or lonely.14 A child is also at increased risk if he or she is forced to assume the parenting role at an inappropriate age.

Who Are The Perpetrators?Research suggests that no more than 10%-

30% of perpetrators of child sexual abuse were strangers.15 In 90% of child sexual abuse cases, the offenders are male and are often described as being unassertive, withdrawn, and emotionless.14 Other common characteristics include a history of abuse (either physical or sexual), alcohol or drug abuse, little satisfaction with sexual relationships with adults, lack of emotional control, and mental illness.

Females can also be perpetrators, but they tend to use persuasion rather than force or the threat of force to control victims (boys are more likely than girls to be abused by a female).14

What Are the Effects of Child Sexual Abuse?The effects of sexual abuse extend far beyond

childhood. Sexual abuse robs children of their childhood and creates a loss of trust, feelings of guilt and self-abusive behavior.

It can lead to antisocial behavior, depression, identity confusion, loss of self-esteem and other serious emotional problems. It can also lead to difficulty with intimate relationships later in life.

Some long-term consequences of sexual abuse include impaired trust, self-destructive behaviors (e.g., cutting, anorexia), hopelessness, depression, and low self-esteem.14 Other long-term effects can include increased risks for:• Teen pregnancy, either as victim or perpe-

trator. In one study, men who were sexually abused before age 10 were 80% more likely than non-abused men to later engage in sexu-al activity resulting in teen pregnancy.16

• Homelessness. A study of homeless women found that childhood maltreatment, includ-ing physical, verbal, and sexual abuse, was a “pervasive and devastating predictor of dysfunctional outcomes,” including chronic homelessness.17

• Drug and alcohol abuse. Research suggests that both women and men who have experi-enced child sexual abuse have an increased risk of drug and alcohol abuse in their adult life.18

Signs of Sexual AbuseAlthough sexually abused children may be too

frightened to report the abuse the following physical signs may suggest abuse:14 vaginal or rectal bleeding; genital pain, itching, swelling, or discharge; difficulty with bowel movements, urinating, or swallowing; recurring complaints of stomachaches and/or headaches; trauma to breasts, buttocks, lower abdomen, or genital or rectal areas; torn, stained, or bloody undergarments; vaginal infections; venereal diseases, or difficulty walking or sitting.

Behavioral signs of child sexual abuse include extreme changes in behavior (loss of appetite, eating disorder, clinginess, withdrawal, aggressiveness); recurrent nightmares, disturbed sleep patterns, or a sudden fear of the dark; regression to infantile behavior (bed-wetting, thumb sucking, excessive crying); fear of a particular person or fear of being left alone with a particular person or at a particular place; frequent lying, and delinquent behavior; or a fall in grades at school. These children may also express unusual interest in or knowledge about sexual matters, express affection in inappropriate ways (for a child his or her age), and even engage other children in sexual activities or act out sexual behaviors (such as intercourse or masturbation). In addition, the victims may have poor relationships with other children, lack self-confidence, or engage in self-destructive behavior (biting oneself, pulling out hair, wrist-cutting).

Consider the possibility of sexual abuse when the child:• Has difficulty walking or sitting• Suddenly refuses to change clothes for gym or

to participate in physical activities• Reports nightmares or bed-wetting• Experiences a sudden change in appetite• Demonstrates bizarre, sophisticated, or un-

usual sexual knowledge or behavior• Becomes pregnant or contracts a venereal

disease, particularly if under age 14• Runs away• Reports sexual abuse by a parent or another

adult caregiver• Attaches very quickly to stranger

Consider the possibility of sexual abuse when the parent or other adult caregiver:• Is unduly protective of the child or severely

limits the child’s contact with other children, especially of the opposite sex

• Is secretive and isolated• Is jealous or controlling with family members

Clinical Strategies for Approaching Medical Examination of Sexual Abuse Victims

Sexual abuse is fundamentally an abuse of power and authority over a child in order to coerce them into inappropriate sexual activities. As a result, children often have difficulty forming trusting relationships, which can include those with health care providers. It is important, therefore, that the medical evaluation of children and teens who have been sexually abused not become an additional experience of powerful adults imposing their authority on the child’s body or removing the child’s control over events in his or her life.19 One way to minimize this potential is to provide them with choices at every step in the medical history and examination, and by conveying a calm, gentle, and unhurried approach, explaining to the patient what to expect during the evaluation.19 If a patient is not cooperative, the provider should not force a complete examination but, rather, should attempt to address the underlying concerns of the child. The approach of the examining clinician and other members of the health care team should be to complete the necessary medical evaluation in the least threatening and most therapeutic manner possible.19

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 2 ON THE NEXT PAGE.

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Emotional AbuseEmotional child abuse is maltreatment resulting

in impaired psychological growth and development.21 It involves words, actions, and indifference. Abusers constantly reject, ignore, belittle, dominate, and criticize the victims. This form of abuse may occur with or without physical abuse, but there is often an overlap.22 Examples of emotional child abuse are verbal abuse; excessive demands on a child’s performance; penalizing a child for positive, normal behavior (smiling, mobility, exploration, vocalization, manipulation of objects); discouraging caregiver and infant attachment; penalizing a child for demonstrating signs of positive self-esteem; and penalizing a child for using interpersonal skills needed for adequate performance in school and peer groups.22 In addition, frequently exposing children to family violence and unwillingness or inability to provide affection or stimulation for the child in the course of daily care may also result in emotional abuse.

Although emotional abuse can be as damaging as physical abuse, it can be harder to identify.22 Few well-validated measures of childhood emotional abuse exist. Clinicians can use a revised version of the Child Abuse and Trauma Scale (CATS) which targets measures for emotional abuse.23

Caregivers can also closely observe children’s behaviors and personalities. Children suffering from emotional abuse are often extremely loyal to the parent, afraid of being punished if they report abuse, or think that this type of abuse is a normal way of life.5

Behavioral indicators of an emotionally abused child include inappropriate behavior that is immature or more mature for the child’s age, dramatic behavioral changes (disruption of activities, clinging or compulsively seeking affection and attention), aggressiveness, uncooperativeness, bed-wetting or loss of bowel control (after a child has been trained), and destructive or antisocial behavior (being constantly withdrawn and sad). Furthermore, poor relationships with peers, lack of self-confidence, unusual fears for the child’s age (fear of going home, being left alone, specific objects), or inability to react with emotion or develop an emotional bond with others are also indicators. Realistically, any of the above behaviors may also be seen in normal children, but a change in pattern of these behaviors is a strong indicator of emotional abuse.5

Consider the possibility of emotional maltreatment when the child:5

• Shows extremes in behavior, such as overly compliant or demanding behavior, extreme passivity, or aggression

• Is either inappropriately adult (parenting oth-er children, for example) or inappropriately infantile (frequently rocking or head-banging, for example)

• Is delayed in physical or emotional develop-ment

• Has attempted suicide• Reports a lack of attachment to the parent

Consider the possibility of emotional maltreatment when the parent or other adult caregiver:5

• Constantly blames, belittles, or berates the child

• Is unconcerned about the child and refuses to consider offers of help for the child’s problems

• Overly rejects the child

Physical Indicators Of Emotional Abuse:• Frequent psychosomatic complaints (nausea,

stomachache, headache, etc.)• Bed-wetting• Self-harm• Speech disorders

Questions for case study:

Case Study 220

Instructions: Review the case below and consider the questions that follow.

1. Is this an example of sexual abuse as defined under Pennsylvania law?

2. How can a clinician balance a due respect for the patient’s wishes and right to privacy with the obligation to report suspected sexual abuse?

A 15 year-old recent immigrant from the Middle East presents with abdominal pain during a regular office visit. During the exam, the patient discloses sexual activity a few weeks prior by her uncle (mother’s brother), who lives in the same community as her immediate family. When told that this may need to be reported, the teen becomes distraught, saying she “could handle” her uncle, and explaining that it was customary in her culture for the family of an affected female child to carry out a vendetta against an abuser, which would force her mother to do something horrible to her own brother. You listen to the patient’s concerns, but are concerned for her physical and emotional well being, and the risk of serious harm from continued abuse.

Commentary: While teens may exaggerate the harms from parental notification, more needs to be learned about this young woman’s family and culture: her concerns should not be minimized or ignored. The physician, by virtue of establishing a doctor-patient relationship with the young woman, owes her respect for her privacy and compliance with her wishes for confidentiality, unless her actions lead to harm to herself or specific others or if, as is the case here, the situation triggers mandatory reporting. This is a difficult decision because the resulting contact with the teen’s mother or uncle against her wishes, may lead the teen to not seek medical care in the future, such as evaluation of physical trauma, evaluation and treatment for STDs, and prenatal care if she becomes pregnant.

Nonetheless, this case does meet the definition of sexual abuse even though the extent to which the young woman consented to the sexual activity is unclear. Under PA law, “actual or simulated sexual activity or nudity for the purpose of sexual stimulation or gratification of any individual” with persons younger than 18 years of age is defined as sexual abuse. The physician must report the situation, although the physician should also offer or arrange counseling about safe sex, contraception, options for pregnant teens, and community shelters/resources.

3. What kinds of services or supports could a clinician, faced with this kind of situation, provide to both the teenager and her family?

12

What is Emotional Abuse Under Pennsylvania CPSL Child Abuse Laws?

Under Pennsylvania’s CPSL definition, causing or substantially contributing to serious mental injury to a child through any act or failure to act or a series of such acts or failures to act.

Serious Mental Injury is defined as a psychological condition, as diagnosed by a physician or licensed psychologist, including the refusal of appropriate treatment, that:• Renders a child chronically and severely anx-

ious, agitated, depressed, socially withdrawn, psychotic or in reasonable fear that the child’s life or safety is threatened; or

• Seriously interferes with a child’s ability to ac-complish age-appropriate developmental and social tasks.

What are the Effects of Emotional Abuse?Emotional abuse can be “more strongly

predictive of subsequent impairments in the children’s development than the severity of physical abuse,” according to psychologist Danya Glaser.24

An infant who is severely deprived of basic emotional nurturance, even though physically well cared for, can fail to thrive and can eventually die. Babies with less severe emotional deprivation can grow into anxious and insecure children who are slow to develop and who have low self-esteem.24

Long-term effects of emotional abuse include: insecurity, poor self-esteem, destructive behavior, angry acts (such as fire setting and animal cruelty), withdrawal, poor development of basic skills, alcohol or drug abuse, suicide, difficulty forming relationships and unstable job histories. Emotionally abused children often grow up thinking that they are deficient in some way. A continuing tragedy of emotional abuse is that, when these children become parents, they may continue the cycle with their own children.24

NeglectNeglect is the most common form of child

maltreatment, accounting for about two-thirds of all reports to child protective services nationwide, and neglect is the leading cause of fatalities associated with child abuse.25

Neglect involves a caregiver’s failure to meet the basic needs of a child, such as food, clothing, shelter, medical care, or supervision.25 Neglect follows a continuum from mild to severe and often is very difficult to define.

Some state definitions include “failure or inability to protect,” which refers to a situation in which a child is exposed to someone who may harm him or her, such as being left with a parent’s drug dealer or a known child molester. In addition, parents might be accused of failing to provide a safe environment by not protecting a child from unsanitary or hazardous living conditions.26

Neglect may be:25

• Physical (e.g., failure to provide necessary food, shelter, or supervision)

• Medical (e.g., failure to provide necessary medical or mental health treatment)

• Educational (e.g., failure to educate a child or attend to special education needs)

• Emotional (e.g., inattention to a child’s emo-tional needs, failure to provide psychological care, or permitting the child to use alcohol or other drugs)Caregivers may not provide proper care for a

variety of reasons, including a lack of knowledge or understanding about the child’s needs, inadequate bonding with the child, or impairment due to substance abuse or to mental illness.26 Although there are cases of co-occurring maltreatment and poverty, living in poverty, in and of itself, does not mean that a child is being neglected

Sometimes cultural values, the standards of care in the community, and poverty may contribute to maltreatment, indicating the family is in need of information or assistance.26 When a family fails to use information and resources, and the child’s health or safety is at risk, then child welfare intervention may be required. In addition, many states provide an exception to the definition of neglect for parents who choose not to seek medical care for their children due to religious beliefs.

What is Neglect Under Pennsylvania CPSL Child Abuse Laws?

Child abuse applies under Pennsylvania’s CPSL when intentionally, knowingly or recklessly causing serious physical neglect of a child, defined as any of the following when committed by a perpetrator that endangers a child’s life or health, threatens a child’s well-being, causes bodily injury or impairs a child’s health, development or functioning:4

• A repeated, prolonged or egregious failure to supervise a child in a manner that is appropri-ate considering the child’s developmental age and abilities.

• The failure to provide a child with adequate essentials of life, including food, shelter or medical care.

What Are The Signs Of Neglect?Neglected children, even when older,

may display a variety of physical, emotional, psychosocial, and behavioral problems which may vary depending on the age of the child.

Consider the possibility of neglect when the child:5

• Is frequently absent from school• Begs or steals food or money• Lacks needed medical or dental care, immuni-

zations, or glasses• Is consistently dirty and has severe body odor• Lacks sufficient clothing for the weather

• Abuses alcohol or other drugs• States that there is no one at home to provide

care• Is inadequately dressed for the weather• Reports caring for younger siblings• Has poor hygiene or smells of urine or feces• Seems malnourished• Has unattended medical or dental problems

Consider the possibility of neglect when the parent or other adult caregiver:5

• Appears to be indifferent to the child• Seems apathetic or depressed• Behaves irrationally or in a bizarre manner• Is abusing alcohol or other drugs

The Clinician’s Role in Cases of NeglectPhysicians are in a unique position to

recognize neglect and protect victims, especially young children, children with disabilities, and other children who are isolated from regular contact with the public. As challenging and unsettling as such cases may be, prompt identification and reporting of suspected neglect can make a real difference to the health and safety of children.12

Cases of neglect are usually complex and involve layers of interactions between family members and social, economic, cognitive, and cultural dynamics surrounding the family. Regardless of the interventions a clinician chooses (e.g., referral for counseling, social services, or economic assistance) the following key steps are recommended to maximize the chances for intervention effectiveness:26

• Build a relationship with the family—when families believe their feelings and concerns have been heard, respected, and considered, they are more likely to be engaged in the plan-ning and actions needed to change the behav-iors that contribute to neglect.

• Develop case and safety plans (i.e., identify strategies with the family that address the ef-fects of neglect and provide guides for chang-ing behaviors).

• Establish clear, concrete goals and provide continuous positive feedback when goals are met.

• Track, analyze, and evaluate family progress with continuous monitoring, frequent check-ins with family members, and the use of quantitative tools for measuring agreed-upon outcomes.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 3 ON THE NEXT PAGE.

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Human TraffickingHuman trafficking is defined by the United

Nations as the recruitment, transportation, transfer, harboring or receipt of persons by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability or of the giving or receiving of payments or benefits to achieve the consent of a person having control over another person, for the purpose of exploitation.27

Pennsylvania has a similar, but not identical definition of Human Trafficking, as well as a specific definition of Labor Trafficking:• Human Trafficking: the recruitment, harbor-

ing, transportation, provision or obtaining of a child for labor or services through the use of force, fraud, or coercion. Under federal law, sex trafficking (such as prostitution, pornog-raphy, exotic dancing, etc.) does not require there be force, fraud, or coercion if the victim is under 18.

• Labor Trafficking: labor obtained by use of threat of serious harm, physical restraint, or abuse of legal process.

Pennsylvania uses the federal definition of ”severe forms of trafficking in persons”:28

• Sex trafficking in which a commercial sex act is induced by force, fraud, or coercion, or in which the person induced to perform such act has not attained 18 years of age

• The recruitment, harboring, transportation, provision, or obtaining of a person for labor or services, through the use of force, fraud, or coercion for the purpose of subjection to in-voluntary servitude, peonage (paying off debt through work), debt bondage (debt slavery, bonded labor or services for a debt or other obligation), or slavery (a condition compared to that of a slave in respect of exhausting la-bor or restricted freedom).

Commercial Sex Act is defined federally as any sex act on account of which anything of value is given to or received by any person.28

What are Examples of Human Trafficking?Many victims of human trafficking are forced

to work in prostitution, but trafficking also occurs as labor exploitation in urban, suburban, and rural areas. Many victims are lured with false promises of well-paying jobs or manipulated by people they trust.29 They are forced or coerced into prostitution, domestic servitude, or other types of forced labor (e.g., agriculture, construction, fisheries, mining industries).

Victims can be found in legitimate and illegitimate labor industries, including sweatshops, massage parlors, agriculture, restaurants, hotels, street peddling, door-to-door sales, begging, and domestic service.29 Although anyone can be at risk for being a victim of human trafficking, most are women and girls.30

People at highest risk include those in extreme poverty, have minimal education, have a history of abuse or instability in their family of origin, or have some other vulnerability (for example, those who are disabled or who may belong to a marginalized or stigmatized gender, ethnic, or cultural group).31

Traffickers use various techniques to control their victims and keep them enslaved. Some traffickers hold their victims under lock and key.

More frequently, however, more subtle techniques are used such as:32

Isolation from:• The public by limiting contact with outsiders

and making sure that any contact is monitored or superficial in nature.

• Family members and friends.

Control:• Confiscation or control of passports or other

identification documents.• Debt bondage through enormous financial ob-

ligations or an undefined or increasing debt.• Control of the victims’ money.

Intimidation/threat:• Use or threat of violence toward victims or

their family members.• Shaming victims by exposing humiliating cir-

cumstances to their families.• Telling victims they will be imprisoned or de-

ported for immigration violations if they con-tact authorities.

Questions for case study:

Case Study 3Instructions: Read the scenario below and answer the questions as it relates to the case presented:

1. Is this an example of neglect as defined under Pennsylvania law?

2. What steps might a clinician take to address this situation?

A single mother brings her 2-year-old son in for a well-child visit. The child appears physically healthy, although somewhat under-weight for age and height. When asked about how the child is cared for while the mother works, the mother explains that she “only works a few hours at a time,” doing house cleaning for other tenants in her apartment complex and that, while she is working, she leaves her son in the living room to watch television. The mother appears to find this behavior normal and, when questioned about the safety of the situation, assures you that she blocks off access to the kitchen and other rooms of the house and leaves the child cups of soda and snacks so he won’t be hungry.

Commentary: Leaving a 2-year-old alone for hours at a time is clearly not ideal since it poses the risk of harm from an unsupervised accident or incident. Although this situation probably does not rise to the level of “serious neglect” as defined in PA law, the physician in this case should still make a report through ChildLine (1-800-932-0313) or through the electronic submission at the Child Welfare portal at www.compass.state.pa.us/cwis. Once the report is filed, GPS can offer services and support for the mother. Additionally, the physician should avoid punitive or condemnatory reactions and, instead, work empathetically with the parent to explore the situation further and provide potential resources that can offer help. The PA Family Support Alliance offers a range of services and family support programs that could potentially be valuable to this single parent struggling to raise a child and earn money at the same time.

3. What community services might be called upon to provide support for the mother and her son?

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The life situations of people who are trafficked are almost always complicated, whether they are under a trafficker’s control, trying to leave, or are already out of a trafficking environment. In addition, trafficked people may not even self-identify as trafficked. Rather they may feel that these are merely the restrictions of their circumstance. They are usually beset with physical, psychological, social, legal, and financial circumstances that can be overwhelming.33

What are the signs of Human Trafficking?Human Trafficking victim identification/warning

signs include, but are not limited to:• A youth that has been verified to be under 18

and is in any way involved in the commercial sex industry, or has a record of prior arrest for prostitution or related charges

• Has an explicitly sexual online profile• Excessive frequenting of internet chat rooms

or classified sites• Depicts elements of sexual exploitation in

drawing, poetry, or other modes of creative expression

• Frequent or multiple sexually transmitted dis-eases or pregnancies

• Lying about or not being aware of their true age

• Having no knowledge of personal data, such as but not limited to: age, name, and/or date of birth

Who is at risk?Youth at risk for human trafficking include

those:• In the foster care system• Who identify as LGBTQ• Who are homeless or runaway• With disabilities• With mental health or substance abuse disor-

ders• With a history of sexual abuse• With a history of being involved in the welfare

system• Who identify as native or aboriginal• With family dysfunction

The Role Healthcare Providers Can Play in Identifying Human Trafficking

Healthcare professionals are uniquely positioned to identify and intervene on behalf of trafficking victims. Outside of law enforcement, healthcare settings are among the few places where the lives of human trafficking victims may intersect with the rest of society, if only for brief periods.34 In a study of 98 sex trafficking survivors, 88% had at least one encounter with a health care provider while they were being trafficked, with 63% of these encounters happening in an emergency department.35

One study noted that human trafficking victims in the U.S. may interact with a range of health care personnel, including primary care providers, sexual and reproductive health care workers, dentists, and providers of traditional or alternative remedies.32 Trafficking victims may even be found working within health care facilities.

Unfortunately, studies have demonstrated that medical care providers are often unprepared to identify trafficking victims.36,37

Identifying Potential Victims of Human Trafficking

Certain patient behaviors and/or companion behaviors can alert health care professionals to a potential human trafficking case.32,38 One common clue is the presence of a person who seems to control both the patient and the situation. Survivors report that their traffickers completed health-related paperwork for them and communicated with clinic staff and health care providers on their behalf.32 The physical proximity of the traffickers perpetuated their coercion and control of the victims, preventing them from communicating with health care personnel directly.32

The presence of an overbearing or controlling companion should trigger concern, and most recommendations suggest that in order to allow patients the opportunity to speak for themselves, clinic or hospital staff should attempt to interview and assess all patients privately. This may require the use of an independent interpreter, since many survivors have limited English proficiency.32

Trained non-clinical workers could be instrumental in helping to maintain separation during potential victim identification interviews in a manner that does not alert potential traffickers to victim identification efforts. Non-clinical staff, such as receptionists, security guards, and accounting personnel, who are made sensitive to these matters through training, may observe patterns and know when and how to respond if a potential trafficker repeatedly presents for multiple patients as a companion, translator, or medical bill payer, regardless of whether these personnel interact with the patients themselves.

Multilingual non-clinical staff who may share a common language with trafficked persons of limited English proficiency may be able to develop a rapport with trafficked persons that facilitates trust and frank communication based on their language or cultural commonalities. It is recommended, therefore, that health care organizations think broadly about the types of employees who are appropriate to receive training about human trafficking in order to enhance opportunities for identification of and response to potential trafficking situations.39

A human trafficking victim may develop a mindset of fear, distrust, denial, and conflicting loyalties. Foreign victims of trafficking are often

fearful of being deported or jailed and, therefore, they may distrust authority figures, particularly law enforcement and government officials. Many victims of both sex and labor trafficking fear that if they escape their servitude and initiate investigations against their trafficker, the trafficker and his/her associates will harm the victims, the victims’ family members, or others.

Additional patient situations, behaviors, or emotional states may suggest human trafficking:40

• Paying cash or having no health insurance• Lacking control of identification documents (ID

or passport)• Having few or no personal possessions• Being reticent for additional testing or ser-

vices due to large debt • Inability to:

° leave home or place of work ° speak for oneself or share one’s own in-

formation• Feelings of helplessness, shame, guilt, self-

blame, and humiliation • Loss of sense of time or space, not knowing

where they are or what city or state they are in• Emotional numbness, detachment, or disasso-

ciation (i.e., “flat affect”)

While not all victims of trafficking have physical indicators that aid identification, many victims suffer serious health issues, which may include:40

• Addiction to drugs and/or alcohol as a way to cope with or “escape” their situation, or as a method of control used by their traffickers

• Symptoms of post-traumatic stress disorder, phobias, panic attacks, anxiety, and depres-sion

• Sleep or eating disorders• Untreated chronic illnesses, such as diabetes

or cardiovascular disease• Signs of physical abuse, such as bruises, bro-

ken bones, burns, and scarring• Chronic back, visual, or hearing problems from

work in agriculture, construction, or manufac-turing

• Skin or respiratory problems caused by expo-sure to agricultural or other chemicals

• Infectious diseases, such as tuberculosis and hepatitis, which are spread in overcrowded, unsanitary environments with limited ventila-tion

• Reproductive health problems, including sex-ually transmitted diseases, urinary tract in-fections, pelvic pain, and injuries from sexual assault or forced abortions

Responding to Victims of Human TraffickingVictims of trafficking do not often disclose their

trafficking situation in clinical settings.31 Health care providers must, therefore, be thoughtful and careful about engaging patients if human trafficking is suspected.

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Before beginning any conversation with a patient, assess the potential safety risks that may result from asking sensitive questions of the patient. Recognize that the goal of your interaction is not disclosure or rescue, but rather to create a safe, non-judgmental place that will help you identify trafficking indicators and assist the patient.40 This may be challenging in the context of busy, time-constrained schedules, but it is possible.

Clinicians should:• Allow the patient to decide if he or she would

feel more comfortable speaking with a male or female practitioner

• If the patient requires interpretation, always use professional interpreters who are unrelat-ed to the patient or situation

• If the patient is accompanied by others, try to find a time and place to speak with the patient privately

• Take time to build rapport with potential vic-tims, or if you do not have the time yourself, find someone else on staff who can develop rapport with the patient

• Ensure that the patient understands confiden-tiality policies and practices, including manda-tory reporting laws

• Use multidisciplinary resources, such as social workers, where available

• Refer to existing institutional protocols for vic-tims of abuse/sexual abuse.

• Contact the National Human Trafficking Re-source Center (NHTRC) hotline (1-888-373-7888) for assistance. Information available at: https://humantraffickinghotline.org/

If a patient has disclosed that he or she has been trafficked:40 • Ensure that safety planning is included in the

discharge planning process • Provide the patient with options for services,

reporting, and resources.• Provide the patient with the NHTRC hotline

number. If the patient feels it is dangerous to have something with the number written on it, have them memorize the number or designate someone in your staff that they can call back to in order to provide that number.

• In situations of immediate, life-threatening danger, follow your institutional policies for reporting to law enforcement. Whenever pos-sible, try to involve the patient in the decision to contact law enforcement.

• If the patient is a minor, follow mandatory state reporting laws and institutional policies for child abuse or serving unaccompanied youth. Most state laws require immediate in-tervention of the trafficked victim is a minor.

• Ensure that any information regarding the pa-tient’s injuries or treatment is accurately doc-umented in the patient’s records, recognizing that, similar to sexual assault examinations, the medical record serves both medical and legal purposes.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 4.

Questions for case study:

Case Study 4Instructions: Read the scenario below and answer the questions as it relates to the case presented:

Spend 5 minutes considering the following questions in light of the information provided earlier in this learning activity:

1. What signs suggest that Sayura might be a victim of human trafficking? What signs argue against that hypothesis?

2. What steps might a clinician take to probe the situation further or obtain more information?

3. What services might a clinician suggest to give Sayura support in the event that she is a victim of human trafficking?

Sayura comes to your clinic for an HIV screening. Although she says she is 19, she appears physically and developmentally much younger. Sayura says she’s mature for her age and very experienced. During the exam she constantly receives texts on her cell phone. She answers the phone and says ‘Daddy, don’t worry, I’ll be done soon.’ She tells the nurse her boyfriend, who is 30, is so in love he can’t be away from her for even one minute.

Although Sayura tests negative for HIV, she has multiple other sexually transmitted diseases. When asked if she uses protection during sex, she shrugs and says ‘sometimes they don’t want to.’ When you ask who ‘they’ are, Sayura says that sometimes she has sex with other men, but won’t say how many. She grows quiet and refuses to answer further questions about her sexual behavior or relationship with her boyfriend.

Commentary: The persistent and frequent contact by the person Sayura refers to as “Daddy” (a commonly-used phrase for men using or trafficking in women for prostitution) as well as Sayura’s reluctance to discuss her sexual behavior strongly suggest she may be a victim of human trafficking. In this case, if the clinician initially meeting with Sayura is male, he should ask if Sayura would like to talk with a female clinician (who might be able to elicit more information about Sayura’s situation). If Sayura continues to be uncommunicative, the clinician should avoid a judgmental or presumptive tone and, instead, empathetically remind Sayura of the risks of her current behaviors and of the availability of support services for young women like her. She could be given the number and/or URL for the National Human Trafficking Resource Center, for example, or of services provided through the PA Family Support Alliance.

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Provisions and Responsibilities for Reporting Suspected Child Abuse

Permissive Reporters are persons who are encouraged, but not required, to report suspected child abuse. Any person may make an oral or written report of suspected child abuse (which may be submitted electronically), or report suspected child abuse to a department, county agency or law enforcement, if that person has reasonable cause to suspect that a child is a victim of child abuse.

Mandated Reporters are persons required to report suspected child abuse if they have reasonable cause to suspect that a child is a victim of child abuse. Mandated reporters include:41

• A person licensed or certified to practice in any health-related field under the jurisdiction of the Department of State.

• A medical examiner, coroner, or funeral direc-tor.

• An employee of a health care facility or pro-vider licensed by the Department of Health, who is engaged in the admission, examination, care or treatment of individuals.

• A school employee• An employee of a child-care service who has

direct contact with children in the course of employment.

• A clergy member, priest, rabbi, minister, Chris-tian Science practitioner, religious healer or spiritual leader of any regularly established church or other religious organization.

• An individual paid or unpaid, who, on the ba-sis of the individual’s role as an integral part of a regularly scheduled program, activity or service, is a person responsible for the child’s welfare or has direct contact with children.

• An employee of a social services agency who has direct contact with children in the course of employment.

• A peace officer or law enforcement official.• An emergency medical services provider certi-

fied by the Department of Health.• An employee of a public library who has direct

contact with children in the course of employ-ment.

• An individual supervised or managed by a per-son listed above, who has direct contact with children in the course of employment.

• An independent contractor who has direct contact with children.

• An attorney affiliated with an agency, institu-tion, organization or other entity, including a school or regularly established religious organization that is responsible for the care, supervision, guidance or control of children.

• A foster parent.• An adult family member who is a person re-

sponsible for the child’s welfare and provides services to a child in a family living home, com-munity home for individuals with an intellectual disability or host home for children which are subject to supervision or licensure by the de-partment under Articles IX and X of the Public Welfare Code.

Important Note: A health care provider must immediately make a report (or cause a report to be made) to the appropriate county agency if the provider is involved in the delivery or care of a child under one year of age who is affected by any of the following:• Illegal substance abuse by the child’s mother.• Withdrawal symptoms resulting from prena-

tal drug exposure unless the child’s mother, during the pregnancy, was: under the care of a prescribing medical professional, and in compliance with the directions for the admin-istration of a prescription drug as directed by the prescribing medical professional

• Fetal Alcohol Spectrum Disorder

Attorneys As Mandated ReportersNote: The amended CPSL includes attorneys

under persons required to report suspected child abuse. Specifically:• Attorneys affiliated with an agency, institution,

organization or other entity, including a school or regularly established religious organization that is responsible for the care, supervision, guidance, or control of children.

Privileged CommunicationsThe privileged communications between a

mandated reporter and a patient or client of the mandated reporter does not apply to a situation involving child abuse or relieve the mandated reporter of the duty to report suspected child abuse. The only exceptions are the following:• As per the Child Protective Services Law

§6311.1 (b.1) Confidential communication made to the member of the clergy are protect-ed under 42 Pa.C.S. §5943. This portion of the Pennsylvania Statute states, “No clergy-man, priest, rabbi or minister of the gospel of any regularly established church or religious organization, except clergymen or ministers, who are self-ordained or who are members of religious organizations in which members oth-er than the leader thereof are deemed cler-gymen or ministers, who while in the course of his duties has acquired information from any person secretly and in confidence shall be compelled, or allowed without consent of such person, to disclose that information in any legal proceeding, trial or investigation before any government unit.”

• Confidential communications made to an attor-ney are protected so long as they are within the scope of 42 Pa.C.S. §§ 5916 (relating to confidential communications to attorney) and 5928 (relating to confidential communications to attorney), the attorney work product doc-trine or the rules of professional conduct for attorneys.

Reporting ProcessMandated reporters are required to report

suspected child abuse under any of the following circumstances:1. The mandated reporter comes into contact

with the child in the course of employment, occupation and practice of a profession, or through a regularly scheduled program, activ-ity or service.

2. The mandated reporter is directly responsible for the care, supervision, guidance or train-ing of the child, or is affiliated with an agency, institution, organization, school, regularly es-tablished church or religious organization, or any entity that is directly responsible for the care, supervision, guidance or training of the child.

3. A person makes a specific disclosure to the mandated reporter that an identifiable child is the victim of child abuse.

4. An individual 14 years of age or older makes a specific disclosure to the mandated reporter that the individual has committed child abuse.

5. Nothing shall require a child to come before the mandated reporter in order for the man-dated reporter to make a report of suspected child abuse.

6. Nothing shall require the mandated reporter to identify the person responsible for the child abuse to make a report of suspected child abuse.

Report DirectlyWhenever a person is required to report in the

capacity as a member of the staff of a medical or other public or private institution, school, facility or agency, that person shall report immediately and directly in accordance with section 6313:• Immediately thereafter notify the person in

charge of the institution, school, facility or agency or the designated agent of the person in charge.

• Upon notification, the person in charge or the designated agent, if any, must facilitate the co-operation of the institution, school, and facility or agency with the investigation of the report. Any intimidation, retaliation, or obstruction in the investigation of the report is subject to the provisions of 18 Pa.C.S. §4958 (relating to intimidation, retaliation or obstruction in child abuse cases). This chapter does not require more than one report from any such institu-tion, school, facility or agency.Important Note: it is not a reporter’s

responsibility to determine if the person who allegedly committed child abuse or harm to a child is a perpetrator. It is not required that the child come before the mandated reporter in order to make a report of suspected child abuse nor are they required to identify the person responsible for the child abuse to make a report of suspected child abuse.

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Frequently Asked QuestionsQ. Does a mandated reporter have to know for sure that the child was abused?A. No. A mandated reporter is only responsible to make the report when they suspect a child is a victim of abuse. Although there are legal exclusions to the definition of child abuse, mandated reporters must report without considering whether or not the case they witness fits within the legal exclusions.

Q. Must a mandated reporter give their name?A. Yes. Mandated reporters must identify themselves and provide contact information for themselves.

Q. What if a mandated reporter has general concerns about a child, but does not suspect abuse?A. Concerns related to the safety of children including, but not limited to, inadequate housing, clothing and supervision, should be referred to ChildLine or the county children and youth agency for assessment as general protective services cases.

The Reporting Process

Making a ReportReports can be made immediately either orally

to ChildLine (1-800-932-0313) or through the electronic submission through the Child Welfare portal at www.compass.state.pa.us/cwis.

If a reporter completes the electronic submission through the portal they have completed their mandated requirement without completing any other forms or notifications. Oral reports are required to be followed up within 48 hours with a written report that is sent to the investigating agency. The approved written form can be found at www.keepkidssafe.pa.gov. The form is under the forms tab (located on the left-hand side of the main page). The form is Report of Suspected Child Abuse (CY47). This is ONLY required if the report is completed orally and not done via electronic submission.

After making the report to ChildLine, A person who is required to report in the capacity as a member of the staff of a medical or other public or private institution, school, facility or agency, must immediately thereafter notify the person in charge of the institution, school, facility or agency or the designated agent of the person in charge. The failure of the mandated reporter to file the report shall not relieve the county agency from any duty under this chapter, and the county agency shall proceed as though the mandated reporter complied with the paragraph above.

Contents of ReportAn oral or written report of suspected child

abuse, which may be submitted electronically, shall include the following information, if known:• The names and addresses of the child, the

child’s parents and any other person respon-sible for the child’s welfare.

• Where the suspected abuse occurred.• The age and sex of each subject of the report.• The nature and extent of the suspected child

abuse, including any evidence of prior abuse to the child or any sibling of the child.

• The name and relationship of each individual responsible for causing the suspected abuse and any evidence of prior abuse by each in-dividual.

• Family composition.• The source of the report.• The name, telephone number and e-mail ad-

dress of the person making the report.• The actions taken by the person making the

report, including those actions taken under section 6314 (relating to photographs, medi-cal tests and X-rays of child subject to report), 6315 (relating to taking child into protective custody), 6316 (relating to admission to pri-vate and public hospitals) or 6317 (relating to mandatory reporting and postmortem investi-gation of deaths).

• Any other information required by Federal law or regulation.

• Any other information that the department re-quires by regulation.

Regarding Applicability of Mental Health Procedures Act

Notwithstanding any other provision of law, a mandated reporter enumerated under section 6311 (relating to persons required to report suspected child abuse) who makes a report of suspected child abuse pursuant to this section or who makes a report of a crime against a child to law enforcement officials shall not be in violation of the act of July 9, 1976 (P.L.817, No.143), known as the Mental Health Procedures Act, by releasing information necessary to complete the report.

What Happens After a Report is Made?ChildLine receives the report and determines

who is to respond to the report, dependent upon the information reported, such as the identity, if known, of the person who allegedly acted to abuse or harm a child. ChildLine will immediately transmit oral or electronic reports they receive to the appropriate county agency and/or law enforcement official.• If a person identified falls under the definition

of perpetrator, ChildLine will refer the report to the appropriate county agency for an inves-tigation.

• If the person identified is not a perpetrator and the behavior reported includes a violation of a crime, ChildLine will refer the report to law enforcement officials.

• If a person identified falls under the definition of perpetrator and the behavior reported in-cludes a criminal violation, ChildLine will refer the report to the appropriate county agency and law enforcement officials.

• If a report indicates that a child may be in need of other protective services, ChildLine will refer the report to the proper county agency to assess the needs of the child and provide services, when appropriate.If a report is labeled as a CPS, ChildLine

forwards the report of suspected child abuse to the local county children and youth agency, which investigates the report to determine if the allegations can be substantiated as child abuse/neglect and also arranges for or provides the services that are needed to prevent the further maltreatment of the child and to preserve the family unit.

For CPS reports, the county children and youth agency must begin an investigation within 24 hours. A thorough inquiry is conducted to determine if the child was abused and what services are appropriate for the child and family. This must be completed within 30 days unless the agency provides justification as to why the investigation cannot be completed, including attempts being made to obtain medical records or interview subjects of the report.

If a report indicates that a child may be in need of other protective services, ChildLine will refer the report to the proper county agency to assess the needs of the child and provide services, when appropriate. Agencies follow the list of requirements for GPS reports when a report is labeled as GPS. Mandated reporters are not responsible for distinguishing between the two types of reports.

Notice to Mandated Reporter (Right-to-Know)If a report was made by a mandated reporter

under section 6313 (relating to reporting procedure), the department shall notify the mandated reporter who made the report of suspected child abuse of all of the following within three business days of the department’s receipt of the results of the investigation:• Whether the child abuse report is founded,

indicated or unfounded.• Any services provided, arranged for or to be

provided by the county agency to protect the child

Penalties for Failure to ReportFailing to Report: A person or official required

to report a case of suspected child abuse or to make a referral to the appropriate authorities commits an offense if the person or official willfully fails to do so.

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An offense under this section is a felony of the third degree if:• The person or official willfully fails to report.• The child abuse constitutes a felony of the first

degree or higher.• The person or official has direct knowledge of

the nature of the abuse.• An offense not otherwise specified above is a

misdemeanor of the second degree.• A report of suspected child abuse to law en-

forcement or the appropriate county agency by a mandated reporter, made in lieu of a re-port to the department, shall not constitute an offense under this subsection, provided that the report was made in a good faith effort to comply with the requirements of this chapter.

Continuing Course Of Action If a person’s willful failure under subsection (a)

continues while the person knows or has reasonable cause to believe the child is actively being subjected to child abuse, the person commits a misdemeanor of the first degree, except that if the child abuse constitutes a felony of the first degree or higher, the person commits a felony of the third degree.

Multiple OffensesA person who commits a second or subsequent

offense under subsection (a) commits a felony of the third degree, except that if the child abuse constitutes a felony of the first degree or higher, the penalty for the second or subsequent offenses is a felony of the second degree.

Statute of limitationsThe statute of limitations for an offense

under subsection (a) shall be either the statute of limitations for the crime committed against the minor child or five years, whichever is greater.

Protection For Reporters

Immunity from liabilityIn general, a person, hospital, institution,

school, facility, agency or agency employee acting in good faith shall have immunity from civil and criminal liability that might otherwise result from any of the following:• Making a report of suspected child abuse or

making a referral for general protective ser-vices, regardless of whether the report is re-quired to be made under this chapter.

• Cooperating or consulting with an investiga-tion under this chapter, including providing information to a child fatality or near-fatality review team.

• Testifying in a proceeding arising out of an instance of suspected child abuse or general protective services.

• Engaging in any action authorized under sec-tion 6314 (relating to photographs, medical

tests and X-rays of child subject to report), 6315 (relating to taking child into protective custody), 6316 (relating to admission to pri-vate and public hospitals) or 6317 (relating to mandatory reporting and postmortem investi-gation of deaths).

Departmental and county agency immunityAn official or employee of the department or

county agency who refers a report of suspected child abuse for general protective services to law enforcement authorities or provides services as authorized by this chapter shall have immunity from civil and criminal liability that might otherwise result from the action.

Presumption of good faithFor the purpose of any civil or criminal

proceeding, the good faith of a person required to report pursuant to section 6311 (relating to persons required to report suspected child abuse) and of any person required to make a referral to law enforcement officers under this chapter shall be presumed.

ConclusionProtecting the safety and well-being of

children is clearly a top priority in Pennsylvania and the nation as a whole. The responsibility to do so is widely shared, from citizens providing safe zones for children and families facing difficult situations, to community partners, and to formal state and federal child protective services systems. Physicians and other healthcare workers play a key role in this effort because they are on the front lines for identifying abuse and reporting it appropriately.

The Pennsylvania laws covering the abuse of children now have expanded definitions of “child abuse” and “perpetrator” and have streamlined the process for mandatory reporting of child abuse, provide penalties for failing to report suspected abuse and protect those individuals who report child abuse. The legislation also promotes the use of multi-disciplinary investigative teams to investigate child abuse-related crimes and supports the use of information technology to increase efficiency and tracking of child abuse.

The use of multidisciplinary teams and information technology will allow caseworkers and the child welfare system as a whole to function as a more holistic system supported by data to drive the most effective approaches to serving Pennsylvania’s children, youth, and families.

ResourcesAdministration for Children & FamiliesOnline: acf.hhs.gov

Keep Kids Safe Online: KeepKidsSafe.pa.govChild abuse hotline: 800-932-0313

National Child Abuse HotlineOnline: acf.hhs.gov/acf-hotlines#chapter-2Phone: 800-422-4453

Pennsylvania Child Welfare PortalOnline: compass.state.pa.us/cwis/public/home

References:1. Pennsylvania Department of Human Services.

Child Protective Services 2018 Annual Report. http://www.dhs.pa.gov/publications/childabus-ereports/index.htm. Accessed July 18 2019.

2. Child Welfare Information Gateway, Depart-ment of Health and Human Services, Chil-dren’s Bureau. What Is Child Welfare? A Guide for Health-Care Professionals. 2013; https://archive.org/stream/www.childwelfare.gov/pubPDFs/cw_healthcare_djvu.txt. Accessed July 18 2019.

3. Child Welfare Information Gateway, Depart-ment of Health and Human Services, Chil-dren’s Bureau. About CAPTA: A Legislative History. 2019; https://www.childwelfare.gov/pubpdfs/%20about.pdf. Accessed July 18 2019.

4. Pennsylvania General Assembly. Title 23, Chap-ter 63 Child Protective Services, subchapters A-E. https://www.legis.state.pa.us/CFDOCS/LEGIS/LI/consCheck.cfm?txtType=HTM&ttl= 23&div=00.&chpt=063.&CFID=2241544 44&CFTO KEN=11851291. Accessed July 18 2019.

5. Prevent Child Abuse America. Recognizing Child Abuse. https://preventchildabuse.org/resource/recognizing-child-abuse-what-par-ents-should-know/. Accessed July 19 2019.

6. Pyles T. Physical Abuse. The Blue Ribbon Project, Supporting victims of child abuse and youth in foster care 2019; https://blueri bbonproject.org/awareness/abuse-neglect/4-child-abuse-neglect/87-physical-abuse.html. Accessed July 19 2019.

7. Prevent Child Abuse America. Preventing Child Physical Abuse. https://preventchildabuse.org/r esource/prevent ing-ch i ld-phys i -cal-abuse/. Accessed August 5 2019.

8. Kolko DJ. Child Physical Abuse. University of Pennsylvania School of Medicine; 2001.

9. Straus M. Corporal punishment of children and depression and suicide in adulthood. In: McCord J, ed. Coercion and Punishment in Long-Term Perspective. New York NY: Cam-bridge University Press; 1994.

10. Milaniak I, Widom CS. Does Child Abuse and Neglect Increase Risk for Perpetration of Vi-olence Inside and Outside the Home? Psychol Violence. 2015;5(3):246-255.

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11. Widom CS, Maxfield MG. An Update on the “Cy-cle of Violence”. National Institute of Justice Research in Brief. 2001;February:1-8.

12. Christian CW, Committee on Child A, Neglect AAoP. The evaluation of suspected child phys-ical abuse. Pediatrics. 2015;135(5):e1337-1354.

13. Case study adapted from: To Report or Not Report: A Physician’s Dilemma, Shanley JR, et al. AMA Journal of Ethics. February 2009.

14. Prevent Child Abuse America. Sexual abuse of children fact sheet. http://preventchildabuse.org/wp-content/uploads/2016/02/sexualabu-seofchildren.pdf. Accessed July 22 2019.

15. Finkelhor D. Answers to Important Questions About the Scope and Nature of Child Sexual Abuse. Los Altos, CA: David and Lucille Pack-ard Foundation; 1994.

16. Anda RF, Felitti VJ, Chapman DP, et al. Abused boys, battered mothers, and male involvement in teen pregnancy. Pediatrics. 2001;107(2):E19.

17. Stein JA, Leslie MB, Nyamathi A. Relative con-tributions of parent substance use and child-hood maltreatment to chronic homelessness, depression, and substance abuse problems among homeless women: mediating roles of self-esteem and abuse in adulthood. Child Abuse Negl. 2002;26(10):1011-1027.

18. Dube SR, Anda RF, Whitfield CL, et al. Long-term consequences of childhood sexual abuse by gender of victim. Am J Prev Med. 2005;28(5):430-438.

19. Finkel MA, Giardino AP. Medical Evaluation of Child Sexual Abuse: A Practical Guide, 3rd Edi-tion. American Academy of Pediatrics; 2009.

20. Case study adapted from: Legal, ethical, and clinical perspectives on the health care professional’s response to child sexual Abuse. Upstate Medical University. Available at: http://www.upstate.edu/bioinbrief/arti-cles/2010/2010-04-case-study-child-abuse.php. Accessed August 5 2019.

21. Garbarino J, Garbarino A. Emotional Maltreat-ment of Children 2nd Ed. Chicago IL: National Committee to Prevent Child Abuse; 1994.

22. Korfmacher J. Emotional Neglect: Being Hurt by What is Not There. Chicago IL: National Committee to Prevent Child Abuse; 1998.

23. Kent A, Waller G. The impact of childhood emo-tional abuse: an extension of the Child Abuse and Trauma Scale. Child Abuse and Neglect. 1998;22(5):393-399.

24. Glaser D. Emotional abuse and neglect (psy-chological maltreatment): a conceptual frame-work. Child Abuse and Neglect. 2002;26(6-7):697-714.

25. Prevent Child Abuse America. Preventing Child Neglect. https://preventchildabuse.org/re-source/preventing-child-neglect/. Accessed July 19 2019.

26. DePanfilis D. Child Neglect: A Guide for Pre-vention, Assessment and Intervention. Wash-ington DC: U.S. Department of Health and Hu-man Services, Administration of Children and Families; 2006.

27. United Nations Office on Drugs and Crime. United Nations Convention Against Trans-national Organized Crime and the Protocols Thereto. 2004; http://www.unodc.org/unodc/en/treaties/CTOC/index.html#Fulltext.

28. United States Trafficking Victims Protection Act of 2000. 114 Stat. 1466 USC, section 7102.

29. Department of Justice. Federal Strategic Ac-tion Plan on Services for Victims of Human Trafficking in the United States, 2013-2017. 2014.

30. United States Department of State. Trafficking in Persons Report. 2014; www.state.gov/doc-uments/organization/226844.pdf. Accessed November 29 2016.

31. Alpert EJ, Ahn R, Albright E, et al. Human Trafficking: Guidebook on Identification, As-sessment, and Response in the Health Care Setting. Boston MA: MGH Human Trafficking Initiative, Division of Global Health and Human Rights, Department of Emergency Medicine, Massachusetts General Hospital;2014.

32. Baldwin SB, Eisenman DP, Sayles JN, Ryan G, Chuang KS. Identification of human trafficking victims in health care settings. Health Hum Rights. 2011;13(1):E36-49.

33. International Organization for Migration. Car-ing for Trafficked Persons; Guidance for Health Providers. Geneva, Switzerland 2009.

34. Trossman S. The Costly Business of Hu-man Trafficking. American Nurse Today. 2008;3(12).

35. Lederer LJ, Wetzel CA. The health consequenc-es of sex trafficking and their implications for identifying victims in healthcare facilities. An-nals of Health Law. 2014;23:61-91.

36. Wong JC, Hong J, Leung P, Yin P, Stewart DE. Human trafficking: an evaluation of Canadian medical students’ awareness and attitudes. Educ Health (Abingdon). 2011;24(1):501.

37. Chisolm-Straker M, Richardson L. Assessment of Emergency Department (ED) Provider Knowledge about Human Trafficking Victims in the ED (Abstract). Academic Emergency Medi-cine. 2007;14(5S):S134.

38. Dovydaitis T. Human trafficking: the role of the health care provider. J Midwifery Womens Health. 2010;55(5):462-467.

39. Grace AM, Lippert S, Collins K, et al. Educating health care professionals on human traffick-ing. Pediatr Emerg Care. 2014;30(12):856-861.

40. National Human Trafficking Resource Center. Identifying Victims of Human Trafficking: What to look for in a healthcare setting. 2016; http://www.acf.hhs.gov/endtrafficking/resource/fact-sheet-identifying-victims-of-human-traf-ficking. Accessed November 30, 2016.

41. Prevent Child Abuse Pennsylvania. Frequent-ly Asked Questions: Mandated Reporters. https://www.Vpreventchildabusepa.org/com-mon-questions. Accessed July 22 2019.

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1. The difference between General Protective Services (GPS) and Child Protective Services (CPS) is that _____________ .A. GPS provides services for adults whereas CPS provides

services for children and adolescents.B. Reports of suspected abuse are evaluated at ChildLine for

GPS, but not CPSC. GPS provides services to abuse cases and CPS provides

services to non-abuse casesD. GPS provides services in non-abuse cases

2. In 2018,_______________ was the leading category of substantiated child abuse reports in Pennsylvania.A. NeglectB. Sexual AbuseC. Physical AbuseD. Sex Trafficking

3. With changes in Pennsylvania law, the term “perpetrator” now includes __________________:A. Any person responsible for a child’s welfareB. Police officersC. Clergy membersD. Teachers

4. The term “child abuse” does not apply to situations in which ____________________:A. The harm occurred as a result of a caregiver using force to

discipline a childB. The perpetrator did not believe he/she was engaging in

abusive behaviorC. The harm or injury resulted from environmental factors

such as inadequate clothing or medical care beyond the control of the parent

D. The perpetrator is an employee of a childcare service and acted out of a sincere religious belief that the behavior was acceptable

5. Child-on-child contact resulting in harm or injury may be considered child abuse unless:A. The abusing child was acting on the orders of an adultB. The harm or injury was emotional in nature, not physicalC. The physical or mental injuries arose in the course of a

dispute, fight, or scuffle entered into by mutual consentD. The perpetrator is younger than age 12

6. The definition of child abuse has been amended to require that acts or failures to act be committed __________________.A. Intentionally, knowingly, or recklesslyB. With premeditated intentC. Intentionally and recklesslyD. With knowledge that the behavior could be physically or

emotionally harmful to the child

7. Bruises resulting from physical abuse typically appear ____________ initially and change color as they heal.A. Black or blueB. Red, green, or yellowC. Brown, green, or yellowD. Red, violet, black, or blue

8. Approximately what percentage of child sexual abuse cases are perpetrated by strangers?A. 10%-30%B. 20%-40%C. 30%-50%D. 40%-60%

9. What is the most common form of child maltreatment?A. Sexual abuseB. NeglectC. Physical abuseD. Emotional abuse

10. What is one possible way to increase the identification in health care settings of people who are being trafficked?A. Install security cameras in waiting roomsB. Train non-clinical staff (e.g., receptionists, security guards)

about ways to identify potential victims or perpetrators of human trafficking

C. Require all patients to fill out a questionnaire about human trafficking

D. Screen all patients using a validated tool for identifying victims of human trafficking

CHILD ABUSE RECOGNITION AND REPORTING IN PENNSYLVANIA

21

Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required.

Return your customer information/answer sheet, evaluation, and payment to InforMed by mail, phone, fax or complete online at course website under NETPASS.

Completion of this course will better enable the course participant to:1. Discuss the fundamental concepts of pain management, including definitions and mechanisms of pain.2. Identify the range of therapeutic options for managing pain, including nonpharmacologic approaches and pharmacologic

(non-opioid and opioid analgesics) therapies.3. Explain how to integrate opioid analgesics into a pain treatment plan individualized to the needs of the patient, including

counseling patients and caregivers about the safe use of opioid analgesics.4. Describe how to safely and effectively manage patients on opioid analgesics in the acute and chronic pain settings,

including initiating therapy, titrating, and discontinuing use of opioid analgesics.5. Discuss recommendations on incorporating emergency opioid antagonists into prescribing practice, utilizing best

practices for co-prescribing emergency antagonists and training family members and loved ones on the use of naloxone. 6. Recognize the risks of addiction following all stages of treatment in the management of pain, identify strategies to

mitigate these risks, and discuss therapeutic options for treatment of opioid addiction.

LEARNING OBJECTIVES

TARGET AUDIENCE

This course is designed for all physicians and health care providers involved in the treatment and monitoring of patients prescribed controlled substances.

COURSE OBJECTIVE

The purpose of this course is to educate prescribers about Risk and Mitigation Strategies (REMS) in accordance with the Food and Drug Administration (FDA) blueprint of prescriber education related to opioid analgesics.

Release Date:06/2018

Exp. Date: 05/2021

Enduring Material

(Self Study)

2 AMA PRA

Category 1 Credits™

PRESCRIBER EDUCATIONFOR OPIOID ANALGESICS

ACCREDITATION STATEMENTInforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENTInforMed designates this enduring material for a maximum of 2 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

22

FACULTY

Paul J. Christo, MD, MBADirector, Multidisciplinary Pain Fellowship ProgramAssociate Professor of Anesthesiology and Critical Care MedicineThe Johns Hopkins University School of Medicine

Beth DoveMedical WriterDove Medical Communications

ACTIVITY PLANNER

Elizabeth ThomasMSN, WHNP-BC, NP-C

DISCLOSURE OF INTERESTIn accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

STAFF AND CONTENT REVIEWERS:

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

DISCLAIMER

*2020. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.

• Paul J. Christo, MD, MBA has received honoraria from GlaxoSmithKline Consumer Healthcare.

FACULTY/PLANNING COMMITTEE DISCLOSURE

The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity:

The following faculty and/or planning committee members have indicated that they have relationship(s) with industry to disclose:

• Elizabeth Thomas, MSN, WHNP-BC, NP-C • Beth Dove

The Pennsylvania Boards of Medicine and Osteopathic Medicine require all licensed physicians with prescriptive authority to complete two (2) credit hours in Pain Management or the Identification of Addiction

or Prescribing/Dispensing Opioids.

OPIOID EDUCATION

This course satisfies two (2) credit hours in opioid education.

SPECIAL DESIGNATION

2

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IntroductionOverview of Pain Management

The practice of pain management requires an understanding of two competing public health problems: the high prevalence and burden of pain and the risks associated with opioid analgesics and other controlled substances often used to treat pain. All healthcare providers (HCPs) who treat pain with opioids are called upon to familiarize themselves with best practices to increase patient and societal safety while boosting patient outcomes for pain relief, function, and quality of life.

Close to 100 million Americans suffer from some type of ongoing pain.1 In National Health Interview Survey Data, 25 million respondents reported living with daily pain, and more than 14 million reported the highest level of pain.2 The higher the impact and severity of pain, the greater the costs in terms of disability, health status, quality of life, and use of health care services.3

Pain is even more common in military veterans, particularly those who have served in recent conflicts: 66% reported pain in the previous three months and 9% had the most severe pain.4 Certain populations are more vulnerable than others to developing more severe chronic pain and disability, including women, older adults, and racial and ethnic minorities.5 Members of some groups, including racial and ethnic minorities and children, are also at risk for having their pain undertreated.5

Pain care is most effective when it combines multiple disciplines and utilizes a broad range of evidence-based pharmacologic and nonpharmacologic treatment options.1,6 For acute pain and for some chronic pain, unresponsive to nonopioid therapies, opioids may form part of a customized treatment plan. Some patients report improved pain and quality of life with opioids.7 However, opioids also bring well-documented risks that include misuse, abuse, opioid-use disorder (OUD), and overdose death. Approximately 11.5 million Americans, or 4.3 percent of the population, misused prescription opioids in 2016.8 Furthermore, of 42,000 opioid-related deaths in 2016, 40% involved prescription opioids.9

This educational activity follows national and state guidelines for the safe prescribing of opioids with the purpose of reducing adverse outcomes with opioids while preserving analgesia for patients who require opioids, particularly when pain is chronic. The goal is for HCPs to acquire the necessary knowledge to consider all available therapies and to create a comprehensive treatment plan, prescribing opioids only when the benefits outweigh the risks.

When a trial of potentially long-term opioids is selected, HCPs should be better equipped to recognize and manage any adverse events that may arise during the course of opioid therapy.

Pain Definitions and MechanismsThe International Association for the Study of

Pain (IASP) defines pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage.”1 As such, pain is protective and essential for survival, serving as a useful warning signal that something has gone wrong. Pain is also a subjective experience with an emotional component. There are no precise clinical markers for pain, which is experienced by the individual as a constellation of biological, psychological, and social factors. Pain varies by type and mechanism:1

• Acute pain has a sudden onset and expected short duration, though episodes may recur

• Chronic pain lasts longer than normal healing and is generally diagnosed after persisting from 3-6 months

• Nociceptive pain is the normal response to any type of stimulus that results in tissue damage

• Visceral pain is nociceptive pain that arises from the body’s organs (may be cramping, throbbing, vague)

• Somatic pain, whether superficial or deep, is nociceptive pain that results from issues within the body’s bone, joints, muscles, skin, or connective tissue (may be localized and stabbing, aching, throbbing)

• Neuropathic pain results from damage to or abnormal processing of the peripheral or central nervous system (CNS) (may be sharp, stabbing, burning, tingling, numb)

• Referred pain spreads beyond the initial injury site

Chronic pain’s many possible causes include injuries, malignancies, diseases that flare up, medical treatments or surgeries, or inflammation that appears as a result of injury or chronic disease. Chronic pain may even occur in the absence of a defined injury or cause.

Ongoing pain can modify the CNS, through which pain is sensed, transmitted, modulated, and interpreted.1 When the nociceptors, or sensory receptors, become sensitized, they discharge more frequently. In peripheral sensitization, this state of heightened neuron excitability occurs at the site where the pain impulse originated in the body; in central sensitization, it occurs in the spinal neurons, which begin to fire spontaneously, resulting in pain that intensifies and lasts far longer than the stimulus applied.1 Sensitization can result in hyperalgesia, where response to pain-causing stimuli is intensified, and allodynia, a pain response to stimuli that normally are not painful.1 Therefore, the resulting pain comes not just from an injury site but from neural impulses. The pathologies created by central sensitization can persist and continue to generate pain impulses indefinitely, far outlasting pain’s usefulness as a warning signal. Chronic pain may be primarily nociceptive, neuropathic, or have mixed nociceptive-

neuropathic characteristics. Examples of nociceptive or inflammatory pain include postoperative pain, arthritis, mechanical low back pain, sickle cell crises, and pain from traumatic injuries. Causes of peripheral neuropathic pain include postherpetic neuralgia and diabetic neuropathy. Central neuropathic pain triggers include spinal cord injury, trigeminal neuralgia, and multiple sclerosis.

Creating a Treatment PlanAcute pain is generally manageable with rest,

over-the-counter (OTC) medications or a short course of stronger analgesics, and resolution of the underlying cause (e.g., trauma, surgery, illness). Prompt management of acute pain is necessary to prevent progression to a chronic state.

With chronic pain, it is essential to treat the cause of pain, whenever a cause can be diagnosed, in addition to managing the pain. When the pain is moderate-to-severe in intensity, it requires a biopsychosocial model of comprehensive treatment in recognition of its complex contributors.1 The complexity of the pain experience involves emotions, attitudes, presence of confounding psychiatric and anxiety conditions, history of response to pain, current living conditions, and many other factors. The presence of a psychiatric condition does not mean the pain the patient is experiencing is not real. Chronic pain affects relationships, work, sleep, function, overall health, and quality of life. This complexity is why a comprehensive approach to pain management should factor in the many contributors from the biological, psychological, and social domains.1 It is also why patients often respond better to a combination of therapeutic modalities rather than a unimodal medication regimen.

A number of guidelines have been developed by professional medical societies, states, and federal agencies to assist HCPs in setting and executing treatment plans for prescribing opioids for chronic pain.10-14 Common recommendations include:• Conduct a physical exam• Collect pain history, medical history, and family/

social history • Consider all treatment options, weighing benefits

and risks of opioid therapy, and prescribe opioids only when nonpharmacologic or nonopioid treatments are ineffective

• Obtain informed consent and implement pain treatment agreements

• Start patients on the lowest effective dose • Conduct urine drug testing (UDT), when

appropriate • Check prescription drug monitoring programs

(PDMPs) to identify past and present opioid prescriptions at initial assessment and during the monitoring phase

• Monitor pain and treatment progress with documentation, using greater vigilance at higher doses

24

• Use safe and effective methods for discontinuing opioids (e.g., tapering, making appropriate referrals to substance abuse treatment or other services)

• Pay close attention to drug-drug and drug-disease interactions

• Recognize special risks with fentanyl patches and methadone

• Titrate slowly and cautiously• Consider using an opioid-specific risk

assessmentThe goals of treatment should be meaningful

to the patient and contain pain relief and functional components.13,14 Even patients with pain conditions or injuries that make complete cessation of pain unlikely can set goals such as sleeping through most nights, returning to work, walking a set distance, or participating more fully in family activities. The self-efficacy involved in collaborating on these goals can help patients gain greater control over their pain and their lives.

Informed consent is critical to a treatment plan containing a trial or continuation of opioid therapy.12,13,15 Treatment plans should be revisited and adjusted frequently to ensure goals are being met and any adverse effects of therapy are addressed.

Nonpharmacologic ApproachesA number of nonpharmacologic and self-

management treatment options are available, which may be used alone or as part of a comprehensive pain management plan. Evidence-based nonpharmacologic options for acute and chronic pain, include:16

• Acupuncture therapy• Chiropractic and osteopathic manipulation• Massage therapy• Physical therapy• Exercise• Mind/body therapies (e.g., mindfulness-based-

stress reduction, cognitive-behavioral therapy)• Movement therapies (e.g., yoga, Tai chi)• Injection treatments

Patients may find helpful a combination of approaches that include nutritional support, healthy lifestyle changes, patient education, sleep hygiene instruction, and relaxation and visualization techniques. Interventional techniques range from the less invasive such as injections (nerve blocks, trigger point injections, epidural steroid injections, joint blocks), transcutaneous electrical nerve stimulation, and various approved medical devices to the more invasive such as surgeries, implantable spinal pumps, and implantable spinal electronic stimulators or peripheral nerve stimulators.

Rather than thinking of these treatments as “alternatives” to conventional treatment, HCPs are encouraged to review the evidence base16 and consider a trial of one or more nonpharmacologic therapies. Unfortunately, barriers are common in obtaining insurance coverage and reimbursement for

nonpharmacologic therapies, and access to trained professionals in these care options is sometimes limited.11 The modalities of cognitive-behavioral therapy, physical therapy, certain injections, exercise and electrical stimulation are generally recognized and covered as having benefit for chronic pain.16

Less invasive measures for pain management should be considered first.13 Education can be an effective means to patient self-management; for example, instruction in proper posture and movement techniques along with advice to remain active are recommended for the treatment of persistent low-back pain.

Nonopioid Pharmacologic Analgesic TherapyNonopioid pharmacologic treatments for pain

include:Acetaminophen (ACET) for pain without

inflammation. All ACET products carry an FDA-required black box warning highlighting the potential for severe liver damage and potential for allergic reactions.17 Dose levels from all medication sources should be evaluated to avoid exceeding the recommended daily dosage.

Nonsteroidal anti-inflammatory drugs (NSAIDs), which includes cyclooxygenase-2 (Cox-2) inhibitors, for pain and inflammation. Risks are elevated with NSAIDs for heart attack, stroke, gastrointestinal bleeding or perforation, and renal and cardiovascular abnormalities, particularly at higher doses and longer duration of use.13 An FDA-required black box warning for all marketing NSAIDs highlights the potential for increased risk of cardiovascular events and serious, potentially life-threatening gastrointestinal bleeding associated with their use.

Skeletal muscle relaxants for pain and muscle spasm for short-term use. Sedation is a common adverse effect. Particular CNS risks are notable with carisoprodol (toxicity) and benzodiazepines (substance dependence and respiratory depression leading to overdose) when prescribed in combination with opioids.16

Antidepressants (serotonin and norepinephrine reuptake inhibitors [SNRIs] and tricyclics) used in low doses for insomnia and neuropathic pain. Depending on class, risks may include anticholinergic effects, sexual dysfunction, weight gain, emotional blunting, and suicidal thoughts.16

Anticonvulsants, such as gabapentin and pregabalin, have mild-to-moderate benefit for neuropathic pain and adverse effects that include drowsiness and cognitive slowing.16

Topical medications include lidocaine, ketamine, capsaicin, and anti-inflammatory drugs such as ketoprofen and diclofenac. Anti-inflammatory topicals are proven beneficial for musculoskeletal pain as is capsaicin for neuropathic pain.16

Many guidelines recommend NSAIDs and ACET as first-line therapies for low-back pain and osteoarthritis, and anticonvulsants and antidepressants as first- and second-line therapies for neuropathic pain with appropriate risk mitigation.13

Analgesic Effects of OpioidsUnderstanding the variety of opioid products,

delivery systems, and formulations that are available to treat pain can assist HCPs in drug selection to maximize analgesia and minimize or prevent adverse effects. Opioids achieve an analgesic effect primarily by inhibiting nociceptive transmission in the CNS. They do this by binding to and activating receptors within the endogenous opioid system.

Mu, kappa, and delta are the three primary opioid receptor types that mediate analgesia. Drugs that bind to these receptors are classified as full agonists, partial agonists, mixed agonist-antagonists, and antagonists (Table 1). Opioids used in clinical practice are typically full mu-agonists that bind selectively to the mu-opioid receptor. When an antagonist occupies the receptor, it displaces the agonist, and is associated with abstinence syndrome (withdrawal). Partial agonists, such as buprenorphine, have high receptor occupancy, some antagonistic effects, and low intrinsic activity at the site. In addition to use in pain treatment, methadone and buprenorphine are used to treat OUD, a process known as medication-assisted treatment (MAT) when combined with behavioral therapy.18 Kappa opioid receptor agonists (including levorphanol, pentazocine, and butorphanol) have been used clinically but are associated with side effects such as dysphoria and hallucinations.

Initiating Opioids: Acute Pain SettingFor acute pain, the therapeutic goal is to prescribe

the lowest dose that controls pain for a duration that lasts only as long as the acute phase. Prescriptions beyond 3 days are usually unnecessary,13 while more severe episodes rarely need more than 7-14 days.13,14 Be aware that localities and states may have strict regulations governing maximum duration of prescriptions.

Nonopioids should be utilized first and preferentially, LAOs should be avoided, and opioids are not recommended for nonspecific back pain, headaches, or fibromyalgia.12 If pain persists beyond the expected healing period, HCPs should reevaluate the diagnosis and treatment plan.

Initiating Opioids: Chronic Pain SettingTreatment of patients who have active cancer

or who need palliative or end-of-life care is not addressed in this activity. For patients with chronic noncancer pain (CNCP) in the outpatient setting, opioids are not considered first-line therapy.12,13 The HCP should weigh and discuss with the patient certain issues regarding expectation of benefit vs. risk when initiating LTOT. While opioids can reduce pain during short-term use, there is scant high-quality evidence that opioids improve pain or function with long-term use, the risk of harms can increase at higher doses, and complete relief of pain is unlikely.19 Furthermore, some evidence indicates that opioids may not be superior to other pharmacologic and nonpharmacologic therapies for chronic pain.16,20

25

The HCP may consider a trial of long-term opioid therapy (LTOT) as one therapeutic option if the patient’s pain:11

• Is severe and ongoing or recurs frequently• Diminishes function or quality of life• Is unrelieved or likely to be unrelieved by

nonopioid therapiesThe HCP should consider the following questions:• Do medical comorbidities increase risk of side

effects?• Do other therapies have better or equal evidence

for the particular pain type and condition?• Do reasonable alternatives to LTOT exist? Are

they available?• Do anticipated therapeutic benefits of LTOT

outweigh known risks?• Does thorough patient evaluation indicate the

patient is likely to adhere to the treatment plan?The patient’s pain type and previous treatments

tried should be evaluated to see if opioid therapy is likely to be effective. For example, one might first try an anticonvulsant for trigeminal neuralgia, a disease-modifying antirheumatic drug for rheumatoid arthritis, a corticosteroid for polymyalgia rheumatica, or various rescue and preventive medications for migraine and stress-related headache.11

Opioids, if administered, are best when used at the lowest effective dose and combined with modalities from other disciplines.11,13

Assessing Patients in PainInitial patient evaluation includes taking a

medical and pain history, performing a physical exam, and conducting appropriate diagnostic testing when indicated. The evaluation should include chief complaint, prior diagnostic findings, results and analyses of laboratory tests and screenings, all previous treatments tried, and comorbid conditions

(including medical, psychiatric, mood and sleep disorders). One should obtain a complete history of current and past substance use and misuse to include prescription drugs, illegal substances, alcohol, and tobacco. Social history is also relevant to include employment, marital history, and family status.11 Women should be screened for contraceptive use and pregnancy or breastfeeding status or intent.13

Pain is assessed by onset, location, intensity, quality, duration, radiation, and variations. Patients should be asked what relieves or increases the pain, how it affects their daily lives and functioning, and what goals they have for pain relief and improved function. A number of pain assessment tools are available to be incorporated into routine clinical practice. The Visual Analogue Scale (VAS) and Numerical Rating Scale (NRS) are sensitive, validated, and widely-used, quick tools to measure pain severity.21 The Brief Pain Inventory (BPI) has good sensitivity, reliability, and validity for pain severity and interference-with-function items, including assessments of mood and sleep.22,23 The McGill Pain Questionnaire (MPQ), also available as a short form, assesses additional pain descriptors (sensory, evaluative, and affective).21 With good validity and reliability, the MPQ is useful for facilitating description of the subjective pain experience but requires a good vocabulary when self-administered. An instrument to assess how well patients cope with chronic pain is the Multidimensional Pain Inventory (MPI), which categorizes patients into three coping styles: Adaptive, Dysfunctional, and Interpersonally Distressed and has been validated for multiple chronic pain conditions.24,25

Patients also should be evaluated for psychosocial, psychiatric, and social factors that can impact pain,

including anxiety, post-traumatic stress disorder (PTSD), and depressive symptoms or disorders. The 9-item Patient Health Questionnaire (PHQ-9) and its variations are brief, reliable, and valid measures to identify depression.13,26 One PHQ-9 item addresses suicidal ideation, an important assessment for patients with chronic pain.27 The Generalized Anxiety Disorder (GAD)-7 and GAD-2 are validated and recommended to assess for generalized, panic, and social anxiety disorders and PTSD.13,28

Additional helpful screening tools are the reliable and valid Beck Depression Inventory II (BDI-II) self-report measure of depression severity,29 and the Beck Anxiety Inventory (BAI),30 which emphasizes somatic components of anxiety. Even more in-depth pain assessment is offered through newer systems such as the Stanford-developed and implemented Collaborative Health Outcomes Information Registry through the use of item banks that capture many physical, psychological, and social functioning domains.31

Patients who are under consideration for a trial of opioid therapy or who are currently taking opioids should have additional initial screening to be described under the section Screening for Risk.

Risks and warnings with opioidsEven at prescribed doses, opioid analgesics

carry the risks of misuse, abuse, OUD, respiratory depression, overdose, and death. Terminology related to opioid use and misuse is shown in Table 2. The risks apply to all brand-name and generic extended release/long-acting (ER/LA) (See Table 8) and immediate-release (IR) opioids.18,32 Opioid combination products containing acetaminophen also carry warnings of the potential for severe liver damage.17 Particular care and increased monitoring are essential during opioid dose initiation, upward titration, rotation, and addition of other CNS-depressant medications.

Table 1. Opioid Analgesic Classifications

Type Generic Name Notes/Cautions

Pure agonists Codeine Dihydrocodeine Fentanyl Hydrocodone HydromorphoneLevorphanol Meperidine* Methadone Morphine Oxycodone Oxymorphone Propoxyphene

*Not recommended for long-term treatment or in patients with renal compromise due to toxicity risks

Agonist-antagonists Partial agonist: Buprenorphine Mixed agonist-antagonists: • Butorphanol • Dezocine • Nalbuphine • Pentazocine

May produce abstinence with physical dependence

Pure antagonists NaloxoneNaltrexone

Administered to reverse opioid effects

Other Tramadol Tapentadol

Dual action mu-agonist and serotonin–norepinephrine reuptake inhibitor Dual action mu-agonist and norepinephrine reuptake inhibitor

26

Studies show patients are particularly vulnerable to respiratory depression at these times.33,34 In addition, patients may suffer harm that includes abstinence syndrome, increased pain, and distress if opioids are suddenly discontinued or tapered too rapidly. An FDA boxed warning details the risks of prescribing opioids and benzodiazepines together, a combination of medications that has increased in recent years but which is associated with extreme sleepiness, respiratory depression, coma, and death.35

Common adverse drug reactions with opioids include lightheadedness, dizziness, sedation, nausea and vomiting, drowsiness, mental clouding, constipation, hormonal deficiencies, pruritis, and myoclonus.13

The disease of OUD is diagnosed using DSM-5 criteria: A minimum of 2–3 criteria are required for a mild substance-use disorder (SUD) diagnosis, while 4–5 is moderate, and 6–7 is severe;39 OUD is specified instead of SUD, if opioids are the drugs of abuse. Addiction, while not a DSM-5 diagnosis, is still a term that is used and generally describes a severe OUD. The presence of tolerance and physical dependence are not in themselves indicators that an OUD has developed.

Before moving on to the next section, please spend the allotted time on Exercise 1.

Table 2. Definitions Related to Opioid Use and Misuse

Term Definition

Tolerance34 A physiologic state of adaptation in which exposure to the opioid results in diminution of its effects over time In patients with “analgesic tolerance,” increased doses of opioid are needed to maintain pain relief

Physical dependence34 A physiologic state characterized by abstinence syndrome (withdrawal) if treatment with an opioid is stopped or decreased abruptly, or if an antagonist is administered

Abuse35 The intentional, non-therapeutic use of a drug product or substance, even once, to achieve a desirable psycho-logical or physiological effect

Misuse35 The intentional therapeutic use of a drug product in an inappropriate way and specifically excludes the definition of abuse

Addiction36 Chronic disease characterized by compulsive, or uncontrollable, drug seeking and use despite harmful conse-quences and long-lasting changes in the brain

Criteria for Opioid-Use Disorders from the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition37*

1. Opioid taken in larger amounts or over a longer period than intended 2. Persistent desire or unsuccessful efforts to cut down or control opioid use 3. A lot of time spent obtaining, using, or recovering from the effects of the opioid 4. Craving or a strong desire to use opioids 5. Recurrent opioid use resulting in a failure to fulfill major role obligations at work, school, or home 6. Continued use despite persistent or recurring social or interpersonal problems caused or exacerbated by

opioid use 7. Stopping or reducing important social, occupational, or recreational activities due to opioid use 8. Recurrent use of opioids in physically hazardous situations 9. Continued use despite knowledge of having persistent or recurrent physical or psychological problems

cause or worsened by opioid use 10. Tolerance as defined by either a need for markedly increased amounts to achieve intoxication or desired

effect or by markedly diminished effect with continued use of the same amount. (Does not apply when used appropriately under medical supervision)

11. Withdrawal manifesting as either characteristic syndrome or the substance is used to avoid withdrawal (Does not apply when used appropriately under medical supervision)

Jan, 28, presents with low-back pain of 2 months duration. Pain is intermittent and aching. Pain intensity is typically 5-10 VAS but spikes to 7-10 after shifts in the call center where she works. The pain came on suddenly without an instigating trauma. She has no radicular symptoms. The pain is helped by yoga stretching and occasional OTC ACET and worsened by periods of prolonged sitting. Her sleep is interrupted by the need to change position in the night, and she reports sleeping 2 uninterrupted hours on average before waking; 5 hours total sleep per night is usual. She awakes unrefreshed and feels her ability to cope with stress is suffering as a result. She has a husband and 3-year-old son but does not join them for dinner as she used to, because she feels the need to lie down in the evening from the pain and fatigue. She has a history of major depression (1 episode in college) and smokes 1 pack of cigarettes daily. She reports no recreational drug use and drinks beer only on the weekends.

EXERCISE 1Instructions: Take 5 minutes to read the case below and answer the question as it relates to the case presented.

On her initial visit, which of the following therapies would you be likely to discuss/rec-ommend?A. IR opioid plus muscle relaxantB. ER opioid plus IR opioid for breakthrough painC. Exercise/physical therapy, option for standing

desk, NSAIDD. Antidepressant for pain and benzodiazepine

for insomniaNonpharmacologic remedies and treatment plans that address underlying causes are preferred. Trialing an NSAID that helps with inflammation, plus adding gentle movement therapies and addressing work-related triggers, may help the patient manage her pain. A CNS-depressant such as a benzodiazepine is not a first-line therapy for insomnia that appears to have an underlying cause (pain) that should be addressed. The best answer is C.

Notes:

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Screening for RiskIf a trial of opioid therapy is warranted, the

patient should be screened for the risk of developing an OUD or other drug abuse behavior that threatens patient wellbeing and precludes successful pain therapy. A number of available screening tools are shown in Table 3. Tools recommended as having good content, face, and construct validity include the revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R),40 the Opioid Risk Tool (ORT),41 and the Diagnosis, Intractability, Risk, Efficacy (DIRE) instrument.42 The DIRE is clinician-administered and is designed to assess for potential harms of opioid therapy as well as whether or not the patient is a good candidate. The SOAPP-R and ORT are patient self-report questionnaires to stratify patient risk of aberrant drug-related behaviors (ADRBs) into categories of low, moderate, or high risk. Of these, the SOAPP-R has the best sensitivity for predicting risk with opioid management but may also have more false positives.43 The Current Opioid Misuse Measure (COMM) is an assessment for patients already on ongoing opioid therapy.44 None have been fully validated in a variety of clinical settings. Such tools are generally chosen by evaluating length, time available, and expertise within the clinic.

Treating HCPs may also apply a less formal set of questions that address patient risk factors if they do so consistently, treating assessment as routine and encouraging patients to share information honestly. Patient risk factors for ADRBs, pulled from the scientific literature, include but are not limited to the

following:40-42,48-55

• Nonfunctional status due to pain• Exaggeration of pain• Unclear etiology for pain• History of rapid opioid dose escalation • Young age• Smoking• Poor social support• Personal history of substance abuse• Family history of substance abuse• Psychological stress

• Psychological trauma• Psychological disease• Psychotropic substance use• Focus on opioids• Sexual abuse• History of legal problems• History of substance-abuse treatment• Craving for prescription drugs• Mood swings• Childhood adversity• Social environments that encourage illicit

substance usePatient and prescriber roles and responsibilities

should be delineated and documented in the patient record. A baseline UDT and query of the state PDMP should also take place before opioids are initiated or continued.11-13 The PDMP is an important tool to inform clinical decisions and to help stop the spread of abuse and diversion as a public health problem. If results indicate unauthorized prescriptions or there are other clinical signs of abuse, results should be discussed with the patient and a specialist referral given.

Clinicians may consider or continue LTOT for patients with CNCP and histories of drug abuse and psychiatric issues only if they are able to implement more frequent and stringent monitoring parameters.13 In such situations, clinicians should strongly consider consultation and co-management with a mental health or addiction specialist.11,13 Prescription of opioids may not be appropriate until the comorbidity has been addressed.11

Opioid therapy in patients with untreated SUD is unlikely to achieve therapeutic aims, and initiating it is not recommended.12 For patients exhibiting active SUD already on LTOT (review criteria for SUD shown in Table 2), the clinician should refer for addiction management and initiate slow, careful tapering with close monitoring of response and suicide risk.12 Sudden discontinuation or tapering that is accomplished too quickly or without MAT may put patients with OUD or other SUD at risk.

Healthcare providers also should remain alert to the risk of respiratory depression leading to overdose. A number of factors have been observed in opioid-related overdose deaths involving patients and people taking opioids nonmedically. The factors include:33,34,56-58

• Middle age • History of substance abuse • Comorbid mental and medical disorders • High opioid dose • Recent upward titration• Recent opioid rotation• Methadone Benzodiazepines Antidepressants• Unemployment • Polysubstance abuse• Recent release from prison• Recent release from abstinence-based addiction

treatment • Sleep apnea• Heart or pulmonary complications (e.g.,

respiratory infections, asthma)• Pain intensity

Before moving on to the next section, please spend the allotted time on Exercise 2 on the next page.

Initial Dosing and Dose TitrationFor outpatient chronic pain management,

opioids are typically administrated through the oral, transmucosal, and transdermal routes. Each route has advantages and disadvantages and safety concerns, some of which are intrinsic to all opioids and some of which are specific the route.

Short-acting opioids (SAOs) are preferred and considered safer when initiating a therapeutic trial of opioids.11 Commonly prescribed SAOs include IR morphine, hydromorphone, oxymorphone, codeine, fentanyl, hydrocodone, and oxycodone.59 Codeine, hydrocodone, and oxycodone are also available in combination with ACET or an NSAID, which limit daily dose due to risk for liver and gastrointestinal toxic effects.59 In pain management, IR opioids, are indicated for pain severe enough to need opioid treatment and for which nonopioid treatments are ineffective or not tolerated.18

Table 3. Examples of Opioid-Use Disorder Risk Assessment Tools

Tool # of items Administered Approximate Time to Complete

Initial Screen Prior to Initiating Opioid Therapy

Opioid Risk Tool (ORT)39 5 Patient 1 min

Revised Screener and Opioid Assessment for Patients with Pain (SOAPP-R)38 24* Patient 5 min

Diagnosis, Intractability, Risk, Efficacy (DIRE)40 7 Clinician 2 min

Pain Medication Questionnaire (PMQ)43 26 Patient 10 min

For Use During Opioid Therapy

Current Opioid Misuse Measure (COMM)42 17 Patient 10 min

Patient Version Prescription Drug Use Questionnaire (PDUQp)44

31 Patient 20 min

Brief Initial Drug Screening Not Specific toPain Population

CAGE-AID (Adapted to Include Drugs)45 4 Clinician 1 min

*4- and 12-item SOAPP formats available

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They have a short half-life and duration of action (typically 2 to 4 hours), and are often prescribed to take as needed every 4 to 6 hours.18 Patients with no or limited exposure to opioids should be initiated at the lowest dose and titrated slowly to minimize adverse effects.11

If patients require long-term maintenance and pain is severe enough to require around-the-clock analgesia that is not adequately relieved by SAOs or other therapies, consider a transition to ER/LA opioids with scheduled dosing.32 ER/LA opioids are not indicated for acute pain and are for use only in patients who are already tolerant to opioids, with rare exceptions.60 It is critical also that HCPs be aware that all transdermal fentanyl and hydromorphone ER products are for use only in opioid-tolerant patients and never for acute or short-term pain.60 Transmucosal IR fentanyl is also for use only in opioid-tolerant patients. Adult patients are considered opioid tolerant if they have received the following dosages of opioids (or equianalgesic dosages of other opioids) for at least one week:13,60 • 60 mg daily of oral morphine• 25 mcg per hour of transdermal fentanyl• 30 mg daily of oral oxycodone• 8 mg daily of oral hydromorphone• 25 mg daily of oral oxymorphone

Product information for individual formulations contain guidance on degree of opioid tolerance necessary for administration and minimum titration intervals.

Dose titration is individualized depending on efficacy, tolerability, and presence of adverse effects. Patients should be monitored carefully, particularly within 24 to 72 hours of opioid initiation or upward titration. Patients who require repeated dose escalations to achieve sufficient pain relief should be reevaluated for the cause, and the risk-to-harm benefit of LTOT should be reconsidered.11

Altering oral ER/LA opioids by cutting, chewing, or dissolving in liquids can release a potentially toxic dose of active ingredient.60 Transdermal systems and buccal films should not be cut, torn, or damaged before use.

Methadone for pain presents special clinical challenges due to a long and variable half-life, risk for toxicity due to accumulation in plasma concentrations during the longer time (several days) necessary to achieve steady-state, and risk for cardiac toxicities due to prolongation of the QTc interval.11,61,62 Methadone-related deaths have occurred in disproportionate numbers relative to the frequency with which it is prescribed for pain.13 Methadone is only for patients whose severe pain is unrelieved by other opioids. Methadone administration requires close monitoring during initiation and dose changes, and caution in patients with heart disease or taking medications with concurrent QTc interval effects. If deemed necessary, methadone should be started at a very low dose (e.g., ≤15 mg/day in divided doses)

and slowly titrated (e.g., by no more than 25%-50%), no more frequently than weekly.11,61 Bear in mind pain relief from a methadone dose lasts only 4 to 8 hours, but methadone remains in the body much longer (8 to 59 hours).62 Patients should be counseled never to exceed prescribed dose, and methadone doses are scheduled, not taken as needed. Practitioners without experience and knowledge of methadone should seek expert consultation before prescribing.61

Most opioids fall into Category C, indicating evidence of potential harm to the fetus from animal studies. Oxycodone is an exception, listed as a Category B medication with no evidence of harm to the fetus from animal studies.63 Codeine and tramadol should be avoided in breastfeeding women due to risks to the infant from ultra-rapid CYP2D6 metabolism in some women.13 In CYP2D6 ultra-rapid metabolizers, codeine changes to morphine and tramadol to M1 faster than in other people, which can result in high and unsafe levels of morphine and M1 in blood and breast milk.64

Considerations with opioids in special populationsWomen should be given information on the potential effects of LTOT for current or future pregnancies, including the risks of life-threatening neonatal opioid withdrawal syndrome (NOWS).13 Babies born to women who are taking opioids are at risk for birth defects (including neural tube defects, congenital heart defects, and gastroschisis), preterm delivery, poor fetal growth, and stillbirth.13

During pregnancy, HCPs and patients together should carefully weigh risks and benefits when making decisions about whether to initiate opioid therapy.13 When caring for pregnant women who are taking opioids, HCPs should arrange for delivery at a facility prepared to evaluate and treat NOWS.13 In pregnant women with OUD, the risk of opioid exposure from MAT should be discussed and balanced against the risk of untreated OUD, which might lead to illicit opioid use associated with outcomes such as low birth weight, preterm birth, or fetal death.65

Several states pain management guidelines recommend the following measures when treating women of child-bearing age:66 • Every woman with reproductive capacity should

discuss with the HCP a method to prevent unintended pregnancy when initiated on opioids

• Agreement should be obtained to inform the HCP if the woman becomes or intends to become pregnant while taking opioids

• Women who plan to become pregnant should be counseled on the risks of opioid exposure to the fetus and referred to an obstetrician

• The obstetrician and HCP should work together to encourage compliance with chronic pain management and prenatal care

• All newly pregnant women should have a urine drug test administered by the appropriate women’s health provider

EXERCISE 2

Joe, 72, presents with disabling osteoarthritis pain in both knees of some years duration. He is taking 40 mg daily of IR hydrocodone/ACET, but pain relief is inconsistent and lasts 2 hours on average. The pain is 5/10 on average, but he experiences spikes to 8/10 that last for days at a time. He has successfully tried physical therapy in the past but feels his ability to participate is now limited by pain. He has had 3 corticosteroid injections, which provided relief that was short lived. His BMI is 33. He no longer works, does not smoke, and has no history of illegal drug use. He drinks 1-2 alcoholic drinks 3 times per week. Depression and PTSD screens are negative, and his SOAPP-R score indicates he is at low risk for abuse behaviors. He takes OTC ibuprofen for times he expects to be active. More often, however, he remains home. His goals include more frequent visits to his daughter’s home, 45 minutes away, and to attend church twice a week. He has many friends in his church and misses socializing with them. The orthopedic surgeon indicates that the patient is not a surgical candidate

How would you structure his therapy?A. Trial an ER opioid at its lowest dose,

request that he discontinue alcohol consumption, and assess in one month

B. Offer topical lidocaine C. Increase the frequency of IR hydrocodoneD. Add a benzodiazepine for relaxation

The patient experiences inconsistent and inadequate short-term pain relief on his current IR regimen and may benefit with an around-the-clock ER opioid trial with appropriate risk mitigation that includes managing alcohol intake. Frequently reassessing the patient for progress in meeting functional goals is an important part of monitoring for chronic pain management and one in which the patient should actively participate. Although the patient is currently at low risk for abusing prescribed opioids, it is necessary to remain alert to changes in the patient’s social environment, pain control, and other stressful factors that could increase risk. The best answer is A.

Instructions: Take 5 minutes to read the case below and answer the question as it relates to the case presented.

29

• If a urine result is positive for unprescribed controlled substances or illicit drugs during a prenatal visit, the woman should have another upon admission for delivery to help identify the infant at risk for NOWS

Patients with renal and hepatic impairment need extra caution in initiation and titration of opioid doses and increased monitoring.13 In patients with renal compromise, accumulation resulting in toxicity has been observed in case studies; monitoring for opioid toxicity and use of nonopioids when possible are advised.67

Avoid LTOT in children and adolescents for most chronic pain problems.14 Accidental exposure to and ingestion of opioids can result in death.

Genetic and phenotypic variations influence how quickly or well individuals metabolize opioids and other drugs.68 Medical conditions, including kidney and liver disease, also cause variations in opioid metabolism.68 Pharmacogenetic testing is available to help guide clinical decision making. For example, the FDA has approved tests to determine whether a patient is a CYP2D6 ultra-rapid metabolizer.64 However, little data exist to inform the practice of pain management, and these tests are not routinely performed.69 Testing may help HCPs make individual treatment decisions while keeping in mind genetics is only one of many factors affecting drug metabolism and responses.

Older adults (≥65 years) require cautious opioid dosing and management as they may have numerous co-occurring medical problems with treatments that increase the risk for polypharmacy and harmful drug interactions.11 Their risk for falls and cognitive effects with sedating medications and their sensitivity to analgesic effects are increased. In addition, prescription drug or other substance abuse may be difficult to spot, mimicking symptoms of common conditions such as dementia, diabetes, and depression. Initial doses should be 25–50% lower than in those who are younger.14

Cancer survivors should be evaluated for a recurrence or secondary malignancy with any new or worsening pain symptoms.14

Sleep disorders co-occur frequently with chronic pain. For patients with moderate or severe sleep-disordered breathing, avoid LTOT whenever possible.13 Some clinicians recommend that all patients who are considered for LTOT receive a sleep study prior to therapy or when higher dosages are considered.61

For patients who experience a nonfatal opioid overdose during pain management, it is recommended to work to reduce opioid dose and discontinue opioids whenever possible.13

Ensure that the patient is optimally treated for depression and other mental health disorders: Consider using tricyclic or SNRI antidepressants for combined analgesic and antidepressant effects.13

Absolute contraindications for LTOT include:12

• Known hypersensitivity to active ingredients or other components of opioid analgesics

• Significant respiratory depression or compromise

• Acute or severe bronchial asthma• Known or suspected paralytic ileus and

gastrointestinal obstruction • Evidence for or history of diversion of controlled

substances (e.g., forged prescriptions, pharmacy robberies, selling own prescription drugs, theft of others’ drugs)

The Department of Veterans Affairs/Department of Defense (VA/DoD) practice guideline lists concomitant use of benzodiazepines as a contraindication to initiating LTOT.12

Pharmacokinetics (PK) influence the bioavailability of a drug, the production and elimination of metabolites, and the activity of metabolic enzymes.68 Most opioids are metabolized through the liver microsomal cytochrome P-450 (CYP) system with CYP2D6 or CYP3A4 being responsible for much metabolism of opioids and many other drugs. Certain clinical applications are relevant. Slow metabolizers of CYP2D6 may gain little benefit from codeine, for example. Opioids metabolized through the CYP450 system, including codeine, oxycodone, hydrocodone, fentanyl, tramadol, and methadone, may have heightened or reduced CYP450-associated effects with drug combinations, while morphine, oxymorphone, and hydromorphone are not as prone to such interactions.70

Drug interactions and other safety issuesThe risk of drug interactions with an opioid

is determined largely by which enzyme systems metabolize the opioid.68 Interactions with inhibitors or inducers of certain enzymes may produce clinically relevant effects.68 Potential drug–drug interactions raise great concern when prescribing opioids as follows:60

• CNS-depressants including alcohol, benzodiaz-epines, sedatives, hypnotics, tranquilizers, and tricyclic antidepressants can potentiate sedation and respiratory depression caused by opioids.

• Alcohol exposure can rapidly release or increase drug level of some ER opioid formulations

• Combining opioids with monoamine oxi-dase inhibitors (MAOIs) increase respi-ratory depression effect; may cause se-rotonin syndrome with certain opioids Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone Initiating CYP 3A4 inhibitors or discontinuing CYP 3A4 inducers can result in higher than ex-pected opioid blood levels leading to overdose

To prescribe safely, one should also comprehend a drug’s effects within the body or pharmacodynamics, such as binding action to opioid and other receptors and the location of the binding action.68 Essentially, all opioid drugs have similar pharmacodynamic actions, although individual response may vary. Both PK and PD contribute to the onset and duration of various effects, such as analgesia, as well as the vulnerability to toxicity.

Daily dosage thresholds are now common and may be part of state law. Some states have limits ranging between ≥50 morphine milligram equivalents (MME)/day to ≥90 MME/day. The CDC recommends prescribing opioids only if nonopioids are ineffective, exercising caution at any dose, prescribing the lowest effective dose, reassessing risk vs. benefit at ≥50 MME/day, avoiding increasing dosage to ≥90 MME/day or carefully considering rationale.13 It must be reemphasized that these recommended ceiling doses do not remove the necessity of exercising caution at any dose or the importance of individualizing the dose.

Medication errors may result from miscommunication, packaging design, confusion caused by similar drug names, and other sources.

Abuse-deterrent formulationsA number of abuse-deterrent formulations (ADFs)

of opioid analgesics are available and numerous additional technologies are in development. The FDA defines abuse-deterrent (AD) properties as those that deter but do not prevent all abuse.37 These formulations generally incorporate physical barriers designed to deter crushing and chewing, chemical barriers to resist extraction of the opioid in common solvents for injection, or opioid antagonists to block euphoria when a pill is altered. If a product has AD properties, the risk of abuse is lower than it would be without these properties. However, because AD technologies aim to frustrate manipulation of the pill, the FDA cautions that abuse by swallowing intact capsules is not addressed.

An ADF may be useful for a person who needs an opioid to manage pain but is at high risk for abuse through routes of administration that include manipulation of the pill, such as chewing, crushing, snorting, or injecting. When prescribing these formulations, HCPs should counsel patients that an ADF may not prevent all forms of overuse and abuse, that addiction to an ADF is still a risk as with any other opioid, and that overdose by ingesting too many pills may still occur. Thus, ADF products still carry a boxed warning.

Data on AD properties are included in the Drug Abuse and Dependence section of the Prescribing Information under 9.2 Abuse and, if missing or located elsewhere, the FDA does not consider the product an ADF. The label contains information on the types of studies conducted and routes of abuse the ADF is expected to deter (e.g., oral, intranasal, insufflation, intravenous).

30

Common opioid side effects with suggested management strategies are listed in Table 4.11

Opioid RotationA patient who suffers inadequate analgesia or

intolerable side effects from one opioid may benefit from rotation to a different opioid, because individual opioid response varies from one drug to another.68 Because mu-agonists produce varied effects, switching a patient to a different drug may allow for pain control at lower doses. Care must be taken in switching to a different opioid, because tolerance to a particular opioid drug does not translate to tolerance to another – a concept known as incomplete cross-tolerance. Patients should be monitored especially closely during any dose or formulation changes.

Equianalgesic dosing tables, conversion charts, and calculators allow for the conversion of any opioid dose to the standard value of morphine, referred to as morphine milligram equivalents (MME) or morphine equivalent doses (MED). Equianalgesic dose tables have limitations in that supporting studies were conducted on single doses in patients with limited opioid exposure and did not incorporate needs for chronic dosing.71 When using equianalgesic dosing tables as a starting point for opioid rotation, HCPs are advised to reduce the dose (≥25% to 50% is advised, more with methadone) when converting to the new opioid.11 A greater reduction is advised in patient who are older or medically frail. A 75% to 90% reduction72 or considering the patient opioid naïve is advised for rotating to methadone followed by careful monitoring.11 Conversions to transdermal routes of fentanyl and buprenorphine require special considerations: HCPs should closely follow instructions in the prescribing information.

Informed Consent and Treatment AgreementsPatients started on LTOT should be informed of

the potential risks and benefits. The most serious risk with any opioid is respiratory depression leading to death. Patients who have never taken opioids or whose medications or doses will be changed should be counseled to expect short-lived or lasting sedation or other cognitive effects. In addition, it is recommended to include product-specific risks (such as dangers of chewing an ER formulation) in the informed consent document.

An informed consent form should be signed by the patient and retained in the medical record. Items recommended in informed consent include:11,12,73

• Potential risks and benefits of opioid therapy • Risks of OUD, overdose, and death even at

prescribed doses• That evidence for benefit of opioids for LTOT in

CNCP is limited• Nonpharmacological and nonopioid therapeutic

options for pain treatment• Potential side effects (both short and long term)

such as cognitive impairment and constipation • The likelihood that tolerance and physical

dependence will develop• Risks of drug interactions and over-sedation • Risks of impaired motor skills affecting driving,

operating machinery, and other tasks • Serious adverse effects• Signs and symptoms of overdose• Risks when combining opioids with other CNS-

depressants, including benzodiazepines and alcohol

• The importance of disclosing all medications and supplements

• How to handle missed doses Opioid treatment agreements (OTAs) that spell out

patient and provider expectations and responsibilities are recommended by most opioid guidelines.11,14 Recommendations of what an OTA should contain include:73

• Treatment goals in terms of pain management, restoration of function, and safety

• Patient’s responsibility for safe medication use (not taking more than prescribed; dangers of using in combination with alcohol, cannabis, or other substances like benzodiazepines; not altering pills)

• Instructions for secure storage and safe disposal • Patient’s responsibility to obtain prescribed

opioids from only 1 clinician or practice • Patient’s responsibility of getting the

prescriptions filled at only 1 pharmacy • Patient’s agreement to periodic drug testing • Prescribing policies, including handling of

early refills and replacement of lost or stolen medications

• Reasons for which drug therapy may be changed or discontinued, including violation of the treatment agreement

• Statement that treatment may be discontinued without agreement by the patient

• HCPs availability policy, including responsibility to make available a covering clinician to care for unforeseen problems and to prescribe scheduled refills

• Education of the patient that the complete elimination of pain should not be expected

Patients should be counseled never to share opioids with any other person. Leftover opioids in the household pose dangers to children and pets, who may ingest them accidentally. Opioids that are unsecured may be stolen by family members or visitors. Opioids should be stored in a locked area or safe that is not available or visible to family members or visitors.11 Leftover opioids, including transdermal fentanyl patches, should not be placed in the trash but should be taken to an authorized drug take-back facility or, if one is not available, flushed down the toilet or washed down the drain immediately.74 Call 1-800-882-9539 or visit the website (https://www.deadiversion.usdoj.gov/drug_disposal/index.html) of the Drug Enforcement Administration (DEA) for more information about drug disposal, National Prescription Drug Take-Back Day events, and local DEA-authorized collectors.

Naloxone AdministrationNaloxone can be used to save lives during

overdose, and its presence increases safety for the patient and others who live in or visit the home.13 Take-home naloxone is recommended with the presence of opioid overdose risk factors, such as history of overdose, history of SUD, clinical depression, opioid dosages ≥50 MME/day, or concurrent benzodiazepine use13 or with evidence of increased risk by other measures. Approved naloxone products have three delivery formulations. One is an injectable delivery system that requires professional training to administer. Two easily administered products are an auto-injection device that provides verbal instructions to the user once activated and a nasal spray that requires no assembly. Patients given an automatic injection device or nasal spray should keep the item available at all times.33 Naloxone administration can cause withdrawal symptoms, and people who have been administered naloxone should have follow-up medical care.

Table 4. Common Opioid Side Effects and Suggested Management Strategies

Side Effect Management

Respiratory depression Screen for sleep apnea; avoid sedatives, benzodiazepines, barbiturates and alcohol

Constipation Increase fiber and fluids; start prophylactic laxative treatment, particularly in elderly

Nausea or vomiting Antiemetic therapy; symptoms tend to diminish

Hormonal deficiencies Screen symptomatic patients (fatigue, sexual dysfunction

Sedation, mental clouding Counsel as to home, work and driving safety and concomitant CNS depressant risks; symptoms tend to diminish

Pruritis Treatments largely anecdotal (may include reducing dose, changing medication)

Hyperalgesia Reduce dose or change medication

31

Laws vary by state regarding immunity for physicians or laypeople administering naloxone and can be checked here: http://www.pdaps.org/datasets/laws-regulating-administration-of-naloxone-1501695139. Signs of an opioid overdose include:61,75

• Small, constricted “pinpoint pupils” • Falling asleep or loss of consciousness • Slow, shallow breathing • Choking or gurgling sounds • Limp body • Pale, blue, or cold skin • Snoring heavily and cannot be awakened • Periods of ataxic (irregular) or other sleep-

disordered breathing • Trouble breathing • Dizziness, confusion or heart palpitations

Patients and their caregivers and other family members should be counseled to do the following if an opioid overdose is suspected:75

• Call 911 immediately • Administer naloxone if available • Try to keep the person awake and breathing• Lay the person on his or her side to prevent

choking• Stay with him or her until emergency workers

arrive Examples of informed consent and agreement

documents are available online from the New Hampshire Medical Society at https://www.nhms.org/content/examples-opioid-informed-consent-agreement. These may be combined into one document and adapted to the HCPs needs and preferences.

The REMS-developed Patient Counseling Guide (Table 9) and product-specific Medication Guide should be given to patients, who, along with their caregivers, should be encouraged to read these materials. Prescribers may download a medication guide for patients at http://www.accessdata.fda.gov/scripts/cder/daf/ and FDA Patient Counseling Guide at https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Patient_ Counseling_Guide.pdf.

Reporting adverse eventsAll suspected adverse events and reactions with

opioids may be reported directly to the FDA’s MedWatch Reporting System by calling 1-800-FDA-1088 (1-800-332-1088); by going online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; or by mail using the Form FDA 3500 available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf.

Ongoing Management of Patients on Opioid Analgesics

Patients on LTOT should be monitored regarding potential misuse and abuse as well as for therapeutic goals of pain relief and function. The CDC has issued a guideline stating that patients on opioid therapy should be reevaluated within 1-4 weeks of initiation

or dosage change and every 3 months thereafter to ensure benefits outweigh risks.13 Other guidance has recommended using risk stratification to set clinic visit frequency and other monitoring measures as determined by patient risk category (low, moderate, or high risk) during initial screening and clinical follow-up.11 The clinical principle is that patients with more comorbidities or higher abuse risk require more stringent monitoring measures and more frequent follow-up than patients with less risk for harm.

HCPs should evaluate and document effects of LTOT on include analgesia, daily activities, adverse effects, aberrant drug-related behaviors, cognition, function, and quality of life. Tools available to assist with frequent reassessment and documentation include the Pain Assessment and Documentation Tool (PADT)76 and the COMM.44 Keep in mind patients may misuse opioids for various reasons that include misunderstanding of medical instructions, unauthorized self-medication of pain, mood, or sleep problems, wish to avoid withdrawal symptoms, desire for psychoactive reward such as euphoria, compulsive use due to OUD, and illegal diversion for financial gain.77

Ongoing periodic monitoring should incorporate checks of the PDMP and UDT.78 The recommended frequency for periodic review of PDMP data ranges from every prescription to every 3 months.13 A consensus-based recommendation for UDT frequency is to test every patient at least 1 time annually and higher-risk patients from 2 to 3 times annually.78 It is best to present UDT, PDMP data, and other monitoring measures to patients as a routine, consensual part of medical care using nonjudgmental language.

Results of a UDT are used to identify the presence of prescribed medications and the use of unauthorized prescription and illegal drugs. The UDT may also help guide clinical decisions, serving as alert to potential drug-drug interactions. The first step is generally immunoassay testing that can be done at the point of care (POC) and help quickly establish whether a new patient has recently ingested illegal drugs or other opioid and prescription drugs.78 The immunoassay detects certain drug classes but typically cannot isolate specific opioids.

If results of a POC test are inconsistent with medical direction, the next step is a quantitative evaluation, usually via gas chromatography/mass spectrometry (GC/MS) technology or liquid chromatography dual mass spectrometry (LC/MS/MS). These tests are more specific than immunoassay and can detect actual drugs and their metabolites. Some laboratories offer definitive testing via LC-MS/MS that may be given as the initial test; however, most guidelines still suggest immunoassay ahead of confirmatory testing due to cost concerns.78

Healthcare providers should exercise caution in interpreting UDT results, recognizing limitations and taking care not to stigmatize patients but to base interpretation on objective results.13

Limitations of UDT include:78

• Cross-reactivity with other drugs or substances• Potential for false positives (e.g., poppy seeds

positive for opiates)• Potential for false negatives• Variable drug metabolism• Laboratory error

Unexpected results, such as the absence of prescribed medications that could indicate diversion, should be discussed with the patient and documented in the record along with plans to address the results.

In the presence of ongoing or severe ADRBs, HCPs should consider that patient suffering may be linked to OUD or other SUD or psychiatric disorders. Criteria of an OUD may be reviewed in Table 2. Signs and symptoms seen in a clinical scenario include:39

• Taking opioids compulsively and long term for no legitimate medical purpose

• If pain is present, taking opioids in excess of prescription

• Obtaining opioids from unauthorized sources• Falsifying or exaggerating medical problems to

receive opioids• Significant tolerance and physical dependence

(also occurs in non-SUD patients)• Conditioned responses of craving that persist

after cessation Other circumstances that may accompany OUD include:39

• History of drug-related crimes• History of legal problems• Marital problems, including divorce• Unemployment and irregular employment

When an active SUD or a recent SUD history is present, HCPs should strongly consider referral to SUD specialists and pain specialists regarding pain management and/or tapering opioids and managing pain with nonopioid therapies.13

Before moving on to the next section, please spend the allotted time on Exercise 3 on the next page.

Discontinuing OpioidsReasons to discontinue opioid therapy may include

failure to achieve sufficient analgesia, intolerable side effects, resolution of pain, development of OUD, or repeated or egregious ADRBs.Serious nonadherence to the treatment plan or other unsafe ADRBs include:11

• Repeatedly increasing dose without HCP knowledge

• Sharing medications• Unapproved opioid use • Use of illicit drugs• Obtaining opioids from unauthorized sources• Prescription forgery• Multiple episodes of losing prescriptions• Polysubstance abuse

32

Before initiating opioid therapy, HCPs should have an exit strategy in place to humanely taper opioids and treat pain or refer for treatment with alternatives to opioid therapy. In an outpatient setting, taper should be done to avoid opioid withdrawal in physically dependent patients. Approaches range from a slow 10% dose reduction per week to a more rapid 25% to 50% reduction every few days.11 It may be medically risky to abruptly discontinue opioids in a physically dependent patient. Taper may be accomplished in a rehabilitation setting if the patient is unable to reduce opioid dose. Consider the expert-consensus guidelines below:12,61

• Evaluate comorbidities, the patient’s psychological condition, and other relevant factors before beginning the taper

• Educate the patient and family about the taper protocol

• When safety allows, consider a 5% to 20% reduction every 4 weeks. Individualize this schedule based on patient needs and symptoms. Some patients may tolerate a faster taper, while others may need to slow the dose adjustments to monthly rather than weekly

• Managing opioid abstinence syndrome if symptoms (e.g., nausea, diarrhea, muscle pain, myoclonus) occur, using nonopioid analgesics and adjuvant agents

• Referral for counseling or other support during the taper if there are significant behavioral issues

• For complicated withdrawal symptoms, refer the patient to a pain specialist or chemical dependency center

Referral should include, as indicated, treatment of OUD, which may include MAT, or management of psychiatric illnesses.33 Diversion of opioids or other controlled substances is a contraindication for continuing opioid therapy.12

Documenting in the Patient Record It is essential to diligently document in the patient

record all treatment decisions, patient counseling sessions, and risk management measures when treating patients with opioids (Table 5). Good documentation facilitates clinical decisions and ensures timely attention to medical issues.

It is also necessary for compliance with federal and state regulations that govern the prescribing of controlled substances and to practice in concert with best practices outlined by medical boards and specialty guidelines for pain treatment. When federal and state law conflict, the more restrictive law applies. The Prescription Drug Abuse Policy System (PDAPS), funded by the National Institute on Drug Abuse, tracks key state laws related to prescription drug abuse here: http://www.pdaps.org/.

Each practitioner must keep current with applicable state regulations, which are evolving rapidly and contain restrictions and directives such as:79 • Expanded PDMPs and new requirements for

their use• Required pain management or prescribing

education • Required written pain treatment agreements• Requirements for a physical exam prior to

prescribing• Requirements for a bona fide patient-physician

relationship• Presentation of patient identification to a

pharmacist prior to receiving opioids• Medicaid plans requiring single prescriber and

single pharmacy for certain high-risk patients

A Primer on Addiction MedicineAddiction, while not a DSM-5 diagnosis, is still a

commonly used term that generally refers to severe OUD.80 As a primary, chronic, neurobiologic disease whose development and manifestations are influenced

by genetic, psychosocial, and environmental factors, a severe OUD is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.1 Understanding the fundamentals of addiction medicine can help HCPs identify and manage patients with severe OUD without the use of stigmatizing language but with the recognition of severe OUD as a disease state.

All reinforcing drugs exert effects as a result of dopamine stimulation in the mesolimbic system of the brain.81 When a drug stimulates the brain’s mu opioid receptors, cells in the ventral tegmental area release dopamine into the nucleus accumbens, causing pleasurable feelings.81 The PK and lipophilicity of the drug and its route of administration influence the speed and amount of dopamine released and thus the degree of reward experienced by the user. Intravenous and inhalational use speeds onset more than oral ingestion. However, ER/LA opioids can be altered by the user to produce a rapid onset of action by crushing, chewing, or dissolving in liquids, for example.60

EXERCISE 3

Luke, 23, presents near clinic closing time and requests 2 prescriptions for ongoing left knee pain, an ER and IR oxycodone formulation. He had 2 surgeries more than 1 year ago. Physical exam shows surgical scars, no swelling, and limited range of motion on flexion. He says he is allergic to NSAIDs and codeine makes him vomit. He has participated in physical therapy but says it made his knee worse. He describes his pain as stabbing and near constant VAS 9/10. He resists UDT screening, claiming it invades his privacy. Initial urine immunoassay is positive for THC and cocaine. A check of the PDMP reveals he has obtained 28 prescriptions for opioids (IR oxycodone/ACET, ER oxycodone) from 4 different providers and 5 pharmacies.

Instructions: Take 5 minutes to read the case below and answer the question as it relates to the case presented.

How do you handle prescribing for this patient?

A. Write ER opioid prescription to last through weekend, refer back to earlier provider

B. Write 30-day ER and IR opioid prescription, order diagnostic tests on injury

C. Do not write opioid prescription today; send UDT for further laboratory testing; refer for addiction specialist evaluation

Notes:

The best choice would be C.

Table 5. Items to Document in the Patient Record11,71

Informed consent

Opioid treatment agreement(s)

Medical history

Results of physical exam, diagnostic, and imaging tests

Pain intensity and level of functioning

Results of risk assessment, screening tools

Rationale for opioid therapy and previous treatments

Description of all treatments provided (date, type, dose, quantity)

Prescription of naloxone provided and ratio-nale

All prescription orders for opioids and other controlled substances

Instructions to patient, including addressing nonadherence and ongoing discussions of risks vs. benefits

Assessments of progress toward achieving therapeutic goals

Notes on consultations with specialists

Presence of adverse events

Adherence to prescribed therapies, including results of UDT and PDMP checks

Notes on continuing, revising, or terminating treatment

Authorization for release of information to other treatment providers

• UDT = urine drug testing• PDMP = prescription drug-monitoring

programs

33

As the stimulation of the brain’s reward system leads to repeated ingestion, other areas of the brain create conditioned associations or lasting memories that associate reward with environmental cues of drug use. Normally, feedback from the prefrontal cortex helps most individuals to overcome drives to obtain pleasure through unsafe actions.81 However, this feedback becomes compromised in individuals who become addicted to drugs. As the person develops tolerance and dependence (susceptibility to withdrawal symptoms), more drug is necessary to obtain the same reward. The locus coeruleus area of the brain plays an important role in the production or suppression of withdrawal symptoms. When an OUD is present, the compulsion to use opioids repeatedly goes beyond the reward drive. This further use promotes long-lasting changes in the brain that disallow the individual to experience pleasure and that underlie the compulsive drug use despite adverse consequences that characterizes OUD.81

Opioids and Concurrent CannabisRelief from pain is the most common condition

patients cite for the medical use of cannabis.82 The scientific literature on the therapeutic use of cannabis is growing, and public sentiment is shifting to accommodate the potential for benefit in pain therapy and other areas.82 Medical cannabis laws are associated with reductions in opioid analgesic overdose mortality on a population level, but cause and effect is not proven.83 However, synthesis of the data has been incomplete to guide clinical choices, and the short- and long-term health and safety effects have remained elusive. There are some data suggesting those who take medical marijuana are similar demographically to those who use marijuana recreationally.84

In 2016, a committee appointed by the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine comprehensively reviewed evidence of harms and benefits with the goal of recommending research directions and identifying areas of therapeutic benefit.82

The committee reported that there is:• Conclusive or substantial evidence that cannabis

is effective for the treatment of chronic pain in adults

• Moderate evidence that cannabinoids (primarily nabiximols) are effective for improving short-term sleep outcomes in individuals with sleep disturbance associated with obstructive sleep apnea syndrome, fibromyalgia, chronic pain, and multiple sclerosis

• Limited evidence that cannabinoids (nabiximols, dronabinol, and nabilone) are ineffective for reducing depressive symptoms in individuals with chronic pain

In adults with chronic pain, those treated with cannabis or cannabinoids were more likely to experience a clinically significant reduction in pain symptoms.82 A number of patients with pain appear

to be replacing opioids with cannabis; however, it is important to note that the FDA has not approved cannabis for the treatment of chronic pain.82 In addition, little is known about the efficacy, dose, routes of administration, or side effects of available cannabis products.

A systematic review and meta-analysis of double-blind randomized controlled trials comparing cannabis preparations to placebo in patients with chronic pain found that cannabis reduced pain intensity compared to placebo, with an overall effect size of -0.61 (-0.84 to -0.37).85 The identified harms included euphoria, dysphoria, disturbances in perception and motor function, altered cognitive function, and gastrointestinal side effects. The studies have several limitations that include short follow-up periods, small sample sizes, and inconsistent and incomplete reporting methods.

Some patients who are taking opioids for pain are also using cannabis concurrently. A prospective cohort study of patients with musculoskeletal pain who are also on a stable dose of opioids was conducted to compare those who endorsed past-month cannabis for pain to those who denied any cannabis or illicit drug use.86 Of 17% who endorsed past-month cannabis use for pain, 31% had a current medical marijuana card, and 66% reported that marijuana was helpful for reducing pain. Those who used cannabis for pain had higher rates of nicotine use, risk for prescription opioid misuse, and hazardous opioid use. No difference between groups were found in opioid dose, pain intensity, pain interference, or depression severity.Because some patients who are taking opioids will elect to use cannabis, HCPs should be aware of certain clinical recommendations:87

• Keep current with relevant federal, state, and institutional policies and laws

• Establish goals of care for cannabis use • Screen for signs of misuse, cannabis use

disorder (CUD), and diversion• Counsel patients on harms and risks on the

basis of symptoms, condition, and comorbidities• Advise on routes of administration using current

evidence base• Continually monitor similarly to opioids (informed

consent, written agreement, regular follow-up, functional status, considering periodic urine testing, symptom severity, and use of other medications or substances)

• Monitor for other harms, including car accidents and falls

• Advise on discontinuation or referral to CUD treatment if pain relief and function goals are not being met without harm

The most common route of administration is smoking, despite risks of pulmonary effects. Some evidence suggests vaporization may be safer in this regard, although other research notes similar exposure as smoking to carbon monoxide and other respiratory toxins.87 Other delivery options include edibles and extracts.

Patients may develop CUD and be unable to stop use on their own even though it is interfering with their health and function. Signs of CUD include:86

• Using a larger quantity or over a longer duration than intended

• Unsuccessful attempts to limit or quit • Significant amounts of time spent obtaining

cannabis • Cravings • School or occupational impairment • Social or interpersonal impairment • Reduction of social, occupational, or recreational

activities • Recurrent use in physically harmful situations • Continued use despite recurrent physical or

psychological harms • Tolerance • Withdrawal Although not specific to pain therapy, useful measures to screen for CUD include:• Single question: How often in the past year did

you use marijuana (never, less than monthly, monthly, weekly, daily or almost daily)86

• The 8-item Cannabis Use Disorders Identification Test-Revised (CUDIT-R)88

• Comprehensive Marijuana Motives Measure89

Use of Short-Acting OpioidsThe FDA has sent letters to 74 manufacturers

of IR opioids notifying them that they must make REMS-compliant training available to prescribing clinicians.91 Once finalized, the action is expected to cover 277 IR opioid analgesics.

The most recent VA/DoD practice guideline recommends against initiating opioid therapy with ER/LA agents and describes additional areas of dosage and clinical considerations for short-acting opioids (i.e.., IR opioids) shown in Table 6.12 No strong evidence supports the choice of one opioid agent over another for LTOT.12 These guidelines are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing and exclusive course of management. These guidelines are designed to provide information and assist decision making.12 In these guidelines are tables for short-acting opioids that have been incorporated into Exercise 4 (Pg. 34). PLEASE SPEND THE ALLOTED TIME COMPLETING THIS EXERCISE.

General Drug Information for the Class of ER/LA OpioidsThe class of ER/LA opioids has some commonalities that limit their usage:60, 90

• Not for use as needed• Not for mild pain or pain that is not expected to

persist for an extended duration• Not for use to treat acute pain• Not for use in opioid-naïve patients: tolerance

is critical to safe use (see individual product PI for criteria for strengths, daily doses, special populations, and product-specific safety concerns)

34

Exercise 5 (Pg. 38) covers general and specific information for ER/LA Opioid Analgesics, including Table 7 and Table 8. PLEASE SPEND THE ALLOTTED TIME COMPLETING THIS EXERCISE.

For detailed information, prescribers can refer to prescribing information available online via DailyMed at www.dailymed.nlm.nih.gov or Drugs@FDA at www.fda.gov/drugsatfda.

SummaryPrescription opioid abuse and overdose is a

national crisis, and HCPs who treat pain are called upon to play a role in prevention. Risk mitigation and best practice strategies include understanding how to assess patients for treatment and how to initiate, modify, and discontinue doses of SA and ER/LA opioids. Familiarity with monitoring practices that include periodic UDT and check of PDMP data is also necessary.

Patients should also receive instruction on proper storage and disposal of opioid analgesics and (when indicated) how to administer naloxone to reverse opioid-related overdose. The goal is to ensure that opioids are used in the clinical context of a comprehensive pain treatment plan that benefits patients without contributing to opioid-related harm in the patient or society.

EXERCISE 4

USE OF SHORT-ACTING, ORALLY-ADMINISTERED OPIOIDS IN ADULTS

Instructions: Spend 20-25 minutes completing the following

1. Conduct a detailed review of Table 6, which includes Drug Information for Short Acting, Orally Administered Opioids in Adults.

2. Complete the learning questions below related to Short Acting, Orally Administered Opioids in Adults only after completing step 1.

1. Name 3 drugs that act as CYP-2D6 inhibitors and describe their effects on opioid metabolism.

2. Name a contraindication for the use of oxymorphone.

3. Name the maximum daily dose of acetaminophen in healthy patients and in patients with alcoholism or hepatic impairment.

4. Describe seizure concerns with use of tramadol.

5. Describe the initial dose of an oxycodone-combination product for an opioid-naïve patient.

35

Table 6. Use of Short-Acting, Orally-Administered Opioids in Adults12

Short-Acting Opioids1

Initial Oral Dosage (in opioid-naïve)

Additional Dosage Information

Analgesic Onset (min) Peak (min) Duration

(hr)

Dosing In Special Populations

Other Considerations

Codeine (alone or in combination with APAP or ASA) - Codeine available as 15, 30 and 60 mg tablets - Combination products vary in codeine content from 15 to 60 mg/dose unit

- 15 to 30mg every 4 to 6 hr - Initial dose based upon codeine component, maximum dose based upon non- opioid component

- Maximum APAP dose: 4000 mg/d (2000 mg/d in chronic alcoholics or in hepatic impairment) - Analgesic ceiling effect occurs with codeine at doses>60 mg/dose - Codeine alone is a weak analgesic; more effective alternatives are available (including codeine in combination with APAP or ASA)

15 to 30 30 to 60 4 to 6

- Elderly or debilitated: Use with caution - Hepatic dysfunction: Conversion to active metabolite (morphine) may be reduced in patients with cirrhosis; avoid use in patients with liver disease - Renal dysfunction: Use lower dosage or an alternative analgesic

- Codeine may be less effective in patients with decreased CYP- 2D6 activity (due to poor CYP- 2D6 metabolism or CYP-2D6 inhibiting drugs2) because of decreased conversion to the active metabolite, morphine - CYP-2D6 ultra-rapid metabolizers3 can have extensive conversion to morphine with increase in opioid-mediated effects

Hydrocodone (in combination with APAP, ASA, or IBU)- Combination products vary in hydrocodone content (2.5 to 10 mg per dosage unit)

- 5 to10mg every 6 hr (hydrocodone component) - Initial dose based upon hydrocodone component - Maximum dose based upon non-opioid component

- Maximum dose: - 60 mg/d (4000 mg/d APAP; 2000 mg/d APAP in chronic alcoholics or hepatic impairment) for hydrocodone + APAP combination OR - 37.5 to 50 mg/d (1000 mg/d IBU) for hydrocodone + IBU combination

10 to 20 60 to 100 4 to 8

- Elderly or debilitated: Use with caution; start with reduced dose (2.5-5 mg) of hydrocodone component - Hepatic dysfunction: Use with caution

- Conversion to the active metabolite, hydromorphone, may be decreased in patients with decreased CYP-2D6 activity (due to poor CYP-2D6 metabolism or CYP-2D6 inhibiting drugs2) - CYP-2D6 ultra-rapid metabolizers3 can have extensive conversion to hydromorphone with potential increase in opioid-mediated effects

Hydromorphone Available as oral liquid 1 mg/ml, and 2, 4, and 8 mg tablets

- 2mg every 4to 6 hr May give an initial dose of 4 to - 8 mg for severe pain

There is no optimal or maximum dose of hydromorphone; patients on LOT are likely to become tolerant4 and require doses higher than the usual dosage range to maintain the desired effect

15 to 30 30 to 60 3 to 4

- Elderly or debilitated: Use with caution, start at 25% to 50% of usual dose at low end of dosing range - Hepatic / Renal dysfunction: Reduce initial dose for moderate impairment, more with severe impairment

Morphine - Available as oral solution (10 or 20 mg/5 ml, or 100 mg/5 ml for opioid- tolerant patients only) or as 15 or 30 mg tablets

10 to 30mg every 4 hr There is no optimal or maximum dose of morphine; patients on LOT are likely to become tolerant4 and require doses higher than the usual dosage range to maintain the desired effect

30 603 to 5

- Elderly or debilitated: Give with extreme caution; use lower dose - Hepatic dysfunction: Use carefully in patients with cirrhosis and consider reducing dose or extending dosing interval by 1.5 to 2 times; half-life may be doubled (3 to 4 hr) and bioavailability is increased - Renal dysfunction: Reduce dose or, if severe renal impairment exists, avoid use (see Other Considerations)

- M6G, an active metabolite, may accumulate in renal impairment - M3G, a metabolite without analgesic activity, may accumulate in renal impairment; this metabolite has been implicated in morphine-induced neurotoxicity, hyperalgesia, and allodynia

36

Table 6. Use of Short-Acting, Orally-Administered Opioids in Adults12 (Continued)

Short-Acting Opioids1

Initial Oral Dosage (in

opioid-naïve)

Additional Dosage Information

Analgesic Onset (min)

Peak (min) Duration

(hr)

Dosing In Special Populations Other Considerations

Oxycodone (alone or in combination with APAP or ASA)- Single-agent oxycodone available as oral solution 5 mg/5 ml, 20 mg/1 ml, and oral tablet 5, 10, 15, 20, and 30 mg- Combination products vary in oxycodone content, 2.5 to 10 mg per dose unit

- 5 to15mg every 4 to 6 hr- Initial dose based upon oxycodone component- Maximum dose based upon non-opioid component

- For combination products, maximum dose is limited by APAP or ASA content (4000 mg/d for both; 2000 mg/d APAP in chronic alcoholics or patients with hepatic impairment)- There is no optimal or maximum dose of oxycodone; patients on LOT are likely to become tolerant4 and require doses higher than the usual dosage range to maintain the desired effect

10 to 15 30 to 60 3 to 6

- Elderly or debilitated: reduce dosage- Hepatic / Renal: Use with caution; consider reducing dose and increasing frequency of dosing

- Conversion to the active metabolite, oxymorphone, may be decreased in patients with decreased CYP-2D6 activity (due to poor CYP-2D6 metabolism or CYP-2D6 inhibiting drugs2)

Oxymorphone- Available as 5 or 10 mg tablets

5mg every 4 to 6 hr

- There is no optimal or maximum dose of oxymorphone; patients on LOT are likely to become tolerant4 and require doses higher than the usual dosage range to maintain the desired effect

30 to 45 N/A4

- Elderly or debilitated: Use with caution and start at low end of dosing range; levels are increased 40% in patients ≥65 years- Hepatic dysfunction:

- Mild hepatic impairment: Use cautiously, start at low end of dosing range- Moderate and severe hepatic impairment: Contraindicated

- Renal dysfunction: Bioavailability is increased 57-65% in moderate and severe impairment; start at lower doses and adjust slowly

- Food has been shown to increase peak levels of oxymorphone immediate-release by 38%; must be taken on an empty stomach at least 1 hr before or 2 hr after a meal- Must NOT be taken concomitantly with alcohol; alcohol (240 ml of 4% to 40% ethanol) can cause highly variable effects on peak drug levels, ranging from a decrease of 50% to an increase of 270% (demonstrated with ER oxymorphone)

Tapentadol- Available as 50, 75, or 100 mg tablets

50 mg every 4 to 6 hr

- Subsequent dose is 50, 75, or 100 mgevery 4 to 6 hr, adjusted to analgesia and tolerability- Second dose may be given 1 hr after the first dose if necessary- Max recommended dose: 700 mg onfirst day, 600 mg on subsequent days- Use tapentadol only under carefulmedical supervision at lowest effective dose- Patients on LOT are likely to becometolerant 4 and require doses higher than the usual dosage range to maintain the desired effect

N/A (rapid) 604 to 6

- Elderly: Consider starting at the lowest recommended dose- Hepatic dysfunction:

- Mild hepatic impairment: No dosage adjustment- Moderate hepatic impairment: Start at 50 mg and give subsequent doses at least 8 hr apart (max. 3 doses in 24 hr)- Severe hepatic impairment: Use is not recommended

- Renal dysfunction: No dosage adjustment for mild or moderate renal impairment; not recommended in severe renal impairment- Respiratory dysfunction: Use with caution because of respiratory depressant effects; consider non–mu opioid agonist analgesics

- Must NOT be taken concomitantly with alcohol which can increase serum tapentadol concentration - If used in combination with other CNS depressants, consider dose reduction of one or both agents- Use with or within 14 days of MAOIs is contraindicated

37

Table 6. Use of Short-Acting, Orally-Administered Opioids in Adults12 (Continued)

Short-Acting Opioids1

Initial Oral Dosage (in opioid-naïve)

Additional Dosage Information

Analgesic Onset (min) Peak (min)

Duration (hr)

Dosing In Special Populations

Other Considerations

Tramadol (alone or in combination with APAP)• Tramadol

available as 50 mg tablet, or in tablet combination with APAP (325 mg APAP, 37.5 mg tramadol)

25 mg every morning • May increase by 25 mg per day every 3 days to 100 mg tramadol/d (25 mg every 6 hr)

• Subsequent increments of 50 mg/d may then be made every 3 days to 200 mg/d (50 mg every 6 hr)

• After titration, may give 50 to 100 mg every 4 to 6 hr

• Maximum daily dose of tramadol: 400 mg/d

• Combination product: maximum 4000 mg/d APAP; 2000 mg/d APAP in chronic alcoholics or in hepatic impairment

<60~120 to 240 6

• Elderly or debilitated: In elderly patients >75 years: give <300 mg/d in divided dose; use with caution in patients

• Hepatic dysfunction: Decrease dosage to 50 mg once every 12 hr in patients with cirrhosis

• Renal dysfunction:• CrCl >30 ml/

min: No change in dose or frequency required

• CrCl <30 ml/min: Increase dosing interval to 12 hr and decrease maximum daily dose to 200 mg

• Dialysis patients: Can receive their regular dose on the day of dialysis (<7% of a dose is removed by hemodialysis)

• Slower initiation and titration improves tolerability

• Inhibits reuptake of serotonin and norepinephrine; concomitant use with MAOIs or SSRIs may increase risk of seizures, serotonin syndrome

• Dose carefully or use another agent in patients on serotonergic agents

• Seizures reported within the recommended dosage range; increased risk above recommended dosage range and in patient with seizure disorder, history of seizures, in conditions with increased risk of seizures, or with other drugs that increase seizure risk; observe maximum dose limits

• Serious anaphylactoid reactions reported, often following first dose; patients with a history of anaphylactoid reaction to codeine and other opioids may be at increased risk

Source: VA/DoD practice guideline for Management of Opioid Therapy (OT) for Chronic Pain ( February 2017) https://www.healthquality.va.gov/guidelines/Pain/cot/VADoDOTCPG022717.pdf. Last accessed June,2018.

1 Check local formulary for available formulations.2 CYP-2D6 Inhibiting Drugs: Antiarrhythmics (amiodarone, propafenone, quinidine [strong inhibitor]); analgesics (methadone [weak inhibitor], propoxyphene);antihistamines (diphenhydramine, chlorpheniramine [in vitro], brompheniramine [in vitro], triprolidine [in vitro]); histamine2 receptor antagonists (cimetidine); neuroleptics (chlorpromazine, haloperidol, methotrimeprazine, perphenazine, thioridazine); protease inhibitors (ritonavir), quinine compounds (hydroxychloroquine, quinacrine, quinine); selective serotonin reuptake inhibitors (fluoxetine, fluvoxamine, paroxetine, sertraline), miscellaneous compounds (clomipramine, ketoconazole, ticlopidine)3 CYP-2D6 ultra-rapid metabolizers include 1% of Asian and Hispanic, 1-10% of Caucasians, 3% of African-Americans, and 16-28% of N. African and Arabic populations.4Opioid tolerance is assumed in patients already taking fentanyl 25 mcg/hr OR daily doses of the following oral agents for ≥ 1 week: ≥ 60 mg oral morphine, 30 mg oxycodone, 8 mg hydromorphone, 25 mg of oxymorphone or equianalgesic dose of another opioid.

APAP = acetaminophenASA = acetylsalicylic acidCNS = central nervous systemCrCl = creatinine clearanced = day(s)ER = extended-releasehr = hour(s)IBU = ibuprofenLTOT = long-term opioid therapyM3G = morphine-3-glucuronideM6G = morphine-6-glucuronideMAOIs = monoamine oxidase inhibitorsmg = milligram(s)min = minute(s)mL = milliliter(s)SSRIs = selective serotonin reuptake inhibitors

38

EXERCISE 5

1. Are ER/LA opioids recommended for treating acute pain? Why or why not?

2. Name three classes of drugs that should be avoided by patients who have been prescribed an ER/LA opioid analgesic. Describe the underlying reasoning for avoiding concurrent use of the drugs.

3. Name 3 safety measures to take during the application of the buprenorphine transdermal system.

4. Describe disposal methods for used or unused fentanyl transdermal patches.

Table 7. Drug Information Common to the class of ER/LA Opioid Analgesic Products

A. ER/LA opioid analgesic products are scheduled under the Controlled Substances Act and can be misused and abused.B. Respiratory depression is the most important serious adverse effect of opioids as it can be immediately life-threatening.C. Constipation is the most common long-term side effect and should be anticipated.D. Drug-drug interaction profiles vary among the products. Knowledge of particular opioid-drug interactions, and the underlying pharmacokinetic and

pharmacodynamic mechanisms, allows for the safer administration of opioid analgesics.i. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound

sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation.

ii. Some ER opioid formulations may rapidly release opioid (dose dump) when exposed to alcohol. Some drug levels may increase without dose dumping when exposed to alcohol. See individual product labeling.

iii. MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity(e.g., respiratory depression, coma). Certain ER/LA opioids are contraindicated with MAOIs (tapentadol, morphine). See individual product labeling.

iv. Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone (ADH).v. Some opioids (methadone, buprenorphine) can prolong the QTc interval.vi. Concomitant drugs that act as inhibitors or inducers of various cytochrome P450 enzymes can result in higher or lower than expected blood levels of

some opioids.vii. See Table 8 for product-specific information.

E. Tolerance to sedating and respiratory-depressant effects of opioids is critical to the safe use of ER/LA opioid analgesics.i. For ER products, patients must meet the criteria for opioid tolerance before using:

a. certain products,b. certain strengths,c. certain daily doses, andd. in specific indicated patient populations (e.g., pediatric patients).

ii. See (Table 8) for product-specific information.F. ER/LA opioid analgesic tablets must be swallowed whole. ER/LA opioid analgesic capsules should be swallowed intact or when necessary, the pellets from

some capsules can be sprinkled on applesauce and swallowed without chewing.G. For transdermal products, external heat, fever, and exertion can increase absorption of the opioid, leading to fatal overdose. Transdermal products with metal

foil backings are not safe for use in MRIs.H. For buccal film products, the film should not be applied if it is cut, damaged, or changed in any way. Use the entire film.I. Follow the instructions for conversion in the Dosage and Administration section (2.1) in the Prescribing Information of each product when converting patients

from one opioid to another.

Prescribers should be knowledgeable about general characteristics, toxicities, and drug interactions for ER/LA opioid analgesic products.

COMMON & SPECIFIC DRUG INFORMATION FOR ER/LA OPIOID ANALGESIC PRODUCTS

Instructions: Spend 20-25 minutes completing the following

1. Read and review Table 7, which includes information regarding general characteristics, toxicities and drug interaction for Extended-Release and Long-Acting Opioid Analgesics.

2. Conduct a detailed review of Table 8, which includes information regarding Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics.

3. Complete the learning questions below related to ER/LA Opioid Analgesics only after completing steps 1 and 2.

3927

Arymo ER Morphine SulfateExtended-Release Tablets, 15 mg, 30 mg, 60 mg

Dosing Interval Every 8 or 12 hours

Key Instructions • Initial dose in opioid-naïve and opioid non-tolerant patients is15mg every8 or 12 hours

• Dosage adjustment may be done every 1 to 2 days.• Take one tablet at a time, with enough water to ensure complete swal-

lowing immediately after placing in the mouth.

Specific Drug Interactions P-gp inhibitors (e.g. quinidine) can increase the exposure of morphine byabout two-fold and increase risk of respiratory depression

Use in Opioid-Tolerant Patients A single dose of ARYMO ER greater than 60 mg, or total daily dose greater than 120 mg, is for use in opioid-tolerant patients only.

Product-Specific Safety Concerns • Do not attempt to chew, crush, or dissolve. Swallow whole.• Use with caution in patients who have difficulty in swallowing or have

underlying GI disorders that may predispose them to obstruction, suchas a small gastrointestinal lumen.

Avinza Morphine Sulfate ERCapsules, 30 mg, 45 mg, 60 mg, 75 mg, 90 mg, and 120 mg

Dosing Interval Once a day

Key Instructions • Initial dose in opioid non-tolerant patients is 30 mg.• Titrate in increments of not greater than 30 mg using a minimum of 3

to 4 day intervals.• Swallow capsule whole (do not chew, crush, or \dissolve).• May open capsule and sprinkle pellets on applesauce for patients who

can reliably swallow without chewing; use immediately.• Maximum daily dose:1600 mg due to risk of serious renal toxicity by

excipient, fumaric acid.

Specific Drug Interactions • Alcoholic beverages or medications containing alcohol may result in therapid release and absorption of a potentially fatal dose of morphine.

• P-gp inhibitors(e.g. quinidine) may increase the absorption/exposure ofmorphine sulfate by about two-fold.

Use in Opioid-Tolerant Patients 90 mg and 120 mg capsules are for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Belbuca Buprenorphine Buccal Film, 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg

Dosing Interval Every 12 hours (or once every 24 hours for initiation in opioid naïve patients and patients taking less than 30 mg oral morphine sulfate equivalents)

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics) Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics

(ER/LA opioid analgesics)

4028

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Key Instructions ◊ Opioid-naïve patients or patients taking less than 30 mg oral morphinesulfate equivalents: Initiate treatment with a 75 mcg buccal film, oncedaily, or if tolerated, every 12 hours.

• Titrate to 150 mcg every 12 hours no earlier than 4 days after initiation.• Individual titration to a dose that provides adequate analgesia and

minimizes adverse reactions should proceed in increments of 150 mcgevery 12 hours, no more frequently than every 4 days.

◊ When converting from another opioid, first taper the current opioid tono more than 30 mg oral morphine sulfate equivalents per day prior toinitiating Belbuca.

• If prior daily dose before taper was 30 mg to 89 mg oral morphinesulfate equivalents, initiate with 150 mcg dose every 12 hours.

• If prior daily dose before taper was 90 mg to 160 mg oral morphinesulfate equivalents, initiate with 300 mcg dose every 12 hours.

• Titration of the dose should proceed in increments of 150 mcg every12 hours, no more frequently than every 4 days.

◊ Maximum dose: 900 mcg every 12 hours due to the potential for QTcprolongation

◊ Severe Hepatic Impairment: Reduce the starting and incremental doseby half that of patients with normal liver function.

◊ Oral Mucositis: Reduce the starting and incremental dose by half that ofpatients without mucositis

◊ Do not use if the package seal is broken or the film is cut, damaged, orchanged in any way

Specific Drug Interactions • CYP3A4 inhibitors may increase buprenorphine levels.• CYP3A4 inducers may decrease buprenorphine levels.• Benzodiazepines may increase respiratory depression.• Class IA and III anti arrhythmics, other potentially arrhythmogenic

agents, may increase risk for QTc prolongation and torsade de pointes.

Use in Opioid-Tolerant Patients Belbuca 600 mcg, 750 mcg, and 900 mcg are for use following titration from lower doses of Belbuca.

Product-Specific Safety Concerns • QTc prolongation and torsade de pointes• Hepatotoxicity

Relative Potency To Oral Morphine Equipotency to oral morphine has not been established.

Butrans BuprenorphineTransdermal System, 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, 20 mcg/hr

Dosing Interval One transdermal system every 7 days

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4129

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Key Instructions • Initial dose in opioid non-tolerant patients when converting from lessthan 30 mg morphine equivalents, and in mild to moderate hepaticimpairment - 5 mcg/hr dose.

• When converting from 30 mg to 80 mg morphine equivalents - firsttaper to 30 mg morphine equivalent, then initiate with 10 mcg/hr dose.

• Titrate in 5 mcg/hour or 10 mcg/hour increments by using no morethan two patches of the 5 mcg/hour or 10 mcg/hour system(s) with aminimum of 72 hours between dose adjustments. The total dose fromall patches should not exceed 20 mcg/hour

• Maximum dose: 20 mcg/hr due to risk of QTc prolongation.• Application• Apply only to sites indicated in the Full Prescribing Information.• Apply to intact/non-irritated skin.• Skin may be prepped by clipping hair, washing site with water only• Rotate site of application a minimum of 3 weeks before reapplying to

the same site.• Do not cut.• Avoid exposure to heat.• Dispose of used/unused patches by folding the adhesive side together

and flushing down the toilet.

Specific Drug Interactions • CYP3A4 Inhibitors may increase buprenorphine levels.• CYP3A4 Inducers may decrease buprenorphine levels.• Benzodiazepines may increase respiratory depression.• Class IA and III anti arrhythmics, other potentially arrhythmogenic

agents, may increase risk for QTc prolongation and torsade de pointe.

Use in Opioid-Tolerant Patients Butrans 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, and 20 mcg/hr transdermal systems are for use in opioid- tolerant patients only.

Drug-Specific Safety Concerns • QTc prolongation and torsade de pointe• Hepatotoxicity• Application site skin reactions

Relative Potency To Oral Morphine Equipotency to oral morphine has not been established.

Dolophine Methadone Hydrochloride Tablets, 5 mg and 10 mg

Dosing Interval Every 8 to 12 hours

Key Instructions • Initial dose in opioid non-tolerant patients: 2.5 to10 mg• Conversion of opioid-tolerant patients using equianalgesic tables can

result in overdose and death. Use low doses according to the table inthe full prescribing information.

• Titrate slowly, with dose increases no more frequent than every 3 to 5days. Because of high variability in methadone metabolism, somepatients may require substantially longer periods between doseincreases (up to 12 days).

• High inter-patient variability in absorption, metabolism, and relativeanalgesic potency.

• Opioid detoxification or maintenance treatment shall only be providedin a federally certified opioid (addiction) treatment program (Code ofFederal Regulations, Title 42, Sec 8).

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4230

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Specific Drug Interactions ◊ Pharmacokinetic drug-drug interactions with methadone are complex.• CYP450 inducers may decrease methadone levels.• CYP450 inhibitors may increase methadone levels.• Anti-retroviral agents have mixed effects on methadone levels.◊ Potentially arrhythmogenic agents may increase risk for QTc

prolonga-tion and torsade de pointe.◊ Benzodiazepines may increase respiratory depression.

Use in Opioid-Tolerant Patients Refer to full prescribing information.

Product-Specific Safety Concerns • QTc prolongation and torsade de pointe.• Peak respiratory depression occurs later and persists longer than

analgesic effect.• Clearance may increase during pregnancy.• False positive urine drug screens possible.

Relative Potency To Oral Morphine Varies depending on patient’s prior opioid experience.

Duragesic FentanylTransdermal System, 12, 25, 37.5*, 50, 62.5*, 75, 87.5*, and 100 mcg/hr (*These strengths are available only in generic form)

Dosing Interval Every 72 hours (3 days)

Key Instructions ◊ Use product specific information for dose conversion from prior opioid◊ Use 50% of the dose in mild or moderate hepaticorrenal impairment,

avoid use in severe hepatic or renal impairment◊ Application• Apply to intact/non-irritated/non-irradiated skin on a flat surface.• Skin may be prepped by clipping hair, washing site with water only• Rotate site of application.• Titrate using a minimum of 72 hour intervals between dose

adjustments.• Do not cut.◊ Avoid exposure to heat.◊ Avoid accidental contact when holding or caring for children.◊ Dispose of used/unused patches by folding the adhesive side together

and flushing down the toilet.Specific contraindications:• Patients who are not opioid-tolerant.• Management of acute or intermittent pain, or in patients who require

opioid analgesia for a short period of time.• Management of post-operative pain, including use after out-patient or

day surgery.• Management of mild pain.

Specific Drug Interactions • CYP3A4 inhibitors may increase fentanyl exposure.• CYP3A4 inducers may decrease fentanyl exposure.• Discontinuation of a concomitantly used cytochrome P450 3A4 inducer

may result in an increase in fentanyl plasma concentration.

Use in Opioid-Tolerant Patients All doses of Duragesic are indicated for use in opioid-tolerant patients only.

Product-Specific Safety Concerns • Accidental exposure due to secondary exposure to unwashed/unclothedapplication site.

• Increased drug exposure with increased core body temperature or fever.• Bradycardia• Application site skin reactions

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4331

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Relative Potency To Oral Morphine See individual product information for conversion recommendations from prior opioid

Embeda Morphine Sulfate ER-NaltrexoneCapsules, 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, 100 mg/4 mg

Dosing Interval Once a day or every 12 hours

Key Instructions • Initial dose as first opioid: 20mg/0.8mg.• Titrate using a minimum of 1 to 2 day intervals.• Swallow capsules whole(do not chew, crush, or dissolve)• Crushing or chewing will release morphine, possibly resulting in fatal

overdose, and naltrexone, possibly resulting in withdrawal symptoms.• May open capsule and sprinkle pellets on applesauce for patients who

can reliably swallow without chewing, use immediately.

Specific Drug Interactions • Alcoholic beverages or medications containing alcohol may result in therapid release and absorption of a potentially fatal dose of morphine.

• P-gp inhibitors (e.g.quinidine) may increase the absorption/exposure ofmorphine sulfate by about two-fold.

Use in Opioid-Tolerant Patients Embeda 100 mg/4 mg capsule is for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Exalgo Hydromorphone HydrochlorideExtended-Release Tablets, 8 mg, 12 mg, 16 mg or 32 mg

Dosing Interval Once a day

Key Instructions • Use the conversion ratios in the individual product information.• Start patients with moderate hepatic impairment on 25% dose that

would be prescribed for a patient with normal hepatic function.• Start patients with moderate renal impairment on 50%, and patients

with severe renal impairment on 25% of the dose that would beprescribed for a patient with normal renal function.

• Titrate in increments of 4 to 8 mg using a minimum of3 to 4 day intervals

• Swallow tablets whole (do not chew, crush, or dissolve).• Do not use in patients with sulfite allergy—contains sodium

metabisulfite.

Specific Drug Interactions None

Use in Opioid-Tolerant Patients All doses of Exalgo are indicated for opioid-tolerant patients only.

Drug-Specific Adverse Reactions Allergic manifestations to sulfite component.

Relative Potency To Oral Morphine Approximately 5:1 oral morphine to hydromorphone oral dose ratio, use conversion recommendations in the individual product information.

Hysingla ER Hydrocodone bitartrateExtended-Release Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, and 120 mg

Dosing Interval Every 24 hours (once-daily)

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4432

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Key Instructions • Opioid-naïve patients: initiate treatment with 20 mg orally once daily.During titration, adjust the dose in increments of 10 mg to 20 mg every3 to 5 days until adequate analgesia is achieved.

• Swallow tablets whole (do not chew, crush, or dissolve).• Consider use of an alternative analgesic in patients who have difficulty

swallowing or have underlying gastrointestinal disorders that maypredispose them to obstruction.

• Take one tablet at a time, with enough water to ensure complete swal-lowing immediately after placing in the mouth.

• Use 1/2 of the initial dose and monitor closely for adverse events, suchas respiratory depression and sedation, when administering Hysingla ERto patients with severe hepatic impairment or patients with moderate tosevere renal impairment.

Specific Drug Interactions • CYP3A4 inhibitors may increase hydrocodone exposure.• CYP3A4 inducers may decrease hydrocodone exposure.• Concomitant use of Hysingla ER with strong laxatives (e.g., Lactulose)

that rapidly increase GI motility may decrease hydrocodone absorption and result in decreased hydrocodone plasma levels.

• The use of MAO inhibitors or tricyclic antidepressants with Hysingla ER may increase the effect of either the antidepressant or Hysingla ER.

Use in Opioid-Tolerant Patients A single dose of Hysingla ER greater than or equal to 80 mg is only for use in opioid tolerant patients.

Product-Specific Safety Concerns • Use with caution in patients with difficulty swallowing the tablet orunderlying gastrointestinal disorders that may predispose patients toobstruction.

• Esophageal obstruction, dysphagia, and choking have been reportedwith Hysingla ER.

• In nursing mothers, discontinue nursing or discontinue drug.• QTc prolongation has been observed with Hysingla ER following daily

doses of 160 mg. Avoid use in patients with congenital long QTcsyndrome. This observation should be considered in making clinicaldecisions regarding patient monitoring when prescribing Hysingla ERin patients with congestive heart failure, bradyarrhythmias, electrolyteabnormalities, or who are taking medications that are known to prolongthe QTc interval. In patients who develop QTc prolongation, considerreducing the dose.

Relative Potency To Oral Morphine See individual product information for conversion recommendations from prior opioid

Kadian Morphine SulfateExtended-Release Capsules, 10 mg, 20mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 100 mg, 130 mg, 150 mg, and 200 mg

Dosing Interval Once a day or every 12 hours

Key Instructions • Product information recommends not using as first opioid.• Titrate using a minimum of 2-day intervals.• Swallow capsules whole (do not chew, crush, or dissolve).• May open capsule and sprinkle pellets on applesauce for patients who

can reliably swallow without chewing, use immediately.

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4533

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Specific Drug Interactions • Alcoholic beverages or medications containing alcohol may result in therapid release and absorption of a potentially fatal dose of morphine.

• P-gp inhibitors(e.g. quinidine) may increase the absorption/exposure ofmorphine sulfate by about two-fold.

Use in Opioid-Tolerant Patients Kadian 100 mg, 130 mg, 150 mg, and 200 mg capsules are for use in opioid- tolerant-patients only

Product-Specific Safety Concerns None

MorphaBond Morphine SulfateExtended-release Tablets, 15 mg, 30 mg, 60 mg, 100 mg

Dosing Interval Every 8 hours or every 12 hours

Key Instructions For opioid-naïve and opioid non-tolerant patients, initiate treatment with 15mg tablets orally every 12 hours. Swallow tablets whole (do not cut, break, chew, crush, or dissolve).

Specific Drug Interactions P-gp inhibitors (e.g. quinidine) may increase the absorption/exposure ofmorphine sulfate by about two-fold.

Use in Opioid-Tolerant Patients MorphaBond ER 100 mg tablets, as single dose greater than 60mg, or a totaldaily dose greater than 120mg, are only for use in patients in whom toleranceto an opioid of comparable potency has been established.

Product-Specific Safety Concerns None

MS Contin Morphine SulfateExtended-release Tablets, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg

Dosing Interval Every 8 hours or every 12 hours

Key Instructions • Product information recommends not using as first opioid.• Titrate using a minimum of 1 to 2-day intervals.• Swallow tablets whole (do not chew, crush, or dissolve).

Specific Drug Interactions P-gp inhibitors (e.g. quinidine) may increase the absorption/exposure ofmorphine sulfate by about two-fold.

Use in Opioid-Tolerant Patients MS Contin 100 mg and 200 mg tablet strengths are for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Nucynta ER TapentadolExtended-Release Tablets, 50 mg, 100mg, 150 mg, 200 mg, and 250 mg

Dosing Interval Every 12 hours

Key Instructions • Use 50 mg every 12 hours as initial dose in opioid nontolerant patients.

• Titrate by 50 mg increments using a minimum of 3-day intervals.• Maximum total daily dose is 500 mg.• Swallow tablets whole (do not chew, crush, or dissolve).• Take one tablet at a time and with enough water to ensure complete

swallowing immediately after placing in the mouth.• Dose once daily in moderate hepatic impairment with100 mg per day

maximum.• Avoid use in severe hepatic and renal impairment.

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4634

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Specific Drug Interactions • Alcoholic beverages or medications containing alcohol may result inthe rapid release and absorption of a potentially fatal dose oftapentadol.

• Contraindicated in patients taking MAOIs.

Use in Opioid-Tolerant Patients No product-specific considerations.

Product-Specific Safety Concerns • Risk of serotonin syndrome• Angioedema

Relative Potency To Oral Morphine Equipotency to oral morphine has not been established.

Opana ER Oxymorphone HydrochlorideER Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg

Dosing Interval Every 12h dosing, some may benefit from asymmetric (different dose given in AM than in PM) dosing.

Key Instructions • Use 5 mg every 12 hours as initial dose in opioid non-tolerant patients and patients with mild hepatic impairment and renal impairment (creati-nine clearance < 50 mL/min) and patients over 65 years of age.

• Swallow tablets whole (do not chew, crush, or dissolve).• Take one tablet at a time, with enough water to ensure complete

swallowing immediately after placing in the mouth.• Titrate in increments of 5 to 10 mg using a minimum of 3 to 7-day

intervals.• Contraindicated in moderate and severe hepatic impairment.

Specific Drug Interactions Alcoholic beverages or medications containing alcohol may result in the absorption of a potentially fatal dose of oxymorphone.

Use in Opioid-Tolerant Patients No product specific considerations.

Product-Specific Safety Concerns Use with caution in patients who have difficulty in swallowing or have under-lying GI disorders that may predispose them to obstruction, such as a small gastrointestinal lumen.

Relative Potency To Oral Morphine Approximately 3:1 oral morphine to oxymorphone oral dose ratio

OxyContin Oxycodone HydrochlorideExtended-release Tablets, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg

Dosing Interval Every 12 hours

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4735

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Key Instructions ◊ For Adults:• Initial dose in opioid-naïve and opioid non-tolerant patients is 10 mg

every 12 hours.• If needed, adult dosage may be adjusted in 1 to 2 day intervals.• When a dose increase is clinically indicated, the total daily oxycodone

dose usually can be increased by 25% to 50% of the current dose.◊ For Pediatric patients (11 years and older): Use only in opioid-tol-

erant patients (see below, Use in Opioid-Tolerant Patients for dosinginformation).

◊ For all patients:• Hepatic impairment: start with one third to one half the usual dosage• Renal impairment (creatinine clearance <60 mL/min): start with one

half the usual dosage.• Consider use of other analgesics in patients who have difficulty swallow-

ing or have underlying GI disorders that may predispose them obstrucu-tion. Swallow tablets whole (do not chew, crush, or dissolve).

• Take one tablet at a time, with enough water to ensure completeswallowing immediately after placing in the mouth.

Specific Drug Interactions • CYP3A4 inhibitors may increase oxycodone exposure.• CYP3A4 inducers may decrease oxycodone exposure.

Use in Opioid-Tolerant Patients ◊ For Adults:• Single dose greater than 40 mg or total daily dose greater than 80 mg

are for use in adult patients in whom tolerance to an opioid of compara-ble potency has been established.

◊ For Pediatric patients (11 years and older):• For use only in opioid-tolerant pediatric patients already receiving and• tolerating opioids for at least 5 consecutive days with a minimum of 20

mg per day of oxycodone or its equivalent for at least two days immedi-ately preceding dosing with OxyContin.

• If needed, pediatric dosage may be adjusted in 1 to 2 day intervals.• When a dose increase is clinically indicated, the total daily oxycodone

dose usually can be increased by 25% of the current total daily dose.

Product-Specific Safety Concerns • Choking, gagging, regurgitation, tablets stuck in the throat, difficultyswallowing the tablet.

• Contraindicated in patients with gastrointestinal obstruction.

Relative Potency To Oral Morphine Approximately 2:1 oral morphine to oxycodone oral dose ratio.

Targiniq ER Oxycodone Hydrochloride / Naloxone HydrochlorideExtended-release tablets, 10 mg/5 mg, 20 mg/10 mg, and 40 mg/20 mg

Dosing Interval Every 12 hours

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

4836

TABLE 10: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Key Instructions • Opioid-naïve patients: initiate treatment with 10 mg/5 mg every 12hours.

• Titrate using a minimum of 1 to 2 day intervals.• Do not exceed 80 mg/40 mg total daily dose (40 mg/20 mg q12) of

Targiniq ER• May be taken with or without food.• Swallow tablets whole. Do not chew, crush, split, or dissolve, as this will

release oxycodone, possibly resulting in fatal overdose, and naloxone,possibly resulting in withdrawal symptoms.

• Hepatic impairment: contraindicated in moderate and severe hepaticimpairment. In patients with mild hepatic impairment, start with one thirdto one half the usual dosage.

• Renal impairment (creatinine clearance < 60 mL/min): start with onehalf the usual dosage.

Specific Drug Interactions • CYP3A4 inhibitors may increase oxycodone exposure.• CYP3A4 inducers may decrease oxycodone exposure

Use in Opioid-Tolerant Patients Single dose greater than 40 mg/20 mg or total daily dose of 80 mg/40 mg are for use in opioid-tolerant patients only

Product-Specific Safety Concerns Contraindicated in patients with moderate to severe hepatic impairment.

Relative Potency To Oral Morphine See individual product information for conversion recommendations from prior opioid.

Troxyca ER Oxycodone Hydrochloride/Naltrexone HydrochlorideExtended-Release Capsules, 10 mg/1.2 mg, 20 mg/2.4 mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2 mg, 80 mg/9.6 mg

Dosing Interval Every 12 hours

Key Instructions • Opioid-naïve and opioid non-tolerant patients: 10 mg/1.2 mg, every 12hours

• Total daily dose may be adjusted by 20 mg/2.4 mg every 2 to 3 days asneeded

• Swallow capsule whole (do not chew, crush, or dissolve).• Crushing, chewing, or dissolving will release oxycodone, possibly result-

ing in fatal overdose, and naltrexone, possibly resulting in withdrawalsymptoms.

• For patients that have difficulty swallowing, Troxyca ER, can also betaken by sprinkling the capsule contents (pellets) on applesauce andswallowing immediately without chewing.

• Do not administer Troxyca ER pellets through a nasogastric or gastrictube

Specific Drug Interactions • CYP3A4 inhibitors may increase oxycodone exposure.• CYP3A4 inducers may decrease oxycodone exposure.

Use in Opioid-Tolerant Patients Single doses of greater than 40 mg/4.8 mg, or a total daily dose greater than 80 mg/9.6 mg are only for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Relative Potency To Oral Morphine See individual product information for conversion recommendations from prior opioid.

Vantrela ER Hydrocodone BitartrateExtended-Release Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg

Dosing Interval Every 12 hours

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

49

Table 8. Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics(ER/LA opioid analgesics)

Key Instructions • Opioid naïve and opioid nontolerant patients: Initiate with 15 mg every 12 hours. Dose can be increased from the current dose to the next higher dose every 3 to 7 days as needed.

• Swallow tablets whole (do not chew, crush, or dissolve).• Mild or moderate hepatic and moderate to severe renal impairment: Initiate therapy with 1/2 of the recom-

mended initial dose in patients with either of these impairments. If a dose less than 15 mg is needed, use alternative analgesic options.

Specific Drug Interactions • CYP3A4 inhibitors may increase hydrocodone exposure.• CYP3A4 inducers may decrease hydrocodone exposure.

Use in Opioid-Tolerant Patients A 90 mg tablet, a single dose greater than 60 mg, or a total daily dose greater than 120 mg are for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Relative Potency To Oral Morphine See individual product information for conversion recommendations from prior opioid.

Xtampza ER OxycodoneExtended-Release Capsules, 9 mg 13.5 mg, 18 mg, 27 mg, and 36 mg(strengths equivalent to 10mg, 15mg, 20mg, 30mg, and 40mg oxycodone hydrochloride, respectively)

Dosing Interval Every 12 hours

Key Instructions • Opioid naïve and opioid non-tolerant patients: Initiate with 9 mg every 12 hours.• Titrate using a minimum of 1 to 2 day intervals.• Take Xtampza ER capsules with the same amount of food in order to ensure consistent plasma levels are

achieved.• Maximum daily dose: 288 mg (8 x 36 mg capsules) because the safety of excipients has not been

established for higher doses• For patients that have difficulty swallowing, Xtampza ER can also be taken by sprinkling the capsule contents

on soft foods or into a cup and then administering directly into the mouth and swallowing immediately. Xtampza ER may also be administered through a gastrostomy or naso-gastric feeding tube.

• Hepatic impairment: Initiate therapy at 1/3 to 1/2 the usual dosage• Renal impairment: (creatinine clearance <60 mL/min): Follow a conservative approach to dose initiation

and adjust according to the clinical situation.

Specific Drug Interactions • CYP3A4 inhibitors may increase oxycodone exposure• CYP3A4 inducers may decrease oxycodone exposure

Use in Opioid-Tolerant Patients A single dose greater than 36 mg or a total daily dose greater than 72 mg is for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Relative Potency To Oral Morphine There are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials

Zohydro ER Hydrocodone BitartrateExtended-Release Capsules, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg

Dosing Interval Every 12 hours

Key Instructions Initial dose in opioid non-tolerant patient is 10 mg.Titrate in increments of 10 mg using a minimum of 3 to 7day intervals.Swallow capsules whole (do not chew, crush, or dissolve).

Specific Drug Interactions • Alcoholic beverages or medications containing alcohol may result in the rapid release and absorption of a potentially fatal dose of hydrocodone.

• CYP3A4 inhibitors may increase hydrocodone exposure.• CYP3A4 inducers may decrease hydrocodone exposure.

Use in Opioid-Tolerant Patients Single dose greater than 40 mg or total daily dose greater than 80 mg are for use in opioid-tolerant patients only.

Product-Specific Safety Concerns None

Relative Potency To Oral Morphine Approximately 1.5:1 oral morpthine to hydrocodone oral dose ratio.Source: FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. May, 2017.

https://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM515636.pdf. Last Accessed June, 2018.

Note: Prescribers should counsel patients on product specific information and ensure that patients are aware that selling or sharing any controlled substance with others is against the law

50

What You Need to Know About Opioid Pain Medicines This guide is for you! Keep this guide and the Medication Guide that comes with your medicine so you can better understand what you need to know

about your opioid pain medicine. Go over this information with your healthcare provider. Then, ask your healthcare provider about anything that you do not understand.

Naloxone is never a substitute for emergency medical care. Always call 911 or go to the emergency room if you’ve used or given naloxone.

TABLE 9. PATIENT COUNSELING GUIDE

Source: FDA Opioid Analgesic REMS https://www.accessdata.fda.gov/drugsatfda_docs/rems/Opioid_Analgesic_2018_09_18_Patient_Counseling_Guide.pdf

Last Accessed September, 2018

What are opioids? Opioids are strong prescription medicines that are used to manage severe pain.

What are the serious risks of using opioids? • Opioids have serious risks of addiction and overdose.• Too much opioid medicine in your body can cause your breathing to stop –

which could lead to death. This risk is greater for people taking other medicines that make you feel sleepy or people with sleep apnea.

• Addiction is when you crave drugs (like opioid pain medicines) because they make you feel good in some way. You keep taking the drug even though you know it is not a good idea and bad things are happening to you. Addiction is a brain disease that may require ongoing treatment.

You can get addicted to opioids even though you take them exactly as prescribed, especially if taken for a long time. If you think you might be addicted, talk to your healthcare provider right away. If you take an opioid medicine for more than a few days, your body becomes physically “dependent.” This is normal and it means your body has gotten used to the medicine. You must taper off the opioid medicine (slowly take less medicine) when you no longer need it to avoid withdrawal symptoms.

How can I take opioid pain medicine safely? • Tell your healthcare provider about all the medicines you are taking, including

vitamins, herbal supplements, and other over-the-counter medicines.• Read the Medication Guide that comes with your prescription.• Take your opioid medicine exactly as prescribed.• Do not cut, break, chew, crush, or dissolve your medicine. If you cannot swallow

your medicine whole, talk to your healthcare provider.• When your healthcare provider gives you the prescription, ask:

º How long should I take it? º What should I do if I need to taper off the opioid medicine (slowly take

less medicine)?• Call your healthcare provider if the opioid medicine is not controlling your pain.

Do not increase the dose on your own.• Do not share or give your opioid medicine to anyone else. Your healthcare

provider selected this opioid and the dose just for you. A dose that is okay for you could cause an overdose and death for someone else. Also, it is against the law.

• Store your opioid medicine in a safe place where it cannot be reached by children or stolen by family or visitors to your home. Many teenagers like to experiment with pain medicines. Use a lock- box to keep your opioid medicine safe. Keep track of the amount of medicine you have.

• Do not operate heavy machinery until you know how your opioid medicine affects you. Your opioid medicine can make you sleepy, dizzy, or lightheaded.

What other options are there to help with my pain? Opioids are not the only thing that can help you control your pain. Ask your healthcare provider if your pain might be helped with a non-opioid medication, physical therapy, exercise, rest, acupuncture, types of behavioral therapy, or patient self-help techniques.

What is naloxone? • Naloxone is a medicine that treats opioid overdose. It is sprayed inside your

nose or injected into your body.• Use naloxone if you have it and call 911 or go to the emergency room right

away if: º You or someone else has taken an opioid medicine and is having trouble

breathing, is short of breath, or is unusually sleepy º A child has accidentally taken the opioid medicine or you think they might

have• Giving naloxone to a person, even a child, who has not taken an opioid medicine

will not hurt them.

Where can I get naloxone? • There are some naloxone products that are designed for people to use in their

home.• Naloxone is available in pharmacies. Ask your healthcare provider about

how you can get naloxone. In some states, you may not need a prescription.• When you get your naloxone from the pharmacy, read the Patient Information

on how to use naloxone and ask the pharmacist if anything is unclear.• Tell your family about your naloxone and keep it in a place where you or your

family can get to it in an emergency.

What things should I know about the specific opioid medicine that I am taking? Your healthcare provider has prescribed ________________________for you.

Read the Medication Guide for this medicine, which is information provided by your pharmacy. Remember this other important information about your opioid medicine:

Dosing instructions: _________________________________________

Any specific interactions with your medicines: _______________________

________________________________________________________

What if I have more questions? • Read the Medication Guide that comes with your opioid medicine prescription

for more specific information about your medicine.• Talk to your healthcare provider or pharmacist and ask them any questions

you may have.• Visit: www.fda.gov/opioids for more information about opioid medicines.

Risk Factors for Opioid Abuse: • You have:

º a history of addiction º a family history of addiction

• You take medicines to treat mental health problems• You are under the age of 65 (although anyone can abuse opioid medicines)

When you no longer need your opioid medicine, dispose of it as quickly as possible. The Food and Drug Administration recommends that most opioid medicines be promptly flushed down the toilet when no longer needed, unless a drug take-back option is immediately available. A list of the opioid medicines that can be flushed down the toilet is found here: https://www.fda.gov/drugdisposal

What should I avoid taking while I am taking opioids? Unless prescribed by your healthcare provider, you should avoid taking alcohol or any of the following medicines with an opioid because it may cause you to stop breathing, which can lead to death:• Alcohol: Do not drink any kind of alcohol while you are taking opioid medicines.• Benzodiazepines (like Valium or Xanax)• Muscle relaxants (like Soma or Flexeril)• Sleep medicines (like Ambien or Lunesta)• Other prescription opioid medicines

51

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89. Lee CM, Neighbors C, Hendershot CS, Grossbard JR. Development and preliminary validation of a com-prehensive marijuana motives questionnaire. J Stud Alcohol Drugs. 2009;70(2):279-287.

90. U.S. Food and Drug Administration. FDA Briefing Document: Joint Meeting of the Drug Safety and Risk Management (DSaRM) Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC): Extended-release and Long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). May 3-4, 2016; https://www.fda.gov/AdvisoryCommit-tees/Calendar/ucm490628.htm. Accessed 3-7-18.

91. Gever J. FDA Begins Enforcing New Policy in IR Opioids. September 28, 2017; https://www.med-pagetoday.com/painmanagement/opioids/68209. Accessed 5-1-18.

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11. When evaluating patients for treatment with extended-release/long-acting (ER/LA) opioid analgesics, which is an important risk to consider? A. Respiratory depression, particularly in elderly patientsB. History of autoimmune disease C. Co-ingestion with nonsteroidal anti-inflammatory drugsD. Numeric pain scale rating >5

12. Which of the following is true of methadone?A. The peak of respiratory depression can persist longer than the

analgesic effectsB. Fewer drug-drug interactions are observed than with other opioidsC. Equianalgesic tables may be used without modification to convert to

another opioidD. Only patients with opioid-use disorder and co-occurring pain should

receive methadone

13. Nonpharmacologic therapies for pain treatment:A. Are most effective when combined with opioid therapyB. Are usually covered by insuranceC. Are encouraged as part of a comprehensive pain treatment planD. Are less effective than nonopioid pharmacologic therapies

14. For which of the following pain conditions are ER/LA opioids indicated?A. Acute or postoperative pain that does not resolve after 1 weekB. As needed for severe headache or migraine pain C. Severe chronic pain as a first-line therapyD. For pain severe enough to require daily, around-the-clock, long-term

analgesia for which alternative treatment options are inadequate

15. According to assessment tools, which of the following factors heighten risk for opioid-use disorder?A. Comorbid psychiatric conditions such as post-traumatic stress

disorderB. A diagnosis of fibromyalgia C. Sleep apneaD. A family history of mental illness

16. Name one method by which patients should be encouraged to dispose of unused opioids:A. Throwing away after separating from the prescription bottleB. Crushing pills and placing in a trash receptacleC. Participating in a community drug take-back eventD. Hiding in a safe, locked location within the home

17. Name one way patients should be monitored for adherence to medical direction during long-term opioid therapy:A. Periodically check prescription drug monitoring programs B. Perform laboratory testing of triglycerides C. Document that physical dependence has not developedD. Periodically warn that medical marijuana use is prohibited during long-

term opioid therapy

18. Which of the following is true of potential drug-drug interactions with opioids?A. Monoamine oxidase inhibitors are preferred antidepressants in

combination with opioidsB. Central-nervous system depressants can potentiate the respiratory

depression effects of opioidsC. Initiation of a CYP 3A4 inhibitor can result in lower blood levels of

opioidsD. Pharmacokinetic, but not pharmacodynamic, effects contribute to the

onset and duration of opioid analgesia

19. In which of the following clinical scenarios may a patient be discontinued from opioids without taper and management of withdrawal symptoms?A. Evidence of illegal diversion includes patient selling prescriptions to

othersB. Patient achieves inadequate analgesia despite titrationC. Patient engages in repeated escalation of opioid doses without

medical authorizationD. Patient experiences intolerable side effects

20. Which of the following is one indication for take-home naloxone with opioid prescription?A. Family history of alcohol use disorder B. History of opioid overdoseC. Opioid dosages ≥20 MME/dayD. Co-prescription of a tricyclic antidepressant

21. Increased monitoring of patient response is essential during opioid dose initiation, upward titration, rotation, and addition of other central-nervous system depressants because:A. Constipation is more common during these timesB. Pain control is often inadequateC. Risk for respiratory depression is heightened D. Substance-use disorder is an expected outcome

22. Urine drug testing as a monitoring measure can tell the clinician which of the following:A. The types and dosages of opioids ingested by the patientB. Whether the patient has an opioid-use disorderC. Whether prescribed medications are present at the point of testingD. Whether the patient has been “doctor shopping”

23. Which of the following factors increases a patient’s risk of opioid misuse?A. Severe migraine painB. History of illicit drug useC. Family history of domestic violenceD. Work as a manual laborer

24. Recommended frequency to check the prescription drug-monitoring database is:A. Once at baselineB. At baseline and every 6 months thereafterC. At baseline followed by every prescription to every 3 monthsD. Only when aberrant drug-related behaviors are observed clinically

25. Which of the following influences the amount of dopamine released and the degree of reward experienced by an opioid user?A. Prior recreational drug useB. Combination with monoamine oxidase inhibitorsC. The route of drug administrationD. The presence of multiple medical comorbidities

PRESCRIBER EDUCATION FOR OPIOID ANALGESICS

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Completion of this course will better enable the course participant to:1. Assess a patient’s suicide risk and collaboratively determine the best treatment method.2. Describe strategies to minimize the risk of future suicide attempts.3. Explain the concept of patient-centered care in the context of suicide prevention.4. Describe the specific challenges of managing suicide in the population of Veterans and active-duty military personnel.

LEARNING OBJECTIVES

TARGET AUDIENCE

This course is designed for all physicians (MD/DO) and other health care practitioners.

COURSE OBJECTIVE

The purpose of this course is to educate physicians about the latest evidence-based practices for assessing suicide risk and managing at-risk patients with non-pharmacological and pharmacological therapies. The course includes focused learning on specific populations at high risk of suicide, including Veterans and active-duty military personnel, older adults, and physicians.

Enduring Material

(Self Study)

6 AMA PRA

Category 1 Credits™

Release Date: 03/2020

Expiration Date: 02/2023

SUICIDE ASSESSMENT & PREVENTION

ACCREDITATION STATEMENTInforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENTInforMed designates this enduring material for a maximum of 6 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required.

Return your customer information/answer sheet, evaluation, and payment to InforMed by mail, phone, fax or complete online at course website under NETPASS.

55

FACULTY

Thomas E. Joiner, PsyDDirector, Psychology ClinicDepartment of PsychologyFlorida State University

Stephen BraunMedical WriterBraun Medical Communications

ACTIVITY PLANNER

Michael BrooksDirector of CME, InforMed

DISCLOSURE OF INTERESTIn accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

STAFF AND CONTENT REVIEWERS

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

DISCLAIMER

*2020. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.

FACULTY/PLANNING COMMITTEE DISCLOSURE

The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity:

• Thomas E. Joiner, PsyD• Stephen Braun• Michael Brooks

The Pennsylvania Board of Medicine and Osteopathic Medicine requires all licensed physicians to complete twelve (12) credit hours in Patient Safety every

licensure period.

PATIENT SAFETY

This course satisfies six (6) credit hours in the area of Patient Safety for physicians

and medical professionals licensed in Pennsylvania.

SPECIAL DESIGNATION:

6

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Introduction

Suicide is a serious and growing public health problem with devastating effects on individuals, families, and communities. While its causes are complex and multi-factorial, the goal of suicide prevention is to reduce those factors that increase risk and simultaneously increase factors that promote resilience and stability. Ideally, prevention addresses all levels of influence: individual, relationship, community, and societal.1

Nationwide, deaths by suicide have increased steadily in the past decade, from11.6 per 100,000 people in 2008 to 14 per 100,000 in 2017 (the latest year for which data are available).2 These rates translate to a 43.6% increase in actual suicide deaths, from 31,610 in 2005 to 45,390 in 2017 or about one suicide death every 11 minutes in the U.S.3 The increase is largely due to higher rates of suicide among men (rates for women have remained largely constant). In 2017, suicide was the 10th leading cause of death overall in the U.S. and was the second-leading cause of death in people aged 10-34 years.1 Many more people think about, or attempt, suicide every year than actually complete suicide: in 2017 an estimated 10.6 million American adults seriously thought about suicide, 3.2 million made a suicide plan, and 1.4 million attempted suicide.1

The suicide rate among Veterans and other military personnel is roughly 1.5 times higher than the suicide rate in the general population after adjusting for age and sex differences.3 In 2017, 6,139 Veterans killed themselves, which is 6.1% higher than the 5,787 Veterans who killed themselves in 2005.3 Between 1999 and 2016 the suicide rate among Veterans and military personnel increased from 10.7 suicide-related deaths per 100,000 service members to 21.5 suicide-related deaths per 100,000 service members.4 In the 27 states for which relevant suicide data were available, 17.8% of suicide victims were Veterans, nearly double the prevalence of Veterans in the population.5

Among the general U.S. population, the most common means of suicide is with guns.5 This pattern holds for the Veteran population as well.3

Self-directed discharge of a firearm is also the most common method used by men (in the general population as well as among Veterans) and the most lethal means relative to other common methods of suicide.6 Among women in the general population, the leading means of suicide are poisoning (drug and non-drug poisoning) and firearms (each was used by 31% of women who died by suicide in 2017).7 Among Veterans, guns were the method of suicide in 70.7% of male suicide deaths and 43.2% of female suicide deaths.3

Other means of suicide in the general population include: overdose of licit or illicit drugs, alcohol or combinations thereof, hanging, poisoning (with chemical compounds such as industrial cleaners or pesticides), carbon monoxide inhalation, suffocation (with plastic hoods or inert gasses), electric shock, immolation, drowning, exsanguination, and evisceration. Hanging deaths have increased in the past decade, with evidence of suicide contagion stemming from media coverage of high-profile celebrities dying by this method.3

The emotional and psychic toll of suicide is profound. A survey of 1,736 randomly-chosen adults, 812 of whom had been exposed to suicide at some time in their lives, suggests that, on average, 135 individuals are affected, to one degree or another, by a single suicide.8 This impact often includes increases in the prevalence and severity of symptoms of depression and anxiety as well as thoughts about suicide in those closest to the victim.

In addition to the emotional toll on the families, friends, and colleagues of those who have died by suicide, as well as on suicide-attempt survivors, suicide has economic costs that are incurred by the individuals, families, communities, states, and nation. These include medical costs for individuals and families, lost workplace productivity, and lost income. The average economic impact of a single suicide death has been estimated as $1.3 million, and the total annual costs associated with

both suicides and suicide attempts in the U.S. is approximately $93.5 billion.9 (The vast majority of this cost is due to lost workplace productivity.) While these metrics do not begin to fully address the impact of each suicide, they do provide some useful measurements on which to base estimates of burden.

This CME learning activity will review the latest evidence-based practices for assessing suicide risk and managing patients with non-pharmacological and pharmacological therapies, as appropriate. Clinicians working in a wide range of medical settings will encounter patients at risk of suicide, and the strategies and guidance contained in this activity will enable them to provide optimal care for patients in crisis.

Inadequate suicide screening in primary care

Despite strong evidence that people who die by suicide are more than twice as likely to have seen a primary care provider as a mental health provider before their death,10 suicide-related discussions in primary care appear to be rare. In a 2011 study of U.S. primary care providers, suicide was discussed in only 11% of encounters with 128 adult patients who had (unbeknownst to their providers) screened positive for suicidal ideation (i.e., who scored >14 points on the Patient Health Questionnaire, question 9 [PHQ-9]).11 In the relatively rare encounters where suicide was discussed, the conversation was more frequently initiated by physicians than by patients, and no male patients initiated suicide-related discussion, suggesting that patients are reluctant to talk about this subject and it is physicians who need to prompt the conversation.

Similarly, 36% of U.S. primary care physicians explored suicide in encounters with standardized patients presenting with major depression or adjustment disorder or those who sought antidepressants.12 Less than one quarter of surveyed primary care pediatricians or family practice physicians in Maryland reported that they “frequently or always” screened adolescents for suicide risk factors.13

Brief history of suicide prevention in the U.S.

In 1958, the first suicide prevention center in the United States opened in Los Angeles with funding from the U.S. Public Health Service.14 Other crisis intervention centers followed. In 1966, the Center for Studies of Suicide Prevention (later the Suicide Research Unit) was established at the National Institute of Mental Health (NIMH) of the National Institutes of Health (NIH). This was followed by the creation of national nonprofit organizations dedicated to the cause of suicide prevention.

In 1970, NIMH convened a task force in Phoenix to discuss the status of suicide prevention in the United States. NIMH presented the findings in the 1973 report Suicide Prevention in the 70s, which also identified future directions and priorities.

Figure 1: Suicides among general U.S. population,on and U.S. Veterans3

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In 1983, the Centers for Disease Control and Prevention (CDC) established a violence prevention unit that brought public attention to a disturbing increase in youth suicide rates. In response, the Secretary of the U.S. Department of Health and Human Services (HHS) established a Task Force on Youth Suicide, which reviewed the existing evidence and issued recommendations in 1989.15

Suicide became a central issue in the United States in the mid-1990s, when survivors of suicide loss mobilized attention and political will to prevent suicide in the nation. Using the United Nations (U.N.) guidelines for the creation and implementation of national strategies published in 1996, these grassroots groups launched a citizen-initiated campaign to encourage the development of a national strategy in the United States. These efforts resulted in two Congressional Resolutions recognizing suicide as a national problem and suicide prevention as a national priority. As recommended in the U.N. guidelines, these groups set out to establish a public and private partnership that would be responsible for promoting suicide prevention in the United States. This innovative public-private partnership jointly sponsored a national consensus conference on suicide prevention in Reno, Nevada, which developed a list of 81 recommendations.

The Reno conference is viewed as the founding event of the modern suicide prevention movement. Informed by its findings, in 1999, Surgeon General David Satcher issued his Call to Action to Prevent Suicide, which emphasized suicide as a serious public health problem requiring attention and action.16 This document introduced a blueprint for addressing suicide prevention through a number of efforts organized under the framework of “Awareness, Intervention, and Methodology” (AIM). It included 15 broad recommendations consistent with a public health approach to suicide prevention, along with goal statements and broad objectives.

In 2001 the HHS Secretary released the National Strategy for Suicide Prevention, which set forth an ambitious agenda, consisting of 11 goals and 68 objectives, organized under the AIM framework.17 The document was meant to serve as a wide-ranging catalyst for social change, with the power to transform attitudes, policies, and services. For the broader suicide prevention community, the National Strategy provided a common point of reference and a resource for advocacy at the state and local levels, while directing more attention to the needs of those affected by suicide.

In the years that followed, several other key developments helped advance suicide prevention in the nation. Among these was the 2002 report Reducing Suicide: A National Imperative, which summarized the state of the science base, gaps in knowledge, strategies for prevention, and research designs for the study of suicide.9 This landmark report presented findings from a 13-member committee formed by the Institute of Medicine in 2000, at the request of several federal agencies.

Activity in the field of suicide prevention has grown dramatically since the National Strategy was issued in 2001. Government agencies at all levels, schools, nonprofit organizations, and businesses have started programs to address suicide prevention. Recent milestones in the history of suicide prevention in the United States include the formation of the National Action Alliance for Suicide Prevention, in 2010, and the revision of the National Strategy in 2012. These milestones represent continuing progress toward the prevention of suicide in this country.

Two key initiativesEnacted in 2004, the Garrett Lee Smith

Memorial Act (GLSMA) was an important legislative accomplishment in the field of youth suicide prevention. The act was named for Oregon Senator Gordon Smith’s son, a college student who died by suicide in late 2003. The GLSMA created the first significant federal grant program directed specifically at suicide prevention. Administered by the Substance Abuse and Mental Health Services Administration (SAMHSA), the program provides grants to states, tribes, territories, and institutions of higher education for the implementation of youth and college suicide prevention efforts. More than 300 GLSMA suicide prevention grants have been funded since the program’s inception, including 27 grants funded through the Prevention and Public Health Fund created by the Affordable Care Act.

Another federal law, the Joshua Omvig Veterans Suicide Prevention Act (JOVSPA) of 2007, has supported the development of a comprehensive program to reduce the incidence of suicide among veterans. Named for a veteran of Operation Iraqi Freedom who died by suicide in 2005, the act directed the Secretary of the U.S. Department of Veterans Affairs (VA) to implement a comprehensive suicide prevention program for veterans. Components include staff education, mental health assessments as part of overall health assessments, a suicide prevention coordinator at each VA medical facility, research efforts, 24-hour mental health care, a toll-free crisis line, and outreach to, and education for, veterans and their families. In the summer of 2009, the VA added a one-to-one “chat service” for veterans who prefer to reach out for assistance using the Internet.

Suicide prevention principles of care

Suicide prevention requires a combination of universal, selective, and indicated strategies.18

Universal strategies target the entire population. Selective strategies are appropriate for subgroups that may be at increased risk for suicidal behaviors. Indicated strategies are designed for individuals identified as having a high risk for suicidal behaviors, including someone who has made a suicide attempt. Just as suicide has no one single cause, there is no single prevention activity that will prevent suicide. To be successful, prevention efforts must be comprehensive and coordinated across organizations and systems at the national,

state/territorial, tribal, and local levels. As with other health promotion efforts, suicide prevention programs should be culturally attuned and locally relevant.14

Suicide prevention efforts seek to reduce the factors that increase the risk for suicidal thoughts and behaviors and increase the factors that help strengthen, support, and protect individuals from suicide. Risk factors are characteristics that make it more likely that a person will think about suicide or engage in suicidal behaviors. Although risk factors generally contribute to long-term risk, stressful events, such as relationship problems, financial difficulties, or public humiliation could provide the impetus for a suicidal act.

Protective factors are not just the opposite or lack of risk factors. Rather, they are conditions that promote strength and resilience and ensure that vulnerable individuals are supported and connected with others during difficult times, thereby making suicidal behaviors less likely (although such factors do not ensure protection and should not be overly-weighted by clinicians).

Risk and protective factors for suicidal behaviors can be found at many levels, from the individual to the community and society at large. The social ecological model (see Figure 2) provides a framework for viewing these factors along four levels of influence: individual, relationship, community, and societal. The figure lists the major risk and protective factors for suicidal behaviors identified in the literature. Because these factors can vary between individuals and across settings, the examples listed in the figure are not comprehensive.

Patient-centered carePatients bring perspectives, values, and

preferences to their healthcare experience that can differ from those of clinicians. The following ideas and suggestions about aspects of care important to patients at risk for suicide emerged from focus groups conducted as part of the 2019 revision of the Department of Veterans Affairs/ Department of Defense guidelines on assessing and managing patients at risk for suicide:4• Recognize the importance of trust between

the patient and his or her provider and/or care team and the necessity for the patient to have consistent, open, and respectful communica-tion in the management of his or her care.

• Provide patients with comprehensive, digest-ible information regarding available preven-tion interventions and treatment options.

• Use a team approach to improve care co-ordination and information sharing among providers to ensure that patients receive comprehensive, individualized, and integrated care plans that are responsive to their goals, values, and preferences.

• Involve family members, caregivers, and support persons in the patient’s care whenever possible in accordance with patient preferences.

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• Encourage a culture shift surrounding suicide risk management within organizations and the community in general to address the stigma surrounding suicide.Providers are encouraged to use a patient-

centered care (PCC) approach that is individualized to patient needs, characteristics, and preferences. Effective, open communication between healthcare professionals and the patient is essential and should be supported by evidence-based information tailored to the patient’s needs. Use of an empathetic and non-judgmental approach facilitates discussions sensitive to gender, culture, ethnicity, and other considerations. The information that patients are given about treatment and care should be culturally appropriate and available to people with limited literacy skills. Treatment information should also

be accessible to people with additional needs such as physical, sensory, or learning disabilities. Family and caregiver involvement should be considered, if appropriate.

Regardless of setting, all patients in the healthcare system should be able to access evidence-based care appropriate to their specific needs or condition. When properly executed, PCC may decrease patient anxiety, increase trust in clinicians, and improve treatment adherence.19

Improved patient-clinician communication and a PCC approach conveys openness and supports disclosure of current and future concerns. As part of the PCC approach, providers should ask each patient about any concerns he or she has or barriers to high quality care he or she has experienced.

Shared decision makingThe Shared Decision Making (SDM) model

was introduced in Crossing the Quality Chasm, a 2001 Institute of Medicine (now called the National Academy of Medicine) report.20 It is readily apparent that patients, together with their clinicians, make decisions regarding their plan of care and management options. Patients at risk for suicide require sufficient information and time to be able to make informed decisions. Clinicians must be adept at presenting information to their patients regarding treatments, expected outcomes, and levels and/or locations of care. Clinicians are encouraged to use the Shared Decision Making model to individualize suicide prevention goals and plans based on patient capabilities, needs, goals, and preferences.

Figure 2: Examples of risk and protective factors in a social ecological model14

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(The VA and the Education Development Center have jointly developed resources regarding mental health and shared decision making that can be found at: https://www.treatmentworksforvets.org/provider/.)

Evaluating Suicide Risk

Suicide risk identification remains an imperfect science in part because, as concerning as suicide rate increases are, death by suicide remains a rare event. Research has demonstrated that there is:3• No all-encompassing explanation for suicide• No single path to suicide• No single path for reducing suicide risk• No single medical cause, etiology, or treatment

or prevention strategy

Although risk factors are derived epidemiologically, and as such cannot be used to predict individual behavior, evidence supports evaluation of key risk factors as a necessary, but not sufficient, component of a comprehensive suicide risk evaluation. These risk factors include:4• A prior suicide attempt• Current suicidal ideation• Recent psychosocial stressors• Availability of firearms• Prior psychiatric hospitalization• Psychiatric conditions (e.g., mood disorders,

substance use disorders) or symptoms (e.g., hopelessness, insomnia, agitation)

It’s important to bear in mind, however, that these risk factors and others such as family history of suicide, substance use disorders, loss, or illness also exist among individuals who do not have suicidal thoughts, attempt suicide, or die by suicide. Much research over the last decade has sought to identify which of the known risk factors are most predictive of suicide, both in the general population and among military/Veteran populations.21,22 These studies largely confirm that the same risk factors at work in non-military populations are present in Veteran/military populations.23 Evidence for military-related unique risk factors is inconclusive. For example, studies have found contradictory evidence about the relationship between military deployment and risk of suicide.3

Co-occurring conditionsCo-occurring health conditions are important

to recognize because they can modify the degree of risk and trajectory of an individual’s suicide-related behavior, impact the assessment and management of suicide risk, influence patient or provider treatment priorities and clinical decisions, and affect the overall provider approach to the management of suicide risk. Providers should expect that many patients will have one or more co- occurring health conditions. Because of the nature of suicide risk management, which sometimes takes place in parallel with ongoing care for co-occurring conditions, it is generally best to manage suicide risk collaboratively with other care providers.

Some co-occurring medical, mental health conditions, or substance use disorders may require early specialist consultation in order to discuss necessary changes in treatment or to establish a common understanding of how care will be coordinated and delivered.

In addition to assessing for co-occurring health conditions, patients and their families may also experience a number of psychosocial factors known to be associated with increased suicide risk. In order to fully assess risk of suicide from a whole-health approach, key psychosocial factors must be assessed as well and may require an interdisciplinary team approach. One example of a highly correlated psychosocial issue is the presence of intimate partner violence (IPV). IPV significantly affects risk, not only of suicide, but also for homicide.

Survivors of IPV are twice as likely to attempt suicide multiple times and the presence of IPV increases risk of murder-suicides significantly.24

Current assessment trends advocate greater awareness of these intersections and for the efforts to prevent suicide as well as IPV in a mutually collaborative manner.

Medical conditions associated with increased suicide risk

Several physical illnesses are associated with an increased risk for suicidal behaviors. The factors that may help explain this increased risk vary by medical condition but can include chronic pain, cognitive changes that make it difficult to make decisions and solve problems, and the challenges and emotional toll that can be associated with long-term conditions and limitations.

CancerCancer is one of the most common physical

illnesses associated with elevated suicide risk. The National Cancer Institute has identified cancers of the mouth, throat, and lung as risk factors for suicidal behaviors.25 While suicide risk tends to be highest in the first few months after diagnosis, risk remains elevated in the first 5 years.26 Fear associated with how the disease is perceived and managed, rather than the fear of death itself, is a frequent precipitator of suicidal behaviors. The consequences or side effects of treatment can also result in psychological problems.27 Fatigue and/or exhaustion, some of the most frequently reported side effects of cancer treatments, can be risk factors for suicidal behaviors. In addition, depression and anxiety are common in cancer patients. About 63 to 85 percent of individuals with cancer who die by suicide meet criteria for severe depression or anxiety. It is not always clear whether these types of mental disorders are triggered by the disease, occur as a consequence of the disease, or are an adverse effect of the treatment itself.27

Degenerative Diseases of the Central Nervous System

Huntington Disease: The prevalence of suicide is believed to be two to four times greater in individuals with Huntington disease than among the general population.28 The lifetime history of suicide attempts ranges from 4.8 to 17.7 percent.28 Major depressive disorder may be present in up to half of patients with Huntington’s disease and is thought to be a consequence of the disease itself, rather than a psychological reaction to having a serious illness, although the causal arrow in this case can plausibly point both ways. In addition, anxiety disorders, obsessive-compulsive disorders, psychosis, mania, aggression, irritability, impulsivity, and personality changes have all been reported in patients with the disease.

Multiple Sclerosis: Studies confirm an increased risk of suicide among patients with multiple sclerosis.29 Lifetime prevalence rates of depression range from 37 to 54 percent, and the prevalence rate of depression is almost three times the lifetime prevalence reported in the general population.30 Generalized anxiety disorder, panic disorder, and bipolar affective disorder (manic episodes) are also present more frequently in these patients.

Parkinson Disease: Parkinson disease is often associated with one or more psychiatric or cognitive disorders, such as depression, psychosis, or dementia.31 Most of the observations support the hypothesis that depression is a primary consequence of brain dysfunction, although situational factors may contribute to mood changes to some extent. Suicide and suicide attempts are uncommon despite the fact that the rates of suicidal ideation are elevated.31 Depression seems to be the most important predictor of suicidal ideation.

Traumatic Injuries of the Central Nervous System

Spinal Cord Injury: Suicide and suicide attempts occur more frequently in those with spinal cord injuries (SCI) than in the general population.32

People with SCI are five times as likely to experience depression compared with the general population, and the rates of depression following a traumatic spinal cord injury may be as high as 45 percent. Others have found that 10 to 13 percent of SCI patients suffer from anxiety and high levels of post-traumatic stress disorder.33

Traumatic Brain Injury: People with moderate to severe traumatic brain injury (TBI) may have widespread cognitive impairment that can affect attention, memory, executive functioning, language and communication, visual-spatial skills, and processing speed. TBI survivors may also have perceptual deficits and motor deficits. Executive brain dysfunction is a contributing factor related to suicidal behaviors. A review of the literature found that on the whole, there is an increased risk of death by suicide (three to four times greater for those with severe TBI), a higher frequency of attempts, and clinically significant suicidal ideation in 21 to 22 percent of the TBI population.34

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Other Disorders of the Central Nervous System

Epilepsy: Reported suicide rates in patients with epilepsy vary widely, from 0 to 25 percent.35

Factors that can affect the rate of suicide include psychological stressors associated with epilepsy, seizure type and frequency, psychic auras, and the presence of associated psychopathology.36

Some studies suggest that suppression of seizures in longstanding epilepsy may be associated with suicide risk, and that suicide does not occur among patients with severe epilepsy. The World Health Organization (WHO) states that increased suicidal behavior in epilepsy is linked to increased impulsivity, aggression, and chronic disability often seen in persons with the illness, and that alcohol and drug abuse also contribute to a greater risk of suicide among these patients.37

Migraine: In general, patients with migraine are two to four times more likely to develop depression, two to six times more likely to develop general anxiety disorder, five times more likely to develop obsessive compulsive disorder, and up to seven times more likely to develop panic disorder than the general population.38 Furthermore, depressed patients are about three times more likely to develop migraine in their lifetime. Migraine with an aura is believed to have a stronger association with psychiatric conditions than migraine without an aura. The relationship between migraine and depression and anxiety appears to be bidirectional, with each increasing the risk of the other condition. The risk of suicidal ideation and attempts is higher among migraine patients, especially in those who have migraine with aura.38

HIV/AIDSMost studies among individuals living with

HIV report lifetime prevalence of suicide attempts that range from 22 to 50 percent.39 Individuals with AIDS are 44 times more likely to attempt suicide than those without AIDS. While most studies report that persons living with HIV/AIDS have much higher suicide rates than the general population or those with other life-threatening illnesses, studies have reported no significant differences in suicide rates between HIV-infected individuals and other groups at risk for suicide, such as injection drug users and psychiatric patients. Hence, HIV status may not be the most relevant factor related to suicide, but rather that other suicide risk factors that are common among HIV-infected individuals play a more important role. Studies have shown that suicide attempts and suicide ideation among people with HIV occur most often in those who have a previous psychiatric history and other social and environmental risk factors for suicide.40 Mood, anxiety, substance abuse, and personality disorders are prevalent among those with HIV.

Chronic Kidney DiseaseThe following psychiatric disorders have been

frequently observed in patients with severe end-stage kidney disease who require hemodialysis: mood disorders, dementia and delirium, drug-

related disorders (e.g., alcohol dependence), schizophrenia and other psychoses, and personality disorders.41 The prevalence of depressive disorders in hemodialysis patients is estimated at 20 to 30 percent, with a rate of 10 percent for major depression. This subset of patients has been noted to be the most likely to request withdrawal from hemodialysis.

ArthritisArthritic disorders often co-occur with

other physical conditions, especially chronic pain conditions including back pain, migraine, and other chronic headaches.42 The association between arthritis and problems such as anxiety, substance use, and personality disorders has been demonstrated in large, population-based studies.43

The relationship between arthritis and suicidal behavior may be largely explained by comorbid mental health disorders alone or in combination with other factors such as level of pain and/or disability that are associated with a lower quality of life.

AsthmaAdolescents with asthma are more likely to

report depressive symptoms, panic attacks, suicidal ideation and behavior, and substance abuse when compared with those without asthma.44 It is not clear whether the association between asthma and depressive and anxiety disorders, as well as with suicidal ideation and behavior, results from a shared underlying process or from shared risk factors.

Mental conditions and/or substance use disorders associated with increased suicide risk

Post-mortem forensic reviews suggest that most, if not all, of those who die by suicide have an identifiable mental illness, though only about one-half of these individuals had received a mental health diagnosis in the year prior to their death.5

Some of the major mental conditions or substance use disorders associated with suicide are reviewed below. Table 1, on page 62, summarizes some of the commonly-used (and freely- available) questionnaires and assessment scales for these issues.

Mood disordersMood disorders are among the most common,

and may be the most life-threatening, psychiatric illnesses.45 Major depressive disorder, also called major depression or unipolar disorder, is characterized by a combination of symptoms, such as sadness and loss of interest or pleasure in once-pleasurable activities, which interfere with everyday life. It has been estimated that 12 to 17 percent of individuals will experience a major depressive episode within their lifetime.45 Although a person may experience only a single episode, more often he or she may have several episodes throughout his or her life.

Bipolar disorders, previously called manic-depressive illness, are characterized by dramatic mood swings, going from an overly energetic “high”

(mania) to sadness and hopelessness (depression). People with bipolar disorder type I have had at least one manic episode along with periods of major depression. Those with bipolar disorder type II have periods of high energy levels and impulsiveness that are not as extreme as mania and also alternate with episodes of major depression. The estimated lifetime prevalence of bipolar disorders is 1.3 to 5 percent.45

More than 60 percent of suicidal deaths occur among individuals with mood disorders. Suicide risk is particularly high among individuals with bipolar disorders, which is strongly associated with suicide thoughts and behaviors. Over their lifetime, the vast majority (80 percent) of patients with bipolar disorders have either suicidal ideation or ideation plus suicide attempts.46 In clinical samples, 14 to 59 percent of the patients have suicide ideation, and 25 to 56 percent attempt suicide at least once in their lifetime.47

Approximately 15 to 19 percent of patients with bipolar disorders die from suicide. The suicide rate among patients with bipolar disorders is estimated to be more than 25 times higher than the rate in the general population.46 Several factors can increase the risk for suicide among patients who have mood disorders. These factors include a recent suicide attempt and a severe major depressive episode, often accompanied by feelings of hopelessness and guilt, a belief that that are few reasons for living, thoughts of suicide, agitation, insomnia, appetite and weight loss, and psychotic features.48

Suicidal behaviors among mood disorder patients occur almost exclusively during an acute, severe, major depressive episode.48 Among patients with major depressive disorder, risk factors for suicide include other comorbid psychiatric conditions, such as post-traumatic stress disorder (PTSD), dependent personality disorder, borderline personality disorder, and substance use disorders. Among those with bipolar disorders, risk factors include a family history of suicide, early onset of bipolar disorders, increasing severity of affective disorders, presence of mixed affective states, and abuse of alcohol or drugs.49

Major depressive disorder often fails to be recognized, diagnosed, or treated.45 It is believed that many men in midlife who have the disorder do not seek treatment for their symptoms, and even when they do, they often drop out of treatment before they reach remission. Evidence is mounting that individuals who have had a stroke or heart attack and/or have chronic diabetes are likely to develop depression related to their physical illnesses.14 Older individuals with these conditions are particularly likely to do so.

Studies have shown that educating primary care providers in the assessment, treatment, and management of depression leads to reductions in suicide.14 Appropriate acute and long-term treatment of depressive disorders, including both pharmacological and non-pharmacological methods (especially cognitive behavioral therapy), greatly reduces the risk of suicide and attempted suicide in this high-risk population.48

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Large-scale, long-term, European observational studies of former inpatients with bipolar disorders show that long-term use of mood stabilizers reduces the risk of suicide, compared to patients who stop taking medication.14 There is also some evidence that psychotherapies can improve compliance and increase the effectiveness of pharmacotherapy, thereby possibly providing more protection against suicide risk.48

Anxiety disordersAnxiety disorders affect about 40 million

American adults aged 18 and older (about 18 percent) in a given year. 50 Unlike the relatively mild, brief anxiety caused by a stressful event like speaking in public, anxiety disorders last for months and can become worse if not treated. These disorders include the following: social phobia, simple phobia, generalized anxiety disorder, panic disorder, agoraphobia, PTSD, and obsessive-compulsive disorder (OCD).

The presence of any anxiety disorder is significantly associated with suicidal ideation and suicide attempts. Anxiety disorders commonly occur along with other mental or physical illnesses, including alcohol or substance abuse, which may mask anxiety symptoms or make them worse.

The presence of any anxiety disorder in combination with a mood disorder is associated with a higher likelihood of suicide attempts in comparison with a mood disorder alone.51 Among adults in the general population (i.e., not in the armed forces or Veterans), panic disorder and PTSD have been found to be more strongly associated with suicide attempts when there is a co-occurring personality disorder.

Borderline personality disorderBorderline personality disorder (BPD) is

characterized by a pervasive pattern of instability in interpersonal relationships, self-image, and emotions. Defining features of this disorder include an unstable mood, serious problems with emotion regulation, a wide range of impulsive behaviors, unstable interpersonal relationships, suicide, and chronic suicidal ideation.52

It has been estimated that between 3 and 10 percent of patients with BPD die by suicide.53

Recurrent suicide attempts, self-injury, and impulsive aggressive acts are often associated with BPD and often result in emergency and inpatient treatment. Suicides in BPD often occur late in the course of the illness and follow long courses of unsuccessful treatment.

New data have emerged on the effectiveness of psychotherapies specifically designed for patients with BPD.54 Research has shown that Dialectical Behavior Therapy (DBT) is effective in reducing the self-injurious behaviors associated with BPD.55

DBT specifically aims to modify the regulation of negative emotion. The main outcomes of DBT are reduced overdoses, ED visits for suicidal behaviors, frequency of self-directed violence, and hospital admissions. The efficacy of medications for BPD is not firmly established.14

SchizophreniaSchizophrenia is a severe, chronic disorder

characterized by disturbances in perception, thought, language, and social function. The risk for suicide in individuals suffering from schizophrenia is particularly high in the early stages of the illness (first 3–5 years of onset).14 A meta-analysis of more than 60 studies found that almost 5 percent of schizophrenic patients will die by suicide during their lifetimes, usually near the onset of the illness.56

Surviving the initial period of heightened risk results in a lesser, although still considerable, risk of death by suicide.56

Table 1. Common assessment tools for mental health disorders or substance use disorders63

Name of tool/measure Number of items Notes

Clinically Useful Depression Outcome Scale (CUDOS)

18 A newer depression severity measure, the CUDOS can be used to monitor symptoms over time in routine clinical practice. The CUDOS is longer than the PHQ-9 and includes a broader Likert scale, which provides greater breadth for tracking ongoing improvement. It generally takes only 3-5 minutes to complete.

Geriatric Depression Scale-Short Form (GDS-SF)

15 Developed specifically for assessing depression severity in older adults, the GDS-SF uses a simple yes/no format and excludes physical symptoms that may be associated with aging or physical health conditions (and which, therefore, can lead to over-estimations of depression severity). The GDS-SF is a good choice for more frail older adults, those with significant medical or physical health conditions or for those who may have more difficulty with other response formats such as Likert scales.

Generalized Anxiety Disorder-7 (GAD-7)

7 The GAD-7 is a widely-used measure of generalized anxiety disorder that is part of the same set of measures as the PHQ-9. It has been shown to have good sensitivity and specificity for screening other anxiety disorders, as well as for showing treatment gains or responses. The GAD-7 is brief and easy to use on a repeated basis.

Clinically Useful Anxiety Outcome Scale (CUXOS)

20 The CUXOS is a recently-developed measure for ongoing monitoring of anxiety symptoms in routine treatment. Unlike the GAD-7, the CUXOS is a broad measure of anxiety symptoms, which may be particularly useful for symptoms comorbid with depression.

PTSD Checklist from DSM-5 (PCL-5)

20 The PCL-5 is a widely-used measure of PTSD symptoms in the VA healthcare system. It allows for provisional PTSD diagnosis and monitoring of symptoms changes during or after treatment.

Insomnia Severity Index (ISI) 7 The ISI is a widely-used measure of insomnia severity that is brief and simple to complete as a self-report measure of symptoms.

Short Inventory of Problems-Revised (SIP-R)

17 The SIP-R assesses negative consequences related to substance use that have been shown to be sensitive to change over time. The measure may be used during initial assessment to help treatment planning as well as to monitor progress or revise treatment plans as needed.

Alcohol and Drug Outcome Measure (ADOM)

20

Leeds Dependence Questionnaire (LDQ)

10 The LDQ is a brief measure of substance dependence developed specifically to assess symptoms of psychological, as opposed to physiological, dependence. The LDQ has been shown to be sensitive to change during treatment and can be used repeatedly.

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The greatest indicator of suicide risk among people with schizophrenia is active psychotic illness (e.g., delusions) combined with symptoms of depression. Increased risk for suicide is also associated with higher levels of education and higher socioeconomic status. Alcohol abuse has been reported in studies examining suicide attempts.56

Nonpharmacological therapies, such as cognitive enhancement therapy, may have great potential for improving the individual’s social and occupational functioning.57 Findings from an evidence review suggest that an integrated psychosocial and pharmacological approach may be useful, and that treating depressive symptoms in patients with schizophrenia is an important component of suicide risk reduction.58

Substance use disordersSuicide is a leading cause of death among

people with substance use disorders (SUDs). Substance use may increase the risk for suicide by intensifying depressive thoughts or feelings of hopelessness while at the same time reducing inhibitions to hurting oneself. Alcohol and some drugs can cause a “transient depression,” heighten impulsivity, and cloud judgment about long-term consequences of one’s actions.

Alcohol abuse is second only to depression and other mood disorders as the most important risk factor for suicide. A 2019 analysis of postmortem data shows that the odds of suicidal behavior are about three times higher among people with alcohol use disorder (AUD) compared to those without AUD.59 Women who receive AUD treatment have about a 16-fold risk for suicide compared with women in the general population, whereas men who have received AUD treatment have approximately a 9-fold risk for suicide compared with men in the general population.59

Among individuals with alcohol use disorders, suicide frequently takes place within the context of a major depression and interpersonal stressors. Aggression, hopelessness, and partner-relationship disruptions are also risk factors. Studies have shown that depression is present in 45 percent to more than 70 percent of those with alcohol and substance use disorders who die by suicide.60

Although less is known about the relationship between suicide risk and other drug use, the number of substances used seems to be more predictive of suicide than the types of substances used. Findings from a few initial studies suggest that treatment of drug abuse may help reduce the risk for future suicidal behaviors.61

SUDs and chronic substance use can lead to consequences and losses that contribute to suicide risk factors. Individuals in treatment for substance use disorders and/or transitioning between levels of care may be especially vulnerable.62 A large number of people in treatment have co-occurring mental disorders that increase suicide risk, particularly mood disorders. At the time these individuals enter treatment, their substance abuse may be out of control, they may be experiencing a number of life crises, and they may be at peaks in depressive

symptoms. In addition, mental disorders associated with suicidal behaviors, such as mood disorders, PTSD, anxiety disorders, and some personality disorders, often co-occur among people who have been treated for substance use disorders.

Crises that are known to increase suicide risk, such as relapse and treatment transitions, may occur during treatment. According to one study, compared with the general population, individuals treated for alcohol abuse or dependence have a 10 times greater risk of eventually dying by suicide.62

Among those who inject drugs, the risk is about 14 times greater than in the general population.62

More is known about the factors that increase the risk of suicidal behaviors among this population than about the factors that may be protective. SUDs share many risk factors with suicide: family history of suicide or child abuse; history of mental disorders, particularly mood disorders; history of or family history of addiction; impulsiveness; feelings of isolation; barriers to mental health and/or treatment; relational, social, work, or financial losses; physical illness/chronic pain; access to lethal methods; and prejudice associated with asking for help.

Perceiving that there are clear reasons to live is thought to be an important protective factor in this group. Other protective factors may include: a child at home and/or childrearing responsibilities; an intact marriage; a trusting relationship with a counselor, physician, or other service provider; employment; religious attendance and/or belief in religious teachings against suicide; and an optimistic or positive outlook. Sobriety can be a protective factor, along with attendance of mutual support group meetings although roughly half of those who die by suicide had no alcohol in their bodies at the time of death.59

Social/environmental factors

Bullying/cyberbullyingBullying among school-age children is now

recognized as a major public health problem in the Western world. 64 Bullying has been defined as a situation in which a person is exposed, repeatedly over time to negative actions on the part of one or more people, which typically involves an imbalance of power. Bullying falls into four general categories: direct–physical (for example, assaults or theft), direct–verbal (threats, insults, or nicknames), indirect–relational (for example, social exclusion and spreading hurtful rumors), and bullying behavior via online communications (cyberbullying).64 Population-based studies indicate that 20% to 30% of school children are involved in bullying, either as bullies or victims.65 In a cross-national study of 113 000 students aged between 11 and 15 years from 25 countries, involvement in bullying varied from 9% to 54%.66 Bullies and victims of bullying are more likely than children uninvolved in bullying to suffer from a wide variety of problems, including low self-regard, depression and anxiety, and violent behaviors.

Numerous cases have been reported in the media in which suicide or attempted suicide has been attributed to bullying. Empirical research has also identified bullying as one of the risk factors for suicidality,67 and adolescents frequently cite interpersonal problems as a precipitant of suicidal behavior.68 In a study by Beautrais et al., the most common precipitants of serious suicide attempts were interpersonal conflicts and relationship difficulties.69 More recent research has examined the association between cyberbullying and psychopathology, including suicide. Surveys on the prevalence of cyberbullying show that it is relatively common among adolescents.64 The CDC reports that rates of cyberbullying are highest in middle school (33%), followed by high school (30%), combined middle/high schools (20%) and primary schools (5%).70

Cyberbullying is unique to other more traditional forms of bullying because of the perpetrator’s anonymity and ability to harass their victim 24 hours a day. Extreme cases of cyberbullying have led to adolescent suicide and longitudinal studies support the view that the effects of bullying can be long-lasting.71 Children involved in bullying, particularly those who were bully victims, at early elementary school age and those who were victims in their early teens, had more psychiatric symptoms at the age of 15 years.72

Strategies exist to reduce the incidence of both bullying and cyberbullying. A comprehensive guideline for preventing bullying, and, hence, lowering the risk of bullying-associated suicide, is available from the CDC which include a range of approaches to strengthen youth’s skills and modifying physical and social environments for youth’s protection.73

Cultural context of suicideSuicidal behaviors can be influenced by

cultural factors in a variety of ways. First, there may be culture-specific patterns in the triggers or precipitants of suicidal behavior. For example, some individuals of Eastern Asian descent may engage in suicidal behavior after they experience the shame associated with loss of face because they failed to meet expectations of their families or others.74

Second, risk and protective factors for suicidal behavior may be influenced by cultural context. For example, acculturative stress among Latino adolescents is associated with higher levels of thoughts about suicide.75 Third, the characteristics of suicidal and related behaviors may differ across cultures, although this possibility has been understudied. Finally, individuals in various cultural contexts may view and understand, and hence react to, suicidal behaviors in different ways. For example, suicidal thoughts or behavior may not be recognized as a problem as readily among African Americans because of a perception among blacks that they are not at risk for suicidality.76

Culture may also affect each of the stages of help-seeking behaviors that can lead to the use of mental health services for prevention or treatment of suicidal behaviors.

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In the first stage of help-seeking, behaviors or difficulties need to be recognized as a problem, but suicide attempts may be perceived, labeled, or tolerated differently in different cultural groups.77

Even if a behavior is recognized as problematic, cultural factors may affect decisions about whether to seek mental health assistance. For example, some cultural groups may not seek formal services because of stigma or concerns that mental health services will be contrary to cultural values (e.g., among young American Indian adolescents, stigma and embarrassment were associated with not seeking help when suicidal). Finally, culture may influence the decision about the type of services or help to seek. For example, recently-immigrated Latino and Asian families may lack familiarity with the health care system or may believe that problems such as suicidal behaviors should be dealt with by the family or faith community rather than specialty mental health services.77

Suicidal behavior and help-seeking occur in a cultural context and are likely associated with different precipitating factors, different vulnerability and protective factors, differing reactions to and interpretations of the behavior, and different resources and options for help-seeking. Awareness of the interface of culture, adolescent suicidal behavior, and help-seeking is essential for culturally competent professionals and an important step to developing effective, culturally sensitive, interventions to reduce suicidal behaviors.

Approaches for assessing suicide riskNumerous methods of identifying suicide risk

have been investigated. These include traditional approaches (e.g., expert review of cases, face-to-face interviews, clinician-administered screening questions, self-report screening tools, gatekeeper training and education) as well as novel approaches (e.g., predictive models based on historical data, machine learning algorithms of social media, biomarkers). Regardless of the screening and identification method, accurate identification of suicide risk remains elusive.78,79 These screening and identification efforts are often hampered by low positive predictive values, high false negative rates (roughly 50%) and high false positives. Combined with the low base rate of suicide, this pattern of findings results in limited actionable information that can be used to guide or develop effective population-based screening programs that can be implemented in clinical and community-based settings. However, evidence suggests that the screening for suicidal thoughts and behaviors does not increase risk for suicide.80,81

ScreeningAs noted above, most suicide screening tools

yield an unacceptably high false-positive prediction rate (i.e., many of those determined to be “at risk” never experience clinically significant suicidal thoughts or behavior) alongside an unacceptably low degree of accuracy when identifying true cases (i.e., a substantial portion of those individuals who die by suicide were not identified by the screening tools).4

However, several studies support the use of the PHQ-9 as a universal screening instrument to identify suicide risk.82,83 Item 9 on the PHQ, as well as possible responses are as follows:84

Item 9: “Over the past two weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?”

Possible Responses: “Not at all,” “Several days,” “More than half the days,” or “Nearly every day.”

Louzon et al. evaluated patients who received the PHQ-9 across care settings and found that higher levels of suicidal ideation, as identified by responses on item 9, were associated with increased risk of death by suicide. 82 Responses on the items were related to risk as follows: “several days” – a 75% increased risk for suicide, “more than half the days” – a 115% increased risk for suicide, and “nearly every day” – a 185% increased risk. Nonetheless, 71.6% of deaths by suicide during the study periods were among those who reported “not at all,” highlighting that use of item 9 alone is likely to result in a number of at risk patients being missed.82

Similarly, Simon et al. examined the relationship between PHQ-9 scores and death by suicide among civilian outpatients receiving care for depression in mental health and primary care clinics, and found that endorsement of responses were predictive of both suicide attempts and deaths within the year post- administration.83 However, as with the Louzon et al. study, there were a notable number of suicides among those who denied thoughts of death or self-harm ideation.

As many individuals are seen by healthcare providers in the weeks and months prior to their deaths by suicide, strategies for early identification within diverse clinical settings are warranted. Emerging data suggest that one strategy to improve early identification is screening for suicide risk in both primary and specialty care settings. Implementation of such screening procedures will require the development and implementation of tools (e.g., templated evaluation forms) and trainings, as well as work flow strategies to address the needs of patients who screen positive. Despite its weaknesses, current guidelines endorse the PHQ-9 as a screening tool since it is positively associated with the degree of risk for suicide-related behavior.4

The evidence base for screening programs and tools is limited by small sample sizes, data from non-adult cohorts, truncated follow-up windows that were too short to determine if the screening tool or process could accurately identify or predict suicidal thoughts and behavior, and the use of proxy outcomes for suicide and suicide-related behavior. For example, the Columbia Suicide Severity Rating Scale (C-SSRS) was evaluated in only 124 adolescents.85 In their conclusions the authors noted, “There were too few studies to assess the diagnostic accuracy of the C-SSRS.” Studies that use larger samples, adult cohorts, mortality as the key outcome, and employ prolonged follow-up periods are needed.

As noted above, no evidence suggests that the act of screening for suicidal thoughts and behavior increases negative affect or the risk of experiencing suicide-related thoughts and behavior.4 Further, no studies have identified any risks or harms associated with specific suicide screening programs or tools. Because of this, providers and healthcare systems are encouraged to administer screening programs for suicide-related thoughts and behavior. Indeed, findings from patient focus groups confirm that some patients will not voluntarily disclose their suicidal thinking, but would report it accurately if they had been asked about it directly.4

As limited data exist regarding implementing the PHQ-9 in large healthcare settings, future research regarding feasibility and acceptability are warranted. Nonetheless, there are sufficient data to encourage use of item 9 to screen for risk, particularly in non-mental health settings, as a component of system-wide suicide prevention efforts.

The U.S. Preventive Services Task Force (USPSTF) recommends that physicians screen teens and adults for depression when appropriate systems are in place to ensure adequate diagnosis, treatment, and follow-up and part of an overall approach to preventing suicide.13 More information can be found at: www.uspreventiveservicestaskforce org

Further research on the topic of suicide screening has been recommended, including:• Assessing and improving temporal accuracy

of screening and assessment tools. This in-cludes development and evaluation of screen-ing tools to predict suicide behaviors occur-ring across various timeframes (e.g., less than one month versus long-term risk).

• Identification of suicide risk subtypes (e.g., acute versus chronic risk).

• Development and testing of strategies to pre-dict and stratify risk that integrate multiple risk prediction methods and data sources, for example combinations of self-report, predic-tive analytics models which use data from the electronic health record, and/or other data sources.

• Further assessment of alternative methods for administering suicide screening questions.

• Determination of the appropriate frequency of screening, including evaluation of whether over- screening has an impact on the positive and negative predictive values of the instru-ment, as well as on patient satisfaction, trust, and engagement.

Predictive AnalyticsThe availability of large healthcare datasets and

machine learning analytics, coupled with modern statistical modeling, computing, and database technologies have introduced opportunities to develop predictive models of suicide and suicide-related behavior. These machine learning algorithms hold the potential to use existing healthcare and other large-scale data repositories to analyze patterns that allow for outcome identification and improved classification accuracy.86

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However, attempts to predict suicide using machine learning algorithms and predictive analytics tend to have low clinical utility. Suicide prediction models, in their current state, yield good overall classification accuracy (among individuals classified as “not at risk,” the algorithm will be correct over 99% of the time), but are poor at accurately predicting future suicide events (among those classified as “at risk,” the algorithm will be correct only about 1% of the time). In other words, these models can accurately determine who is not at risk for suicide (a high base rate outcome representing the vast majority of the population and data in the system), but are generally unable to determine who is at elevated risk for suicide-related behavior (a rare outcome).4 The nascent literature on this topic already suggests that this finding is consistent across the military, VA, and civilian healthcare systems, and is directly related to, and limited by, the suicide mortality rate in the population of interest. The inability to predict who will experience the targeted outcome is the fatal flaw for most predictive algorithms. Use of these models is likely to result in high rates of false positive identification as high risk (potentially leading to wasted resources, mistrust of healthcare systems, and discrimination), as well as an unacceptable risk of false negatives (the occurrence of suicide among those that the model determined to be “not at risk”).

Additionally, the application of predictive analytics to rare healthcare-related outcomes is so new that critical ethical and practical concerns have yet to be fully addressed, including what interventions should be provided to those who are classified as being at risk for suicide, especially if the majority of the cases being classified as “at risk” represent false positive identifications.87

Recognizing that suicide is not predictable in the near term does not exclude other clinical imperatives. Regardless of suicide or suicide attempt as an eventual outcome, patients’ pathways to distress and decompensation always warrant individualized support and treatment.

Acute Warning SignsIn addition to predictive analytics and routine

screening, patients at risk for suicide can be identified via the presence of acute warnings signs for suicide. Warning signs are individual factors that signal an acute increase in risk that the patient may engage in suicidal behavior in the immediate future (i.e., minutes to days).

Recognition of warning signs is the key to creating an opportunity for early assessment and intervention. Three direct warning signs are particularly indicative of suicide risk:1. Communicating suicidal thought verbally or in

writing2. Seeking access to lethal means such as

firearms or medications3. Demonstrating preparatory behaviors such as

putting affairs in order

The presence of one or more of these warning signs is a strong indication that further assessment is needed. Indirect warning signs (e.g., agitation,

hopelessness, insomnia, shame) are thoughts, feelings, and/or behaviors that may, or may not, be associated with suicidal thoughts and behavior.

Patient-specific warning signs can be assessed by asking patients to describe thoughts, feelings, and behaviors experienced prior to the most recent exacerbation of suicidal ideation or behavior. If a patient reports experiencing any common warning signs, the provider can then directly ask the patient if they are experiencing thoughts of suicide. (See the management algorithms below for guidance about how to follow-up with a patient who presents with current warning signs.)

EvaluationIt is rare for suicidal ideation to be the chief

problem in the outpatient setting.88 More often, patients have symptoms that may ultimately be related to suicidal ideation. For example, a patient may have gastrointestinal upset related to increased stress or depression. On further assessment, additional risk factors for suicide may be present.

Evidence shows that inquiring about suicide does not increase suicidal ideation or attempts. In a randomized trial of 443 adult patients with depression, there was no statistical difference in suicidal ideation or behavior between participants assigned to early questioning about suicidal thoughts and those assigned to delayed questioning.89

Direct inquiry concerning suicidal ideation in patients with risk factors is associated with more effective treatment and management because it allows the physician to gain necessary information while potentially alleviating patient anxiety.90

Risk factors to be included as part of a comprehensive evaluation of suicide risk are summarized in Table 2.

The evidence base in support of factors that can protect against suicidal behavior is limited. Nonetheless, evaluation of such factors, particularly those associated with reasons for living, should be included in a comprehensive suicide risk evaluation. Potential benefits of a suicide risk evaluation include improved likelihood of a therapeutic alliance and improved prediction of suicide risk.

As noted, evidence reviews have not identified a specific risk evaluation instrument or method (e.g., structured clinical interview, self-report measures, and predictive analytic models) that is sufficient to determine future risk of suicide.4

However, performing suicide risk evaluation is a critical function for mental health providers, as well as primary care, emergency department personnel, and other providers. Currently, there are many assessment tools and methods used by providers to evaluate and manage suicide risk. These assessment tools provide a standardized way of eliciting information from individuals that can help inform risk management strategies.

Given the lack of evidence supporting the use of a single instrument or method, clinicians should be cautious when conducting a suicide risk evaluation, and not rely on any of these tools alone. This approach is consistent with current clinical

models and best practices (e.g., therapeutic risk management), which highlight the importance of using multiple tools and methods, such as structured clinical interviews augmented with valid and reliable self-report measures, as part of an evidence-based process for evaluating suicide risk.4

Recommended questions to ask in the assessment of suicidal intent include:3• Are you currently thinking about or have you

recently thought about death or harming your-self?

• Have you thought about how you would harm yourself? What is your plan?

• Do you have access to a method of suicide (e.g., gun and bullets, poison, pills)?

• What has kept you from acting on these thoughts?

• Do you have any intention of following through with the thoughts of self-harm?

• What are your plans for the future?• Have you or a family member ever attempted

suicide in the past?• Have you or a family member ever been di-

agnosed with or been treated for anxiety, de-pression, or other mental health problems?

• Are you currently using alcohol or drugs (illicit or prescription)?

• Have there been any changes in your employ-ment, social life, or family?

• Do you have friends or family with whom you are close? Have you told them about these thoughts?

Additionally, behavioral observations may provide information about the severity of symptoms and level of risk. Patients who present with a disheveled appearance or poor hygiene, or who seem withdrawn or agitated, along with recent or current suicidal ideation may be at increased risk of suicide attempts. A mental status examination can be used to assess patient functioning and inform the course of treatment. Although the USPSTF found insufficient evidence to recommend for or against routine screening for suicide risk in a primary care setting, screening instruments for depression, anxiety, and alcohol use further substantiate the severity of symptoms. Because no validated predictive tools exist, clinical judgment guides the decision-making process.88

Eliciting suicidal ideationNo single method or “best practice” exists for

eliciting suicidal ideation from patients. Although some patients may tell their physician about suicidal thoughts without prompting, this is not common. Often patients feel shame or embarrassment about suicidal thoughts, or they may simply not want to share them because they are, in fact, intent on completing the act. Clinicians should, therefore, raise the topic by using open-ended questions and gradually focusing on direct ones.91 It may be easier to broach the subject while exploring mood symptoms or discussing negative feelings.

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Table 2. Factors to consider during a comprehensive evaluation suicide risk4

Factor Category Factors to Consider

Self-directed violence-related • Current suicidal ideation• Prior suicide attempt(s)• Preparatory behaviors • Past or present suicidal intent • Non-suicidal self-directed violence behaviors

Current psychiatric conditions/current or past mental health treatment • Mood disorders• Anxiety disorders• Psychotic disorders• Personality disorders • Substance use disorders• Eating disorders• History of psychiatric hospitalization

Psychiatric symptoms • Hopelessness• Depressed mood• Anxiety/panic• Insomnia• Problem solving difficulties• Agitation• Anger• Rumination• History of alcohol use• Decreased psychosocial functioning • Hallucinations

Recent bio-psychosocial stressors • Loss of a relationship (e.g., break-up, divorce, death)• Loss of job• Risk of losing stable housing/homelessness• Exposure to suicide• Traumatic exposure (e.g., bullying, IPV, sexual assault, physical assault, emo-

tional abuse)• Social isolation• Legal/disciplinary issues• Financial problems • Transition of care (e.g., discharge from inpatient, change in medication,

change in therapist) • Barrier to accessing care

Availability of lethal means • Access to firearms• Access to other lethal means

Physical health conditions • History of traumatic brain injury (TBI) with moderate to severe TBI being greater than mild (concussion)

• Cancer diagnosis

Demographic factors • Lesbian, gay, bisexual, or transgender sexual orientation or gender identity

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Questions for case study:

Case Study 1

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Gabriela, age 19, has been brought to the local emergency department after being found unconscious on the floor of her mother’s living room, an empty pill bottle nearby. The bottle is a prescription for a tricyclic antidepressant made out to the patient’s mother. Gabriela is breathing shallowly and has no spontaneous movement, although she reacts to deep, noxious stimuli by opening her eyes and moving her extremities. She is admitted to intensive care and intubated to protect her airway from aspiration in the event of vomiting.

The friend who found Gabriela says that Gabriela had only been living with her mother for a couple of days because her boyfriend recently left her. The friend reports that Gabriela is currently unemployed and had dropped out of college after two years.

Thirty-six hours after admission, you visit Gabriela as her primary care physician. She has been extubated and is awake, sitting up, and talking to a young man at her bedside. You have known Gabriela for many years, and know that her parents divorced when she was 11 years old. Two years later she became depressed and was briefly under psychiatric care for suicidal ideation. She has a history of periods of anger and despondency, but has not tried to commit suicide until now.

As you enter the room, Gabriela smiles sheepishly and asks, “Can I go home now?”

1. What would your initial approach be to obtain information you need to determine if, in fact, Gabriela should be released?

2. Would an around-the-clock “sitter” in her room be justified as a suicide prevention strategy?

3. What kinds of referrals would be appropriate to offer Gabriela as supports for coping with the life issues she is facing?

A step-wise approach to eliciting suicidal ideation is illustrated in Figure 3 in which the clinician begins by asking a general question about whether the patient has ever had any thoughts of death or felt that he or she is better off dead. A positive response to this question prompts the next question—whether the patient has thoughts of self-harm. If there are no thoughts of self-harm, the patient is said to have passive suicidal ideation. The primary care practitioner should then explore and mitigate any additional risk factors for suicide, and help the patient get in touch with relevant community resources, such as crisis helplines. With the patient’s permission, the patient’s risk can be made known to a family member or close friend. Conversely, if thoughts of self-harm are present, the patient is said to have active suicidal ideation and should be given a same-day psychiatric assessment. The primary care physician should ask further questions to look for behavior that suggests intent (e.g. making a suicide note or distributing personal belongings), or whether there is a specific plan to carry it out. Any patient who communicates a specific intent or plan for suicide requires urgent psychiatric referral and should be transported to the emergency room.

Risk stratificationWhile it is an expected standard of care, there

is insufficient evidence to recommend for or against the use of risk stratification to determine the level of suicide risk. A valid and reliable tool to classify the degree of risk that accurately represents a patient’s suicide-related thoughts and behavior (i.e., risk stratification) remains elusive.

In a study by Large et al. just over half of the suicide-related deaths observed occurred among patients in the high-risk category who were admitted to inpatient psychiatric facilities.92

The odds ratio for suicide in the high- risk group compared to the low-risk group was 7.1, but this is in the context of a patient population that all met criteria for admission to inpatient psychiatry. A 2016 study described similar findings in patients seeking psychiatric services who had a suicide attempt, demonstrating a 56% sensitivity (correct identification of true positive cases) and 79% specificity (correct identification of true negative cases) of a high-risk categorization.92 In both systematic reviews, however, approximately half of all suicide-related deaths occurred in the low-risk categories. Methodological variations across these studies with respect to the patient population, as well as criteria and methods for determining

different levels of risk, likely contributed to the inconsistent findings. Thus, the evidence for risk stratification remains inconclusive.

Nonetheless, providers should not be discouraged from completing comprehensive assessments to determine level of risk and appropriate risk mitigation strategies. Risk stratification, when completed as part of a comprehensive evaluation, enables providers to formulate a clinical impression of a patient’s suicide risk, which can help inform risk mitigation strategies and treatment decisions.

Additionally, as patients move between providers, relocate, progress through levels of care, and transition from military service to Veteran status, it is useful to have a consistent lexicon for identifying and communicating a patient’s level of risk (i.e., high, intermediate, or low acute or chronic risk). Therefore, consistent and standardized approaches to suicide risk assessment and stratification, such as those depicted in the algorithms below, can enhance the clinical utility and feasibility of conducting risk stratification in an equitable and replicable manner.

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Figure 3. Step-by-step assessment of suicidal ideation91

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Decision-making algorithms

Figure 4 depicts the first in a set of algorithms designed to facilitate decision-making processes used in managing patients at risk for suicide. The simplified approach depicted by the algorithms (Figures 4, 5, and 6) allows the provider to assess the critical information needed at the major decision points in the clinical process.

The algorithms include:

• An ordered sequence of steps of care• Recommended observations and examinations• Decisions to be considered• Actions to be taken

Figure 4: Algorithm A for identifying suicide risk4

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Figure 5. Algorithm B: Evaluation by Provider4

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Figure 6. Algorithm C: Management of patients at acute risk for suicide4

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After assessing a patient at risk and following the appropriate steps as recommended in the algorithms above, physicians should assign the patient a risk category (i.e., acute vs. chronic risk, and, within each class, high, intermediate, or low risk). Tables 3 and 4 summarize the main features of each category and the actions recommended for each.

Short-term managementAfter necessary medical stabilization (in the

event of a suicide attempt), an environment that provides adequate patient protection must be selected. Patients who have suicidal ideation, but no plan or means in place, and who have good social support may be treated as outpatients.88 With patient permission, close family or friends should be involved to ensure patient safety and adherence.90

Suicide prevention contracts have not been shown to reduce suicide attempts and should generally be avoided.93

Inpatient admission should be offered for patients with specific plans for suicide who have the means to complete their plan. In many states, involuntary admission is an option. Physicians should be aware of the statutes related to suicide risk in their jurisdictions.

Table 3. Essential features and action steps for patients with acute suicide risk4

Level of Risk Essential Features Action

High Acute Risk • Suicidal ideation with intent to die by suicide• Inability to maintain safety, independent of

external support/help

Common warning signs:• A plan for suicide• Recent attempt and/or ongoing preparatory-

behaviors• Acute major mental illness (e.g., major

depressive episode, acute mania, acute psychosis, recent/current drug relapse)

• Exacerbation of personality disorder (e.g., increased borderline symptomatology)

• Typically requires psychiatric hospitalization to maintain safety and aggressively target modifiable factors

• These individuals may need to be directly observed until they are transferred to a secure unit and kept in an environment with limited access to lethal means (e.g., keep away from sharps, cords or tubing, toxic substances)

• During hospitalization co-occurring condi-tions should also be addressed

Intermediate Acute Risk • Suicidal ideation to die by suicide• Ability to maintain safety, independent of

external support/helpThese individuals may present similarly to those at high acute risk, sharing many of the features. The only difference may be lack of intent, based upon an identified reason for living (e.g., children), and ability to abide by a safety plan and maintain their own safety. Preparatory behaviors are likely to be absent.

• Consider psychiatric hospitalization, if related factors driving risk are responsive to inpatient treatment (e.g., acute psychosis)

• Outpatient management of suicidal thoughts and/or behaviors should be intensive and include: frequent contact, regular re-assess-ment of risk, and a well- articulated safety plan

• Mental health treatment should also address co-occurring conditions

Low Acute Risk • No current suicidal intent AND• No specific and current suicidal plan AND• No recent preparatory behaviors AND• Collective high confidence (e.g., patient, care

provider, family member) in the ability of the patient to independently maintain safety

Individuals may have suicidal ideation, but it will be with little or no intent or specific current plan. If a plan is present, the plan is general and/or vague, and without any associated preparatory behaviors (e.g., “I’d shoot myself if things got bad enough, but I don’t have a gun”). These patients will be capable of engaging appropriate coping strate-gies, and willing and able to utilize a safety plan in a crisis situation.

• Can be managed in primary care• Outpatient mental health treatment may also

be indicated, particularly if suicidal ideation and co-occurring conditions exist

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When in doubt regarding the need for admission, inpatient care is the more prudent option. However, if a patient is referred for admission, but not placed in the hospital, he or she may experience additional stress and increased feelings of helplessness.88

Regardless of the treatment setting, ensuring patient safety is a primary concern. Caregivers should be told to remove weapons and medications that could be used for deliberate self-harm and

should monitor the patient frequently. During inpatient admissions, patients may need to stay in a locked unit where they do not have access to stairwells, light fixtures, and other installations that could be used for hanging.

Frequent contact with staff can help in the identification of suicide warning signs.88

Treatment of underlying psychiatric or substance abuse disorders should be initiated as early as possible and should be tailored to individual patients. This treatment should generally consist of some form of pharmacotherapy plus psychological evaluation and treatment.

Table 4. Essential features and action steps for patients with chronic suicide risks4

Level of Risk Essential Features Action

High Chronic Risk Common warning sign:• Chronic suicidal ideation

Common risk factors:• Chronic major mental illness and/or person-

ality disorder• History of prior suicide attempt(s)• History of substance use disorders• Chronic pain• Chronic medical condition• Limited coping skills• Unstable or turbulent psychosocial status

(e.g., unstable housing, erratic relationships, marginal employment)

• Limited ability to identify reasons for living

These individuals are considered to be at chronic risk for becoming acutely suicidal, often in the context of unpredictable situational contingencies (e.g., job loss, loss of relationships, and relapse on drugs).These individuals typically require:• Routine mental health follow-up• A well-articulated safety plan, including

lethal means safety (e.g., no access to guns, limited medication supply)

• Routine suicide risk screening• Coping skills building• Management of co-occurring conditions

Intermediate Chronic Risk • These individuals may feature similar chronic-ity as those at high chronic risk with respect to psychiatric, substance use, medical and pain disorders

• Protective factors, coping skills, reasons for living, and relative psychosocial stability sug-gest enhanced ability to endure future crisis without engaging in self-directed violence

These individuals typically require:• Routine mental health care to optimize

psychiatric conditions and maintain/ enhance coping skills and protective factors

• A well-articulated safety plan, including lethal means safety (e.g., safe storage of lethal means, medication disposal, blister packaging)

• Management of co-occurring conditions

Low Chronic Risk • These individuals may range from persons with no or little in the way of mental health or substance use problems, to persons with significant mental illness that is associated with relatively abundant strengths/ resources

• Stressors historically have typically been endured absent suicidal ideation

• The following factors will generally be missing: ° History of self-directed violence ° Chronic suicidal ideation ° Tendency towards being highly impulsive ° Risky behaviors ° Marginal psychosocial functioning

• Appropriate for mental health care on an as needed basis, some may be managed in primary care settings

• Others may require mental health follow- up to continue successful treatments

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Long-term managementEven after initial stabilization and improvement

of suicidal ideation, the patient remains at increased risk. Patients who attempt suicide have a risk of death in the following year 100 times greater than that of the general population.94 Therefore, it is important to involve the patient’s social support system in assisting with management. In addition to frequent contact with the primary care physician, the patient should have access to behavioral health specialists, as well as community programs such as Alcoholics Anonymous or Narcotics Anonymous if substance abuse or dependence is involved.

For patients with personality disorders, particularly borderline, histrionic, and narcissistic disorders, suicidal gestures and intent may become common and chronic in nature. The physician must be vigilant in taking each threat seriously, because gestures may become lethal. Physicians should regularly assess for suicide risk level and coping resources, and help patients identify problem-solving techniques. If the patient remains at a high risk of self-harm, referrals to emergency services and specialty care are recommended.

Evidence-based non-pharmacological treatments to reduce suicide risk

Most effective treatments to reduce risk for suicide attempt include psychotherapy.13 In fact a systematic review by the USPSTF found that psychotherapy reduces the risk of suicide attempts by 32% compared with usual care in adults.95

The most commonly-studied psychotherapy interventions are cognitive behavioral therapy and related approaches, including dialectical behavior therapy, problem-solving therapy, and developmental group therapy. Other approaches include psychodynamic or interpersonal therapy.

Although most of these treatments are not customarily administered by primary care providers in the office, patients can be referred to behavioral health providers for them. The primary care provider can play a continuing supportive role in the care of these patients by monitoring them during the process, providing follow-up, and coordinating with other care providers.

Cognitive behavioral therapyCognitive behavioral therapy (CBT) teaches

patients to identify and change problematic thinking and behavioral patterns with the expectation that this will impact their emotional experience.96 This is typically done by having patients identify proximal thoughts, images, and core beliefs that were activated prior to self-directed violence. Cognitive and behavioral strategies are then typically applied to address the identified thoughts and beliefs. Development of a relapse prevention plan is typically conducted near the end of therapy. Typically patients attend fewer than 12 CBT sessions.

Four systematic reviews/meta-analyses have examined the effect of CBT on suicide-related outcomes.96-99 Seven studies (with a total of 988 participants) that were included in these reviews specifically targeted suicide risk as part of the intervention. Although there are some mixed findings, there is moderate evidence overall that CBT-based interventions focused on suicide prevention are effective at reducing repeat incidents of self-harm. For example, Brown et al. found that patients who had presented to the hospital following a suicide attempt and received Cognitive Therapy for Suicide Prevention (CT-SP) as compared to those who received usual care, were 50% less likely to report a repeat suicide attempt during the follow-up period.100 Another randomized trial of a suicide-specific, individual, brief CBT intervention for suicide prevention conducted with active duty soldiers found that soldiers who received the intervention, as compared to those who received treatment as usual, were 60% less likely to make a suicide attempt in the follow-up period.101 While there is evidence that CBT has positive effects in terms of reducing suicide attempts, there is insufficient evidence at this time to suggest that CBT reduces suicide, (the quality of the evidence in studies looking at this outcome is low).96 There were no harms related to receiving CBT reported in the systematic reviews/meta-analyses that included these studies.

There may be variability in provider and patient preferences regarding this type of treatment. While many patients and providers appreciate the structured nature of CBT, and generally find it acceptable, some patients find the homework to be challenging and burdensome, and some decline to participate. Yet, as compared to patients not receiving evidence-based treatments, patients receiving CBT tend to get more consistent and lengthier (per session) care. CBT is also typically time-limited, which is appealing to many patients. Most behavioral health therapists in VA and Department of Defense (DoD) settings are trained

in CBT but would likely need some additional training in how to employ a CBT intervention specifically focused on suicide prevention.

Dialectical Behavioral TherapyDialectical Behavior Therapy (DBT) was

originally developed to treat individuals with borderline personality disorder, a subpopulation at heightened risk for non-suicidal and suicidal self-directed violence. DBT combines elements of CBT, skills training, and mindfulness techniques with the aim of helping individuals develop skills in: (1) emotion regulation, (2) interpersonal effectiveness, vand (3) distress tolerance.4

Based on a growing body of research, DBT has been found to reduce non-suicidal and suicidal self-directed violence among patients with BPD and recent self-directed violence. A systematic review by Hawton et al. included five trials that assessed the effectiveness of DBT in participants diagnosed with borderline personality disorder referred to outpatient services following a suicide attempt.96 One small trial included in the Hawton review compared a DBT-oriented psychotherapy with client-oriented therapy.102 At post-treatment, there was evidence of a significant treatment effect for DBT compared to client-oriented therapy for suicidal ideation and repetition of self-directed violence among patients diagnosed with borderline personality disorder.

Similarly, McMain et al. evaluated the clinical effectiveness of brief DBT skills training as an adjunctive intervention to treatment as usual for patients with borderline personality disorder at high risk for suicide.103 At the conclusion of the study, the DBT group demonstrated significant reductions in non-suicidal and suicidal self-directed violence compared to those in the active waitlist condition.

Despite general consistency in the evidence supporting DBT to reduce self-directed violence and suicidal ideation among individuals with borderline personality disorder who have reported recent self-directed violence, there is some variability in provider and patient preferences regarding this treatment. DBT appeals to both providers and patients due to its multifaceted components (e.g., mindfulness, interpersonal effectiveness) that emphasize patient engagement and autonomy. Moreover, findings from focus groups indicate that patients have had positive experiences with treatment modalities that include various complementary and integrative therapies such as mindfulness, which is an integral component of DBT.4

DBT is typically delivered as a multimodal treatment package that includes a manualized DBT skills group, individual psychotherapy, and 24-hour crisis response (when needed). As such, it offers patients the opportunity to benefit from group discussions, and is aligned with patient preferences for one-on-one interactions with providers. Although the clinical utility and acceptability of DBT among providers and patients are well established, access to standard DBT may be restricted due to limited resources and a shortage of clinicians who have been trained in the full model of DBT.

No Evidence for No-Suicide Contracts

“No-suicide contracts” or “No-harm contracts” are a relatively common suicide prevention intervention. No-suicide contracts are not the same as safety plans. They involve statements from patients promising not to harm themselves or that they will contact someone in the event that they are unable to maintain their own safety. Although commonly used, the practice of forming no-suicide contracts should be discouraged, as there is no evidence to suggest that such contracts reduce suicide tendencies.

They may instead be used by patients to hide their actual suicidal intents.

Source: Ng CWM, et al. Depression in primary care: assessing suicide risk. Singapore Med J. 2017;58(2):72-77.

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The body of evidence supporting DBT for suicide prevention includes limitations such as risk of bias due to blinding procedures and imprecision with respect to the degree of uncertainty (based on variance or sample size) around an outcome’s effect size.

Collaborative Assessment and Management of Suicidality

Collaborative Assessment and Management of Suicidality (CAMS), provides a method for therapists to join with the patient in a collaborative endeavor to develop a shared understanding of the suicidal episode, explore the degree of risk for self-harm, and develop a plan for ensuring the patient’s safety. Studies to date have shown promise for this approach, including evidence suggesting that patients resolve suicidality more quickly using this approach compared with conventional interventions.104

An open-trial, case-focused pilot study assessed an inpatient adaptation of CAMS, spread over a period averaging 51 days.105 The intervention was provided via individual therapy to a convenience sample of 20 patients (16 females and four males, average age 36.9 years) who were hospitalized with recent histories of suicidal ideation and behavior. Results showed statistically and clinically significant reductions in depression, hopelessness, suicide cognitions, and suicidal ideation, as well as improvement on factors considered “drivers” of suicidality. Treatment effect sizes were in the large range (Cohen’s d > .80) across several outcome measures, including suicidal ideation.105

Crisis response plansCompleting a crisis response plan has been

found to decrease suicide attempts among individuals with an acute history of suicidal ideation during the past week and/or a lifetime history of suicide attempts. A study by Bryan et al. found a statistically significant difference in the number and proportion of suicide attempts, favoring crisis response planning over treatment as usual.106

This intervention was associated with significantly fewer inpatient days than the Contract for Safety Intervention.

There is no evidence in the literature or in clinical expert opinion that there is any harm with completing a crisis response plan. This process is collaborative and should be patient centered. As there is no empirical evidence to support the usage of “no harm” or “no suicide” contracts, implementing crisis response plans and safety plans are the preferred strategies.

At a minimum, a crisis response plan involves a collaboration between a patient and clinician that includes the following components:4• A semi-structured interview of recent suicidal

ideation and history of suicide attempts• Unstructured conversation about recent

stressors and current complaints using sup-portive or reflective listening techniques

• Identification of clear signs of crisis (behavior-al, cognitive, affective, or physical)

• Self-management skill identification including things that can be done on the patient’s own to distract or feel less stressed

• Identification of social supports including friends, caregivers, and family members who have helped in the past and who they would feel comfortable contacting in a crisis

• Review of crisis resources including medical providers, other professionals, and the suicide lifeline

• Referral to treatment including follow-up ap-pointments and other referrals as needed

A crisis response plan is similar to a Safety Planning Intervention, which has also been associated with a reduction in suicidal behavior and increased treatment engagement among suicidal individuals. A large-scale study (n=1,640), involved a cohort comparison design using the Safety Planning Intervention plus follow-up services and was associated with about 50% fewer suicidal behaviors over a six-month follow-up and more than double the odds of engaging in outpatient behavioral health care.107 See Table 5 for a comparison of Crisis Response Planning and the Safety Planning Intervention (SPI).

Considerations for patient safety are part of a comprehensive treatment plan in behavioral health environments with the highest risk period for suicide attempts occurring up to 12 weeks after discharge from the hospital. The transition from inpatient to outpatient behavioral health care is a particularly susceptible time and current standards of care include safety planning as an important component of discharge planning to help patients maintain safety as they transition out of inpatient care.

The evidence supporting Crisis Response Planning and Safety Planning Interventions is limited by small sample sizes and confounders in the analyses. Even though evidence quality is low, these interventions do not require specialized training and are not setting-dependent. Patient focus groups revealed the importance of a patient-centered, collaborative process that encourages family and friend involvement and respectful relationships with providers which is consistent with the crisis response plan. Patients tend to be satisfied with this intervention. There were improved outcomes in suicide attempts, fewer inpatient days, and no potential harms or adverse events identified.

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Problem-Solving TherapyProblem-Solving Therapy (PST) is one type

of cognitive-behavioral psychotherapy specifically aimed at improving an individual’s ability to cope with stressful life experiences through active problem solving.108 A 2000 systematic review by Hawton et al. reported a trend towards reduced repetition of deliberate self-harm for patients enrolled in PST, although the difference was not statistically significant due, perhaps, to the heterogeneity of outcome measures across the included studies.109

More recent research, however, supports PST on the outcomes of reduced repeat self-directed violence and suicidal ideation among patients with a history of self-directed violence. Notably, the majority of this research has been conducted on patients with a “history of self-harm.”

Table 5. Comparison of Crisis Response Planning and Safety Planning Intervention

Crisis Response Planning Safety Planning Intervention

• Semi-structured interview of recent suicidal ideation and chronic history of suicide attempts

• Unstructured conversation about recent stressors and current com-plaints using supportive listening techniques

• Collaborative identification of clear signs of crisis (behavioral, cognitive, affective or physical)

• Self-management skill identification including things that can be done on the patient’s own to distract or feel less stressed

• Collaborative identification of social support including friends, care-givers, and family members who have helped in the past and who they would feel comfortable contacting in crisis

• Review of crisis resources including medical providers, other profession-als and the suicide prevention lifeline (1-800-273-8255)

• Referral to treatment including follow-up appointments and other referrals as needed

• Semi-structured interview of a recent suicidal crisis • Recognizing warning signs of an impending suicidal crisis • Recognizing how an increase and decrease in suicidal risk provides an

opportunity to engaging in coping strategies • Employing internal coping strategies without contacting another person

for distraction from suicidal thoughts • Using social contacts and social settings as a means of distraction from

suicidal thoughts • Using family members, caregivers or friends to help resolve the crisis • Contacting mental health professionals or agencies, including crisis

intervention services • Limiting access to lethal means • Consider prescribing naloxone for patients at risk for opioid overdose

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“Self-harm” was studied as the primary outcome, however these studies have not differentiated between suicidal versus non-suicidal self-harm.

The strongest evidence for PST comes from a randomized clinical trial conducted by Hatcher et al. with approximately 1,000 patients who presented to a hospital after self-directed violence.110 The primary outcome was additional hospital presentation(s) with self-directed violence at one year. By design, the study included separate analyses for first-time and repeat presentations at the index episode. As compared to usual care, neither the total sample who received PST, nor the subsample of participants whose index visit was their first presentation with self-directed violence had significantly different rates of repeat self-directed violence at 12 months. Among participants for whom the index episode was a repeat event, however, those who received PST were significantly less likely to present again with self-directed violence. This sub-group had a 39% lower risk of a further presentation for self-directed violence after a year. Additionally, patients who received PST (regardless of type of self-directed violence history) reported more significantly reduced suicidal ideation as compared to those who received usual care at three months and one year follow-up.110

Additional studies, with much smaller samples, have examined the effect of PST on self-directed violence and suicidal ideation with mixed results.4

Three studies provide additional evidence for PST’s benefit on repeat self- directed violence and five studies support a reduction in suicidal ideation. Of note, the delivery of PST varied across these

studies, but all were less than 10 sessions. There were no harms related to PST reported in the literature.

The “Window to Hope” (WtoH) group treatment intervention (a type of problem-solving therapy) was developed for patients with at least moderate levels of hopelessness and with a history of moderate to severe traumatic brain injury. It has been found to improve hopelessness in patients at risk for suicide.111 WtoH is structured around four core therapeutic strategies: (1) behavioral activation, (2) cognitive restructuring, (3) problem solving, and (4) relapse prevention. Brenner et al. reported significant patient improvement in hopelessness but not suicidal ideation. Findings from this trial support the efficacy of WtoH as a psychological intervention to reduce hopelessness among those with moderate to severe traumatic brain injury.

The WtoH intervention is a manualized 16-20 hour group treatment intervention delivered in 8-10 group sessions composed of group formation, behavioral activation, CBT and cognitive restructuring, problem solving, compensatory techniques to address existential challenges associated with the recovery process, and relapse prevention.

Patients engaged with the WtoH intervention tend to get reliable and lengthier (per session) care which is consistent with their values and preferences. The WtoH program was delivered in the dyad format, which provided benefits of peer-based normalization and validation of experiences

without the larger group format with which some patients are uncomfortable. This treatment has high feasibility and acceptability to patients, but providers must be trained in the specific protocol. Patient focus groups revealed that group formats may be burdensome to patients, and individual treatments are sometimes preferred. There is limited access to this treatment, as there are few providers with adequate training.

Although the evidence base for PST is limited by small sample sizes and confounders in some analyses, it is a pragmatic approach, suitable for a sizeable proportion of patients at risk for suicide.4 The intervention can be relatively easily taught, is usable by a range of clinicians, brief, and is comparatively inexpensive. PST is also consistent with patient values and preferences by inherently incorporating consistent and lengthier (per session) care and continuity with a single care provider. Although not all providers are trained in PST, and some patients may find the homework challenging, most providers and patients find PST to be an acceptable treatment option.

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Enhanced Care, Care Bridging, and Case Management

Case management services link the healthcare system to the patient and coordinate the service components so that patients can achieve successful community living.

Questions for case study:

Case Study 2

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Stephanie is a 29-year-old female elementary school teacher. She is doing well at work and is rated highly on her performance evaluations; however, away from the office, she struggles with several personal issues. During an annual meeting with her principal, Stephanie is not as cheerful as usual, her mood is down, and she does not want to talk about her personal feelings. Concerned, the principal encourages Stephanie to contact the school district’s confidential health service. Stephanie calls the program to schedule an appointment.

Stephanie presents for her appointment on time and appropriately dressed, although she appears tired and depressed. She completes a detailed, computer-assisted intake tool that includes an assessment of physical and mental well-being, which includes the PHQ-9 question: “Over the past two weeks, how often have you been bothered by thoughts that you would be better off dead or of hurting yourself in some way?” She answers “Several days.”

During her in-person interview Stephanie reports that she experienced physical and mental abuse as a child, and that she has severe anxiety as well as great difficulty connecting with others and maintaining stable relationships as a result of the abuse. She admits to the clinician that she has thought about suicide in the past but she is vague about how acute her feelings about suicide are currently.

1. How would you categorize Stephanie’s suicide risk?

2. What approach would you take to help reduce Stephanie’s risk?

3. What non-pharmacological therapy, if any, might be appropriate to suggest to Stephanie to help her cope with her anxiety and suicidal thoughts?

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Nurse and social work case management and care coordination provide an enterprise-wide effort that ensures high-quality, integrated behavioral health care.

Case management is a complex process involving many different activities. It is an important behavioral health service delivery model composed of a number of different activities for nurse and social work case managers. The case management model includes selecting cases, identifying and assessing patient needs, developing plans, providing needed services, and monitoring and evaluating provided services. The Case Management Society of America identifies a set of case management practice standards.112

This includes assessment, planning, facilitation, care coordination, evaluation, and advocacy for the comprehensive needs of individuals’ families and caregivers. Case management activities include resource use and management, sociopsychological and financial support, rehabilitation activities, effectiveness evaluation, and ethics and law. Clinical nurse and social work case management has been shown to decrease psychiatric readmission rates, decrease family burden, improve family and caregiver satisfaction with services, decrease cost of care, and improve continuity of care.4

Summary of non-pharmacological treatments and future directions

Although evidence supports the use of a variety of non-pharmacologic treatments for individuals with suicidal ideation and/or a history of self-directed violence behavior, additional research is needed to assess the impact of these

interventions across heterogeneous populations of at-risk individuals, to identify specific components of the modalities most strongly associated with a positive effect, and to assess their impact on a wider set of outcomes. Future research could explore the following topics:• Non-pharmacologic interventions to mitigate

suicide risk assessed across varying settings (e.g., outpatient, inpatient, residential) and contexts (e.g., individual, dyad, group), and with different types of clinical providers.

• How best to disseminate and implement CBT for patients with a history of self-directed vi-olence.

• Evaluation of WtoH among more general at-risk populations of Veterans and service mem-bers.

• Assessment of the effectiveness of DBT in populations other than patients with border-line personality disorder.

• Evaluation of strategies to implement proto-col-adherent DBT in DoD and VA settings.

• Clarification of which components of safety and crisis response planning interventions contribute most directly to reduction in risk for suicidal thoughts and behaviors (e.g., disman-tling studies).

Evidence-based pharmacological treatments to reduce suicide risk

Data support the use of a few pharmacological interventions in suicide prevention. In a 2016 large-scale meta- analysis of various suicide risk reduction approaches, antidepressant pharmacotherapy

treatment in adults was associated with reduced suicide risk, while initiation of pharmacotherapy did not lead to an exacerbation of suicide risk.113

In people aged over 75 years with depression, there is a clear beneficial effect of pharmacotherapy on the risk of attempted and completed suicide.In children and adolescents, increased risk of suicidal thoughts has to be taken into account when starting pharmacotherapy for depression. However, given the increased risk of suicide in untreated depression and the absence of an increased risk of suicide associated with pharmacotherapy, currently available evidence does not support the avoidance of initiation and continuation of pharmacotherapy for depression in children and adolescents.113 In addition to antidepressants ketamine, lithium, and clozapine may offer benefits for reducing suicidal thoughts in selected patients (see detailed discussions below). The impact of medication-assisted treatments for opioid use disorder, alcoholism, or nicotine addiction (e.g., buprenorphine, naltrexone, methadone, topiramate, acamprosate, varenicline) on suicide outcomes is a particularly important area of inquiry given the increased risk of suicide among those with a substance use disorder.

KetamineKetamine infusion as a single dose at 0.5

mg/kg has moderate evidence for acute symptom improvement of suicidal ideation within 24 hours of treatment, with a moderate effect size that continues for one week114 and even up to six weeks.115

Questions for case study:

Case Study 3

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Jeremy is a 32-year-old single, college-educated black male. He lives with a roommate and works as a graphic artist. He is talented, gets jobs easily, but has trouble keeping them. He experiences intense shame about the quality of his work. Jeremy periodically engages in non- suicidal self-injurious behaviors by cutting himself without suicidal intent on his upper arms with a knife. He has never tried to end his life but has had intermittent active suicidal ideation with a plan to jump from the roof of his building. On two occasions, he has gone to the roof and contemplated jumping but did not. Jeremy uses alcohol, and binges on cocaine. He has aggressive episodes (e.g., gets into verbal confrontations with strangers). Jeremy reports being physically abused by his older brother until he was 10 years old. Jeremy had 3 years of outpatient therapy for depression and has been to the ED twice for non-suicidal self-injurying behavior and active suicidal ideation. His ideation and urges to self-harm fluctuate.

1. How would you categorize Jeremy’s suicide risk?

2. What kinds of referrals might be appropriate to help Jeremy address his issues surrounding substance use and history of physical abuse?

3. What non-pharmacological therapy, if any, might be appropriate to suggest to Jeremy to help him cope with his feelings of shame and inadequacy at work?

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In a meta-analysis of ketamine trials, 55% of patients after 24 hours and 60% at seven days reported no suicidal ideation.114 Evidence indicates there is a risk of a transient elevation in blood pressure in a small number of patients that resolved without significant sequelae.

Despite general consistency in the evidence supporting ketamine for treatment of suicidal ideation in an acute care setting, there is some variability in provider and patient preferences regarding this treatment. Ketamine infusion was administered in inpatient hospital settings to patients who predominantly were admitted to receive the therapy and released 24 hours following positive response to treatment. Recommendations for patient management following discharge are uncertain because there are no long-term studies assessing the utility of ketamine on suicidal ideation following initial infusion. These studies were done in populations with major depressive disorder and suicidal ideations; other comorbidities were not addressed.

Considering the potential risk of addiction, continued repeat administration of ketamine is not recommended.4 Ketamine has known dissociative effects and other emergence reactions that could exacerbate psychotic symptoms. However, as there are few interventions that result in such a rapid response with as large an effect size, the benefits of offering this treatment to patients with suicidal ideation make it a potentially important tool for providers to have available.

At the same time, this must be balanced with important barriers to ketamine therapy as patients may not be receptive to receiving an infusion administered in an inpatient setting, and ketamine therapy may not be an option for patients living in rural areas, where its availability may be limited. (In March, 2019, the U.S. Food and Drug Administration approved a ketamine nasal spray which may reduce some of these patient barriers.116) Finally, an important treatment consideration is that there are no current data to support ketamine’s effect on suicide attempts or deaths; further research is needed on long-term outcomes.

The body of evidence supporting ketamine use for suicide prevention has some limitations, including a very narrow, targeted effect on the symptom of suicidal ideation, with unknown impact on the outcomes of suicide attempt or suicide. The evidence base would benefit from more diversity in study populations; most participants in existing ketamine studies have a primary diagnosis of mood disorder and patients with substance use disorders or psychotic disorders are excluded. Given the harms versus the benefits, caution should be used for repeated administrations or in other populations. Additionally, the window of effect is a short duration, with no evidence to support repeated administration for persistent suicidal ideation.

LithiumLithium has been shown to reduce the risk

of suicide in patients with unipolar depression or bipolar disorder. Several cohort studies and

systematic reviews have shown lithium maintenance to be associated with fewer suicidal behaviors and deaths.4,113 Cipriani et al. noted that the effects of lithium were not specific to a patient population with suicidal ideation, broadening the population in which lithium may be considered an appropriate treatment beyond those who present with acute suicidal ideation.117

Despite general consistency in the evidence supporting the use of lithium, there is some variability in provider and patient preferences regarding this treatment. Lithium discontinuation due to a variety of side effects (e.g., gastrointestinal upset, tremor, polyuria, polydipsia, weight gain, hypothyroidism, leukocytosis) contribute to a large variation in adherence. Toxicity with lithium may result in lithium overdose as a serious adverse effect, as well as additional presentations of side effects that may not resolve with removal of lithium including thyroid abnormalities, polyuria, and renal toxicity leading to reduced renal clearance. Its use is also limited by the low therapeutic index of lithium and the potential for toxicity with concurrent disease management. Lithium should be used with significant caution with elderly patients and patients with comorbidities (e.g., seizure disorder, chronic kidney disease). Achieving target blood levels requires blood monitoring, which may negatively impact the feasibility of using lithium and decrease patients’ and providers’ assessment of its benefits. Renal adjustments to dosage are required for creatinine clearance ≤50 mL/min.

The body of evidence for lithium is limited by conflicting results on the primary outcome when an active pharmacologic control was used.117 When prescribing lithium to patients at risk for suicide, it is important to consider extended release versus immediate release formulations, and to pay attention to the risk of overdose by limiting the amount of lithium dispensed. Consider methods to reduce risk of toxicity in overdose, such as dispensing smaller quantities and safe medication storage options (e.g., having a caregiver or family member store the medication for the patient). If overdose is identified as a lethal means for the patient, consider an alternative to lithium for treatment.

ClozapineThe antipsychotic medication clozapine has

been found to reduce suicidal behaviors in patients with schizophrenia or schizoaffective disorder.118

Other studies have also demonstrated a lower overall risk of suicidal behaviors compared to other treatments. A 2005 meta-analysis found a lower risk of death by suicide, suicide attempts, and suicidal behaviors during long-term treatment with clozapine.119 In 2003 as a result of these findings, the FDA approved an indication for reducing risk of suicidal behaviors in patients diagnosed with schizophrenia or schizoaffective illness. Unfortunately, the quality and consistency of the studies are highly variable, with only one randomized trial of moderate quality that compared clozapine to an alternative antipsychotic, olanzapine. This population was found to have a twelve times greater risk than the general population

for death by suicide, which was highlighted in the meta-analysis.119 The importance of weighing the potential benefits of clozapine, which may reduce risk for suicide and suicidal behavior in a high-risk population, is critical to long-term management of risk. Evidence also indicates some level of harm associated with clozapine. While study results suggest that antipsychotic medications may protect against suicide risk, the evidence appears to be most favorable for clozapine. An additional review found that treating depressive symptoms in patients with schizophrenia is a vital component of suicide risk reduction.120

It is possible that some of the success attributed to clozapine can be attributed to the surveillance approach required by the Clozapine Risk Evaluation and Mitigation Strategy (REMS) monitoring program. The REMS program mandates frequent visits to healthcare providers for monitoring laboratory results before dispensing medication refills. Because of significant risks associated with clozapine such as agranulocytosis, it is most often used as the antipsychotic of last resort. Patients may be unwilling to commit to the level of monitoring and blood draws required for the REMS program. Repeated blood draws on a weekly basis are not only inconvenient for the patient, but may also cause pain and discomfort. Other significant adverse effects of the medication include: weight gain, lipid abnormalities, sialorrhea, somnolence, and the rarely occurring but serious adverse events of myocarditis and cardiomyopathy.

There are significant challenges to clozapine use in certain subgroups of patients, such as the elderly and the homeless, both because of the medication’s side effects and difficulties accomplishing the required monitoring through the REMS program. In the specific population of patients for whom the drug is indicated, the evidence may be considered sufficient with small benefit.4

Antidepressant medicationsAs noted above, a large-scale meta-analysis

found that antidepressant pharmacotherapy treatment in adults was associated with reduced suicide risk, while initiation of pharmacotherapy did not lead to an exacerbation of suicide risk.113

These relatively recent data harmonize previous conflicting evidence from meta-analyses of earlier trials about whether antidepressants trigger suicide attempts in adults with major depression. Some meta-analyses of randomized controlled trials (RCT) found significantly elevated rates of (attempted) suicide in antidepressant arms relative to placebo,121,122 whereas others did not.123,124 A study by Khan et al. likewise found no statistically significant differences between antidepressants and placebo, but their study was based on patient exposure years (PEY), an approach that has been questioned since the vast majority of attempted suicides in randomized trials occur within the first 3–4 weeks of acute treatment.125

Some clinicians have advocated for the use of antidepressants, either as single agents or combined agents (i.e., two antidepressants from different antidepressant classes, such as an atypical antidepressant added to a selective serotonin reuptake inhibitor).126

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Antidepressants may still be used to treat mood disorders in these high-risk populations; however, they should be accompanied by patient education and additional monitoring (e.g., scheduled visits, telephone calls).

Post-acute care for those at risk of suicide or who have attempted suicide

CommunicationSending periodic caring communications

(e.g., postcards, letters) following a psychiatric hospitalization for suicidal ideation or suicide attempt has been found to reduce the rate of suicide death, attempts, and ideation for individuals receiving the communications. The caring communications intervention was originally studied by Jerome Motto. In a 2001 randomized trial, periodic caring letters were sent to participants who had dropped out of treatment within 30 days after discharge from psychiatric inpatient care.127 The letters were sent at least four times a year for five years. Analyses revealed a significantly lower suicide rate (p=0.04) for those receiving the letters for the first two years. The letters were short, non-demanding, and sent at regular intervals.

A 2016 trial randomized 2,300 patients who had attempted self-poisoning to receive follow-up postcards plus usual treatment.128 Following discharge, eight postcards were mailed at 1, 2, 3, 4, 6, 8 and 12 months with a ninth postcard sent on the patient’s birthday. Among postcard recipients there was a significant reduction in suicidal ideation from 58.6% to 46.6% and a reduction in suicide attempts from 9.1% to 6.2%.128

Chen et al. randomized 761 patients who had attempted suicide to receive case management services alone or case management services with the receipt of a single postcard (n=373) sent at the three-month conclusion of case management services. The postcard contained a list of unique coping strategies for the patient as well as a list of resources.129 Chen et al. observed that sending the single postcard had no effect.

Based on research findings from randomized trials, the receipt of periodic caring communications (e.g., postcards, letters) has been shown to reduce the rates of suicide death, attempt, and ideation for those receiving the communication versus control groups that did not receive the communications. The research further indicates that receipt of a single postcard does not have an effect on outcomes. The common factors for caring communications showing an effect were periodic communications over a period of time of at least 12 months.

The evidence supporting caring communications is limited by the varying communication intervals and cultural adaptations across studies. Other considerations regarding this recommendation include: communication format (e.g., postcard, letter, email, text); use of non-demanding, supportive, culturally adapted messaging; communication delivery barriers for population subsets; and logistical considerations of staff availability to reply to communications with

consideration of expectations of a time-sensitive response, such as text communications versus letters. Overall, caring communications are a low-cost, low-risk intervention that has been associated with lower rates of suicide death, attempt, and ideation.

The sample messages below are illustrative of the caring communications approach and can be adapted for use by a range of health care professionals.130

Sample 1:

Dear (first name),

It has been a little while since you were at (name of practice or organization), and we hope things are going well for you. If you would like to send us a note, we would enjoy hearing from you.

Best wishes,(Name, title, and either mailing address or email address for correspondence)

Sample 2:

Dear (first name),

It was great to meet you at (name of practice or organization). We hope you are doing well. We just wanted to send a quick note to let you know we are thinking about you and wish you well. If you’d like to reply to us or send us an update, we would be happy to hear from you.

Best wishes,(Name, title, and either mailing address or email address for correspondence)P.S. Please note the following resources that are available to you(Brief list of local and national suicide prevention services. See Appendix A of this learning activity for examples.)

Home visitsA single home visit has been shown to increase

outpatient treatment engagement among patients recently discharged from psychiatric inpatient care. Specifically, among patients who failed to attend their initial outpatient appointment, a single home visit by a nurse resulted in a subsequent increase in treatment compliance compared to those who did not receive a home visit (51.2% versus 39.8%).131

Findings from another study showed that an initial home visit followed by weekly or biweekly phone contacts resulted in higher treatment engagement than those in the control group.132 Other studies focused on the delivery of time- limited interventions in the home setting post-acute care (i.e., discharge from ED or inpatient psychiatric unit) showed mixed results for reducing self-directed violence behavior.4

These studies did not differentiate between suicidal and non-suicidal behavior and the interventions offered in the home setting ranged from case management to brief psychodynamic interpersonal therapy.

Despite general consistency in the evidence supporting home visits for increasing treatment engagement among those recently discharged from psychiatric inpatient care, there is some variability in provider and patient preferences regarding this treatment. The patient focus group revealed an interest in including family members, caregivers, or support persons in treatment discussions. In line with this preference, home visits could provide an opportunity to interact more directly with family members, to involve them in discussions, and to problem solve around barriers to engaging in outpatient treatment. A single home visit is unlikely to be burdensome to patients and is consistent with a patient-centered approach. Home visits, on the other hand, may increase burden on the healthcare system. Issues related to provider safety also need to be considered.

The body of evidence had some limitations including confounders in the analysis and how a home visit was defined. Other considerations regarding this recommendation included the fact that the benefits of improving treatment engagement during an especially high-risk period (i.e., transition from inpatient to outpatient care) outweigh the potential harm of adverse events, which was small. Patient values and preferences regarding home visits and check-ins post-acute care were not specifically addressed in the focus group. However, a home visit may prove a more natural opportunity to involve family members, caregivers, or support persons for patients who have this preference. Along these lines, some patients may have a strong preference not to include family members, caregivers, or support persons especially if family relations are a notable source of stress. Although this recommendation focuses on a very specific subset of those at increased risk of suicide, namely those that have recently discharged from inpatient care but did not attend their initial outpatient appointment, home visits will incur additional costs and burden for the healthcare system. Feasibility will vary across systems of care and certain patient populations (e.g., those who are homeless) will not be able to access this type of follow-up care.

WHO Brief Intervention modalityThe World Health Organization (WHO) Brief

Intervention and Contact (BIC) treatment modality consists of a one hour individual information session as close to the time of discharge as possible and, after discharge, nine follow-up contacts (phone calls or visits, as appropriate) according to a specific timeline up to 18 months (at 1, 2, 4, 7 and 11 week(s), and 4, 6, 12 and 18 months), conducted by a person with clinical experience (e.g., doctor, nurse, psychologist).”133 WHO BIC has been found to significantly decrease suicides among patients with a history of suicide attempt in low- to middle-income countries (e.g., China, Iran, India, Brazil, Sri Lanka).98 In the three trials of the WHO BIC intervention, there were significantly fewer suicides in the group that received the intervention compared to those receiving usual care (3 versus 24 suicides; p <0.0001).98

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The WHO BIC protocol demonstrates that systematic long-term contacts after discharge in addition to usual care can have a positive impact on preventing subsequent deaths by suicide among those presenting to the ED following a suicide attempt.

Generalizability of the intervention to high-income countries where psychiatric treatment and/or referral is a component of usual care following ED presentation for suicide attempt, may be limited. Thus, the added benefit of WHO BIC to usual care in higher income countries is unclear. However, even in high-income countries, regular follow-up after ED discharge for suicide attempt is not routine, and when it does occur, can vary substantially with respect to the frequency and duration of follow-up contacts. The WHO BIC protocol provides structure for follow-up contacts, while offering flexibility because the follow-up contacts can occur either in person or over the phone and can be made by a range of providers. The follow-up contacts occur over a period of 18 months, which can be resource intensive, and it is possible that some patients may experience this as burdensome.

The body of evidence has some limitations including attrition and selection bias, limited validity of source of data for suicide deaths, and confounders in the analysis. The benefits of this intervention, including reductions in suicide deaths, outweigh the potential harm of adverse events. Patient values and preferences were somewhat varied and generalizability to high-income countries is unclear.

Summary and future directionsGrowing evidence in the area of post-acute

care points to potential benefits of close monitoring and follow-up as well as strategies to improve continuity of care and treatment engagement among those recently hospitalized or following an ED visit. Along these lines, there are several areas for which evidence is either emerging or lacking including the effectiveness of different modalities for conducting follow-up (e.g., telehealth methods), dose-response (number of follow-ups and timing), who should conduct follow-ups (clinician versus peer support), and assertive outreach for those who do not engage in outpatient treatment or follow-up care. Research on the impact of brief interventions in the ED, such as safety planning, combined with repeated follow-up contacts on suicide specific outcomes (i.e., suicide and suicide attempts), is also needed. The following areas are priorities for future research:• Buddy- or peer-delivered post-discharge sup-

port following psychiatric hospitalization on treatment engagement

• Case management and care facilitation• Telehealth monitoring following psychiatric

hospitalization• Interventions to facilitate treatment engage-

ment (including dose-response) following ED visit or psychiatric hospitalization for suicidal ideation or attempt

• Effective implementation strategies of WHO BIC in the U.S.

• Cultural adaptation and modernization of car-ing communications (e.g., caring texts)

Technology-based interventionsTelehealth modalities

Available research on technology-based interventions to reduce the risk of suicide is relatively limited and has focused on electronic delivery of treatment protocols in lieu of face-to-face delivery. None of the available studies assessed the effectiveness of telehealth as it is practiced in some private or public organizations (i.e., face-to-face treatment delivered in a virtual environment).

Studies assessing electronic delivery of treatment protocols included a systematic review by Witt et al. of stand-alone digital interventions (e.g., CBT based, acceptance based, problem solving, interpersonal, mood monitoring, crisis planning) for the self-management and/or treatment of suicidal ideation or behaviors compared to a variety of control conditions.134 At follow-up, no significant between-group differences were observed in reporting of suicidal ideation or suicide attempt. However, at the post-intervention assessment there was evidence of a reduction in suicidal ideation in sub-analyses of three pre-test/post-test observational studies and five RCTs. Only one of the RCTs assessed the intervention against face-to-face delivery, finding no difference in suicidal ideation scores.135 The authors noted that treatment adherence was poor in a majority of the included studies. Similarly, a systematic review by Leavey and Hawkins found no difference in suicidal ideation or suicidal behavior at follow-up with e-health CBT interventions (e.g., internet, computer, telephone delivery) compared to face-to-face CBT or treatment as usual.97

One RCT assessed whether web-based CBT with and without telephone support is effective in reducing suicidal ideation in callers to a helpline compared with treatment as usual.136 No significant between-group differences in suicidal ideation were observed at 6- or 12-month follow-up; however, suicidal ideation declined significantly over the 12-month study period for all groups. The authors note this may represent regression to the mean because both study groups had high initial levels of suicidal ideation. The quality of evidence for this study is low. Another RCT examined the effect of an online intervention, eBridge, on readiness to engage in treatment among college students screening positive for suicide risk through an online survey.137 This intervention included personalized electronic feedback and optional online exchanges with a counselor delivered in accordance with motivational interviewing principles. Although not a primary outcome of the study, suicidal ideation was assessed at follow-up with no difference observed between the intervention and control group. The study did find a significantly higher readiness to engage in treatment in the intervention group.

Overall, although the body of evidence did not demonstrate a favorable impact on critical outcomes, there was no evidence of harm with any of the interventions. This was based on the

evidence of impact on suicidal ideation across the studies included in the Leavey and Hawkins systematic review that assessed electronic delivery of CBT compared to face-to-face delivery or treatment as usual. Although a sub-analysis of eight studies included in the Witt et al. systematic review, reflecting moderate quality of evidence, suggest the digital interventions were associated with decreased post-treatment suicidal ideation, only one of the studies directly compared electronic to face-to-face treatment delivery. Although this body of evidence suggests digital interventions may lead to short-term decreases in suicidal ideation compared to no active treatment, it does not support an assumption of equivalence with face-to-face treatment delivery.

Despite insufficient evidence for or against technology-based behavioral health treatment modalities over face- to-face delivery, the benefits slightly outweigh the harms of considering these modalities as a vehicle for delivering treatment protocols to individuals with suicidal ideation, especially when there exist substantive barriers to in-person care. Individuals participating in patient focus groups had limited experience with telehealth modalities, but expressed enthusiasm for their use and felt these interventions would improve their access to high-quality care. Participants reported frustration with seeing multiple providers, both within a treatment facility due to provider availability and across locations due to frequent travel, resulting in decreased continuity of care.

Telehealth as a mechanism for providing face-to-face treatment for suicidal thoughts and behaviors may provide opportunities for improved access to and continuity of care for patients regardless of geographic location, travel, deployment status, etc.

The availability of telehealth across a variety of platforms (e.g., internet based) may also increase access by decreasing stigma related to seeking behavioral healthcare in a specific building/location. Important considerations, however, include accessibility of and comfort using technology- based interventions; concerns about Health Insurance Portability and Accountability Act (HIPAA) compliance and patient safety; network security and vulnerabilities; and comfort with using smartphones or other handheld devices/tablets. Older populations and individuals living in rural or remote areas with less reliable internet may not be able to effectively access services.

Technology as adjunct to routine preventionStudies evaluating the effect of technology-

based interventions as adjuncts to routine suicide prevention treatment are rare and the two available studies did not include the critical outcomes of suicidal ideation or suicide attempt as primary study outcomes.138,139 A randomized pilot study by Kasckow et al. assessing the feasibility of post-discharge telehealth monitoring (Health Buddy) in addition to Intensive Case Monitoring (ICM), compared to ICM alone, in Veterans with schizophrenia hospitalized for suicidal ideation found no group differences using remission (i.e., Beck Scale for Suicidal Ideation Score = 0) as the outcome.139

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Findings did support, however, the feasibility of implementing a telehealth monitoring system for monitoring post-discharge suicide risk in Veterans with schizophrenia and suicidal ideation.

Bush et al. conducted a parallel-group RCT with two groups of Veterans in active mental health treatment who had recently expressed suicidal ideation.138 Participants were randomized to use either the Virtual Hope Box (VHB); a smartphone app to improve stress coping skills, suicidal ideation, and perceived reasons for living; or printed materials about coping with suicidality. Both interventions were provided to supplement treatment as usual. VHB users reported significantly greater ability to cope with unpleasant emotions and thoughts at three and 12 weeks compared to the control group, but no between-group differences were observed for suicidal ideation or any of the other outcome measures. Participants also reported high levels of satisfaction with the intervention.

Although evidence to date does not demonstrate a favorable impact on critical outcomes, the studies reviewed demonstrated feasibility and acceptance of technology-based adjuncts to augment routine treatment. Bush et al. demonstrated significant improvement in coping with unpleasant emotions and thoughts at all time points in the VHB study and observed a 79% completion rate in the intervention group.138 A large proportion of VHB users reported regular and frequent engagement with the material and felt it was easy to use, helpful, and beneficial in dealing with stress and emotional difficulties.138

There was also no evidence of harm with any of the interventions, and technology-based adjunct treatment may help with patient engagement and self- management.

This body of evidence was limited by serious imprecision. Other considerations include the lack of evidence of harm, alignment with patient values and preferences, accessibility and patients’ comfort with technology-based interventions; concerns about HIPAA compliance and patient safety; network security and vulnerabilities; and comfort with using smartphones or other handheld devices/tablets. Older populations and individuals living in rural or remote areas with less reliable internet may not be able to effectively access services, however in other groups technology-based adjunct treatment may help with patient engagement and self-management. Further research is required to support recommendations for or against the use of technology-based interventions as an adjunct to usual care.

Summary and future directionsEvidence to date is limited to recommend for

or against technology-based behavioral health treatment, monitoring, and assessment modalities in lieu of traditional face-to-face care. Notably, none of the included studies assessed the efficacy of face-to-face treatment provided in a virtual, or “telehealth,” environment as currently practiced. Studies assessing the use of digital delivery of established treatment protocols (e.g., CBT) for self-management of suicidal thinking and behaviors,

with minimal or no direct provider interaction, show promise at reducing suicidal ideation in pre-test/post-test observational studies and RCTs using waitlist or attentional controls. However, variability in interventions, inclusion criteria, control groups, and outcomes hinders assessment of efficacy and determination of effect size. Studies assessing technology-based adjuncts to routine behavioral health care were also rare and limited. Findings suggest these approaches may be feasible and acceptable, but further research is required to assess their impact on the critical outcomes of suicidal ideation and behavior. While much research is required, these approaches represent potentially important avenues for increasing access to and augmenting existing care. Priorities for future research include:• Assessing the equivalence or non-inferiority

of real-time virtual clinical encounters versus in-person delivery of established non-phar-macologic suicide prevention interventions (e.g., CBT), including whether the effective-ness of these interventions varies by suicide risk level, population characteristics (patient and provider), and/or treatment type

• Assessing the equivalence or non-inferiority of self-guided digital receipt versus in-person delivery of established non-pharmacologic suicide prevention interventions (e.g., CBT) including whether the effectiveness of these interventions varies by suicide risk level, pop-ulation characteristics (patient and provider), and/or treatment type

• Assessing the feasibility, acceptability, barri-ers, and facilitators to using virtual modalities, including telehealth (e.g., telephone, video) or self-guided digital interventions for both pa-tients and providers

• Assessing the efficacy and effectiveness of ad-junctive technology-based interventions (e.g., digital/ mobile applications used for symptom monitoring or augmenting treatment) for sui-cide prevention, including whether the effica-cy/effectiveness of these interventions varies by suicide risk level, population characteristics (patient and provider), and/or treatment type

• Assessing the feasibility, acceptability, barriers, and facilitators to using adjunctive technolo-gy-based interventions for both patients and providers

Population & Community-based Interventions

BackgroundOver a half-century of public health strategy has

focused on population-level and community-based interventions for suicide prevention. A National Strategy for Suicide Prevention, renewed in 2012, encompasses three community-based strategic directions, wrapped around an all-encompassing emphasis on surveillance and research:14

• Creating supportive environments that pro-mote healthy and empowered individuals, fam-ilies, and communities

• Enhancing clinical and community preventive services

• Promoting the availability of timely treatment and support servicesProximate risk factors for suicide have been

exhaustively identified, however, using the results of these studies to create effective, community-based prevention has been elusive in military and Veteran populations which, as noted previously, have seen increases in suicide rates concomitant with the establishment of federal suicide prevention efforts.

Lethal means safetyImplementing lethal means safety, including

firearm safety, reducing access to poisons and medications associated with overdose, and barriers to jumping from lethal heights, are ways to reduce population-level suicide rates.

Access to firearms is a risk factor for death by suicide. Firearms are used in half of suicides in the U.S., and approximately 90% of suicide attempts involving firearms result in death.140 Recent studies have shown that differences in state laws regulating firearms access, and that higher state- level firearms ownership rates,141 are associated with firearm-related and overall suicide rates, even after accounting for important demographic and geographic factors.142,143 Veterans and military service members are more likely to use firearms as a method for dying by suicide compared to the general population.144 Military service members often have ready access to firearms, and Veterans have higher rates of firearm ownership compared to their civilian counterparts.145

Weapons restrictions in individuals are buttressed by state and Federal law and policy measures. For instance, felons cannot own or carry weapons. Sentences of over one year in courts-martial result in a report to a national database that prohibits weapons purchase and ownership.

Population-based weapons restrictions have been effective in a Western military population, even if limited in generalizability by geographic variability and changes in gun statutes, cultural attunements, and greater rates of weapons ownership in the U.S. compared to other Western nations. A naturalistic epidemiological study in the Israeli Defense Forces ascertained the effect of unit-by-unit weapons storage on bases for 18-21 year old soldiers on weekend leave, showing a dramatic reduction in suicide death on weekends, but not weekdays, in this population-based cohort.146 Randomized studies have yet to systematically ascertain effects of population-based weapons restrictions.

Means safety counseling (MSC; also referred to as “lethal means counseling”) approaches have been developed in an effort to reduce deaths by firearms and other means. MSC consists of discussions between clinicians and persons at elevated risk for suicide. Less than half of U.S. gun owners report safely storing their firearms (defined as all guns stored in a locked gun safe, cabinet, or case; locked into a gun rack; or stored with a trigger lock or other lock).147

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Examples of MSC recommendations, depending on level of risk, include storing firearms in locked cabinets, using gunlocks, giving keys to these locks to family, caregivers or friends, temporarily transferring firearms to someone legally authorized to receive them, removing firing pins, or otherwise disabling the weapon. MSC approaches have not been shown to reduce suicide, but have been shown to impact firearm storage practices.148,149

Another commonly used method for suicide is poisoning, including medication overdose. Access to opioid medications has been associated with increased rates of intentional and unintentional overdose death.150 One study demonstrated that increased access to acetaminophen was paralleled with increased rates of suicide attempts and death by suicide via overdose in the United Kingdom.151

Gatekeeper training for suicide prevention—a key tool for increasing engagement into preventative services for suicide, which includes programs such as Question, Persuade, and Refer (QPR) and Applied Skills in Suicide Training (ASIST)—has not been found to improve population-level suicide rates in each of the U.S. states.152

Every state has fostered a community-based approach to suicide prevention since the turn of the century.

Community-based suicide prevention may be constrained, however, by the immense complexity of population processes, including sociocultural variables, and historically suboptimal interactions between healthcare systems and suicide prevention programs. Gatekeeper training is illustrative. An initial systematic review of studies published from 1980-1995 found that knowledge about suicide improved in gatekeeper training but there were both beneficial and harmful effects in terms of help-seeking, attitudes, and peer support.153 Mann et al. made a qualified endorsement of gatekeeper training, provided that formalized roles and care pathways were available.154 The review noted some community-based awareness programs are not evidence-based and do not reflect current knowledge of suicide prevention or provide routine evaluation of effectiveness and safety for preventing suicidal behavior. No RCT showed that gatekeeper training alone affects suicide rates.113

Research gaps exist in community-based interventions as mechanisms to reduce suicide risk. A Canadian RCT in First Nations community members—family members, police, teachers, and clergy—demonstrated that the ASIST training had no positive impact on self-reported gatekeeper skills.155

Also, compared to a resilience retreat, the ASIST training was associated with a slightly higher likelihood of reporting suicidal ideation.

One non-comparative study examined the feasibility of using an online gatekeeper to direct individuals searching for suicide-related keywords to a website encouraging use of an e-mail consultation service. The results were limited, and strength of evidence was very low, but modest levels of treatment engagement and improvement in mood were seen.4

No studies that address the effects of crisis lines or peer-to-peer counseling lines met inclusion criteria. These lines have existed for decades, yet there is insufficient evidence to comment on their effectiveness in reducing population-level suicide rates.

The body of evidence had limitations including confounders in the analyses. Community-based interventions, including gatekeeper training and buddy support, had insufficient evidence upon which to make recommendations. There was a lack of evidence that potential benefits (e.g., definitive management of suicidality resulting in an aggregate decrease in death) outweigh the potential harm of adverse events, which could include fostering contagion or bypassing evidence-based care. Patient values and preferences for care emanating from community-based training can vary greatly, with a balance needing to be struck between potentially stigmatizing care delivered in the healthcare system and confidential care delivered by non-privileged community gatekeepers.

Currently, the most robust evidence for population-level interventions to prevent suicide is lethal means reduction, particularly those supported by legislation (e.g., firearm regulations, pesticide availability, changes to packaging of analgesics) and environmental interventions (e.g., structural barriers at suicide hot spots).There continues to be limited evidence for other public health and community-based interventions, including gatekeeper training, targeted media campaigns, and 24/7 crisis lines, on population-level suicide outcomes.

More research is needed on the effect on suicide rates of these programs, particularly those tailored to service member and Veteran populations. Given that many of these programs and interventions are delivered concurrently as part of a multi-faceted suicide prevention approach, research in this area requires special methodological approaches to examine the potential synergistic effects of combining multiple strategies.

Research is also needed to understand the impact of universal or selective application of specific lethal means safety interventions (e.g., blister packaging medication, distribution of gun locks and other safe storage mechanisms) on suicide and suicide attempts. Along these lines, examining the impact of provider- or peer- driven lethal means safety counseling on individual safety behaviors (e.g., use of safe storage mechanism, removal of a weapon from home during times of crisis) and suicide outcomes is also needed.

Talking about guns at homeHow a question about guns is posed can made a difference to how open and forthcoming a patient is about this key piece of information. Instead of asking: “Do you have access to a gun?” Consider one of the following questions:1. “Lots of people in (name your state) have guns at home. Research shows that a suicidal person

is safer if they don’t have access to guns. What some gun owners in your situation do is store their guns away from home until they’re feeling better, or lock them and ask someone they trust to hold the keys. If you have guns at home, I’m wondering if you’ve thought of a strategy like that.”

2. “I don’t know if you have guns at home, but if you do, research shows that a suicidal person is safer if they don’t have access to guns. What some gun owners in your situation do is store their guns away from home until they’re feeling better, or lock them and ask someone they trust to hold the keys. If you have guns at home, I’m wondering if you’ve thought of a strategy like that.”

Source: Caring for adult patients with suicide risk: a consensus guide for emergency departments. Suicide Prevention Resource Center (SAMHSA), 2015.

Lessons from the United KingdomThe adoption of the following 9 suicide prevention recommendations by mental health systems

across England and Wales has greatly reduced suicide rates among patients.1. Providing 24-hour crisis teams2. Removing materials that could be used for suicide3. Conducting follow-up with patients within 7 days of discharge4. Conducting assertive community outreach, including providing intensive support for people with

severe mental illness5. Providing regular training to frontline clinical staff on the management of suicide risk6. Managing patients with co-occurring disorders (mental and substance use disorder)7. Responding to patients who are not complying with treatment8. Sharing information with criminal justice agencies9. Conducting multidisciplinary reviews and sharing information with families after a suicide.

In 1998, few of the 91 mental health services in the study were carrying out any of these recommendations. By 2006, about 71 percent were doing so. Over time, as more recommendations were implemented, suicide rates among patients declined. Each year, from 2004 to 2006, mental health services that implemented seven or more recommendations had a lower suicide rate than those implementing six or fewer. Among all recommendations, providing 24-hour crisis care was linked to the largest decrease in suicide rates.

Source: While D, Bickley H, Roscoe A, et al. Implementation of mental health service recommendations in England and Wales and suicide rates, 1997-2006. Lancet. 2012;379(9820):1005-1012.

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Summary of strategies and approaches to prevent suicide

As noted, suicide occurs in response to multiple biological, psychological, interpersonal, environmental and societal influences that interact with one another, often over time. Thus efforts to prevent suicide must encompass multiple levels of focus including the individual, relationships, communities, and society as a whole. Figure 7, from the CDC, summarize the strategies and approaches reviewed in detail earlier.

Specific at-risk populations

Members of the Armed Forces and VeteransKayla Williams had been home only a few

months after serving as an Army sergeant and Arab linguist in the Iraq War, but her marriage (to a combat-wounded Veteran with post-traumatic stress disorder) was falling apart. Now she was in her bathroom with a gun in her hand, contemplating suicide.157

“The toilet and sink faded to nothingness in my field of vision and my focus narrowed. My hands were pale next to the black of the handgun, and the cuticles I shredded under stress stood out on my white skin, red and raw. I took a deep breath to steady myself, still my sudden trembling. This gun, this choice. It offered me a way out, and freedom from the fear that nothing would change. The thought of nothingness descending upon my consciousness seemed like it would be a relief—all the stress and fear and anger and confusion gone, replaced by blessed nothingness.”158

Williams stepped back from the brink. With the help of counseling for both herself and her husband, she recovered, rebuilt her marriage and career, and wrote two books about her experiences both in and out of the military. She is now the director of the Military, Veterans and Society program at the Center for a New American Security. She lives near Washington DC with her husband and two children.

In recent years suicide has claimed more lives among military personnel than combat. More than

45,000 Veterans and active-duty service members killed themselves between 2013 and 2019, which is more than 20 deaths a day (Table 6).159 The number of Veterans and service members lost to suicide in one year now surpasses the total American military deaths in Afghanistan and Iraq, as of 2019.159

(Note: other epidemiological data relevant to Veterans and the military were presented in the Introduction to this learning activity.)

Two frequent co-occurring conditions in those who attempt suicide are mental illnesses and substance use disorder. Among Veterans who died by suicide in 2017, 58.7% had a diagnosed mental health or substance use disorder.3 Suicide rates were highest among Veterans with bipolar disorder or who had an opioid use disorder (Figure 8).3

Suicide rates among Veteran users of Veterans Health Administration (VHA) services have been found to be affected by economic disparities, homelessness, unemployment, level of military service connected disability status, community connection, and personal health and well-being.

Figure 7. Suicide prevention strategies and approaches156

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Exercise 1

Instructions: Spend 5-10 minutes reviewing Figure 7, then consider the following questions:

1. Which of the strategies and approaches are feasible in primary care settings?

2. Which strategies might be appropriate for the population of Veterans or military service personnel?

3. Which strategies might be appropriate for individuals at risk of suicide who are already hospitalized or in a mental health care institution of some kind?

Figure 7. Suicide prevention strategies and approaches156 (Continued)

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The following details highlight VHA Veteran experiences across these domains:3

Economic Disparities: Veterans enrolled in VHA care were less likely to be employed and had lower income levels than Veterans not receiving VHA care. Some Veterans report difficulty in transitioning to civilian positions. Their highly developed skills obtained in the military may not translate to higher-level positions in the civilian world. In addition, unemployment and poverty are correlated with homelessness among Veterans.

Homelessness: In January 2017, the U.S. Department of Housing and Urban Development Point-in-Time Count estimated that 40,000 Veterans were homeless and just over 15,300 were living on the street or unsheltered on any given night. Homelessness appears to play a role in suicide for VHA patients. VHA patients with indications of homelessness or who received homelessness-related services had higher rates of suicide than other VHA patients.

Service Connection: VHA patients with military service connected disability status may have lower risk of suicide than other VHA patients.

Social Connection: Isolation has been shown to be a risk factor for suicide. Among VHA patients, suicide rates have been found to be highest among those who were divorced, widowed, or never married and lowest among those who married. Also, among VHA patients, suicide rates were elevated among individuals residing in rural areas.

Health and Well-Being: VHA Veterans who died by suicide were more likely to have sleep disorders, traumatic brain injury, or a pain diagnosis. In addition, mental health diagnoses (including bipolar disorder, personality disorder, substance use disorder, schizophrenia, depression, and anxiety disorders), inpatient mental health care, prior suicide attempts, prior calls to the Veterans Crisis Line, and prior mental health treatment were also associated with greater likelihood of suicide.

In summary, the sociocultural context of suicide provides a complex entwining of factors associated with, but not directly predictive of, suicide. Therefore, meaningful improvement of suicide prevention efforts is possible only through a systematic and unified public health approach addressing international, national, and community-level issues and resources paired with individualized support, care, and personal responsibility.

Veteran-focused suicide prevention initiatives

Between fiscal years 2013 and 2019, the U.S. congress appropriated more than $1 billion for suicide prevention programs in the Department of Defense and Veterans Affairs Administration.160 VA suicide prevention strategies are organized into three levels of strategic focus.3 First, universal strategies aim to reach all Veterans. These include public awareness and education campaigns regarding the availability of suicide prevention resources for Veterans and the promotion of responsible media coverage. Second, selective strategies are designed for some Veteran subgroups that may be at increased risk for suicidal behaviors.

Examples include targeted outreach to women Veterans, to Veterans with substance use challenges, and to Veterans with recent separation from military service. And third, indicated strategies are designed for the relatively few individual Veterans who are identified as having high risk for suicide. Indicated strategies include referral to the Veterans Crisis Line and clinical review and outreach for those Veterans in the highest tier of predicted statistical risk.

Unfortunately, many Veterans are not aware of the services available to them or of the many initiatives designed to reduce suicide risk. Mental health treatment is a mysterious “black box,” with their knowledge and perceptions of mental illness and treatment shaped largely by often inaccurate or incomplete media portrayals and anecdotal information or references from peers.63

A summary of current DoD/VA initiatives follows:

Veterans Crisis LineThe Veterans Crisis Line is the world’s largest

provider of crisis call, text, and online chat services.

Table 6: Total and daily average numbers of suicide deaths among Veterans, 2005-

20173

Year Suicide Average Per Day

2005 5,787 15.9

2006 5,688 15.6

2007 5,893 16.1

2008 6,216 17.0

2009 6,172 16.9

2010 6,158 16.9

2011 6,116 16.8

2012 6,065 16.6

2013 6,132 16.8

2014 6,272 17.2

2015 6,227 17.1

2016 6,010 16.4

2017 6,139 16.8

Figure 8. Suicide rates per 100,000 among Veterans with mental health or substance use disorders3

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The 27/7 service is used by approximately 650,000 people each year.

Suicide researchThe VA supports clinical research into

evidence-based psychotherapy techniques, medications, and behavioral, complementary, and alternative approaches to treating PTSD and other mental health conditions associated with suicidality among Veterans.

Community partnershipsThe VA has expanded partnerships with

hundreds of organizations and corporations at national and local levels to raise awareness of suicide prevention resources and to educate people about how they can support Veterans and service members in their communities. One example is the 2018 Mayor’s Challenge, an initiative co-sponsored with SAMHSA, launched in 24 cities to provide tools and technical assistance for addressing Veteran suicide.161

Clinical partnershipsThe VA is partnering with community-based

mental health providers to expand the network of local treatment resources for Veterans in need who live in remote locations without access to existing VA locations.

OutreachThere are more than 400 VA Suicide Prevention

Coordinators and their teams located at every VA Medical Center, which work to connect Veterans with care and to educate the community about suicide prevention programs and resources.

Assessment of VA mental health servicesThe VHA Strategic Analytics for Improvement

and Learning program (SAIL) provides a standardized way to assess the quality of mental health services in VA facilities. Facilities with lower-than-average levels of access and quality, as indicated by the SAIL program, have been shown to improve those services within 6 months, and facilities with excellent access and quality have generally maintained performance over the years.

Integration of mental health professionals into VA primary care

The Primary Care-Mental Health Integration (PCMHI) program embeds mental health providers in primary care settings to improve same-day access to services. Since tracking began in 2008 the VA has served over 2 million patients through PCMHI, and mental health visits increased 20% between 2014 and 2017.

Universal screeningIn 2018 the VA implemented the largest

standardized suicide risk assessment in U.S. health care. More than 1.8 million Veterans received this screening, with approximately 84,000 (3%) reporting suicidal ideation.

Mental Health Treatment CoordinatorsAs of 2018, approximately 1.3 million

Veterans has an assigned Mental Health Treatment Coordinator who is tasked with the job of ensuring continuity of care between providers and who provides the Veteran with a consistent and reliable point of contact, especially during care transitions.

Expansion of evidence-based treatmentsMore than 12,700 VA mental health clinicians

have been trained in evidence-based treatments, including prolonged exposure (PE) and/or cognitive processing therapies, as well as medication treatments indicated for a variety of conditions.

Care related to military sexual traumaIn 2017 every VHA health center provided

free military sexual trauma (MST) outpatient care to both women and men. More than 1,325,000 MST-related outpatient visits were provided, a 9% increase from 2016.

Women’s Mental HealthA national network of Women’s Mental Health

Champions in nearly every VA health care center exists to facilitate consultations, and develop local resources to support gender-sensitive mental health care. In addition the VA has developed many clinical training resources for providers who treat women Veterans, including a monthly teleconference series, and web-based training courses that include live demonstrations and role- playing exercises.

Lethal means safety for Veterans and military service members

As noted earlier, Veterans and military service members are more likely to use firearms as a method for dying by suicide compared to the general population.144 Military Service Members often have ready access to firearms, and Veterans have higher rates of firearm ownership compared to their civilian counterparts.145

One systematic review reported statistically significant increased risk of suicide with presence of firearms in the house.113 Department of Defense healthcare providers, like their VA and civilian counterparts, have no restrictions regarding inquiries and recommendations pertaining to weapons ownership or carriage. The Department of Defense has long had mechanisms for leaders to arrange sequestration of military and civilian- issued weapons in armories, for operational units during leave periods, for individuals under treatment for behavioral health conditions, or for any individual exhibiting behaviors of concern.

Weapons restrictions in individuals are buttressed by state and Federal law and policy measures in both VA and Department of Defense. For instance, felons cannot own or carry weapons. Sentences of over one year in courts-martial result in a report to a national database that prohibits weapons purchase and ownership.

Population-based weapons restrictions have been effective in a Western military population, even if limited in generalizability by geographic variability

and changes in gun statutes, cultural attunements, and greater rates of weapons ownership in the U.S. compared to other Western nations. A naturalistic epidemiological study in the Israeli Defense Forces ascertained the effect of unit-by-unit weapons storage on bases for 18-21 year old soldiers on weekend leave, showing a dramatic reduction in suicide death on weekends, but not weekdays, in this population-based cohort.146 Randomized studies have yet to systematically ascertain effects of population- based weapons restrictions.

Means safety counseling (MSC; also referred to as “lethal means counseling”) approaches have been developed in an effort to reduce deaths by firearms and other means. MSC consists of discussions between clinicians and Veterans at elevated risk for suicide. Approximately one third of Veterans store at least one firearm loaded or unlocked.162 Examples of MSC recommendations, depending on level of risk, include storing firearms in locked cabinets, using gunlocks, giving keys to these locks to family, caregivers or friends, temporarily transferring firearms to someone legally authorized to receive them, removing firing pins, or otherwise disabling the weapon. MSC approaches have not been shown to reduce suicide, but have been shown to impact firearm storage practices.148,149

Another commonly used method for suicide among Veterans and military Service Members is poisoning, including medication overdose. Access to opioid medications has been associated with increased rates of intentional and unintentional overdose death.150

One study demonstrated that increased access to acetaminophen were paralleled with increased rates of suicide attempts and death by suicide via overdose in the United Kingdom.151

Gatekeeper training for suicide prevention—a key tool for increasing engagement into preventative services for suicide, which includes programs such as Question, Persuade, and Refer (QPR) and Applied Skills in Suicide Training (ASIST)—has not been found to improve population-level suicide rates in each of the U.S. states, VA, and DoD.152

Buddy support, incorporated into programs such as Comprehensive Soldier Fitness, which have a practical and theoretical nexus to military suicide prevention and resilience programming, does not have a sufficient evidence base to demonstrate efficacy in preventing suicide, suicide attempts, or suicidal ideation.163

Coping skillsA range of skills have been shown to improve

the ability of Veterans to cope with stress, anxiety, difficult life situations, and other factors plausibly associated with increased suicide risk. Clinicians may want to offer training on the skills summarized below in consultation with the Veteran and in light of factors such as the patient’s existing coping skills and abilities, the complexity of the skill, patients preference and other personal factors such as the nature of the Veteran’s current distress or impaired attentional, affective, or interpersonal functioning and current maladaptive coping tendencies.63

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The skills below are organized hierarchically from more basic and easily-learned skills to more complex skills. It is generally recommended to start with the easiest skills and progress to more challenging skills upon mastery of the fundamental skills. By reducing physiological arousal, these skills may also facilitate the implementation of higher-order skills in therapy.

Basic relaxation skillsRelaxation skills are among the most

straightforward for patients to practice and implement and generally have quick and noticeable effect. Providers should encourage Veterans to use one or more of the Basic Relaxation Skills both for reducing acute stress in stress-provoking situations and in an ongoing manner for lower one’s “emotional temperature.” The latter use of Basic Relaxation Skills can have the effect of improving mood and increasing one’s stress tolerance threshold by, for example, lowering levels of cortisol, the stress hormone, and stimulating the parasympathetic nervous system.

Meditative breathingMeditative Breathing is a core relaxation skill

that patients can cultivate to develop a sense of controllability during states of agitation or arousal and to achieve a general sense of calm. This skill involves two components—diaphragmatic (or abdominal) breathing and a meditative component. First, the provider teaches the patient how to engage in diaphragmatic breathing (a process also referred to as “breathing retraining”).

Prior to teaching the skill (and relaxation skills in general), it is important for the provider to briefly educate them about the underlying rationale and physiology, rather than just teaching the skill. Patients are taught that diaphragmatic breathing, or breathing from the belly, involves a deeper, healthier way of breathing. Most people breathe from the chest or thoracic cavity (known as thoracic breathing), which is a much shallower type of breathing.

Patients should be informed that the two types of breathing have very different physiological effects on the body. Diaphragmatic breathing activates the parasympathetic nervous system, turning off the body’s stress response (sympathetic nervous system) and resulting in a slowing of one’s heartbeat and lowering of blood pressure. Shallow breathing, on the other hand, often contributes to stress and activation of the sympathetic nervous system.

After educating the Veteran about the rationale, function, and effects of diaphragmatic breathing, the provider demonstrates thoracic vs. diaphragmatic breathing by placing their right hand on their stomach and left hand on their chest and inviting the patient to do the same, observing which hand moves with each type of breathing. Next, the provider leads the patient through the diaphragmatic breathing exercise, instructing the Veteran to inhale through the nose, causing the belly to expand and fill with air, hold for three seconds, and then

exhale through the mouth. Because diaphragmatic breathing is typically new to most individuals and replaces habitual thoracic breathing, the provider should note that this skill may feel unnatural at first but becomes much easier with dedicated practice. (A tutorial on diaphragmatic breathing and its effects on the stress response system is available in the Breathe2Relax mobile application developed by the Department of Defense National Center for Telehealth and Technology. The app is free to use and may be accessed at: www.t2health.dcoe.mil/apps/breathe2relax.)

A second component of Meditative Breathing involves adding a simple meditative element. After the patient is taught diaphragmatic breathing, they are instructed about the meditative component. Before leading the patient through this, the provider should describe this component so the patient can anticipate what to expect and natural challenges they may encounter (e.g., intrusion of thoughts). Then, the provider asks the patient to sit straight up in a comfortable position, close their eyes, and begin engaging in diaphragmatic breathing, inhaling through their nose and exhaling out of their mouth. While doing so, they are instructed to focus on their breathing and to redirect their thinking back to their breathing (including the sound, rate, temperature of each breath of air), when they find their mind wanders. The provider guides the patient through the exercise, with periodic and soothing reminders to “focus only on your breathing” and to notice the sound, temperature, and path of each breath. The provider periodically notes that “if your mind wanders, gently guide your thinking back to your breathing.”

Progressive muscle relaxationProgressive Muscle Relaxation (PMR) is an

empirically supported skill in which patients tense and then relax various muscle groups to reduce muscle tension and achieve a sense of calm.63 PMR targets increased muscle tension that accompanies amygdala activation, which is often interpreted by patients as a sign of danger. Specifically, PMR involves tensing of different muscle groups for approximately five to seven seconds, followed by gradual relaxation of muscle group and focus on the sensation of warmth and relaxation for approximately 30 to 40 seconds.

The provider leads the patient through each muscle group while the patient is in a seated position, though the provider may note that the patient may engage in the exercise at home while lying on their back. As the provider leads the Veteran through the exercise, they may state, “Now I’d like you to make a fist with your right hand, holding it as tight as you can, holding and focusing on the tension,…continuing to hold and focus on the tension” and “Now I’d like you to release your fist, letting go of all the tension out of your fingertips, feeling the warmth that emerges when you let go of the tension and focusing on it as it dissolves away.” Like diaphragmatic breathing, patients practice relaxation for homework in between sessions.

PMR is generally contraindicated in individuals with arthritis or physical pain that may be

exacerbated by systematic muscle tensing. With such individuals, an alternative approach that has been shown to be effective is to instruct the patient to imagine tensing and relaxing specific muscle groups.

Mindfulness meditationMindfulness Meditation has received extensive

and rigorous empirical examination, with a spate of studies in recent years demonstrating the significant utility and efficacy of Mindfulness Meditation for a variety of mental health and other issues, as well as additional studies currently underway.63,164

Mindfulness Meditation often involves focusing attention on internal experiences, sensations, and aspects of self, and it uses specific techniques. Mindfulness Meditation requires repeated practice and discipline to maximize impact and utility.

For thousands of years, the practice of mindfulness has served as a powerful tool for increasing attentional focus and living in the present moment. In recent years, practitioners of modern medicine have embraced mindfulness for helping patients to manage stress, cope with illness and medical procedures, and promote overall healthy living. Mindfulness practice has been incorporated into many different areas of health care, including oncology, chronic pain and disease, sports medicine, and pre- and post-surgical contexts. Moreover, mindfulness practice has recently been adopted by employers to promote employee well-being and organizational performance. Within mental health, mindfulness has received significant interest and attention over the past three decades.

More recently, mindfulness practice has increasingly been incorporated as a specific component or adjunct to treatment and has been shown, in some contexts, to be a promising standalone intervention, with additional research currently underway.

Mindfulness practice generally involves three components: (1) remaining focused on the present, rather than ruminating over the past or anxiously anticipating the future, (2) being intentional in whatever activity is being pursued, and (3) being nonjudgmental, refraining from affixing labels like “good” or “bad” to one’s experience. Mindfulness Meditation involves the specific practice of mindfulness that can be easily taught and incorporated into Veterans’ lives. The goal of these exercises is to help cultivate mindful awareness of the present moment and increase attentional control. This, in turn, promotes acceptance of emotional experience, sensation, and thought, facilitating adaptive responses to negative emotion and coping with stress and physical pain.

Mindfulness Meditation practices and guided exercises exist for many different areas of focus and individual needs (e.g., general stress, anxiety, sleep, self-compassion, happiness, frustration, blame, guilt) and may be tailored to individuals’ experiences. Some Mindfulness Meditation exercises have features in common with and build on the more general Meditative Breathing exercise described above; however, whereas Meditative Breathing is focused on promoting relaxation,

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Mindfulness Meditation is focused on increasing awareness. Relaxation may be a by-product of Mindfulness Meditation, but it is not the primary outcome targeted.

Prior to introducing Mindfulness Meditation, it is important to explain the purpose of and rationale for mindfulness practice, noting the benefits of nonjudgmental awareness and acceptance of internal experiences (e.g., emotions, thoughts, sensations) on both mental and physical health. This includes but is not limited to increased affect tolerance, adaptability, and overall coping capacity, as well as improved concentration and focus, which can help with getting the most out of treatment. Ultimately, through mindful practice, patients may come to see thoughts and feelings as transient experiences. This can help to decrease identification with a momentary affective state, facilitating greater self-understanding and self-compassion. In noting the benefit of mindfulness, the provider may specifically note the effectiveness of mindfulness with Veterans, referring to either clinical experience and/or empirical research. For instance, mindfulness-based interventions have been shown to reduce symptoms of anxiety, PTSD, depression, and suicidal ideation and improve mental health functioning in Veterans.165,166

When introducing Mindfulness Meditation, it can be useful to ask the Veteran what, if anything, they know about mindfulness. Getting a sense of the patient’s preexisting knowledge and beliefs can help with knowing how much and what to emphasize in the rationale and introduction. Some individuals have a highly inaccurate understanding of mindfulness and meditation, often mistaking them for something religious or mystical. Although it has its roots in Eastern philosophy and practice, Mindfulness Meditation is largely used as a skill in mental health prevention and treatment and is not promoted in most health arenas as either religious or mystical, but secular (i.e., not regarded as religious, spiritual, or sacred). As well, patients may express more openness and confidence in practicing Mindfulness Meditation after engaging in the previously described coping skills, such as Meditative Breathing and Progressive Muscle Relaxation. In fact, Mindfulness Meditation can be introduced as a skill designed to build on the previously introduced skills, although it is important to remind the patient that mindfulness is not about achieving a relaxed state; rather, it is about being aware.

At the conclusion of any Mindfulness Meditation exercise, the provider should discuss the Veteran’s reactions to the exercise and explore how they might incorporate these practices and exercises into their daily life. Many high quality, free mobile applications now exist that make it simple to practice and incorporate Mindfulness Meditation in one’s routine, with many applications able to provide a reminder at specific times and offering brief exercises that may be completed virtually anywhere. Providers are encouraged to become familiar with different apps and to review in session one or more that appear to be a good fit for particular patients.

Cognitive DefusionCognitive Defusion involves specific techniques

designed to help individuals observe the process of thinking and notice thoughts as thoughts, rather than take them as fact or allow them to overly influence behavior.167 Cognitive Defusion helps patients to become less “fused” with their thinking by teaching them to look at thoughts instead of from thoughts, viewing thoughts as thoughts rather than literal truths. In this way, Cognitive Defusion teaches patients a new way of relating to their thoughts. The strategy does not involve changing or reshaping the content of maladaptive thoughts but engaging in mindful observation and disentanglement from these thoughts. Cognitive Defusion has been shown to be effective as a standalone stress management technique. Cognitive Defusion can be used in conjunction with Basic Relaxation Skills, as well as with Mindfulness Meditation, as part of helping patients to engage in nonjudgmental awareness of their thoughts, situation, and surroundings and to remain in the present moment. Veterans who take particularly well to Mindfulness Meditation and the concept of nonjudgmental awareness may be especially well-suited to learning and using Cognitive Defusion.

Cognitive reappraisalCognitive Reappraisal involves adjusting or

reframing the meaning one gives to a situation in order to alter their emotional response.168

Although often used synonymously with cognitive restructuring, Cognitive Reappraisal is a more basic technique that lends well to use as a general coping strategy. Cognitive restructuring, a central strategy of CBT, involves changing maladaptive thoughts by systematically identifying and examining the validity and function of thought, as opposed to the more basic process of reappraising or reframing of the situation. Learning Cognitive Reappraisal skills can provide Veterans with foundational cognitive coping abilities that can be useful for subsequently learning cognitive restructuring or extending in CBT or other treatment.

Providers may teach Cognitive Reappraisal by indirectly guiding patients in reappraising a specific situation in their lives and demonstrating how they appraise—and reappraise—situations that affect how they feel. Through the use of Guided Discovery, the provider helps the Veteran to develop new perspective on or a new way of looking at the situation. First, the provider identifies a scenario where the patient formulated an extreme or narrow appraisal resulting in a strong negative reaction. Next, the provider inquires about the emotional or other (e.g., physiological) effect of the patient’s appraisal in order to help the patient gain awareness of the impact of their thinking on how they feel. Using non-directive questioning, the provider then helps the patient develop a new, modified, or broadened appraisal of the situation based on the facts of the situation, being mindful not to convince the patient or reject their thoughts and feelings about the situation. After helping the patient through the process of reappraisal, the provider highlights the patient’s alternate or

broadened view of the situation and the resulting change in the Veteran’s emotional reaction.

Command consultationMilitary commanders expect to be cognizant

of major events in the lives of Service Members under their charge. Command consultation is an important aspect for treatment of behavioral health conditions and is a relevant part of military treatment planning.4 Command involvement in the care of the Service Members is always considered in the context of balancing split fiduciary roles, to both patients and commands, in military medicine.

In order to foster a culture of support throughout the Department of Defense and dispel the stigma of seeking mental health care, military healthcare providers employ a presumption, buttressed in Department of Defense instructions addressing mental health evaluations and command interactions to minimize stigma, to defer notification of a Service Member’s commander indefinitely unless the deferral is overcome by notification standards listed in Department of Defense policy. In disclosure to commands, clinicians provide a minimum amount of information—only enough to satisfy the purpose of the disclosure.

Healthcare providers notify commanders under the following circumstances: harm to self, harm to others, harm to mission, inpatient care, acute medical conditions interfering with duty, substance abuse treatment, command-directed mental health evaluations, treatment of personnel in sensitive positions, or circumstances when execution of the military mission outweighs the interest served by avoiding notification.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 4 ON THE NEXT PAGE.

Suicide in prisons and child welfare settingsSuicide is a common cause of death in secure

justice settings. More than 400 suicides occur annually in local jails at a rate three times greater than among the general population, and suicide is the third leading cause of death in prisons.169

Youth involved in the juvenile justice and child welfare systems have a high prevalence of risk factors for suicide. Juveniles in confinement have life histories that put them at higher suicide risk, including experiences such as mental disorders and substance abuse; physical, sexual, and emotional abuse; and current and prior self-injurious behavior.

Youth in foster care share many of these traumatic experiences. In one study, children in foster care were almost three times more likely to have considered suicide and almost four times more likely to have attempted suicide than those who had never been in foster care.170 Suicide among youth in contact with the juvenile justice system occurs at a rate about four times greater than the rate among youth in the general population.171 Research suggests that youth engage in more than 17,000 incidents each year in juvenile facilities, that more than half of all detained youth reported current suicidal ideation, and that one-third also had a history of suicidal behaviors.171

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Risk factors for suicide among both juvenile and adult inmates include: a history of or existing mental illness and substance abuse; a history of suicidal behaviors; lack of mental health care; a history of abuse (e.g., emotional, physical, sexual); family discord/abuse; impulsive aggression; a history of interpersonal conflict; prior involvement in special education; legal/disciplinary problems; family history of suicide; poor family support; prior offenses; referral to juvenile court; and coming from a single-parent home.14

Protective factors against suicide among juvenile and adult inmates include: a sense of control over one’s own destiny; problem-solving and conflict resolution skills; adaptable temperament; support from and connections to family and community; positive school or employment experience; specific plans for the future; religious/spiritual/cultural beliefs that protect against suicide; housing that is “suicide-resistant” (i.e., free of protruding objects and means/methods for suicide) and that is proximal to staff and peers; and availability of mental health services that are provided consistently by qualified, trained, and supportive staff who provide strong community linkages and referrals and ensure continuity of care.14

Experts theorize that jail suicides may have two primary causes: (1) jail environments are conducive to suicidal behaviors; and (2) the inmate faces a crisis situation. Studies conducted by the National Center on Institutions and Alternatives and commissioned

by the U.S. Department of Justice recommend that all sites develop and implement comprehensive policies and programming addressing suicide prevention, intervention, and care in the aftermath of a suicide death or attempt.14

These policies and programs should include: initial and annual training for all direct care, medical, and mental health personnel; initial intake and ongoing assessment of incarcerated persons; enhanced communication along the continuum of justice system; levels of supervision for persons at risk of self-harm and suicide; appropriate suicide-resistant housing; intervention; reporting; mortality/morbidity incident review; and critical incident stress debriefing.172 Because inmates can be at risk for suicide at any point during confinement, the biggest challenge for those who work in the justice system is to view the issue as requiring a continuum of comprehensive suicide prevention services aimed at the collaborative identification, continued assessment, and safe management of individuals at risk for suicidal behaviors.

A dramatic reduction in the rate of suicide within county jails throughout the United States in the past 20 years has been attributed to increased staff training, better identification of inmates who may be at risk for suicidal behaviors, and the implementation of comprehensive programming.14

Recent efforts for suicide prevention for youth involved in the juvenile justice system include: targeting state-level juvenile justice agency directors/administrators with training developed to encourage comprehensive policy development; training direct care staff working in juvenile facilities; improving data collection and research within the population; increasing collaboration between mental health and juvenile justice systems; and improving policy and programming.

LGBTQ individualsStudies over the last four decades suggest

that individuals who are lesbian, gay, bisexual, transgender, or queer (LGBTQ) may have an elevated risk for suicide ideation and attempts.14

Across many different countries, a strong and consistent relationship between sexual orientation and nonfatal suicidal behavior has been observed.173 A meta-analysis of 25 international population-based studies found the lifetime prevalence of suicide attempts in gay and bisexual male adolescents and adults was four times that of comparable heterosexual males.174

Lifetime suicide attempt rates among lesbian and bisexual females were almost twice those of heterosexual females. Lesbian, gay, and bisexual (LGB) adolescents and adults were also found to be almost twice as likely as heterosexuals to report a suicide attempt in the past year.

Questions for case study:

Case Study 4Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Reggie is a 58-year-old retired Army Warrant Officer who completed four tours in the Middle East—two in Iraq, and two in Afghanistan. He retired from active duty due to service-connected injuries including migraines, nerve damage, and back and neck pain. He is unable to work due to these medical conditions and has 80% disability through the VA. Reggie and his family (wife and three children) recently moved into a small rental house after they lost their home to foreclosure. Reggie’s wife works two jobs to “make ends meet” and frequently expresses dissatisfaction with the marriage and, more generally, their life together. His oldest child, age 20, was recently arrested for possession of marijuana with intent to sell, his second arrest in the past two years. Reggie describes his two younger children as “doing OK,” although he worries about the impact of the move to the smaller house on the children, and he feels distant from them due to his medical and other struggles.

Reggie was referred to Mental Health by his neurologist who was treating his migraine headaches. Reggie completed a psychodiagnostic evaluation session, which revealed that he meets criteria for major depressive disorder, with an onset soon after he announced his retirement. Reggie reported that he does not know what to do with himself now that he is retired, remarking, “I have no purpose now.” Although he says he does not sleep well, he indicated that he gets a total of 10–12 hours of sleep per day because he takes frequent and lengthy naps durinvg daytime hours. Reggie indicated that he has little interest in pursuing activities that he used to enjoy, such as playing drums and following NASCAR, and remarks that he has so much difficulty concentrating that he probably would not be able to do these activities anyway. He stated that he has no intent to harm himself, although he commented that this could change if his wife were to leave him. Reggie denied a history of depression or symptoms of PTSD (despite experiencing combat-related injuries on two of his tours in the Middle East, and despite previously trying psychotherapy).

1. What types of strategies might help Reggie cope with some of the issues in his life?

2. What pharmacological treatment options might be appropriate for Reggie?

3. How might Reggie be monitored for signs of increased suicide risk?

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A later meta-analysis of adolescent studies concluded that LGB youth were three times more likely to report a lifetime suicide attempt than heterosexual youth, and four times as likely to make a medically serious attempt.175 Across studies, 12 to 19 percent of LGB adults report making a suicide attempt, compared with less than 5 percent of all U.S. adults; and at least 30 percent of LGB adolescents report attempts, compared with 8 to 10 percent of all adolescents.

Most studies have found suicide attempt rates to be higher in gay/bisexual males than in lesbian/bisexual women, which is the opposite of the gender pattern found in the general population. As in the overall population, there is some evidence that the frequency of suicide attempts may decrease as LGB adolescents move into adulthood,176 although patterns of suicide attempts across the lifespan of sexual minority people have not been conclusively studied. Within LGB samples, especially high suicide attempt rates have been reported among African American, Latino, Native American, and Asian American subgroups.177

Suicidal behaviors in LGBTQ populations appear to be related to “minority stress,” which stems from the cultural and social prejudice attached to minority sexual orientation and gender identity.178 This stress includes individual experiences of prejudice or discrimination, such as family rejection, harassment, bullying, violence, and victimization. Increasingly recognized as an aspect of minority stress is “institutional discrimination” resulting from laws and public policies that create inequities or omit LGBTQ people from benefits and protections afforded others.14 Individual and institutional discrimination have been found to be associated with social isolation, low self-esteem, negative sexual/gender identity, and depression, anxiety, and other mental disorders. These negative outcomes, rather than minority sexual orientation or gender identity per se, appear to be the key risk factors for LGBTQ suicidal ideation and behavior. An additional risk factor is contagion resulting from media coverage of LGBTQ suicide deaths that presents suicidal behavior as a normal, rational response to anti- LGBTQ bullying or other experiences of discrimination. Further research is needed to explore the pathways to suicidal behaviors for transgender individuals, including the impact of prejudice and discrimination.

Factors that foster and promote resilience in LGBTQ people include family acceptance, connection to caring others and a sense of safety, positive sexual/gender identity, and the availability of quality, culturally appropriate mental health treatment. Strategies for preventing suicidal behaviors in LGBTQ populations include: reducing sexual orientation and gender-related prejudice and associated stressors; improving identification of depression, anxiety, substance abuse, and other mental disorders; increasing availability and access to LGBT-affirming treatments and mental health services; reducing bullying and other forms of victimization that contribute to vulnerability within families, schools, and workplaces; enhancing factors

that promote resilience, including family acceptance and school safety; changing discriminatory laws and public policies; and reducing suicide contagion.

Collaboration between suicide prevention and LGBTQ organizations is needed to ensure the development of culturally appropriate suicide prevention programs, services, and materials, and to facilitate access to care for at-risk individuals.

Men in midlifeMen in their adult years, from their early 20s

through their 50s, account for the bulk of suicides and the majority of years of life lost due to suicide.179

Yet there has been relatively little research on this demographic group, when compared with the number of studies conducted with adolescents and older adults.14

Although research exploring the recent surge in suicide in midlife is lacking, existing studies suggest that the factors that may increase the risk for suicidal behaviors in this group are similar to those among other age groups and in both sexes: mental illness that can be discerned from retrospective analyses (particularly mood disorders), substance use disorders (particularly alcohol abuse), and access to lethal means. However, these factors are likely to be exacerbated by other risk-related characteristics that occur more frequently among males, such as the underreporting of mental health problems, a reluctance to seek help, engagement in interpersonal violence, distress from economic hardship (e.g., unemployment), and dissolution of intimate relationships.14 More research is needed on the pathways and mechanisms that contribute to suicide among midlife men, using developmental approaches that examine the occurrence and timing of risk factors as they are expressed across the life course.

Prevention efforts are especially challenging for men because they are less likely to show signs of depression, report suicidal ideation, or seek help or accept it from others, and they often hide their suicide plans or preparations. Several projects have focused on organizational-level components for early intervention and education.180-182 Although studies in other countries point to the positive protective effects of means restriction, no such programs have been successfully implemented in the United States. In terms of changing individual- level trajectories toward suicide, early classroom interventions to enhance interpersonal skills have been shown to reduce suicidal behaviors in early adulthood.183

Additional targets for intervention include: preventing exposure to violence in early developmental periods, such as bullying/peer victimization, childhood abuse, and domestic violence; enhancing academic engagement and reducing school drop-out rates; mitigating or preventing persisting alcohol and drug misuse; and developing a diverse array of community-based programs that engage men who otherwise would not seek care in traditional health settings or in settings that provide care for mental or substance use disorders. Many of these efforts now are being focused on Veterans. However, few

data are available at this time to identify a particular evidence-based suicide prevention approach targeting men in midlife.

Older menSeveral factors can increase the risk for

suicidal behaviors among older men, including the presence of a mental disorder. Research suggests that older adults who die by suicide are more likely to meet criteria for affective disorders (especially major depressive disorder) than younger adults. Other important risk factors include physical illness and functional decline. Finally, an extensive body of literature indicates that social disconnection increases risk for death by suicide in older men.184

Suicide in late life is qualitatively different than in younger adults. Older adults are more likely than younger adults to die by suicide as a result of their first suicide attempt, in part because older adults are more likely than younger adults to use highly lethal means to attempt suicide.184 Another important difference is that older adults are less likely than younger adults either to have reported suicidal ideation or to have sought mental health treatment prior to their deaths. Research suggests, however, that most older adults who die by suicide are seen by primary care physicians in the last three months of life.10

Although many suicide prevention efforts have targeted youth, older adults have also become a focus of suicide prevention. Many national and regional conferences have featured the topic, and many states have broadened or are in the process of broadening their suicide prevention strategies to include older adults. Some states (e.g., Oregon and Maine) have separate plans for this age group. Mental health parity for Medicare is now being phased in so that seniors in the United States will have the same copay (20 percent) for mental health care as for physical health care.

Several interventions appear to offer significant promise for the prevention of suicide in late life. Most of these interventions have focused on treating depressive symptoms.184 Because older men do not generally seek mental health treatment, the most effective methods of treating mood disorders in older adults may involve integrating evidence-based depression treatment into the work of primary care offices, social service agencies, and aging services organizations that focus on addressing the needs of older adults. Research has shown that collaborative care models that combine pharmacological and psychosocial treatments for depressive symptoms may be particularly useful. Finally, there is evidence that interventions that attempt to decrease social isolation and disconnection in late life may reduce risk for death by suicide.184

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 5 ON THE NEXT PAGE.

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Suicide among physiciansPhysicians die by their own hands at a rate

much higher than that of the general public.185-187

The suicide rate among female physicians is approximately 130 percent higher than that of the general female population. For male physicians, the suicide rate is approximately 40 percent higher than that of the general male population.185 Although there is no single cause for suicide, it most often occurs when a person’s life circumstances, stressors, and health issues—especially inadequately treated or untreated mental health issues—lead to feelings of hopelessness and despair.

Physicians may be vulnerable to suicide because of high self-expectations, intense professional pressure, a prevailing culture of self-reliance, and ready access to (and knowledge about) lethal means.188 The Medscape National Physician Burnout & Depression Report 2018 showed that 66% of male physicians and 58% of female physicians who reported burnout, depression, or both had never received professional help, were not currently seeking professional help, and did not plan to seek professional help.189

An exacerbating factor in physician suicide may be the fact that most U.S. state medical licensing boards include questions about the physician’s mental health history on their applications, despite new recommendations to the contrary from the Federation of State Medical Boards, American

Medical Association, and American Psychiatric Association.188 Such questions may make physicians afraid that seeking help for a mental health issue will affect their ability to practice medicine or damage their professional reputation.

Organizations and employers can help by creating a forum for physicians to openly recognize and discuss issues in medicine that impact their mental health. For example, more than 440 health care organizations around the world offer The Schwartz Center’s Schwartz Rounds program (www.theschwartzcenter.org) in an effort to provide a safe space for physicians and other health care professionals to honestly share their experiences, thoughts, and feelings about topics drawn from actual patient cases. This type of open communication may help normalize the often difficult realities of medicine and make counseling available for physicians in a safe and confidential place, at a time the physicians can actually access it.188

Coping with suicide

A suicide puts stress on the patient’s loved ones as well as health care workers who were involved in the care of the patient. These stressors may include personal and legal ramifications. Bereavement after suicide is similar to that after other causes of death; however, survivors are more likely to feel shame and to blame themselves for the loss.190

The physician should be prepared to support the family members through this difficult transition. Survivors have reported that their needs vary from formal counseling with professionals to more informal social support from friends, family, and support groups.191

In situations in which the physician must face an angry family, prudent steps include careful documentation; notification of hospital, managed care, and malpractice risk management teams; and taking care to compassionately give condolences to the family without assigning blame.190

Some physicians who have had a patient die by suicide report feelings of guilt and personal responsibility, as well as descent into a mood disorder. This is particularly common among those who think they missed warning signs or could have done more to protect their patient.192 If physicians develop suicidal ideations, they may be at increased risk of a suicide attempt because of their advanced medical knowledge and access to lethal means. To cope with this stress, physicians should have access to social support and medical and psychological care.193

Caring for survivorsThe impact of suicide can be profound and

sometimes devastating for those who are left behind. Each year, more than 13 million people in the United States report that they have known someone who died by suicide that year.194

Questions for case study:

Case Study 5

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Sharma is an 84-year old retired professor of business at the local university. He is married with three grown children and 3 grandchildren. You have been his primary care physician for many years and know Sharma well. Although Sharma has been exceptionally healthy most of his life (he is vegetarian, exercises regularly, and does not smoke) he was diagnosed with ALS 16 months ago. The disease first manifested as a “floppiness” in Sharma’s left foot, which was at first attributed to minor nerve damage. But then Sharma’s wife noticed some slight slurring in his speech, which triggered the complete assessment that resulted in his diagnosis.

Since the diagnosis the disease has progressed steadily. Sharma has lost 40 pounds due to muscle atrophy and resultant inactivity, and, in the past 3 months swallowing became very difficult, often resulting in choking episodes that left him gasping and coughing for many agonizing minutes. His speech is now very slow and slurred, but he can still make himself be understood. To minimize the risk of choking, he was given a percutaneous endoscopic gastrostomy 3 weeks ago, and he is now using it with a “Liquid Hope” nutritional fluid. Although his body is failing, Sharma’s mind is as quick, clear, and stable as ever. He does crossword puzzles, reads, and listens to music.

Sharma has requested this meeting, and one of his daughters has accompanied him. He says he has come to thank you for your care over the years, but that he has decided to end his life by stopping eating and drinking. “I only agreed to this tube so that I could live long enough to say my goodbyes,” Sharma says, slowly. “You know me, doctor. I always said that if life became miserable, I would simply end it. Well, that time has come. This is no way to live. I’m going to stop eating this Sunday when my son can come and all three of my children can care for me at home. In my condition, it shouldn’t take long.” You notice tears well up in his daughter’s eyes.

1. How would you respond to Sharma’s decision?

2. Would it be appropriate to prevent Sharma’s suicide by involuntarily admitting him to a hospital?

3. What could you ethically do to support Sharma, physically and emotionally, in the coming days?

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Moreover, exposure to suicide carries risks for elevated rates of guilt, depression, and other psychiatric symptoms, complicated grief, and social isolation. There is also compelling evidence that individuals bereaved by suicide (also referred to as “survivors of suicide loss”) may have an increased risk for suicide completion themselves.195 Therefore, helping those who have been bereaved by suicide is a direct form of suicide prevention with a population known to be at risk.

The term “postvention” was coined by Dr. Edwin Shneidman who described it as “appropriate and helpful acts that come after a dire event.”196 Rather than just being support for survivors, he posited that focus should also be put on the alleviation of the effects of stress in the survivors whose lives are forever altered by suicide. One of the earliest comprehensive suicide postvention programs was the LOSSteam program developed by the Baton Rouge Crisis Intervention Center in Baton Rouge, Louisiana.197 The LOSSteam program is unique in that it is an “active postvention” program. The LOSSteam goes to the scene of a suicide to help survivors cope with their loss. LOSSteam volunteers provide referrals to a variety of support resources. There is, however, insufficient evidence for or against the principles employed in this program in regard to suicide outcomes.4

The Tragedy Assistance Program for Survivors (TAPS) provides a comprehensive military and Veteran suicide postvention program that addresses each of the key principles of the Survivors of Suicide Loss Task Force National Strategy outlined above.4

Since beginning their suicide support program 10 years ago, TAPS has provided postvention support for over 9,000 military family survivors. TAPS uses a three-phase approach including stabilization, grief work, and posttraumatic growth. There is insufficient evidence for or against the therapeutic principles employed in this program in regard to suicide outcomes.4

Conclusions

Many people know a friend or a loved one who has attempted or died from suicide or have been affected as a result of a suicide in their community, school, workplace, or place of worship. As this learning activity has demonstrated, even though suicide is relatively uncommon at a population level, the 45,390 people who died by suicide in 2017 translate into roughly one suicide death every 11 minutes in the U.S. For every American who dies by suicide, many others attempt suicide, and many more suffer the despair that leads them to consider taking their own life.

Suicide exacts a heavy toll on those left behind as well. Loved ones, friends, classmates, neighbors, military comrades, faith leaders, and colleagues all feel the effect of these deaths. The largest number of suicidal deaths each year occurs among middle-aged men and women, sapping the workforce of individuals needed to sustain the economy. The fact that suicidal behavior occurs among some of our most marginalized citizens is also troubling.

Reducing the number of suicides requires the engagement and commitment of people in many sectors in and outside of government, including public health, mental health, health care, the Armed Forces, business, entertainment, media, and education. Physicians and other health care workers play vital roles as well in the overall effort to prevent suicide, and this learning activity has presented the most up-to-date information available to guide decision-making, compassionate care, and effective management for those struggling with forces in their lives that seem to leave them with no option but suicide.

Bottom line messages:

1. Suicidal patients are more likely to see a primary care physician than a psychiatrist in the months preceding their death. Primary care physicians are therefore in a unique position to identify at-risk individuals and possibly intervene.

2. Acknowledging and discussing suicide may help to reduce suicidal ideation and identify high-risk patients who require urgent intervention—it will not increase the risk that a patient will think of, or attempt, suicide.

3. Use the PHQ-9 and/or other tools for assessing suicidality or depression. The information acquired can add to the overall information obtained during a thorough suicide assessment.

4. Some suicidal risk factors are amenable to intervention, whereas some are not.

5. Apart from strategies to reduce the risk factors for suicide, interventions should also aim to strengthen protective factors.

6. Eliciting suicidal ideation requires a step-wise approach, by first using open-ended questions and gradually focusing on direct ones.

7. All persons with clear-cut, active suicidal ideation should be sent to the designated hospital for urgent psychiatric care.

8. Safety plans should be discussed and developed with all patients who are at risk of suicide.

9. Depressed or suicidal patients should be connected to available community resources.

Appendix A: Patient Resources

Suicide in America—Information brochure, National Institute of Mental Health. http://www.nimh.nih.gov/health/ publications/suicide-in-america/index.shtml

NIMH Publications—Webpage of National Institute of Mental Health; order free brochures and booklets on depression and other topics.

After an Attempt: A Guide for Taking Care of Yourself After Your Treatment in the Emergency Department— Brochure, Substance Abuse and Mental Health Services Administration, also available in Spanish. Available at: http://store.samhsa.gov/shin/content/SMA08-4355/SMA08-4355.pdf

After an Attempt: A Guide for Taking Care of Your Family Member After Treatment in the Emergency Department—Brochure, Substance Abuse and Mental Health Services Administration, also available in Spanish. Available at: http://store.samhsa.gov/shin/content/SMA08-4357/SMA08-4357.pdf

With Help Comes Hope—Support webpage for persons living with suicidal thoughts and suicide attempts. Available at: http://lifelineforattemptsurvivors.org/

National Suicide Prevention Lifeline—24-hour/7-day-a-week telephone hotline (800-273-8255) or chat via text by accessing the link at suicidepreventionlifeline.org

The Way Forward: Pathways to Hope, Recovery, and Wellness with Insights from Lived Experience—Suicide Attempt Survivors Task Force of the National Action Alliance for Suicide Prevention. Available at: http:// actionallianceforsuicideprevention.org/sites/actionallianceforsuicideprevention.org/files/The-Way-Forward- Final-2014-07-01.pdf

References for this activity can be found at references.cme.edu

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SUICIDE ASSESSMENT & PREVENTION

26. In 2017, what was the rank of suicide as a cause of death in the United States?A. 2nd leading causeB. 5th leading causeC. 10th leading causeD. 14th leading cause

27. About how much higher is the suicide rate among Veterans as compared to the non-Veteran population?A. 1.5 times higherB. 2 times higherC. 2.5 times higherD. 6 times higher

28. The three levels of strategies for suicide prevention are _________, _________, and ____________.A. Federal, state, and localB. Community-wide, organization-wide, and individualC. Universal, selective, and indicatedD. Universal, selective, and individual

29. What is the name of the conceptual model that frames suicide risk as a balance between protective factors and risk factors at different levels?A. Psycho-social risk modelB. Suicidality risk modelC. Multi-level social risk modelD. Social ecological model

30. Which of the following is a tenet of the Patient-Centered Care model for suicide prevention?A. Provide patients with access to medical and mental health

servicesB. Provide patients with occupational and social services

supports to minimize suicide riskC. Provide patients with comprehensive, digestible information

regarding available prevention interventions and treatment options

D. Provide patients with appropriate medico-legal counseling related to suicide risk factors

31. What is one of the advantages of adopting a Patient-Centered Care model of suicide prevention?A. Decreased risk for depressed moodB. Improved adherence to treatmentC. Decreased rate of completed suicidesD. Increased use of social support services

32. Which of the following is a true statement about suicide risk?A. Suicide risk is highest in young people and lowest in older

adultsB. Suicide tends to develop in discrete steps of increasing risk C. There is no single path for reducing suicide riskD. Evidence shows that the PHQ-9 question is the most accurate

way to identify people at risk for suicide

33. Which of the following is a true statement about suicide risk in Veteran and non-Veteran populations?A. The same risk factors for suicide are at work in non-Veteran

populations as in Veteran and military populationsB. Some risk factors, such as exposure to trauma, are more

important in Veteran populations compared to non-Veteran and military populations

C. Being deployed to a combat zone is a unique risk factor for suicide among Veterans

D. Chronic pain is a suicide risk factor more common among Veterans than non-Veteran populations

34. Which of the following is a direct warning sign of acute suicide risk?A. Being diagnosed with major depressive disorderB. Demonstrating preparatory behaviors such as putting affairs

in orderC. Getting divorced or experiencing the break-up of a long-term

relationshipD. Withdrawing from previously-enjoyed social situations

35. Which of the following is true about asking patients about suicide or suicidal thinking?A. Since suicide is difficult to predict, it is best to ask all patients

about suicide on a regular basisB. Inquiring about suicide is a less reliable approach to

assessment than standardized questions such as the PHQ-9C. Asking about suicide may plant the seeds of suicidal thinking

in a patient’s mindD. Inquiring about suicide does not increase suicidal ideation or

attempts

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36. When attempting to elicit suicidal ideation from a patient, it is best if clinicians ________________?A. Use a step-wise approach starting with general questions

about mood and moving to more specific questions as indicatedB. Obtain verbal consent before asking about suicide, since this is

a potentially traumatizing line of inquiryC. Avoid using the phrase “suicide” and, instead, use “self-

harm,” or “self-inflicted harm”D. Begin with specific questions about self-harm and move to

broader questions about risk factors, such as life situations, as indicated

37. What would be an appropriate course of action for a patient determined to be at an intermediate level of acute suicide risk?A. Direct observation until transfer to a secure medical or

psychiatric unitB. Intensive outpatient management of suicidal thoughts and/or

behaviorsC. Rapid initiation of evidence-based pharmacological treatments

for reducing suicide riskD. Management in primary care setting with focus on co-occurring

conditions

38. Which non-pharmacological treatment modality has been shown to reduce the risk of suicide attempts by helping patients identify and change problematic thinking and behavioral patterns?A. Cognitive behavioral therapyB. Dialectical behavioral therapyC. Interpersonal cognitive therapyD. Psychodynamic psychotherapy

39. Which non-pharmacological treatment modality focuses on helping patients cope with stressful life experiences by actively working on difficulties?A. Problem-solving therapyB. Dialectical behavioral therapyC. Psychodynamic psychotherapyD. Crisis response planning

40. Which pharmacological therapy has been shown to improve acute suicidal symptoms for up to a week after only a single dose?A. MethylphenidateB. Selective serotonin reuptake inhibitorC. Ketamine infusionD. Lithium

41. Which pharmacological therapy has been shown to reduce suicidal behaviors in patients with schizophrenia or schizoaffective disorder?A. QuetiapineB. RisperidoneC. ClozapineD. Olanzapine

42. What post-acute care modality has been shown to reduce the rate of suicide death following a psychiatric hospitalization for suicidal ideation/attempt?A. Home visits by social workersB. Cognitive behavioral therapyC. Periodic caring communicationsD. No-suicide contracts

43. Which therapeutic modality may allow treatment for suicidal thoughts and behaviors regardless of geographic location or access to traditional care facilities?A. TelehealthB. Suicide chat hotlinesC. Webinar suicide education programsD. App-based coping skills programs

44. Which kind of suicide-prevention initiative has not been found to improve population-level suicide rates, either in the general U.S. population or among Veterans?A. Gatekeeper training programsB. Lethal means counselingC. Telehealth modalitiesD. Universal suicide screening programs

45. In an effort to dispel stigma and foster a culture of support throughout the Department of Defense, which policy has been put into place?A. Outreach efforts to encourage confidential meetings between

service members and military mental health staffB. “Don’t ask/don’t tell” policies related to disclosure of suicidal

thoughts or behaviorsC. 1-month delay in notifying commanders about a service

member’s disclosure of suicidal thoughts unless such delay is overcome by existing notification standards.

D. Indefinite deferral of notifications to a commander about a service member’s use of mental health services unless such deferral is overcome by existing notification standards.

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Completion of this course will better enable the course participant to:1. Describe the prevalence of physician stress, emotional distress, depression, and suicide.2. Explain at least three factors that can increase risk of physician emotional distress, and three factors that can mitigate or

reduce risk of emotional distress.3. Identify technology-related factors related to physician emotional distress and strategies for addressing those factors.4. Describe interventions that physicians can engage in to improve resilience and wellness and reduce the risk of emotional

distress.

LEARNING OBJECTIVES

TARGET AUDIENCE

This course is designed for all physicians (MD/DO) and other health care practitioners.

COURSE OBJECTIVE

The purpose of this course is to educate physicians about the prevalence of physician dissatisfaction and emotional distress, ways of measuring and quantifying that dissatisfaction and distress (e.g., using indicators such as burnout, depression, stress, anxiety, or suicidal ideation), as well as pros and cons of using these different indicators. The course will also cover factors that increase risk for burnout, and factors that can mitigate or reduce that risk. The course reviews the multi-factorial nature of burnout, examining contributory causes at the level of individual physicians, the organizations in which they work, and at higher systems levels, such as the ways that technology can either exacerbate, or reduce, the experience of burnout.

Enduring Material

(Self Study)

6 AMA PRA

Category 1 Credits™

Release Date: 03/2020

Expiration Date: 02/2023

PREVENTING CLINICIAN BURNOUT

ACCREDITATION STATEMENTInforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

DESIGNATION STATEMENTInforMed designates this enduring material for a maximum of 6 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Read the course materials

Complete the self-assessment questions at the end. A score of 70% is required.

Return your customer information/answer sheet, evaluation, and payment to InforMed by mail, phone, fax or complete online at course website under NETPASS.

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FACULTY

Douglas A. Mata, MD, MPHClinical FellowMemorial Sloan Kettering Cancer Center

Stephen BraunMedical WriterBraun Medical Communications

ACTIVITY PLANNER

Michael BrooksDirector of CME, InforMed

DISCLOSURE OF INTERESTIn accordance with the ACCME Standards for Commercial Support of CME, InforMed implemented mechanisms, prior to the planning and implementation of this CME activity, to identify and resolve conflicts of interest for all individuals in a position to control content of this CME activity.

STAFF AND CONTENT REVIEWERS

InforMed staff, input committee and all content validation reviewers involved with this activity have reported no relevant financial relationships with commercial interests.

DISCLAIMER

*2020. All rights reserved. These materials, except those in the public domain, may not be reproduced without permission from InforMed. This publication is designed to provide general information prepared by professionals in regard to the subject matter covered. It is provided with the understanding that InforMed, Inc is not engaged in rendering legal, medical or other professional services. Although prepared by professionals, this publication should not be utilized as a substitute for professional services in specific situations. If legal advice, medical advice or other expert assistance is required, the service of a professional should be sought.

FACULTY/PLANNING COMMITTEE DISCLOSURE

The following faculty and/or planning committee members have indicated they have no relationship(s) with industry to disclose relative to the content of this CME activity:

• Douglas A. Mata, MD, MPH• Stephen Braun• Michael Brooks

This course satisfies six (6) credit hours in the area of Patient Safety for physicians and medical professionals licensed in

Pennsylvania.

The Pennsylvania Board of Medicine and Osteopathic Medicine requires all licensed physicians to complete twelve (12) credit hours in Patient Safety every

licensure period.

PATIENT SAFETY

SPECIAL DESIGNATION:

6

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Introduction

The work of a physician can be difficult—long hours, extensive paperwork, and complex patients can leave physicians feeling overworked and exhausted. Since physicians are high achievers by nature, many tend to push themselves to see more patients and do more work than resources allow. Often, there is little time or consideration for the needs of the physician in this fast-paced environment, which can lead to dissatisfaction and emotional distress.

The field of medicine is in the midst of significant technological, regulatory, policy, and societal changes that contribute to an increasingly stressful work environment for physicians and other health care professionals. Physicians can be caught between the ethics and values they have vowed to uphold in terms of care for their patients, and the demands of their work environments that conspire to make it ever more difficult for them to adhere to those goals. The resulting stress can lead to emotional exhaustion, depersonalization, and a loss of a sense of professional efficacy, which, taken together, have been described in the literature as “burnout” although this term has been defined many ways and has not been rigorously articulated in terms of objective symptoms in the same way that other mental illnesses (e.g., major depressive disorder) have been.1

Burnout is harmful to the clinicians themselves, it may impair the quality of care they give to their patients, and it is costly for organizations facing workforce shortages and problems retaining high-quality providers. Indeed, high levels of physician burnout are being leveraged by providers of “concierge” medical practices, in which patients pay monthly or yearly fees in return for improved access to their doctors, a shift in medicine that some fear may be siphoning off high-quality physicians from standard medical practice settings.2

Clinician burnout is a difficult problem to tackle because it is complex and multi-faceted. Factors contributing to burnout include: high workloads, administrative burdens, and poorly-designed technologies (e.g., electronic medical records systems). Regulatory and institutional polices, payer requirements, and burdensome technologies all challenge the humanist motivations that energize and give meaning to the work that physicians and other healthcare workers do every day. Solutions and remedies for burnout, therefore, require transformations at all levels of medicine, from the personal to the organizational and political.

In its 2019 report on physician wellbeing and the problems of emotional exhaustion and job dissatisfaction, the National Academy of Sciences, Engineering, and Medicine called for the following actions to address key issues:1• Attention to burnout early in professional de-

velopment and the implementation of changes to reduce stressors in the learning environ-ment

• Engagement of organizational leaders in the external environment to reduce redundancy,

avoid unnecessary requirements, and improve workplace efficiencies

• Transformation of poorly-designed technologies into well-designed and implemented systems that are integrated into the clinical workflow to improve usability and inter-operability

• Actions by medical societies, state licensing boards, specialty certification boards, medical education and health care delivery organizations to reduce the stigma for clinicians seeking help for psychological distress, and increased assistance for these cliniciansThis learning activity will explore in detail each

of these areas with a particular focus on steps physicians can take to manage their own stress and reduce the risk that they will become a victim of burnout.

Scope of the problem

The phenomenon of clinician burnout was first described in 1974 by the psychologist Herbert Freudenberger, who often volunteered at a free clinic for drug addicts the East Village of New York City.3 Over time, Freudenberger observed emotional depletion and accompanying psychosomatic symptoms among the clinic’s volunteer staff. He called the phenomenon “burnout,” borrowing the term from drug-addict slang. Freudenberger defined burnout as exhaustion resulting from “excessive demands on energy, strength, or resources” in the workplace, characterizing it by a set of symptoms including malaise, fatigue, frustration, cynicism, and inefficacy:

“There is a feeling of exhaustion, being unable to shake a lingering cold, suffering from frequent headaches and gastrointestinal disturbances, sleeplessness and shortness of breath. The burnout candidate finds it just too difficult to hold in feelings. He cries too easily, the slightest pressure makes him feel overburdened and he yells and screams. With the ease of anger may come a suspicious attitude, a kind of suspicion and paranoia. The victim begins to feel that just about everyone is out to screw him. He becomes the ‘house cynic.’ Anything that is suggested is bad rapped or bad mouthed. A sign that is difficult to spot until a closer look is taken is the amount of time a person is spending in the free clinic. A greater and greater number of physical hours are spent there, but less and less is being accomplished. He just seems to hang around and act as if he has nowhere else to go. Often, sadly, he really does not have anywhere else to go, because in his heavy involvement in the clinic, he has just about lost most of his friends.”—Herbert Freudenberger

Importantly, Freudenberger’s description of burnout was anecdotal and not determined by rigorous clinical observation or modern epidemiological methods. In the following decade the social psychologist Christina Maslach developed a model of burnout consisting of three dimensions:

emotional exhaustion, depersonalization, and a diminished sense of personal accomplishment.4 These remain the most-commonly used indicators of burnout, although the field is now changing and this conceptualization is being de-emphasized by some researchers who are using other indices or metrics to measure emotional distress among physicians, such as depression (see the section on assessment below for a more detailed exploration of these concepts.)

Determining the scope of the physician burnout problem is challenging. There is substantial heterogeneity in the research methods employed by investigators studying burnout, including variability in the measures used to evaluate burnout symptoms and the approaches to dichotomizing burnout. Studies have also varied widely in sample size, the types of clinicians included (e.g., single occupation versus multiple health care disciplines), practice settings, participation rates, and in adjustments for potential confounders. A 2018 systematic review of 182 studies involving 109,628 healthcare workers in 45 countries found at least 142 unique definitions of overall burnout, which suggests a significant disagreement in the literature about what constitutes burnout.5 Prevalence estimates of overall burnout ranged widely, from 0% to 80.5% with similarly wide ranges for emotional exhaustion (0% to 86.2%), depersonalization (0% to 89.9%) and low personal accomplishment (0% to 87.1%).5

In the past decade, a set of influential national studies of U.S. physicians found levels of burnout ranging from 40% to 54%, although these studies are subject to various methodological critiques, detailed below.6-9 Much lower levels of burnout among physicians were found in an analysis by Rotenstein et al., of 9 studies (total n=9,859) that used a rigorous definition of burnout—namely, scores on the Maslach Burnout Inventory (MBI) emotional exhaustion subscale of ≥27 points and a score on the depersonalization subscale ≥10, and a score on the personal accomplishment subscale ≤33 points (Figure 1). The overall prevalence of burnout, using this strict definition across these 9 studies was about 6%, although the authors cautioned against considering “burnout” as a dichotomous phenomenon (i.e., present or absent) at all, and instead favored measuring physician dissatisfaction and emotional distress using other methods.

Although some studies have attempted to assess trends in levels of physician emotional exhaustion and professional dissatisfaction, methodological weaknesses limit their interpretability. When assessed with the MBI, 45.5% of 7,227 physicians reported at least 1 symptom of burnout in 2011, the level increased to 54.4% (of 6,767 physicians) in 2014, and then dropped back to 43.9% in 2017 (the last year for which data are available) (Figure 2).9 These data should be interpreted cautiously, however, since the same individuals were not assessed at each time point in these studies.

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Some studies have attempted to measure physician emotional distress using a depressive symptoms paradigm, since major depressive disorder has been very well-characterized as a mental disorder and instruments for assessing depression have been well-validated. A 2016 systematic review and meta-analysis of 183 studies evaluating depression, depressive symptoms, and suicidal ideation among medical students found an overall pooled prevalence of screening positive for depression of 27.2% (with significant heterogeneity among studies).10 The overall prevalence of reporting suicidal ideation was 11.1%. Similar levels of screening positive for depression and suicidal ideation were found in meta-analyses of studies of resident11 and attending physicians.5

Importantly, these studies assessed the prevalence of individuals who screened positive for depression using validated case-finding instruments, and not major depressive disorder itself, the prevalence of which would be expected to be substantially lower. This is an important distinction, because even though validated depression screening questionnaires provide useful and clinically significant information on depressive

symptomatology (which could be secondary to work stress), they do not always provide accurate estimations of the prevalence of criterion-defined major depressive disorder.12

A 2004 meta-analysis revealed that physicians are more likely to commit suicide than non-physicians, and that women physicians are more likely to commit suicide than male physicians. The combined results of 25 studies show that suicide is 40% more common among male physicians (compared to the general population) and suicide is 130% higher among female physicians compared to the general population.13

Comparisons of working conditions and levels of emotional distress between physicians and the general population showed, not surprisingly, that physicians tend to work more than those in other professions. For example, in 2017, physicians reported working a mean of 12 hours more per week than those in non-medical fields (mean weekly hours 52.6 vs. 40.3 hours).9 Even more starkly, 38.9% of physicians (out of 3,906) reported working more than 60 hours a week compared to only 6.2% (of 5,194) of the general population respondents.

Given these differences, it is also unsurprising that, using a 2-item burnout measure, physicians reported higher levels of emotional exhaustion (36.4% vs. 24.8%), depersonalization (18.0% vs. 13.5%), and overall burnout (39.8% vs. 28.1%) compared to the general population.9

Even after adjusting for age, sex, relationship status, and hours worked per week, physicians remained at increased risk for burnout compared with the general U.S. working population (OR 1.39; 95% CI 1.26-1.54). Physicians also had a significantly lower rate of satisfaction with work/life integration than the general U.S. working population (40.0% vs. 61.0%), even after adjusting for age, sex, relationship status, and hours worked per week (OR 0.77; 95% CI 0.70-0.85).9

Levels of burnout among physicians vary by practice setting and specialty. Physicians in private practice appear to have a roughly 30% higher risk for burnout compared to those in academic settings.8,9 Data suggest that physicians with substantial direct patient care responsibilities, or who are on the “front lines” of access to health care systems have the highest levels of burnout. Specific fields at high risk include emergency medicine, family medicine, general internal medicine, and neurology.1

Levels of physician burnout may also be related to demographic factors, with younger workers at higher risk than more seasoned physicians. This effect is not, apparently, due to a generational effect since it has been consistently observed in studies over the past 20-30 years. Younger workers face some distinct challenges as they establish their careers and attempt to balance their personal and professional lives, particularly if their personal lives involve caring for children. Women physicians are at increased risk for burnout compared to their male colleagues after adjustment for other personal and professional factors.9,14 Burnout is more likely to manifest as emotional exhaustion in women, compared to men, with men more likely to experience depersonalization. Life events such as a personal illness, an illness in a loved one, the birth of a child, or the death of a close loved one are also associated with higher risk of burnout.15

Assessing burnoutIn 1981 the social psychologist Christina

Maslach proposed the Maslach Burnout Inventory (MBI)4 consisting of three scales (22 items in all) to measure the extent of an individual’s symptoms in each dimension, which remains the most commonly-used instrument to assess burnout (the MBI has been used in about 88% of burnout research publications).5 The three dimensions on the MBI are: emotional exhaustion, depersonalization, and a diminished sense of personal accomplishment.

Emotional exhaustion describes feelings of being emotionally overextended and exhausted by one’s work. Sample statements about emotional exhaustion include “I feel used up at the end of the workday,” “I feel like I’m at the end of my rope,” and “I feel fatigued when I get up in the morning and have to face another day on the job.”

Figure 1. Prevalence estimates from studies using strict definitions of burnout.5

MBI-HSS EE ≥27, DP ≥10, and PA, ≤33

Golub et al, 2008 14 351 4.0 (2.2-6.6)

Arigoni et al, 2009 22 368 6.0 (3.8-8.9)

Brøndt et al, 2008 10 379 2.6 (1.3-4.8)

Pedersen et al, 2013 10 381 2.6 (1.3-4.8)

Pedersen et al, 2016 56 1173 4.8 (3.6-6.2)

Lesage et al, 2013 170 1440 11.8 (10.2-13.6)

Goehring et al 2005 62 1755 3.5 (2.7-4.5)

Pantenburg et al, 2016 195 1784 10.9 (9.5-12.5)

Maticorena -Quevedo et al, 2016 82 2228 3.7 (2.9-4.5)

Subtotal 621 9859

Figure 2. Comparison of burnout in physicians and the general population over time9

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Depersonalization describes an unfeeling and impersonal response toward the recipients of one’s care or service. Sample statements about depersonalization include “I’ve become more callous toward people since I took this job,” “I worry that this job is hardening me emotionally,” and “I don’t really care what happens to some patients.”

The dimension of personal accomplishment is a measure of feelings of competence and successful achievement in one’s work with people. Sample statements about a reduced sense of personal accomplishment include “I don’t deal very effectively with my patients’ problems,” “I don’t think I’m positively influencing other people’s lives through my work,” and “I can’t easily create a relaxed atmosphere with my patients.”

There are multiple questions for each of the subscales (22 questions in all on the most frequently-used version) and responses are in the form of a frequency rating (“never,” “a few times a year or less,” “once a month or less,” “a few times a month,” “once a weekly,” “a few times a week,” “every day”). The instructions for the use of the MBI specifically warn users not to dichotomize the results (i.e., to avoid artificially creating two categories of “burned out” and “not burned out”) and not to combine the scores from separate subscales into a single “burnout scale.” Instead, the instructions suggest that scores been seen as a continuous measure of increasing levels of professional stress for which widely varying approaches to management might be appropriate.16 Nonetheless, many researchers have ignored these recommendations and have defined their own cutoff levels for scores indicating “burnout.”

Because the 22-item version is not always practical, a 2-question version is sometimes used, with the following questions: “I feel burned out from my work,” and “I have become more callous toward people since I took this job.” These two items have been shown to have strong and consistent correlations with key outcomes in medical students, residents, and practicing surgeons.17 A response of “once a week” or more on single items indicates a high degree of burnout in each domain. Variations on the MBI have been developed for human services workers, educators, students, and “general use.” The MBI has been translated into dozens of languages and permission to use it can be obtained via mindgarden.com.

In addition to the MBI, the following assessment instruments have been used for research or other purposes:• Oldenburg Burnout Inventory (OBI) (eval-

uates physical, cognitive, and affective ex-haustion and disengagement from work). Availability: proprietary but free for use with permission. The OBI excludes a measure of personal accomplishment. It consists of 16 positively and negatively formulated items used to evaluate 2 dimensions of burnout, which can be interpreted as continuums ranging from disengagement to dedication (i.e., the identification continuum) and from exhaustion to vigor (i.e., the energy contin-uum).

The OBI assesses the cognitive and physical components of exhaustion in addition to the affective component that is included in the MBI. The OBI can be used to assess burnout in all employees, irrespective of their occupation.

• Copenhagen Burnout Inventory (CBI) (evalu-ates personal burnout [6 items], work-related burnout [7 items], and client-related burnout [6 items]). Availability: proprietary but free for use with permission. The CBI was developed by Krinstensen et al.,18 and validated during the Danish longitudinal PUMA study in 1997. Like the OBI, the CBI can be used across a range of professions.

• Stanford Professional Fulfillment Index (a 16-item survey that covers burnout [work ex-haustion and interpersonal disengagement] and professional fulfillment. Response options are on a five-point Likert scale [“not at all true” to “completely true” for professional ful-fillment items and “not at all” to “extremely” for work exhaustion and interpersonal disen-gagement items]). Availability: proprietary but free for use by not-for-profit organizations with permission.

• Mayo Clinic Physician Well-Being Index (9-item self-assessment tool). Availability: proprietary with price for use dependent on type of pro-fession and size of organization. A total score is calculated by adding the number of ‘yes’ responses with responses to meaning in work and satisfaction with work-life balance items resulting in 1 point being added or subtract-ed, resulting in a score range of -2 to 9. In a sample of physicians, medical students, and US workers, every one point increase in score resulted in a step-wise increased probability of distress and risk for adverse personal and professional consequence.

Assessing depression and/or suicidal ideationAs noted above, some researchers favor

assessing depressive symptoms in physicians as a proxy for work-related dissatisfaction and emotional distress, rather than the more amorphous “burnout.” The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, outlines the following criterion to make a diagnosis of depression (i.e., Major Depressive Disorder [MDD]).20 The individual must be experiencing five or more symptoms during the same 2-week period and at least one of the symptoms should be either (1) depressed mood or (2) loss of interest or pleasure.1. Depressed mood most of the day, nearly every

day.2. Markedly diminished interest or pleasure in all,

or almost all, activities most of the day, nearly every day.

3. Significant weight loss when not dieting or weight gain, or decrease or increase in appe-tite nearly every day.

4. A slowing down of thought and a reduction of physical movement (observable by others, not merely subjective feelings of restlessness or being slowed down).

5. Fatigue or loss of energy nearly every day.6. Feelings of worthlessness or excessive or in-

appropriate guilt nearly every day.7. Diminished ability to think or concentrate, or

indecisiveness, nearly every day.8. Recurrent thoughts of death, recurrent suicid-

al ideation without a specific plan, or a suicide attempt or a specific plan for committing sui-cide.

To receive a diagnosis of depression, these symptoms must cause the individual clinically significant distress or impairment in social, occupational, or other important areas of functioning. The symptoms must also not be a result of substance abuse or another medical condition. Importantly, the diagnosis of MDD requires an in-person assessment by a health professional (as opposed to self-assessments or assessments using online survey instruments) which enhances the reliability of a diagnosis.

A common and well-validated assessment tool for MDD is the Patient Health Questionnaire-9, which asks 9 questions with answers scored as: 0 points for “not at all,” 1 point for “several days,” 2 points for “more than half the days,” and 3 points for “nearly every day.” Scores of 4 or lower suggest minimal depression that probably does not require treatment and scores above 10 suggest a high probability of MDD. The PHQ-9 is commonly used in epidemiological studies of depression in which in-person psychiatric interviews would be untenable due to cost, anonymity, or for logistical reasons. Studies employing the PHQ-9 can generate prevalence estimates of “screening positive for depression” (e.g., the proportion of surveyed individuals who scored 10 or higher on the scale) or can produce depressive symptom estimates as a continuous variable.

World Health Organization Definition of Burnout19

In 2019 WHO revised its definition of burnout, which aligns with, but is subtly different than, the Maslach paradigm:

Burnout is a syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed. It is characterized by three dimensions: (1) feelings of energy depletion or exhaustion; (2) increased mental distance from one’s job, or feelings of negativism or cynicism related to one’s job; and (3) reduced professional efficacy. Burnout refers specifically to phenomena in the occupational context and should not be applied to describe experiences in other areas of life.

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As noted earlier, just because an individual person screens positive on the PHQ-9 does not mean that they would meet formal criteria for MDD. Nonetheless, screening positive may indicate clinically significant depressive symptoms, which could, for example, be due to workplace stress. The PHQ-9 has also been shown to accurately assess a patient’s level of suicidal ideation.21 The PHQ-9 is available free at www.mdcalc.com.

Other commonly-used tools for screening for MDD (or assessing depressive symptoms as a continuous variable) include:22

• Beck Depression Inventory• Hamilton Depression Rating Scale• Major Depression Inventory• Zung Self-Rating Depression Scale• Center for Epidemiologic Studies Depression

Scale

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 1.

Symptoms of burnoutAs mentioned above, recent trends in

the clinical environment may be exacerbating physician burnout, including the industrialization of health care delivery, using measures of accountability and transparency without regard to the negative consequences on clinicians and patient care, the rapid pace of change, greater influence of information technology on the patient encounter, and changing expectations of patients as consumers.24 These changes may create an imbalance in which the demands of a clinician’s job are greater than the resources available to complete the job effectively and induce a range of associated negative symptoms.

Physicians who are burned out can experience a range of symptoms including:25

• Absenteeism• Reduced job satisfaction• Decreased self-esteem• Increased medical errors

• Insomnia• Withdrawal and isolation• Decreased productivity• Anxiety• Being irritable with patients• Exhaustion• Depression• Suicidal thoughts• Impaired concentration and attention• Relationship difficulties at home or at work• Excessive use of alcohol or other drugs, in-

cluding prescription drugs• Feeling detached from peers, patients, family,

and friends• Feeling dread before going to work

Questions for case study:

Case Study 1

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

Michael R. Rose, a medical student in his twenties in Boston, recalled his first year of medical school as a time when he felt energetic and focused on his studies. But only a year later, he felt constant fatigue and had hypersomnia, lost his ability to concentrate on his studies, lost interest in doing things he used to enjoy (e.g., exercise), and felt depressed, despondent, and passively suicidal. He self-administered an anonymous online version of the 9-item Patient Health Questionnaire and scored >10, indicating that he had screened positive for major depressive disorder. He then self-referred to a clinic where he received a formal diagnosis of major depression after an in-person clinical interview. He started dual therapy with counseling sessions and an SSRI. Over the following weeks he gradually felt better, and his depression went into remission. He reported having two additional bouts/relapses of major depression later in medical school, both of which responded to treatment. He noted that epidemiological studies have demonstrated that approximately one quarter of medical trainees screen positive for depression during a given year, yet only a minority seek treatment.10 After an internal struggle with the stigma that still adheres to depression, Rose wrote an article about his experiences in the New England Journal of Medicine.23 “Once a critical mass of afflicted and stigmatized people begin speaking up, perhaps the environment of fear, shame, and judgment can be extinguished, and norms can change,” he wrote.

1. What are the diagnostic criteria for major depressive disorder, and how does major depression differ from burnout?

2. What are some of the risk factors for major depression? How do they overlap or differ with those for burnout?

3. What are some potential reactive and/or proactive interventions that a medical school or hospital could implement to identify and help students like Rose? What are potential barriers to implementing such interventions?

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Personal and professional consequences of physician emotional distress

Physical and mental health effectsNumerous studies have shown positive

associations between physician emotional distress (quantified as either burnout or depressive symptoms) and a range of deleterious physical and psychological conditions including increased risks for cardiovascular disease, high cholesterol levels, type 2 diabetes, musculoskeletal pain, fatigue, headaches, gastrointestinal issues, respiratory problems, and severe injuries.26 Resident physicians with burnout have been shown to be at higher risk for needle sticks, bodily fluid exposures, and motor vehicle accidents.27

Studies have also found that physician burnout is associated with almost a 200% greater chance of suicidal ideation,28 with a dose-response relationship between burnout and suicidal ideation (independent of depression) found in multiple studies.28-30 Clinicians experiencing burnout may also have higher rates of alcohol misuse, which may be related to self-medicating as a way to cope with job-related stress.31

Burnout frequently co-exists with depressive symptoms. Burnout and major depressive disorder appear to be distinct, but inter-related, disorders.32 A prospective longitudinal study suggested that burnout may predispose clinicians to depression, rather than vice-versa.33 However, other studies have suggested that burnout may be a subtype of depression, with substantial overlap in predisposing factors and symptoms.32

Ironically, some of the same characteristics that allow physicians to excel can make them more vulnerable to burnout. For example, many successful physicians attribute their success in training to their emotional and physical strength, drive for success, and conscientiousness. They are rewarded for being the first to arrive, not attending to their physical or emotional needs, and being the last to leave. As valuable as such characteristics can be, they can also act as barriers to seeking and receiving needed help. Physicians may view taking time for self-care or asking for help as selfish, weak, or irresponsible, or they may fear that coworkers or employers will view them in these ways. They may also be concerned about repercussions associated with licensure or believe that distress and burnout are normal parts of being a physician, an attitude that may be reinforced by a professional culture that minimizes distress until it reaches dangerous levels.

Many physicians and medical students may not even realize they need help.10,34 A 2016 meta-analysis of studies evaluating depression in medical students found that only 15.7% of those students who screened positive for depression actually sought psychiatric treatment.10 A 2014 study involving 1,150 U.S. surgeons found that their ability to reliably determine their level of distress was very poor.35 In fact, among those with the lowest levels of well-being, most believed their well-being was at or above average levels. This lack of awareness may lead physicians to ignore signs of burnout when they occur.

Medical errorsThe association between symptoms of clinician

burnout and medical errors is unclear and the evidence base for these associations is weaker than generally appreciated. A meta-analysis of 47 studies conducted between 2002 and 2017 found that burnout negatively affected quality of care in a number of ways, including an increased risk of self-reported patient safety incidents (OR 1.96; 95% CI 1.59-2.4), poorer self-reported quality of care due to low professionalism (OR 2.31; 95% CI 1.87-2.4), and reduced patient satisfaction (OR 2.28; 95% CI 1.42-3.68).36 However, the two studies in this meta-analysis that used actual objective data on medical errors (as opposed to self-reported errors) found a negative association (Kwah et al, 2016),37 or no association (Linzer et al., 2009).38 It is possible that the higher rates of self-reported errors in the observational studies reporting positive associations might result from a misperception of errors by clinicians who are actually depressed and, thus, hyperaware of the possibility of patient harms from their attitudes or performance.

A 2018 study of 6,586 U.S. physicians in active practice used multivariate logistic regression and mixed-effects hierarchical models to evaluate associations between burnout, well-being measures, work unit safety grades, and medical errors.39 Among the participants 54.3% reported symptoms of burnout, 32.8% reported excessive fatigue, and 6.5% reported recent suicidal ideation. Physicians reporting errors were more likely to have symptoms of burnout (77.6% vs. 51.5%, P<0.001), fatigue (46.6% vs. 31.2%, P<0.001), and recent suicidal ideation (12.7% vs. 5.8%, P<0.001), although, again, these associations may reflect misperceptions influenced by depression.39

A study evaluating emotional exhaustion in 1,425 physicians and nurses working in intensive care units found conflicting evidence. Patient mortality was predicted by emotional exhaustion and length of stay (LOS) was predicted by higher workload, but burnout did not predict LOS and workload did not predict mortality rates.40

Organizational impactsClinician emotional distress has costs for

organizations, as well as for society at large due to higher levels of absenteeism, chronic work disability, hospital admissions due to mental and physical disorders, higher turnover, and poorer job performance.33 Clinicians with burnout may also be more likely to leave their profession completely and pursue non-health care-related jobs. Collectively, these factors make it more difficult for health care organizations to maintain an adequate and competent professional workforce. A 2019 study estimated that the economic cost of turnover and reduced productivity due to burnout among U.S. physicians was roughly $4 billion each year.41

Burnout-related impairments in care can also negatively affect the overall perception by patients of a hospital or other health care organization. For example, a study of emotional exhaustion among nurses found an increased likelihood that patients will rate a hospital poorly, will not recommend

the hospital for care, and will perceive their communications with nurses unfavorably.42

In summary, clinician burnout has significant personal and professional consequences as well as negative effects on the organizations in which these clinicians work. In addition to the potentially harmful consequences for patients and clinicians, burnout inflicts substantial costs to society and health care organizations.

Factors associated with clinician emotional distress

Many factors are involved in clinician emotional distress, some at the personal level, some at organizational levels, and others at higher regulatory or system levels. To the extent that such factors are potentially modifiable, a better understanding of them may allow individuals and health care leaders to make changes that reduce the risk of clinician burnout and, thus, reduce the negative consequences of that burnout on patients, physicians, and the organizations in which they work.

The overall health care work environment involves the following components: worker capacity and needs, job content, organizational conditions and culture, and personal considerations. Factors can either increase or decrease the risk of burnout. For example, the following job demands could increase the risk of burnout: high workloads and time pressure, intrinsic aspects of clinical work (i.e., the nature of the illnesses being treated), or work inefficiencies (for example administrative burdens or ineffective technologies). On the other hand, factors such as having meaningful work, control over one’s job, and availability of social support from peers and supervisors can reduce the risks of burnout (see Table 1).

Job demands• Excessive workload, unmanageable work

schedules, and inadequate staffing• Administrative burden• Workflow, interruptions, and distractions• Inadequate technology usability• Time pressure and encroachment on

personal time• Moral distress• Patient factors

Job resources• Meaning and purpose in work• Organizational culture• Alignment of values and expectations• Job control, flexibility, and autonomy• Rewards• Professional relationship and social

support• Work-life integration

Table 1. Work system factors involved in clinician burnout24

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Job demandsJob demands are a function of work frequency

and duration, work intensity, and the nature of the work itself, including the environment in which the work is performed.1 Job demands can often be measured by objective metrics such as shift duration, rotation, and frequency, patient load, as well as with measures of patient complexity or acuity. Work schedules and activities (including after-hours work) vary significantly by specialty. Emergency physicians, nurses, and pharmacists are shift workers, whereas surgeons and many specialist internists have more irregular schedules which include intermittent “call” shifts or other after-hours work. Thus, measures of job demand will vary depending on the clinician’s job. For inpatient nurses, for example, a common metric of job demand is the number and length of shifts, while for work intensity it is nurse-to-patient ratio, adjusted for some measure of patient acuity. As a multi-dimensional concept, job demand is assessed in many different ways, with the results operationalized into different descriptive variables such as workload, time pressure, and inadequate staffing.

When a work environment is inefficient (and especially when it requires many tasks that are considered by the clinician to be lower priority than or a distraction from direct patient care) the demands of the job may exceed a physician’s available capacity or skill set.43 Poorly-designed work systems and constantly high job demands can exhaust employees, and repeated exposure to suffering, death, or social inequities without sufficient structural mechanisms to address them can set the stage for emotional exhaustion and burnout.

Other job-related factors in burnout include having a low level of autonomy or flexibility, or working in an organizational culture or with leaders that do not support individual work goals. When the overall job resources available do not fit with what is required to achieve the goal of quality patient care, burnout can ensue.

WorkloadPhysicians have historically had higher-than-

normal workloads, and many physicians have a “comes with the territory” attitude toward this

aspect of the profession. Nonetheless, data from studies across a range of industries clearly demonstrate that excessive workload is associated with increased worker stress as well as an increase in errors and accidents.1 In an 2017 observational study of 124 intensive care unit (ICU) nurses, an increase in task demands and in nurses’ subjective report of their workload was associated with higher levels of self-reported medication-related adverse events.44 In a survey of pediatric nurses, both mental workload (related to interruptions, divided attention, and being rushed) and the perception of staffing adequacy were predictors of burnout.45 In a systematic review of 71 studies of burnout in surgeons, total work hours, frequency of call, and patient load were all associated with high emotional exhaustion.46 And a 2007 survey of 978 critical care physicians in French ICUs found that workload (number of night shifts per month and time since last non-working week) was a strong independent predictor of burnout.47

Three components of workload (working more than 52 hours a week, taking calls at night, and doing work at home) have been found to correlate with higher levels of burnout. A multivariate analysis of a survey of 7,288 U.S. physicians showed that for every extra hour worked beyond 51.8 hours per week, the odds of burnout increased by about 2 percent.48 Taking calls at night is particularly taxing, with studies showing that for each additional night on call per week, the odds of burnout increase between 3 and 9 percent.49 Finally, a study of 1,490 U.S. oncologists found that for each extra hour spent at home working (e.g., on electronic documentation), there was a 2 percent increase in the odds of burnout.50

“Being a physician has been and always will be a stressful job. This is a fundamental feature of our profession for a simple reason. We are dealing with hurt, sick, scared, dying people, and their families. Our work takes energy even on the best of days. Our practice is the classic high-stress combination of great responsibility and little control. This stress is inescapable as long as you are seeing patients, no matter what your specialty.”

--Dike Drummond, MD, family physician51

The effects of a high workload, however, can be modified by other factors. For example, a number of studies across professions show that job control and degree of professional commitment, may mediate observed associations between job demands and burnout.52 Other studies show that workloads will be perceived as lower when a clinician finds greater meaning in his or her work, has greater control over the logistics of the job, feels a sense of community with coworkers, or works in a supportive organizational culture.1

Extended work schedules have been justified by the idea that if the same clinician cares for the same patient for extended periods of time, there will be fewer care transitions (i.e., handovers) and thus a lower likelihood of errors and care gaps. But evidence does not support this notion. When shift schedules are actively managed, including using structured handovers, there do not appear to be differences in quality of care between extended schedules and those with reasonable work breaks. For example, in a study of 45 clinicians in five ICUs taking care of 1,900 patients, the clinicians were cluster-randomized in half-month rotations to either a continuous schedule (14 consecutive all-day shifts) or weekday coverage with weekend cross-coverage by colleagues (interrupted schedule).53 No significant differences were observed between the groups in either patient length of stay or mortality.

For physicians and advanced practice providers, increasing expectations concerning productivity and the number of patients seen each day have resulted in shorter office visits, and there is often not enough time for clinicians to complete clinical documentation or other tasks (e.g., order entry) during the workday. The introduction of electronic patient portals has led to increased electronic messages and patient queries, although evidence is mixed on whether patient portals are linked to improved patient outcomes.54

Some data suggest that the use of patient portals may increase patient phone calls and overall workload and create additional work for health care professionals.55 This often results in professionals having to perform many tasks outside of regular work hours by remotely accessing the electronic health record (EHR) to complete professional work on personal time.

EMR vs. EHR: What’s the Difference?Electronic medical records (EMRs) are digital versions of the paper charts in clinician offices, clinics, and hospitals. EMRs contain notes and information collected by and for the clinicians in that office, clinic, or hospital and are mostly used by providers for diagnosis and treatment. EMRs enable providers to track data over time, identify patients for preventive visits and screenings, monitor patients, and improve health care quality.

Electronic health records (EHRs) are built to go beyond standard clinical data collected in a provider’s office and are inclusive of a broader view of a patient’s care. EHRs contain information from all the clinicians involved in a patient’s care and all authorized clinicians involved in a patient’s care can access the information to provide care to that patient. EHRs also share information with other health care providers, such as laboratories and specialists. EHRs follow patients – to the specialist, the hospital, the nursing home, or even across the country.

Source: HealthIT.gov. What are the differences between electronic medical records, electronic health records, and personalhealth records? Available at: https://www.healthit.gov/faq/what-are-differences-between-electronic-medical-records-electronichealth- records-and-personal. Accessed December 5, 2019.

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Although such work is compensated for hourly employees, it is typically not compensated for physicians, advance practice providers, and other clinicians. This can often lead administrators to erroneously conclude that they have “increased productivity” without increasing costs when, in reality, they have simply extended the work week of health care professionals and stolen time from their families and personal activities.1 Based on EHR time-stamp data, the average family physician now spends approximately 28 hours per month completing clinical documentation on nights and weekends when he or she is not on duty.56

Clinical documentation and online patient messages are not the only professional tasks clinicians might perform on personal time. Continuing medical education (CME) and the maintenance of certification are frequently performed on nights, weekends, and even vacation time since most organizations do not provide dedicated time for their completion. Clinicians also must complete a number of required training modules each year, typically mandated by regulators, covering topics such as patient safety, infection control, the Health Insurance Portability and Accountability Act (HIPAA), and human subjects protections. Independent of CME and maintenance of certification, health care professionals must keep abreast of advancing knowledge in their field by reading the literature. Because the pace at which medical knowledge is expanding has accelerated significantly, the time required to stay current has also increased, which is another demand on personal time.

Time pressures can be particularly acute for academic physicians who historically have divided their time between clinical work and educational and training work. The performance of these physicians is typically measured using an academic yardstick which requires them to engage in substantial educational activities (lectures and presentations) and produce a specified number of manuscripts and grants in defined timeframes as a requirement for retaining their positions.

To increase revenue, many academic centers have reduced the proportion of time allocated to scholarly pursuits and increased the time devoted to clinical care without adjusting any of the academic performance expectations.1 Most academic centers still have a similar set of criteria for the publications, presentations, grants, and educational responsibilities that are required to retain a position. Accordingly, the requirements for scholarly activity necessary to preserve job security have been increasingly shifted to personal time on nights and weekends.

All of these variables have led to the encroachment of professional tasks into personal time for physicians to a much greater degree than for most other fields. In most settings, this work is not clearly compensated. These professional activities steal time from family, relationships, self-care, and personal pursuits, creating problems with work-life integration as well as with getting adequate sleep, all of which fuel burnout.

Moral distressMoral distress is the anguish experienced

when clinicians perceive that they have participated in a morally undesirable situation or been unable to act in accord with their professional ethical values under conditions of constraint or duress. Pressure to act contrary to ethical standards can arise from patients or their surrogates, the clinical team, or the external environment. Examples include: providing potentially harmful or futile treatment; providing care that prolongs dying; or witnessing clinicians who give false hope to patients or family members. Among nurses, poor communication, insufficient input to clinical decisions, clinical disagreements with physicians, unsafe staffing, and unnecessary tests and procedures also contribute to moral distress. Witnessing patient care suffer as a result of a lack of provider continuity was identified by a sample of interprofessional clinicians as a key driver of moral distress.57 Data from a measure of moral distress among health care professionals indicated that the most common sources of moral distress among physicians were related to a lack of resources that compromised patient care, and lack of administrative action.58

Studies of moral distress among interprofessional clinicians showed that nearly 20 percent of respondents were considering leaving their jobs because of moral distress, which has implications for workforce sustainability.59 The ethical climate of a practice setting, along with the frequency of exposure to morally distressing situations, are postulated to exacerbate moral distress.

Repeated episodes of moral distress can have a cumulative effect over time, causing feelings of depletion, disillusionment, and despair.60 Several studies have described a relationship between moral distress and burnout among nurses, as well as among critical care clinicians, with those having higher moral distress scores being more likely to experience burnout.61 in a study of 1,156 physicians from various specialties, caring for dying patients was found to be associated with an increased likelihood of symptoms of burnout.62 Several studies in primary care physicians suggest that interactions with patients who ignore medical advice, insist on unnecessary tests or treatments, or exhibit disrespectful behavior is associated with greater job dissatisfaction and emotional exhaustion.63

LonelinessLoneliness is defined as a lack of meaningful

interpersonal relationships or interactions and can affect clinicians of all ages and backgrounds. This subjective feeling of loneliness depends more on the quality of relationships than on the number of people in one’s social network. Loneliness is a subjective distress that has been linked to burnout among internal medicine residents.64 Conversely, increased support from family and friends reduces loneliness among resident physicians and subsequently helps reduce burnout.65

A survey of 197 practicing physicians found a prevalence of loneliness of 43% (assessed with the 3-item University of California, Los Angeles Loneliness Scale, the Abbreviated Maslach Burnout Inventory, and 2-item Primary Care Evaluation of Mental Disorders Patient Health Questionnaire).66 The prevalence of loneliness increased with age, ranging from 5% in respondents aged <35 years to 37% of those aged >55 years. Physicians experiencing greater feelings of loneliness were more likely to report at least one manifestation of burnout (64.8% vs. 35.2%, p <0.01). Loneliness was also associated with increased levels of depression and emotional exhaustion. These relationships between depression, emotional exhaustion, and loneliness were maintained even when adjusted for participants’ sex, age, and duty hours.

Distractions and interruptionsAlthough many of the interruptions in the

daily life of a physician are clinically relevant and/or unavoidable, the number and consequences of such interruptions can be exacerbated by poorly-designed workflows or EHRs. Excessive (and often irrelevant) or poorly-timed EHR alerts or “decision support” prompts lead to “alert fatigue,” divided attention, and burnout.67 A study of 422 family physicians and general internists found that adverse workflow (defined in terms of time pressure and chaotic environments) was associated with symptoms of emotional exhaustion.38 Interruptions disrupt clinicians’ work flow, are associated with lower-quality care, add to cognitive burden and forgetfulness, and delay task completion.

Administrative burdenA common physician complaint is the amount

of time required for tasks that are not direct patient care, such as inputting information into EHRs, or filling out forms for billing or insurance issues. A 2016 study of 57 U.S. physicians observed for 430 hours found that for every hour they spent with direct face time with patients, they spent roughly 2 hours on EHR and desk work.68 An observational study of 142 family physicians in Wisconsin found that an average of 4.5 hours were spent during the workday on an EHR, and another 1.4 hours were spent every day after clinic hours on the EHR.56

Clinicians tend to view administrative tasks as less meaningful than direct patient care, hence, to the extent that finding meaning in one’s work mediates burnout, higher levels of administrative burden could be expected to correlate with higher levels of burnout. A 2017 study of 1,774 physicians bears this out. After adjusting for gender, race, specialty, and years of experience, a higher percentage of time spent on administrative duties was associated with decreased career satisfaction and more burnout.69 Study respondents reported that administrative tasks adversely affected their ability to deliver high-quality care and to focus on patient encounters.

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Another study of 585 physician residents and faculty found that those who spent more than 6 hours per week after hours using the EHR were almost three times more likely to report burnout.70

Physician harassment by patientsAlthough it is tempting to assume that the power

in the patient/provider relationship resides with the physicians (and, thus, would reduce the tendency of patients to cross personal boundaries) in fact patients can, and do, breach those boundaries and engage in verbal, emotional, or sexual harassment, which can add significant stress to already over-taxed clinicians.71 Some harassment is inadvertent, such as when a patient with dementia or delirium says or does something that is inappropriate. But often the harassment is intentional: patients may repeatedly ask for a date, for example, make sexist or off-color jokes or references, be inappropriately physical, or become aggressive when rebuffed. Regardless of the underlying reason, this type of sexual harassment can be harmful to the physician, the physician-patient relationship, and the care that is given.72-74

Observational evidence suggests it is not a trivial problem for physicians and may occur more often than other types of sexual harassment in the profession. A 2018 Medscape non-randomized poll of 1,045 physicians and nurses found that 73% of female nurses and 46% of male nurses reported being sexually harassed by patients, and 58% of female physicians and 39% of male physicians reported such harassment.75 By specialty, emergency physicians, dermatologists, and plastic surgeons were more likely to experience harassment from patients, and obstetricians/gynecologists, pediatricians, and radiologists were least likely.71

A number of factors can predispose patients to behave inappropriately, including dementia/cognitive impairment, administration of sedative hypnotics (particularly propofol) and patients feeling nervous or embarrassed. Some patients, such as those who ask a physician out for a date, may not understand that the professional boundaries of the physician-patient relationship are stricter than those in social situations.

Strategies for dealing with harassment by patients will vary depending on the presumed etiology of the behaviors, but approaches include:71

• Adopting clear policies that professional con-duct is expected of patients and violations will be reported, even in cases where the behav-ior is associated with a medication or disease state

• Saying something directly to the patient about the behavior

• Documenting all inappropriate behaviors in the medical record to alert other medical staff who may deal with the patient and to serve as a reference in case of false accusations by the patient

• Taking extra precautions with a known culprit, such as having another physician or a nurse in an exam room

• Using distraction and redirection to interrupt inappropriate behaviors in patients with cog-nitive impairment

• Pairing patients with a history of harassment with physicians and nurses of the same sex, if appropriate

• Reporting a patient to a disruptive behavior committee if one exists at their hospital

• Safety measures within the exam room, includ-ing possibly leaving the door open and sitting closer to the door than the patient

Difficult patientsPrimary care providers typically will experience

10% to 15% of patient encounters as “difficult.”76 Difficult patients were more likely to have mental disorders, multiple somatic symptoms, more severe symptoms, poorer functional status, more unmet expectations, and higher use of health services (e.g., “frequent fliers”). Encounters with difficult patients may trigger feelings of anger, frustration, and despair, potentially leading to emotional exhaustion and burnout.77 Difficult encounters frustrate patients as well as providers. Compared to other patients, patients leaving difficult visits are more likely to have unmet expectations and to feel dissatisfied with their care.

Prior studies have shown that medical and psychiatric complexities are associated with PCP perceived visit difficulty,78 and that the nature and extent of patient requests influence perceived difficulty independent of such complexity.

Patient requests for diagnostic testing or treatment occur in approximately half of primary care visits.79 PCPs often accede to these requests, and request fulfillment is associated with higher patient satisfaction. Yet PCPs do not fulfill up to one-third of patient requests, and they may even decline requests in ways that do not meet patients’ informational or emotional needs. In addition, because patient requests may lead to patient–PCP miscommunication or PCP perception that the patient is demanding or controlling, requests may introduce conflict and tension into the encounter, regardless of whether they are fulfilled. Patient requests for opioid pain medication may be especially likely to foster conflict during primary care encounters,80 and requests for diagnostic tests may introduce tension if the requested test is not recommended by clinical guidelines, such as neuroimaging for uncomplicated headache.

An observational study of 824 patient visits occurring from June 2010 to March 2012 found that patients requested diagnostic tests, pain medications, or specialist referrals in 37.2%, 20%, and 30% of visits, respectively.81 In this study, the perceived difficulty of patients was significantly higher when patients requested diagnostic tests. The study authors note that “the challenge of responding to patient request for low-value tests may be particularly vexing for primary care providers.” With increasing use by patients of internet-based health information services, the rate at which patients make inappropriate demands on physicians may be increasing and, with it, added stress on the provider/patient relationship.

Drs. Sharon Hull and Karen Broquet, family medicine physicians at Southern Illinois University School of Medicine have noted that difficult patients can be categorized by patient characteristics (e.g., angry or manipulative patients, somatizing patients, grieving patients), physician characteristics (e.g., fatigued or harried physicians, dogmatic or arrogant physicians), and situational issues (e.g., language and literacy issues).82 They assert that being aware of these factors and being prepared to address them head-on can help with prevention, particularly highlighting the importance of “mindful practice” and good communication skills (e.g., remaining seated, actively listening, and asking open ended questions).

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 2 ON THE NEXT PAGE.

Job resources

Meaning and purpose in workBoth meaning and purpose are critical to

clinicians’ professional identity.83 In a sample of 1,289 U.S. physicians, “sense of calling” was strongly associated with elevated levels of meaning in life. In this study, physicians reporting burnout symptoms were less likely to report life satisfaction, commitment to direct patient care, and high life meaning.83 In a national study of more than 2,200 U.S. physicians, physicians with burnout were less likely to identify medicine as a calling.84 For nurses, the concept of “calling to nursing” is associated with improved meaningfulness in work, career commitment, personal well-being and satisfaction, and work engagement.85

Finding meaning in work can protect clinicians from burnout. A study of 300 Israeli physicians found that the existential meaning derived from work was a significant protective factor against burnout.86 In contrast, when dissonance arises between what clinicians find meaningful and the reality of their daily work tasks, they may experience increased work stress and burnout. Physicians who report spending less than 20 percent of their time on the professional activity they find most meaningful have higher levels of burnout.6 In a related study, the amount of personally rewarding hours spent each day was found to be positively associated with more career and life satisfaction and commitment to clinical practice.83

Alignment between work activities and what an individual finds meaningful has also been shown to be related to burnout in samples of nurses. For example, a better person–job match in six areas of work–life (manageable workload, control, reward, community, fairness, and values) had a direct protective effect against burnout (i.e., emotional exhaustion and cynicism) in a cross-sectional survey of 215 registered nurses.87

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Questions for case study:

Case Study 2

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

You are a clinician at a busy ambulatory care clinic with a high patient load, a cumbersome electronic medical record system, and long wait times for patients. Your second-to-last patient of the day is a 45-year-old man who reports difficulty sleeping, headaches, and longstanding lower back pain. After you calm the patient down from his complaints about his wait time, he requests opioid pain relievers for his back pain. When you suggest using an NSAID and exercise, he balks and exclaims that “All you doctors are the same! You don’t take me seriously and you never solve my problems.” In your review of his medical record, you note that he has presented multiple times to the clinic and emergency room over the past year to request opioid pain relievers and anxiolytics, and that he has been diagnosed with a substance use disorder and major depression. You prescribe the patient an NSAID and despite his protests, don’t give in to prescribing an opioid. You then discharge him from the clinic and take a moment to recuperate before seeing your last patient.

1. How could you have handled the difficult patient differently? What tools and interview skills can you employ to de-escalate difficult patient encounters, thereby reducing both patient and clinician stress?

2. What specific skills advocated by Drs. Hull and Broquet could address issues arising from difficult patients? How could you teach the physicians in your practice about these skills?

3. Think of a recent difficult patient in the clinic or in the hospital. How could you have handled the situation differently? To what degree did your personal characteristics as a physician, including your self-perceived wellness, contribute to that encounter?

“The patient is what is keeping the doctor from falling further into burnout. The physician–patient relationship and the desire for doctors to help their patients is the core of why physicians entered medicine. Yet, a gap is pushing them apart.”—Zohal Ghulam-Jelani88

Organizational culturePerceptions of low organizational support,

organizational politics, or insufficient resources offered for professional development may increase the risk of burnout among clinicians. For example, having inadequate time for professional development was an independent predictor of burnout in a multivariate analysis performed on a national sample of 783 neurosurgeons.89

Management and policy decisions and change-management processes influence the daily work lives of health care professionals and set the tone for decision latitude and interprofessional collaboration. Another important component of an organization’s culture is the ethical climate, which influences the way clinicians appraise their relationships, leadership, and workplace.

Overall organizational culture can be reflected in a clinician’s satisfaction with the overall work environment. In contrast, healthy work environments have been positively associated in nurses with job satisfaction, retention, and better patient outcomes

and negatively correlated with emotional strain (emotional exhaustion, burnout, compassion fatigue, and stress).1

For example, in a sample of more than 2,300 physicians in Germany, higher satisfaction with the work environment was associated with lower emotional exhaustion and depersonalization.90 Similarly, in a study of more than 26,000 nurses, better work environment quality was associated with less burnout and job dissatisfaction after controlling for wages and other covariates.91 In a retrospective, two-stage study of nurses employed in hospitals between 1999 and 2006, improvements in perceptions of the work environment were associated with lower adjusted rates of emotional exhaustion, job dissatisfaction, and intent to leave.92 The 2018 National Survey of Critical Care Nurse Work Environments, which involved more than 8,000 acute and critical care nurses, found that nurses working in clinical units actively addressing work environment issues rated the work environment more positively than nurses who were not working in such units.93

In addition, studies suggest that when clinicians believe that their personal values and expectations about their work are aligned with the values of the organization in which they practice, job satisfaction increases, which helps to lower the risk of burnout.38 When values or expectations conflict between practitioners and their organization

the resulting dissonance can intensify stress and increase burnout risk. A longitudinal survey in a sample of practicing primary care physicians working in a large integrated delivery system found that values dissonance along with workload and job control were the largest drivers of burnout.67 In a study of 88,605 U.S. Department of Veterans Affairs employees, alignment between stated values and the organization’s behaviors and decisions was associated with more favorable perceptions of organizational culture, which in turn was related to employee satisfaction and worker engagement.94

A sense of job control is also associated with burnout. Several cross-sectional studies of physicians suggest that a low sense of control of the practice environment, having little autonomy, and a perceived lack of involvement in decision making all correlate with burnout.67 A study among obstetricians and gynecologists, for example, found that low perceived control over one’s professional life was independently associated with burnout after controlling for work-life integration, partner support, and current work-related stress.95 And a small longitudinal study of primary care physicians found that job control was central to the experience of burnout, suggesting that physicians need to be involved in practice-related decisions to help reduce organizational-level factors that increase burnout risk.67

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One factor that does not appear related to burnout is physician income. In a national sample of about 900 general and subspecialty physicians, no relationship was found between gross income and burnout.96 Evidence does point, however, to an increased risk of burnout when compensation is based on productivity. A 2008 study of 7,900 surgeons reported that incentive pay based entirely on an individual’s billings was associated with a 37 percent increased odds of burnout, after controlling for demographics, years in practice, subspecialty, hours worked per week, number of nights on call, practice setting, and other professional factors.6 Another study, in 1,490 U.S. oncologists, similarly found that the risk of burnout increased with greater reliance on productivity-based compensation.50 Other studies have found that financial stress or concerns about future earnings are independent predictors of burnout.89

One’s relationships with colleagues can also either buffer against burnout or exacerbate burnout. A study of more than 900 critical care physicians in France found that impaired relationships with physician colleagues was independently linked with higher levels of burnout.47 Poor interpersonal relationships between professional disciplines has also been associated with higher levels of burnout. For example, conflicts between physicians and nurses increased levels of burnout in one study while better relationships with nurses, and the head nurse, were independently associated with lower risk of burnout.47 A separate study in a sample of orthopedic surgeons found that perceived stress with other faculty and nursing staff was correlated with burnout.97

Work/life balanceCompared to other U.S. workers, physicians

are less likely to be satisfied with their work/life integration or balance, a finding that remains even after controlling for work hours and other factors.9 Satisfaction with work/life integration among physicians varies substantially by specialty, age, sex, work hours, and practice setting. The burden of personal responsibilities is also influenced by home dynamics, such as the age of one’s children and having a partner who is employed.98 Lower satisfaction with work/life integration is associated with a higher risk of burnout, and, when struggles with work/life integration occur, work/home conflicts can occur, and such events also increase the risk of burnout.

Work/home conflicts are commonly experienced by physicians, especially among women, those in dual-physician relationships, and early career physicians. A prospective longitudinal cohort study of medical internship in the U.S. (n=3,121 interns) evaluated the degree to which work responsibilities interfered with family life or was associated with depressive symptoms.99 Both men and women experienced a marked increase in depressive symptoms during their internship year, with the increase being statistically significantly greater for women.

When work-family conflict was accounted for, the sex disparity in the increase in depressive symptoms decreased by 36%, suggesting that work-family conflict may be an important potentially modifiable factor that is associated with elevated depressive symptoms in training physicians.

Both having a recent work/home conflict and solving a work/home conflict in favor of work (rather than being able to solve in a manner that enables one to meet both work and home responsibilities) were associated with burnout for both sexes in a national sample of more than 7,800 U.S. surgeons and a smaller sample of 465 academic general and subspecialist internists.49 A longitudinal study of physicians working in Norway found that a failure to experience a reduction in work/home interference over a 5-year time span after medical school graduation was an independent predictor of emotional exhaustion 15 years after medical school graduation.100

Individual factors related to emotional distressBurnout can be related to a host of factors

that work on an individual basis such as personality, mood, sleep deprivation, relationship issues, health issues, and prior history of goal achievement. People vary in their capacity to adapt to work stress and these differences may relate to intrinsic traits such as gender, personality, and general disposition, or temporary circumstances such as mood or attention affected by sleep, use of drugs, or stress. A prospective study of about 2,000 physicians in the United Kingdom, for example, found statistically significant associations between high levels of neuroticism or introversion and increased risk of burnout.101 On the other hand, having a sense of control or an easygoing, receptive personality appears to moderate the effects of burnout-related work factors.102

Being comfortable with decision making and having a strong belief in one’s own self efficacy and abilities may also reduce burnout risk. In a study of nearly 600 Canadian nurses, a higher level of self-efficacy in one’s ability to cope with interpersonal workplace conflict was correlated with lower levels of burnout.103 A study of 130 physicians in Spain found that anxiety about decision making was associated with burnout even after controlling for age, gender, and patient characteristics, and that a more accepting attitude about death (as opposed to avoidance of the issue) was related to a lower risk of burnout.104

Decision making, particularly in the context of chronic or terminal care, can be very stressful. Many physicians feel helpless in the face of a patient's struggle with terminal illness. Medical students also experience patient’s deaths as emotionally draining even when they were not close to the patients. One common response is simply to disappear, leaving the care of such a patient in the hands of other members of the health care team or to the family. Another common response to the physician's feelings of helplessness is a need to take control, to fix it. Doctors tend to be most comfortable when they can do something: prescribe medications, order tests or even develop new communication skills.104

ResilienceResilience is the ability to persevere, remain

positive, and maintain performance and well-being under adversity. Resilience is considered a continuous, dynamic state that can be nurtured into a stronger and more effective attribute, at least up to a point. The term resilience includes concepts of self-regulation and mindfulness and also the capacity for self-monitoring, limit setting, and attitudes that promote engagement with difficult issues at work, hence it is relevant to the study of physician burnout.

Studies suggest that higher levels of resilience may decrease the risk of burnout among nurses. A 2015 survey found that greater resilience was associated with lower levels of emotional exhaustion and a higher sense of personal accomplishment in a sample of nurses practicing in high-intensity settings.105 In another survey of 744 critical care nurses, high resilience was also associated with a lower likelihood of burnout as well as a lower likelihood of posttraumatic stress disorder, anxiety, and depression.106 Higher levels of resilience in nurses have also been associated with improved work relationships, increased job satisfaction, improved professional quality of life, and increased overall well-being.1

Although “mindfulness” is variously defined in studies, there has been consistent evidence for a positive association with this component of resilience and a lower risk of burnout. A 2018 survey of 566 surgical residents in the U.S., for instance, found that high scores on a measure of “dispositional mindfulness” were associated with significantly lower levels of burnout, stress, anxiety, suicidal ideation, and depression.107 A smaller study involving 75 first-year medicine and psychiatry residents found that those classified with burnout (28% of the sample) scored lower on questionnaires assessing mindfulness and coping ability.108

System-level approaches to reduce emotional distress

As detailed above, many factors contributing to physician burnout exist at a systems or organizational level. Although the leaders of health care organizations understandably desire actionable, evidence-based solutions to reduce burnout, such evidence remains relatively limited.1 Nonetheless, many efforts have been, and are being, made both nationally and worldwide, to create work systems that enhance professional well-being and reduce factors associated with burnout. Importantly, the few systematic reviews and meta-analyses conducted to date suggest that organization-focused interventions (e.g., schedule changes and workload reductions) are actually more effective at reducing overall burnout than interventions focused on individuals (for example programs to improve physician resilience), although both types of approaches are probably needed.109 Taking a system-level approach has been recommended by some authors because it attempts to target the root causes of burnout rather than treating the “symptoms” of burnout.

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“Health care organizations throughout the United States are implementing committees and support groups in an attempt to reduce burnout among their physicians, but these efforts are typically focused on increasing resilience and wellness among participants rather than combating problematic changes in how medicine is practiced by physicians in the current era.”—John Squiers, MD, Baylor University Medical School110

Building social supportsPoor professional relationships and social

isolation at work, as noted above, contribute to clinician burnout, one symptom of which is “broken” relationships between people and their work. This suggests that strategies for improving workgroup civility and social cohesion might help reduce physician burnout. A model program along these lines is the Civility, Respect, and Engagement at Work (CREW) initiative developed by the Veterans Health Administration to improve the social climate of workgroups.111 Workgroup participants meet weekly or bi-weekly with a trained facilitator to set goals and improve ways in which they work together as a unit. The sessions emphasize respectful interpersonal interactions and building trusting relationships between unit staff and management. In a pre–post comparison, the CREW intervention was found to achieve significantly greater employee civility ratings than the control sites, which showed no improvement.

The efficacy of the CREW process was also demonstrated in a controlled study that examined the impact of CREW on nurses’ empowerment, experiences of coworker and supervisor incivility, and trust in nursing management.112 Compared with controls, the intervention group reported greater improvements in access to support, resources, total empowerment, trust in management, and supervisor incivility as well as improved job satisfaction and significant reductions in the depersonalization/cynicism dimension of burnout. The changes in emotional exhaustion were not significant.

Another organizational intervention to build professional relationships and social support was evaluated in a randomized controlled trial of 74 practicing physicians at the Mayo Clinic in 2014.113 The intervention consisted of a series of facilitated physician discussion groups that met for an hour about once every other week for 9 months. The 35 participants of the intervention group attended an average of 12 of 19 sessions. Topics discussed during the group sessions included meaning in work, personal and professional balance, and caring for patients. The institution provided the participants with protected, paid time to attend each session.

Compared with controls and a non-study cohort, participants in the facilitated small-group intervention reported improvement in meaning, empowerment, engagement in work, and depersonalization (one of three dimensions of burnout). Based on these studies it appears that initiatives promoting system strategies to foster interprofessional teamwork and civility, reduce disruptive behavior, and build trust among team members can contribute to reducing clinician stress and promote healthier workplaces.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 3.

Strengthening teamworkStrategies that establish or improve efficient

care teams are likely to target multiple work factors, such as workload, social relationships, job control, and autonomy. Using a pre–post quasi-experimental design, Gregory et al., evaluated an organization-level workload intervention at a primary care practice within a large, urban, integrated health care delivery system.115 The intervention consisted of a distinct work process and model change within the primary care clinics. This involved shifting from a dyad practice structure composed of a clinician (physician, advanced practice nurse, or mental health provider) and a certified medical assistant to a team-based structure of two clinicians and three

certified medical assistants who worked together to manage a patient panel. In this team-oriented work model, physicians’ assessments of their workload, the emotional exhaustion dimension of burnout, and depersonalization were lower after 3 months; at 6 months post-intervention emotional exhaustion and depersonalization improvements were sustained, but the improvement in the workload was not.

Similarly, a study of clinician and staff perceptions of their work teams showed that positive perceptions of team culture were associated with less emotional exhaustion among clinicians. Clinicians who had positive perceptions of their team culture and also who routinely worked with the same team members, had lower emotional exhaustion scores.116

In contrast, a study of the Veterans Health Administration’s team-based model, the Patient Aligned Care Team (PACT), found that being assigned to a PACT team was an independent predictor of higher risk of emotional exhaustion, as was spending 25–50 percent of one’s time on work that could be done by someone with less training and working in a chaotic work environment with overwhelming work demands.117 On the other hand, participants on an adequately staffed PACT team and those who reported that their teams used participatory decision making had significantly lower odds of symptoms of emotional exhaustion. Teams included a primary care provider (physician, nurse practitioner, or physician assistant), a nurse care manager, a clinical associate (licensed practice nurse or medical assistant), and an administrative clerk.

Clinicians with 2 or more years of tenure had higher odds of burnout than those with less than 6 months on the job (OR range = 2.13–2.68). The authors theorize that this may be a common feature of working on a job for a long time—the longer an individual works in the same job, the more emotionally exhausted by it that person may be.

Questions for case study:

Case Study 3114

Instructions: Spend 5 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

Dr. Olufunso Odunukan, a cardiology fellow in Mayo School of Graduate Medical Education, experienced burnout and fatigue as a resident and witnessed burnout in colleagues. He grew impatient with the lack of support from his organization. “I grew frustrated at the lack of interventions to curb stress and fatigue among residents and fellows and felt we had to do something,” he says.

Odunukan developed a program to combat stress and fatigue among medical trainees by providing creative outlets in the arts and humanities. Called the Fellows’ and Residents’ Health and Wellness Initiative (FERHAWI) it introduced programs such as watercolor painting classes, ballroom dancing, origami, and meditation classes held every other week.

In a preliminary qualitative analysis, Odunukan says that residents who engaged in FERHAWI activities reported less fatigue and improved work-related motivation compared to their counterparts who were randomized to a usual noon conference. A longitudinal cohort study of the program conducted for three months replicated the initial findings. Odunukan and his colleagues are now hoping to expand this initiative to other training programs within the School of Graduate Medical Education.

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Alternatively, the authors suggest, these longer-tenure workers may be more resistant to organizational change, and thus they may feel the stress of the PACT transformation more acutely, and their pre-existing habits and expectations may be more ingrained.

These results point to the need for organizational interventions that are deployed over the long run and involve multiple changes that target various work system factors, such as appropriate staffing, participatory decision making, and meaning of work (e.g., increased time spent working at the top competency level or providing care that is aligned with professional values).

One unanticipated negative consequence was that, although PACT was designed to break down silos and de-fragment patient care, there was a perception that the individual PACT teams became silos themselves.118 Understaffing of PACT teams, which often meant nurses splitting time between two or more PACTs, often made it difficult for these individuals to fulfill their assigned roles. Many respondents reported that patients had a positive view of PACT and felt more involved in their care under the model. However, many also reported that the model put a strain on staff. Namely, respondents reported insufficient staffing levels, a lack of sufficient training, scheduling complications, new duties without promised resources, less time with patients, and team dysfunction when there was a weak team member.

Another team-based care delivery intervention, which was assessed in a mixed-methods study, involved assigning advanced practice nurses (APNs) to support, coach, and encourage junior doctors during overtime shifts in an urban hospital in Australia.119 The APNs facilitated collaboration between the junior doctors and ward nurses in order to assist with patient management and delegation of tasks. The junior doctors who worked

with APNs reported less stress and anxiety during their shifts, reported receiving assistance to develop technical skills, and had more opportunities and support to develop cognitive skills. Both the APNs and junior doctors reported that the staffing structure fostered teamwork and eased many of the difficulties seen on overtime shifts.

The improvements included better delegation of tasks, greater awareness across the team of the patients on the ward, and improved interdisciplinary collaboration compared to shifts without the collaborative staffing model. Overall, the intervention had a greater effect on less experienced doctors. The authors hypothesized that early experiences of collaboration among clinicians may play a role in establishing habits that extend through the clinicians’ careers and foster interprofessional practice. Interventions that reorganize the work among team members have the potential to reduce clinician burnout, but team members must have sufficient resources to balance the demands and expectations put on the team. With any team-based intervention or redesign, it is important to proactively and regularly monitor and, if needed, adjust changes to avoid shifting the work burden from one discipline to another.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 4.

Promoting positive clinical work environmentsTwo national programs have been designed to

improve the clinical work environment: the Magnet Recognition Program and the American Medical Association’s (AMA) Joy in Medicine Recognition program.

The American Nurses Credentialing Center’s (ANCC’s) Magnet Recognition Program is an organizational model designed to improve the work environment for nurses in a hospital setting,

although results of program evaluations may be relevant to physicians as well. The Magnet program emerged from a study by the American Academy of Nursing in 1981 to “examine characteristics of systems impeding and/or facilitating professional nursing practice in hospitals”.120 This study suggested that the key organizational characteristics needed to support nurses were empirical outcomes, transformational leadership, structural empowerment, exemplary professional practice, and new knowledge, innovations, and improvements. These components form the Magnet model and serve as a framework for improving nurses’ work environment. The model encourages organizations to improve the modifiable features of the nurses’ work environment, such as staffing adequacy, leadership, clinical autonomy, interdisciplinary effort, and professional governance; this parallels many of the work system factors that contribute to clinician burnout. As of 2019, about 10 percent of U.S. hospitals have achieved Magnet Recognition Program designation.121

There is some evidence that nurses in Magnet hospitals are less burned out and more satisfied with their jobs. A study comparing nurses in Magnet and non-Magnet hospitals found that nurses in Magnet hospitals rated their work environment better and were 18 percent less likely to be dissatisfied and 13 percent less likely to have high levels of burnout.122

In a longitudinal study assessing improvements to the work environment in Magnet–recognized hospitals compared with to other hospitals, Kutney-Lee et al., found significant perceived improvements over time in the quality of the work environment (e.g., more collegial nurse–physician relations and participation in hospital affairs).123

Case Study 4114

Instructions: Spend 5-10 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

Dr. Greg Feldman, MD, was a star resident in Stanford’s Department of General Surgery. A graduate of Harvard Medical School, he was described as warm, outgoing, and happy. He seemed to be very good at balancing his work and non-work life and cared about getting other residents to have fun both at work and outside the hospital.

But in 2011, not long after starting his vascular surgery fellowship training in Chicago, Feldman committed suicide. He was 33.His death shocked the Stanford surgery department. Department leaders decided to take steps to address underlying issues affecting

resident physician health. They created the Balance in Life (BIL) program, a holistic, multifaceted effort with the primary aim of facilitating physical and mental health among resident trainees. A “resident-only” clubhouse was created where physicians can have a quiet space to discuss and reflect on their days. They have developed a system that provides protected, weekly time when trainees can meet with a therapist alone or as a group in a confidential setting. They have implemented a curriculum that enhances wellness and teamwork. A strong sense of community has emerged since the initiation of yearly retreats, team sports events, and other outings. Finally, a “big-sib/little-sib” mentoring program that pairs younger trainees with more experienced ones provides guidance for new members of the program.

The BIL program creates an environment where asking for help is welcomed, encouraged, and supported and it has become in integral part of the overall training program at Stanford.

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By the end of the study, nurses in Magnet hospitals had significantly lower adjusted levels of high emotional exhaustion (29.7 versus 38.4 percent, p<0.001), lower job dissatisfaction (21.2 versus 30.9 percent, p<0.001), and lower intention to leave their employer (8.9 versus 13.4 percent, p<0.01) than nurses in hospitals that were non-Magnet throughout the study period. The authors concluded that better work environments in Magnet hospitals was an explanation for improved nurse outcomes, including burnout.123 In addition to reduced burnout, job dissatisfaction, and intention to leave, there is some evidence that the changes involved with Magnet-recognition are associated with improved patient safety and lower odds of patient mortality.124

Although these studies suggest that the Magnet model is one way organizations can improve their work environments, two systematic reviews have shown mixed results regarding the association of Magnet Recognition Program recognition and nurse outcomes. In a 2014 systematic review, two studies reported higher levels of job satisfaction among nurses in Magnet versus non-Magnet hospitals, but a third study failed to find a difference in satisfaction ratings between Magnet and non-Magnet hospitals.125

Another systematic review found mixed results in terms of nurse and patient outcomes in Magnet versus non-Magnet hospitals.126 Among the four included studies that assessed nurse outcomes, three showed improvements in job satisfaction, burnout, or intention to turnover. The authors of this review noted the lower quality of the research of the included studies (which were largely retrospective or cross-sectional) and concluded that it is difficult to isolate the impact of accreditation programs like the Magnet Recognition Program from other factors such as potential differences in resources, culture, and leadership between hospitals that choose to seek Magnet designation and those that do not. It is worth noting that the review did not include the longitudinal study of Kutney-Lee et al. discussed above.

Despite these mixed findings, seeking Magnet designation appears to be one way HCOs can improve the clinical work environment, at least for nurses.

In 2019 the AMA launched the Joy in Medicine Recognition Program to bring attention to organizations that have tried to improve physician satisfaction and reduce burnout.127 The program grants the AMA Joy Award at three levels (bronze, silver, gold) across six competencies—commitment, assessment, leadership, efficiency of the practice environment, team work, and peer support. Organizations must meet the criteria for five of six competencies at either the bronze, silver, or gold level to receive the award. The Joy in Medicine Recognition Program encourages organizations to address physician burnout and satisfaction by dedicating resources and implementing workplace changes to combat it. Interventions implemented by healthcare organizations to reduce physician burnout include technology-related changes (e.g., collaborative and streamlined documentation, in-basket management), and team work changes (e.g., small group discussions).

The Joy in Medicine Recognition Program has not yet been formally evaluated to determine if the required steps to achieve recognition are associated with improvements in burnout and satisfaction among clinicians.

An additional national effort is the Leadership Alliance, convened by the Institute for Healthcare Improvement, which consists of 40 participating North American hospitals, associations, and other care systems that have developed a set of “radical redesign” principles intended to guide transformational changes in health care.128 One of these principles is dedicated to eliminating administrative barriers that add little or no value to clinical care, interrupt clinician workflow, frustrate patients and clinicians, or are otherwise wasteful of time and resources. To accomplish this, the participating organizations asked their clinicians and patients “If you could break or change any rule in service of a better care experience for patients or staff, what would it be?”

Only 22 percent of the rules identified were actual statutory and regulatory requirements. The rest were either organization-specific requirements (62 percent) or organization behaviors with little or no legal or regulatory basis (16 percent). In most cases, local organizations could change or eliminate many of the rules identified in this process without violating any legal, regulatory, or statutory requirement.128 While the impact of this initiative on the work environment has not been evaluated, it illustrates a relatively simple process by which local organizations can identify eliminate wasteful and unnecessary rules that are diverting time and resources and may be contributing to clinician burden.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 5.

Healthy working environments to promote well-being

The nature of the professional milieu in which the clinicians, staff, patients, and families experience daily health care delivery is critical for enhancing professional well-being, improving patient care, and reducing the risk of burnout. A “healthy work environment” describes a workplace that is safe, empowering, and satisfying and that includes effective cross-disciplinary communication, collaboration, and decision making; appropriate staffing; recognition; and authentic leadership.

The retention of clinicians and patient outcomes are significantly affected by the health of the work environment. Aiken and colleagues found that nurses who worked in healthier work environments reported significantly lower levels of burnout and job dissatisfaction and better quality-of-care outcomes.129 For nursing, a healthy work environment is often measured on five dimensions: (1) nurse participation in hospital affairs; (2) nursing foundations for quality of care; (3) nurse manager ability, leadership, and support of nurses; (4) staffing and resource adequacy; and (5) collegial nurse–physician relations.130

Case Study 5114

Instructions: Spend 5-10 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

Early in his tenure as Dean of Student Affairs at Vanderbilt School of Medicine, Scott Rodgers, MD, a board-certified psychiatrist and alumnus of the medical school, observed how the current structure of medical education nationwide was creating a toxic environment where the emphasis for students was on surviving, not thriving. Students were suffering from depression, burnout, and a lack of mental resiliency.

In 2005, Rodgers and a group of students formed the Student Wellness Program, a school-wide effort that has become a model for other medical schools and graduate training programs. The program includes activities such as yoga classes, community service events, healthy cooking classes, forums on nutrition and sleep, and a mentoring program that pairs second-year students with first-year students.

Now nearly every student participates in at least two wellness activities during their training. According to Rodgers, the key to the program’s success is “empowering and partnering with those who have the most at stake—the medical students themselves.”

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Structured descriptors of the characteristics of a healthy work environment for other clinicians have not been as clearly articulated, although they could be expected to include many, if not all, of these dimensions.

As with other major organizational endeavors, an executive leader is needed to oversee and coordinate the activities aimed at enhancing professional well-being. Similar to the situation in past decades when the positions of chief medical officer, chief nursing officer, and chief quality and safety officer were created in response to the recognition of a critical unmet need for leadership within healthcare organizations, some organizations are now creating a senior leadership position to oversee the new suite of responsibilities to address clinician wellbeing. Much like the chief quality officer, this new leader must be able to transcend individual silos in order to catalyze progress across all divisions, departments, and work units and focus exclusively on the professional fulfillment and well-being of the individuals in the organization.

The title of this position may vary across organizations, with the “chief wellness officer” being a common choice. Some organizations designate this person as a senior or associate dean or vice president. The key responsibilities of the executive leader in charge of professional wellbeing include evaluating the current scope of the problem and reporting the results throughout the organization, benchmarking, designing and implementing an interprofessional organization-wide strategy, overseeing broad system-level efforts to drive improvement in the dimensions most relevant to the local organization, and communicating with outside entities.1 Designating an executive leader dedicated to well-being in an organization will be insufficient, however, unless a diverse team and sufficient resources are provided to allow collaborative solutions to produce effective interprofessional results.

Organizational efforts for tackling clinician burnout should be coordinated with activities related to patient safety and employee safety and health because many of the same work system factors influence clinician burnout as well as worker and patient safety. For example, extended work hours and fatigue have been associated with both medical errors and needle-stick injuries, and high workloads, a major contributor to clinician burnout, also adversely affects patient safety.

For nurses there is good evidence that a “healthy work environment” is associated with improved patient safety, a reduction in occupational injuries, and improved nurse well-being.131 Patient safety, employee safety (e.g., occupational injuries) and clinician burnout are inter-related—they share contributory factors and may influence or affect each other. On the other hand, improperly designed patient safety or quality improvement initiatives can have adverse effects on employee safety and clinician well-being as well as on other aspects of patient care. Patient safety interventions that increase front-line clinician workload, time pressure, or clerical burden can unintentionally

result in decreased attention to other aspects of care quality, contribute to staff burnout and job dissatisfaction, and even impair clinician health (e.g., work-related stressors that contribute to chronic illness).132

There have been calls from various quarters for the coordination and integration of the various goals (patient safety, occupational safety, professional well-being) into a single comprehensive safety program.133 Despite the parallels among patient safety, occupational safety, and clinician burnout, these organizational functions within healthcare organizations tend to be separate, reflecting the largely independent external (e.g., state and federal) infrastructures, regulations, standards, and reporting requirements of these equally-laudable goals. There can be tension between the various groups and their goals as well as potential constraints with regard to organizational resources.

While there are likely benefits and disadvantages to either an integrative or collaborative approach to patient safety, occupational safety, and clinician well-being at the organizational level, the goals and organizational mechanisms need to be closely aligned and coordinated. This should include having a strong safety culture (broadly defined), educated and engaged leadership, common organizational processes or infrastructure when possible, clear frontline expectations and engagement, and effective measurement and feedback systems. At a minimum, with organizationally separate entities there must be effective communication, mutual consideration of requirements, constraints and unanticipated consequences, effective coordination, and a substantial alignment of organizational goals and resources at the most senior leadership level. Additionally, a shared focus on improving patient care can align efforts, reduce competition, and contribute to a healthier work environment.

Including physicians in decision-makingAlthough it might sound obvious, to be effective,

efforts at the organizational level addressing clinician burnout require significant input and genuine involvement from the clinicians themselves. This is not unlike approaches recommended in other health care improvement domains including health information technology design and patient safety. In this human-centered design approach, clinicians are intimately involved in co-designing interventions to improve their work environment and reduce burnout.

The co-design approach with genuine clinician participation may foster the development of innovative approaches to reduce clinician burnout.134 The most meaningful and sustainable improvements often involve the active participation of those closest to the work.135 Not only should clinicians be asked about their degree of burnout, but they should have an active role in translating their insights, experiences, and expertise into identifying, testing, evaluating, implementing, and continually enhancing proposed improvements that foster well-being and a healthy work culture.

Clinician participation in developing and implementing solutions for addressing burnout can actually be part of the solution to reducing burnout since it provides a path for engaging clinicians, giving them opportunities to work with others (social support), to learn from others (meaning in work), and allows them to exert greater control over their work environment (autonomy).136 In addition, since organizational changes can be stressful, the participation of clinicians in the change process can provide the channels for them to support each other and bring up ideas about how to better manage the change.

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 6 ON THE NEXT PAGE.Creating an aura of psychological safety

An essential part of addressing physician burnout is the need for health care organizations to support clinicians’ ability to discuss, report, and address burnout, its sources, and its consequences without fear of shame, retaliation, marginalization, or disrespect.137 An organization’s culture should support an environment in which clinicians feel safe (i.e., psychological safety) to report and to receive individual support when experiencing burnout or other forms of distress.

An initial step is to assess the current state in order to establish a baseline level of burnout and professional well-being within the organization.1 This is typically accomplished through organization-level surveys, but can also include other methodologies. To achieve honest and accurate data, it is important to attend to psychological safety in the data collection and reporting processes for both individual clinicians and the organization. Attending to psychological safety at the individual level means that surveys or other data collection should either be anonymous or confidential with appropriate safeguards in place to ensure that responses cannot be identified by other members of the organization and to alleviate any concerns that an individual’s responses may affect future status (e.g., credentialing or privileging decisions, employment) in the organization.

At the organization level, psychological safety means that the institution’s willingness to ask for honest and unvarnished feedback as a means for improving work environments will not be used to damage or tarnish the reputation of the organization and its leaders. Both practices are necessary to create a trustworthy practice environment.

It is important that the results of such surveys be shared transparently with all members of an organization (e.g., those who participated in the survey). This should include both a high-level summary of the results for the organization at large and results that are specific to occupation (e.g., nurses, physicians, pharmacists, advanced practice providers) and specialty or unit. Individuals should receive reports relevant to them. For example, a physician should receive the results of the aggregate organization-level results, results summarizing the experience of physicians in the organization, and the physician’s work-unit-level results.

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Case Study 6114

Instructions: Spend 5-10 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

In response to signs of burnout, depersonalization, and emotional exhaustion among residents at the University of Alabama at Birmingham Tinsley Harrison Internal Medicine Residency program, a Resident Wellness Committee was created in 2013.

To prevent depersonalization, community service projects were organized that specifically did not involve medical care. Examples include working on community gardens, helping with baseball games for children with disabilities, or volunteering for Habitat for Humanity building projects. The goal of these projects was to get residents out of the hospital to see different aspects of their community and spend time together. The community service also aimed to diminish feelings of inadequacy.

To address emotional exhaustion, the Committee started a Memorable Patient Lecture series in which faculty share positive stories about patients they may have known for years or decades, a type of relationship residents have yet to experience in their early careers. To combat a lack of autonomy, a problem-solving subcommittee was formed to work on one or two stressors a year with resident-driven solutions.

When results are shared, attention should be given to creating an atmosphere of learning. It is critical that organizational leaders avoid any perception of blaming frontline staff for the results or exerting pressure for them to remediate the results. Additionally, when solutions can be co-created rather than imposed, the likelihood of meaningful and sustainable progress is possible.

There can be downsides to the public reporting of survey data, especially for the purposes of ranking or comparing healthcare organizations. Such public-ranking systems often have negative consequences and create negative incentives. For example, the public rating systems of the “best hospitals” in the United States has led organizations to try to game the system and the metrics by which they are ranked, rather than to engage in authentic efforts to improve the underlying factors that the ranking system is intending to capture. Given the

highly subjective nature of questions about burnout and well-being, organizations would have ample opportunity to engage in subtle or overt coercion and manipulation of results. Public reporting could also influence contracting and the ability to recruit clinicians. Hence there are tremendous pressures that may prompt euphemistic rather than honest reporting when psychological safety is not created for both individuals and organizations.

Using the Patient-Centered Medical Home model to reduce burnout

The Patient-Centered Medical Home (PCMH) has been proposed as a solution to numerous challenges facing the US primary care system, including a reduction in physician burnout. Originally promoted by medical professional organizations, it has been widely endorsed by health care systems, provider groups, public and private payers,

employers, and others. The PCMH model includes features such as greater care management by registered nurses and clinical pharmacists, as well as pre-visit, outreach, and follow-up activities by medical assistants and nurses.

“Team huddles”—short, all-team daily planning meetings—are common as are visual displays to identify and track issues (see Table 2). In some models physicians are exempted from productivity-based salary adjustments to encourage care activities outside of in-person visits.

A study of 26 clinics using the PCMH model found that reducing the physician panel size to 1,800 patients, increasing flexibility for longer patient visits, reducing the number of face-to-face visits per day, and increasing care team staffing improved work satisfaction and levels of burnout.138

Table 2. Components of Patient-Centered Medical Home Model that could reduce physician burnout138

PCMH Component Description

Virtual medicine Use email, Internet, and phone contacts to enhance access for patients, help patients prepare for visits, follow up on appoint-ments, and substitute for in-person visits. Use EHRs to streamline prescription refills, health risk appraisals, and to provide patients with “after visit summaries.”

Chronic care management Create collaborative care plans to guide patients and care-team activities. Promote self-management and support it with group visits, behavior-change programs, and peer-led chronic illness workshops. Use motivational interviewing techniques and brief negotiation skills with patients facing chronic illness.

Visit preparation Contact patients in advance to clarify concerns and set expectations. Prepare physicians with records reviews, patient education materials, and other resources prior to visits.

Patient outreach Use quality-deficiency reports to document unmet care needs and follow up all discharges and emergency or urgent care visits.

Telephone call management Redesign telephone call intake systems to bypass administrative options and connect patients directly with care teams.

Care-team huddles Develop short, all-team meetings to collectively plan daily schedules, balance supply and demand, distribute tasks, and trouble-shoot problems.

Visual displays Use visual display systems to track team performance, workplace rounds, root-cause analyses, and plan/do/check/act improve-ment cycles.

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The percentage of staff reporting that they were “extremely satisfied” with their workplace increased from 38.5 percent at baseline to 42.2 percent at follow up, and levels of reported burnout decreased from 32.7 to 25.8 percent after implementing the PCMH model.

Technology-related factors in burnoutAlthough the deployment of technology in

medicine has brought many improvements in quality of care and efficiency, the rapid change can also be associated with risks and negative consequences for clinicians and patients. Poorly-designed and deployed technology is a contributory factor in clinician burnout and professional well-being.

Although all types of technologies affect the clinical work environment and the experiences of clinicians and patients, much of the current literature on technology in the context of clinician burnout focuses on health IT and, more specifically, the EHR. Health IT is ubiquitous in modern U.S. health care and involves several factors:• The frontline care delivery team uses health

IT throughout the care delivery process—for diagnostic coding and billing purposes and to communicate with patients and caregivers outside of the clinical setting—and it sends patients home with technology for their own use (e.g., test strips, devices, software appli-cations)

• Health care organizations must make deci-sions about what health IT to adopt, imple-ment, and manage within their organization

• The external environment designs, develops, regulates, and at times mandates the use of health IT throughout the health care system.Well-designed health IT will support the delivery

and management of care. By supporting the individuals involved in the care delivery process—both the care delivery team and patients and caregivers—technological innovations can make the process of providing and receiving care more efficient and reliable. But poorly designed health IT, while well intentioned, may introduce frustrating processes into the care delivery experience and make the experience more difficult and error prone.

For example, compared to handwritten paper health records, a well-designed EHR allows clinicians to review a patient’s medical history, make orders, and document treatment plans and diagnoses more quickly and accurately. A poorly-designed EHR, however, may require unnecessary work or require clinicians to enter redundant information. This will frustrate clinicians (who must spend extra time with the EHR) and patients (whose providers are preoccupied managing the EHR during their encounters). In addition, over-burdensome documentation requirements may make an otherwise well-designed EHR frustrating to use simply because the time needed to complete what is required is overbearing.139 Physicians have reported that well-functioning EHRs can improve professional satisfaction by fostering better communication between clinicians and patients (via patient portals), by facilitating better access

to patient data, and by facilitating the delivery of quality care.140

Well-designed health IT should be easy to use and help a clinician do his or her job more effectively, efficiently, and safely. Patient-centered technology, such as patient portals that allow patients to communicate with their clinicians via secure messaging, can improve both patients’ and clinicians’ experiences by facilitating efficient communication outside of the office setting and giving patients easier access to their medical information.140 While the 2012 Institute of Medicine (IOM) report Health IT and Patient Safety: Building Safer Systems for Better Care described key attributes of safe health IT, these attributes also more broadly apply to effective, efficient, and usable health IT:141

• Easy retrieval of accurate, timely, and reliable native and imported data

• Simple and intuitive data presentation• Easy navigation• Provides evidence at the point of care to aid

decision making• Enhances workflow, automates mundane

tasks, and streamlines work, without increas-ing physical or cognitive workload

• Easy transfer of information to and from other organizations and clinicians

• No unanticipated downtime

Health IT lacking these attributes will frustrate users, lead to workarounds, and may contribute to medical errors and clinician burnout. In contrast, a well-designed system that includes these attributes will be one that clinicians want to use.

EHRsHealth IT—including, but not limited to,

EHRs—that is well-designed to meet clinicians’ and patients’ needs and that is integrated seamlessly into care processes will improve both clinicians’ and patients’ experiences with health care delivery and the quality of that care.141 Health IT enhances the ability of clinicians and patients to collect and retrieve patients’ health-related information. It can also facilitate access to the world’s medical knowledge base at the point of care. Additionally, the EHR, has the potential to improve decision making, increase patient safety, and reduce medical errors through computerized provider order entry, electronic prescribing, and decision support systems (including alerts and reminders).

Ideally, EHRs would share a common electronic vocabulary that would facilitate the continuity and coordination of care by providing access to different providers in different locations and contributing to a single version of a patient’s medical record.142 In a complex health care delivery system, the EHR has many different users and stakeholders. The EHR is not only the primary tool for documenting clinical information, it also serves as the documentation source for regulatory compliance, revenue cycle management and billing, and materials management.

Even within the clinical team, documentation tasks in the digital environment change with each

software installation, with physicians, nurses, pharmacists, dentists, therapists, unit secretaries, and others shifting documentation tasks among themselves with system updates. In many complex medical systems, the clinical team is just one stakeholder with limited authority when decisions concerning the deployment of technology are made. In most health systems the ultimate responsibility for capital spending—including health IT—rests with the financial and administrative team.

When systems are used by all, those leaders most often make the judgment call if trade-offs among user interests are required. While overall satisfaction with the EHRs remains low,143 most clinicians see their value and potential and do not want to go back to paper documentation. However, for a variety of reasons, the EHRs are not as usable or well aligned with clinical workflow as most clinicians would desire and are associated with clinician burnout and decreased professional satisfaction.144 In addition to the EHR’s usability issues, over-burdensome administrative and clerical requirements may make an otherwise well-designed EHR frustrating to use simply because of the time required to fulfill the requirements.

Physicians have reported that well-functioning EHRs can improve professional satisfaction by fostering better communication between clinicians and patients (via patient portals, as discussed below), by facilitating better access to patient data, and by facilitating the delivery of quality care.140 Physicians also are hopeful that technology can solve many of the problems they currently face. However, understanding how EHR-associated activities contribute to burnout is a prerequisite for developing solutions.

EHR AdoptionRapid EHR adoption in the United States was

spurred by the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009. As of 2017, almost all hospitals and nearly 80 percent of private practices were using certified EHRs.145 The speed at which Congress allocated HITECH Act funds led some organizations to quickly expand existing proprietary EHRs, while others purchased and deployed commercially available systems with less than customary deliberation and preparation. Commercial vendors focused on meeting the rapid new demand with associated requirements, implementing functionality without due regard for usability.145 In addition, the speed of action required in this political environment did not allow for fostering the framework needed to achieve inter-operability. Though there were many improvements expected with EHR adoption—including better quality, less errors, lower costs—clear challenges exist, and the full promise has not been achieved.139

Installation of new systems is often difficult, and there has often been a steep learning curve associated with the introduction of digital health records.

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Lin et al. examined associations between the adoption of health IT and Medicare patient mortality using Medicare data from 3,249 U.S. hospitals linked to the American Hospital Association’s annual hospital survey data on health IT capabilities.146 Overall, they found that in the first year after a hospital’s implementation of basic EHR functionality (operationalized as the number of discrete features such as patient demographics, clinical notes, and test results), mortality actually increased.

However, over time and with the adoption of increased EHR functionality (i.e., the addition of more features), mortality then progressively decreased, suggesting that a maturation period is needed before the benefits to mortality are realized. The greatest adverse effects on patient outcomes in the initial implementation appeared to occur in smaller and less-resourced (e.g., critical access) hospitals; however, these same hospitals saw greater improvements over time thereafter. Prior studies on patient outcomes after initial EHR implementation have had variable results. Nevertheless, this and other literature supports the claim that deliberate national and organizational investments in iterative improvements in health IT using a human-centered systems approach can reasonably be expected to pay off in terms of both better patient and clinician outcomes.

Regardless of the causes, the EHRs have become a major source of dissatisfaction as well as of burnout among physicians. Although there is limited evidence that older physicians are less satisfied with the EHRs than their younger counterparts, satisfaction with the EHRs is low across all age groups.143 Numerous studies have reported that greater use of the EHR is associated with more clinician burnout.

The EHR factors most commonly identified as being associated with clinical burnout relate to problems with usability (computerized provider order entry) and message basket alerts, interoperability, and the increased administrative and clerical burdens on clinicians to meet the documentation, regulatory, and quality reporting requirements.144 Training in EHR functionality may lead to some gains in sense of usability/control and satisfaction with EHR use, but training alone may not yield improved work efficiency as documented by time spent on the EHR after work hours.147 This may be, in part, due to usability issues of the user interfaces.

In an effort to reduce technology-related workload and administrative burden, one health care organization asked its employees “to nominate anything in the EHR that they thought was poorly designed, unnecessary, or just plain stupid.”148 This program led to multiple changes in the EHR (e.g., removing 10 of 12 most frequent alerts for physicians), additional staff training (e.g., regarding documentation tools), and other organizational changes (e.g., reducing the frequency of required evaluation and documentation).

While the impact of the program on clinician burnout was not evaluated, such an organizational intervention seems promising since it removes activities and work that should not be performed, therefore reducing clinician workload (a major contributor to clinician burnout).

Clinical Usability of Current EHRsEHRs with well-designed features that are

deployed with an attention to clinical workflow can improve care effectiveness and safety. Physicians report that such EHRs can facilitate better communication with their patients and improve some aspects of care quality, and there is evidence that EHR use is associated with improvements in clinical note quality (compared with paper records). But the picture is complex. For example, well-designed and implemented computerized provider order entry (CPOE) can reduce medication errors.149 However, patient outcomes may not improve significantly or may even get worse immediately after CPOE implementation, perhaps because CPOE implementation is associated with numerous changes in workflow, clinician communication, and unanticipated consequences.150

Many studies describe EHR usability problems, particularly during a clinical encounter, and EHR usability problems may be contributing to patient harm.151 Cluttered visual displays, for example, or settings with incorrect defaults may make it easier to order the wrong medication or a medication at an incorrect dose.

Some studies suggest there may be a higher incidence of inaccurate clinical findings documented in the EHR than in paper records, likely due to the inherent challenges of electronic structured data entry or user interface design issues.152 While the EHR’s underlying structural design and user interface design decisions play an important role because most commercial EHRs are highly configurable, many usability problems are the result of configuration decisions made at the organizational level.

There is some evidence that usability improvements to the EHR are associated with better cognitive workload and performance among physicians as well as with prescriber satisfaction and efficiency.153 However, there are still too few published, scientifically valid usability evaluations at various stages of EHR system development. The standardized menus for billing, reporting, and regulatory purposes may also adversely affect usability. Those menus may not accurately reflect the uniqueness of a particular clinical situation. This in turn forces clinicians to make unnecessary clicks and use a “best fit” approach to move through the EHR and complete their clinical work, which is one factor contributing to clinician dissatisfaction.140

Workflow changes in an EHR implementation may also result in a shift in clinical documentation duties, such as additional requirements for physicians to order medications or nurses to request durable medical equipment. In the past, others closer to the clinical operation, such as pharmacy or materials management staff, may have handled these tasks.

In part because of EHR workflow and usability deficits, many physicians spend as much, or more, time working in the EHR fulfilling routine clerical, reimbursement, and regulatory documentation requirements as they do with their patients.68 Similarly, a systematic review of studies on nurses’ experiences with EHR adoption found that nurses commonly resorted to workarounds to adapt to changing workflows to meet documentation needs.154 Nurses also reported difficulty accessing the information they needed to make patient care decisions.

A more recent study found that usability among nurses continues to be a significant challenge that has implications for patient care. The authors suggest that nurses are essential collaborators as the EHRs and other health IT continues to evolve.155 Asynchronous alerts, or inbox notifications within the EHR, communicate time-sensitive information to a clinician regarding patient test results, medication refill requests, or messages from other clinicians. Generally these alerts (or messages) do not interrupt the work of a clinician but rather appear in an inbox that the clinician must check (although local configuration determines the exact way the alerts behave in the EHR). The alerts, however, often go unchecked.

In fact, one study showed that the more alerts there were in a primary care physician’s inbox, the less likely the physician was to open a newly-received alert, suggesting that the burden of the alerts has a compounding effect.156

While there is some evidence that EHR use is associated with improvements in clinical note quality (compared with paper records), time demands, navigation, and the quality of the information in the EHR are still sources of frustration among many clinicians. Copying and pasting information is a common practice when using an EHR and may lead to the erroneous migration of excessive information without the appropriate context and create bloated notes which include redundant or clinically irrelevant information. This makes it difficult and time consuming to locate the clinically important information, contributes to navigation problems, and can contribute to patient safety issues.157

Reduced face-time with EHRsThere are many changes in the team dynamic

that result from the introduction of the EHRs. One that must be taken into account is a decrease in face-to-face interaction between doctors and nurses, or between doctors of different professional specialties. When this face-to-face interaction is no longer part of the performance of clinical tasks, it becomes necessary to foster team relationships in other ways.

In team care settings, EHR use is associated with improved access to information within a well-functioning team, but there can be usability issues associated with the EHRs specific to team-based care.139 For example, in some cases the entire team (including nurses and non-clinicians) lacks full access to the EHR when such access would help them perform simple tasks involved in clinical care maintenance or the management of care.

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It is difficult for clinicians to navigate through notes from many team members (nurses and other non-physician providers), and many of the EHRs do not have integrated messaging, which further impedes efficient teamwork. Furthermore, as implemented, EHR systems may allow only one team member at a time to enter information in a patient’s chart, which can result in frustrating delays and workflow interruptions.

The provider relationship with health IT remains complicated. For example, providers have reported that finding data and e-prescribing were more efficient with EHRs, while information sharing and the documentation process have remained as significant problems with the EHRs over the intervening decade. In particular, the prolonged time spent working in the EHR during patient visits can adversely affect the clinician–patient relationship and patient satisfaction.158

Physicians perceive EHR use as negatively altering patient interactions, and it can interfere with the gathering of psychosocial and emotional information, thereby impeding the development of therapeutic relationships with patients.159 Patient interaction is a critical aspect of clinicians’ work; therefore, these perceptions may adversely affect clinician satisfaction. The usability and interoperability problems with the EHR, combined with the demands of documentation and reporting requirements, create an administrative and clerical burden for clinicians that allows less time for patient care or non-work-related activities. According to one study, primary care physicians spend more than half of their work hours interacting with the EHRs.56 This study also found that during clinical visits, primary care physicians spent 44 percent of their time “computer facing” and only 24 percent on direct patient communication.

Another observational study found that ambulatory physicians (n = 57) in four specialties spent 37 percent of their time in the exam room on EHR and desk work versus 53 percent on direct patient interaction.68 In the inpatient setting, several time studies have found that medical interns spend at least 40 percent of all inpatient work time interacting with the EHR and that these increased documentation demands are associated with erosions (12–13 percent) in the amount of time spent directly interacting with patients. For every hour spent with a patient, physicians spend an additional 1–2 hours on the EHR at work, with additional time spent on the EHR at home after work hours.68

Similarly, nurses also may spend up to 50 percent of their time documenting in the EHR.122 Especially in the first year post-implementation, clinicians spend more time interacting with current EHR systems than they had spent documenting in paper health records, although this is likely dependent on many factors, including EHR design and local configuration. The increased documentation time associated with EHR use has been linked with clinician burnout.70,160

Furthermore, having insufficient time to complete documentation is also a predictor of burnout. In the 2019 survey study by Gardner et al., reports by physicians of having insufficient time for documentation were associated with an almost three-fold increased odds of reporting burnout, while reports of spending an excessive amount of time documenting at home were associated with almost double the odds of burnout.160

These requirements on top of poor interaction design have increased the likelihood of lengthy and often less usable clinical notes. In a recent brief report concerning the use of a particular commercial EHR system, Downing et al. showed that U.S. physicians’ clinical notes were, on average, nearly four times longer than those of clinicians in other developed countries—even though they were using the same EHR system.161 The authors suggest that the reason for the difference is that physicians in other countries are not required to fulfill many of the reimbursement and other documentation regulations that are applicable in the United States.

Another burden that clinicians face is the time spent on the reporting of quality metrics for healthcare organization, payors, and regulators. Although providers embrace the role of measurement in improvement, legislators, regulators, and payors often do not agree on how or what to measure. Even within the same institution, there are many needs for quality data and measurement that are duplicative and too often burdensome. According to one study, practices spend more than 15 hours per week per physician on quality reporting.162 Despite this, many EHRs do not include the functionality needed to fully report mandated quality measures.

Generating tailored electronic reports of clinical quality measures is challenging—measure specifications are often not customizable, and making the needed changes to provide useful quality reports would be too costly and time consuming for individual practices. There is also a lack of integration of other mandated administrative tasks into the EHR, such as for the Prescription Drug Monitoring Program (PDMP) and pre-authorization, which requires duplicative data entry and slows workflow. These programs grew out of an urgent societal need to address the opioid epidemic and a clinical need for gathering all available Schedule II drug data at the time of prescribing.

The way that data from these initiatives are presented to the prescriber in his or her workflow, however, is obtrusive and has led to unanticipated burdens. Similarly, legitimate concerns for organizational cybersecurity and patient privacy have led to policies and procedures that have had unanticipated and undesirable consequences for clinicians.

In isolation, federal policies may be manageable in terms of their impacts on workflow. However, combined with policies required by cybersecurity insurers and intuitional policies driven by local risk management, well-meaning efforts can become a heavy weight borne by clinicians at the point of care. For example, the need to log out after each

use, even in clinical areas not accessible to the public, can add appreciable computer time to a busy clinicians’ day. This burden is compounded by multiple log-ins and other screens, especially when multiple non-communicating systems must be accessed concurrently during patient care delivery. Although other solutions for managing the threat of an unauthorized log-in such as by using an RFID device carried by the provider or biometric log-in capabilities are available, these are not widely deployed.

Early design decisions by major EHR vendors may have contributed to suboptimal user experience and increased clinician documentation burden. For example, for many current EHR systems, a very early design conceptualization was that the electronic systems should simply be a paper record replacement rather than a re-envisioning of care delivery which could have taken greater advantage of the full benefits of electronic data management. Additionally, there remains a general unwillingness to standardize clinical and operational practices, not just at a national level, but within organizations and even single clinics.

New technologies, new challengesThe pace of technological innovation in health

care is accelerating. Many developments, such as artificial intelligence (AI), predictive analytics, genomic medicine, and robotics, have real potential to both enhance care quality and reduce clinicians’ workload. Other developments, such as social media and patient-facing health IT, could connect providers and patients and provide new ways for them to enhance their relationships.

Over time, technology can enhance people’s lives, but the risk of negative, unanticipated consequences always exists. Technologies on the horizon carry both the promise of positive change and the risk of further increasing clinicians’ work stresses and burnout. Furthermore, over the past two decades, the increased technological sophistication of care in the United States has come with exponential increases in health care costs. If this latter trend continues, health care may be increasingly out of the reach of many. In addition, the resulting systemic pressures for cost containment and greater clinical efficiency could adversely affect clinician well-being.

Artificial intelligence and machine learningAdvances in emerging technologies are

occurring at an accelerating rate in the health care sector and are transforming the clinical practice of medicine. Physicians report that they hope future innovations, such as the use of AI and natural language processing, can address many of the frustrations they currently experience in using the EHRs.

For example, current health IT applications are increasingly able to recognize clinician’s speech, identify tumors on radiological or pathological images, and propose differential diagnoses based on structured data about patients’ signs and symptoms.

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Importantly, there are many different AI methods that have different goals and that take different approaches to achieving a task or solving problems and consequently have different applications and outcomes. For example, data mining (i.e., the examination of large datasets to draw inferences about relationships), often uses AI techniques.

Machine learning (ML), a type of AI, can be used to direct scarce resources—such as population health teams—based on the risk of hospitalization or worsening disease. ML could be used to remove the burden from providers of payer prior authorization or fraud waste and abuse audits. The most important attribute of this AI method is that the system uses its outputs and new data to refine or improve its ongoing performance without explicit human intervention. The result is an adaptive, dynamic, or learning system.

Deep learning is an ML approach that typically uses multilayered neural networks to achieve better performance accuracy (but that requires more hardware and more training). Deep learning is particularly good for elucidating “hidden” but potentially important patterns within very large unstructured datasets. In medicine, deep learning algorithms are already performing some diagnostic tasks more accurately than physicians.163 The technology also has the potential to assist clinicians by suggesting appropriate, evidence-based clinical actions that align with the latest evidence. This could relieve some of the pressure that clinicians face in managing emerging medical information—something that many struggle to keep up with and that likely contributes to the overall work burden and stress.

Additionally, it is becoming increasingly common for robotic surgery enabled with AI to assist in microsurgical procedures to help reduce surgeon variations that could affect patient recovery. Precision medicine allows physicians to select medicines and therapies to treat diseases based on an individual’s genetic profile in order to provide the most effective treatment for a given patient and thus improve care quality while reducing unnecessary diagnostic testing and therapies. While emerging technologies hold promise in helping to reduce clinician burden and are not currently part of the immediate pressures relating to clinician burnout, it is possible that they will become a factor within the next several years as the technologies mature and their adoption becomes more widespread. In addition to the pace of change, which may be a source of stress for clinicians, the adoption of new technologies into mainstream medicine will require the integration of such technologies into existing clinical workflows, practice guidelines, and support systems.

The implementation of emerging technologies also will require additional education and training of practitioners to ensure that they are properly using the technologies in the evaluation, diagnosis, and treatment of patients. Additionally, patient expectations that clinicians should maintain pace with state-of-the-art medicine in order to deliver the best available quality of care also may serve as a stressor.

Similarly, healthcare organizations and clinicians may struggle with questions about liability and malpractice associated with technology use, the performance and accuracy of newly adopted technology, the evaluation of technological choices, and staying current with technological advances. AI applications designed to manage intake and triage patients based on their reported symptoms and complaints are already in the marketplace and are being increasingly adopted by leading healthcare organizations.

While the real-world application of this technology is just beginning to emerge and few AI technologies have received FDA approval, the use of AI methods to reduce clinical burden is one promising application of the technology in medicine. For example, AI-based applications have the potential to auto-populate structured EHR fields by extracting pertinent information from open-ended physician notes, using voice recognition during the patient encounter, identifying relevant data from older medical records, and interpreting lab results.164 Health systems could also potentially use this same technology to automate quality reporting, automate coding and billing, assist in error detection, and improve diagnostic accuracy. While much of the technology needed to accomplish this already exists in other settings, adapting the technology to do this in a health care setting is still under development.

An example of an AI-based clinical tool is Microsoft’s EmpowerMD, which was developed as a virtual scribe that “listens” to clinical encounters and autopopulates EHRs, allowing the clinician to devote his or her full attention to the patient. At the end of the encounter, the clinician reviews (and accepts or modifies) the pre-populated EHR.165 Other innovations, such as the ability to search patient records by voice command (rather than clicking and scrolling or typing), automatically integrating lab results into the patient record, intelligent alert prioritization, and auto-populating billing and documentation requirements based on doctors notes, remain aspirational at this point, but would also help alleviate some of the burden clinicians currently face in using EHRs.

Fundamental changes will be required before some of the technological innovations described above can become commonplace. Most current EHRs were built to facilitate transactions and information essential for billing and were not intended to be fully interactive digital platforms for supporting patient care. Thus, EHR vendor platforms as well as the national health IT infrastructure will need to be restructured. Ubiquitous health IT interoperability and data standards will be required. Government regulatory and compliance policies and rules will need to be modified to accommodate automated, albeit more verifiable, documentation.To encourage vendors to develop the technological solutions, federal processes and policies permitting their use will be essential. There are both human capital and financial implications to developing and implementing such complex technological solutions.

Finally, buy-in from both patients and clinicians will be essential for this to succeed. Further research into acceptability and adoption, particularly at the care team level, is warranted to ensure that the innovations are effectively integrated into the care delivery process.

TelehealthTelehealth is the use of electronic information

and communication technologies to provide health care. Commonly, telehealth is delivered via Internet-based video conferencing connecting patients to clinicians in different locations in either real time or asynchronously; however delivering care via other modalities, such as by telephone or mobile application, is also considered telehealth.

Two 2016 reviews, one in primary care and one in mental health care, found that telehealth is both feasible and acceptable to patients across different populations. It can improve efficiency and reduce cost and is as effective as in-person care for appropriate clinical conditions.166,167 Newer developments in this space include the remote delivery of medical procedures (e.g., “telesurgery”) and tele-assistive specialty care, where either human experts or AI systems provide remote guidance during in-person clinician–patient encounters.

Little published research has examined the relationship between the use of telehealth by clinicians and clinician burnout. In a study of the use of telehealth for child psychiatry patients in an emergency room, the length of stay was reduced, as was the time that on-call psychiatrists spent traveling.168 The authors noted that the improved efficiency associated with reducing the psychiatrists’ travel burden by more than two hours per day freed up time for activities outside of work. In theory, this could reduce stress and reduce burnout. A small pre–post comparison study of the effects of an overnight telehealth service in a critical care system found that nurses in the intervention group reported small but significant improvements in communication, in their psychological working conditions, and on a burnout sub-scale (although it was unclear how burnout was measured).169 There were no improvements in the parallel control group.

The effects of telehealth on clinician well-being warrant more study; to the extent that telehealth reduces the factors known to contribute to burnout (e.g., workload, time pressure, work frustrations, and clerical/administrative tasks) or that it increases physician autonomy, it could be beneficial. However, poorly designed telehealth user interfaces or unrealistic patient lists, for example, will likely have the opposite effect. Thus, like any other technology or work process innovation, the design and implementation are critical factors in its success.

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Medical scribesMedical scribes have been proposed as a way

of addressing clinician burnout since they can help reduce the EHR-related demands experienced by clinicians and, in particular, by physicians (e.g., the administrative burden of documentation, time spent on the EHRs outside of regular hours, the EHRs interfering with patient–clinician relationships during encounters). Scribes are trained to assist physicians in documenting patient encounters in real time. Physicians review and approve the notes drafted by scribes.

Scribes can be in-house personnel (e.g., medical assistants in a primary care clinic) or outsourced personnel hired through a scribe company.170 Scribes have been mostly used in emergency departments and primary care settings. For instance, in primary care the use of medical

scribes has produced improvements in physician satisfaction, including satisfaction with EHR use and clinic workflow and perceptions concerning the amount and quality of time spent with patients.170 In a crossover study of 18 primary care physicians in 2 primary care facilities, primary care physicians reported spending less after-hours time in EHR documentation and more time interacting with patients.171 Scribes can help improve the timeliness of encounter documentation.

In general, patients report neutral or positive experiences with medical scribes. Whereas the use of medical scribes seems to improve work system factors known to increase physician burnout (e.g., reducing administrative burden), there is no clear evidence for its impact on physician burnout.

While adding scribes to a clinical team requires a financial investment, there is some evidence that

the overall increase in efficiency that they bring leads to a net-revenue gain.172 Scribes can be a meaningful addition to a team-based model and improve how a practice functions. That said, more fundamental solutions are needed to address issues of EHR design and workflow integration. Thus, it is important that the increased use of scribes does not distract health care actors from exploring and developing other solutions, such as improvements in the usability of EHR documentation (including the use of templates and macros), and the development of assistive technologies (e.g., speech recognition, artificial intelligence tools).173

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 7.

Case Study 7

Instructions: Spend 5-10 minutes reading the case study below and considering the questions that follow.

In 2016, Dr. Philip Kroth, a specialist in biomedical informatics, hypothesized that the increasing use of health information technology, including electronic health and medical records, could lead to fatigue and burnout among clinicians.174 He decided to use validated surveys to investigate potential associations between electronic health record design and stress and burnout among physicians at several different medical centers. His team identified several concerns about EHR design, including:

1. Excessive data entry requirements2. Long cut-and-pasted notes3. Inaccessibility of information from multiple institutions4. Notes geared toward billing5. Interference with work-life balance6. Problems with posture and pain attributed to the use of EHRs

These design features accounted for a modest proportion of stress and burnout risk. Possible solutions highlighted by Dr. Kroth included allowing notes to be more geared toward clinical care rather than billing, shortening the length of clinical notes, switching to a “quiet dark” philosophy in which normal clinical and lab data are hidden by default (thus reducing cognitive load on the users), hiring medical scribes, improving ergonomic work conditions, and working with vendors and local information technology teams to speed up the EHR interface.

Some healthcare systems, such as Hawaii Pacific Health in Honolulu, have enlisted front-line users to improve the EHR. Melinda Ashton, a physician from that hospital, described a program called “Getting Rid of Stupid Stuff” that asked all employees to review their daily EHR practices and nominate issues that were “poorly designed, unnecessary or just plain stupid.”148 Using these data, they removed 10 frequently-ignored alerts the EHR pushed to physicians.

1. What concerns identified by Dr. Kroth’s team are also issues at your workplace? Are there additional concerns unique to your practice environment that her team didn’t identify?

2. How could the solutions put forth by Dr. Kroth and Dr. Ashton be applied to your institution?

3. Think of three specific daily annoyances with your EHR software that could be fixed or eliminated without adversely affecting patient care. Who would you speak with to request these changes?

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Emotional distress among medical studentsPrevalence

Many medical students, residents, and faculty perceive burnout and depression to be an inevitable part of education and training.175 Indeed, studies suggest that they are, in fact, relatively common. A 2016 systematic review and meta-analysis of 183 studies evaluating depression, depressive symptoms, and suicidal ideation among medical students found an overall pooled prevalence of screening positive for depression of 27.2% (with significant heterogeneity among studies).10 The overall prevalence of suicidal ideation was 11.1%. Similar levels of depression or depressive symptoms and suicidal ideation were found in meta-analyses of studies of resident11 and attending physicians.5

Estimates from a comprehensive narrative review of articles about medical student burnout (1990–2015) were that 35 to 45 percent of medical students had high emotional exhaustion, 26 to 38 percent had high depersonalization, and 45 to 56 percent had at least one symptom of burnout, although the cut-off levels of scores on assessment instruments varied by study and may not be clinically significant.176 In addition, high emotional exhaustion, high depersonalization, and overall burnout were more prevalent among medical students than in a national sample of age-similar college graduates not studying medicine.177

A multicenter study of 4,287 U.S. medical students found that among the students identified as being burned out, only about 25% had recovered after 1 year.29

A national study of 3,588 second-year residents found that variation in prevalence of burnout by specialty was similar to the variation found in studies of practicing physicians.178 The analysis found that training in urology, neurology, emergency medicine, ophthalmology, and general surgery was independently associated with higher relative risks of burnout symptoms relative to training in internal medicine (the RRs ranged from 1.23 to 1.48), after controlling for other factors.178

One’s risk of burnout, as a medical student, may vary by where one trained as an undergraduate. The prevalence of burnout among U.S. medical residents may vary according to where the individual trained prior to residency. A study of 16,394 internal medicine residents in the 2008-2009 academic year found that international medical graduates were less likely to have burnout (45.1% vs. 58.7%, P<0.001), a finding that persisted on multivariate analysis that controlled for debt and other factors.179 Similarly, a small study of 150 medical residents from 13 specialties training in two hospitals showed that residents who had completed medical school outside of the U.S. had significantly lower emotional exhaustion and depersonalization.180

Imposter syndromeRelated to burnout, but less investigated, is

the phenomenon of impostor syndrome (IS) or impostorism. This clinical syndrome is characterized by chronic feelings of self-doubt and fear of being discovered as an intellectual fraud.181

Despite evidence of abilities, those suffering from IS are unable to internalize a sense of accomplishment, competence, or skill. Overall, they believe themselves to be less intelligent and competent than others perceive them to be. A 1998 study by Henning et al., found that among medical, dental, nursing, and pharmacy students, 30% scored as impostors.182 Within this population, IS was found to be the strongest predictor of general psychological distress. A similar study by Oriel et al found imposterism present in approximately one third of their sample of family medicine residents.183 This was despite the fact that all the respondents felt they were receiving the training necessary to succeed in their careers. Although the literature on IS remains preliminary, existing studies suggest a higher prevalence of IS in foreign-trained residents.184 Other work has found a significantly higher prevalence among women as compared to men.181

There may be an association between the experience of IS and one’s career or training stage. Villwock et al., found that fourth year medical students experienced a significant increase in IS.181 This may be due to the students preparing for and participating in the match process for residency, a highly competitive and stressful time. This is consistent with the suggestion by Clance that impostor feelings are most pronounced when faced with new challenges.185 As the student progresses through training, they assume more responsibility and autonomy. For the medical student, this culminates in the first day of intern year, when they are called “doctor” but typically do not feel like the knowledge-able physician they desire to be. In addition to the stresses associated with the matching process, it is possible that fourth year medical students feel IS more acutely than in prior years because they are closest to their first day as a doctor. IS, especially in relation to burnout, remains an area in need of further investigation among the medical student population.

Factors contributing to student/resident burnout

Learning and workplace conditions appear to be important drivers of emotional exhaustion and professional dissatisfaction among medical students, as is true of practicing clinicians. An analysis of 1,701 U.S. medical students found that learning climate factors (e.g., being on a hospital ward rotation or a rotation requiring overnight call) were associated with burnout.186 Longitudinal data showed that higher satisfaction with the learning environment was an independent predictor of not having burnout at baseline or 1 year later among medical students.

There is conflicting evidence about the relationship of work hours and workload to burnout among medical students. A study of first- and second-year (pre-clinical) medical students reported no significant association between hours spent in lectures and small groups, hours of clinical experiences, hours and number of exams, or weeks of vacation and any measure of student well-being, including burnout, quality of life, or depressive

symptoms.187 In a study of third- and fourth-year medical students, workload characteristics (e.g., number of patients cared for last week, call schedule, inpatient/outpatient rotation) and the current specialty of the clinical rotation were not independent predictors of burnout.186 In a study of first-year pharmacy residents, however, a relationship was found between higher work hours and greater levels of stress.188 And among medical residents, work hours, excessive workload, and overnight call frequency have been shown to increase the risk of burnout97, but the studies are inconsistent.176

A 2005 study of 684 residents in otolaryngology–head and neck surgery reported a strong positive linear relationship between emotional exhaustion and hours worked which persisted after adjusting for potential confounders.189 Additionally, no relationship was found between self-reported workload, work hours, call frequency and burnout in two longitudinal studies of residents conducted in 2003–2008.190,191 Studies also reported mixed findings related to resident well-being and the 2011 Accreditation Council for Graduate Medical Education (ACGME)-mandated changes to shift length, night float rotations, and protected sleep time.192 For example, a study of first-year internal medicine residents found similar year-end prevalence of burnout in cohorts that trained before and after the 2011 ACGME changes.193 In a 2012 single-institution study only 23% of the residents thought that the 2011 duty-hour policy had a positive impact on their well-being, and most thought the policy had a neutral or negative impact on patient care.194

In response to concerns raised by medical school program directors about the rigidity of its policy, ACGME reviewed the 2011 duty-hour standards and revised the policy in 2017. Whether the changes had any impact on burnout is unclear. The 2018 iCOMPARE trial, published in the New England Journal of Medicine, however, found no significant differences in mean emotional exhaustion or depersonalization scores between cohorts of residents in 63 internal medicine programs who trained under a flexible policy that resembles the 2017 ACGME requirements and those who trained under the 2011 ACGME standard duty-hour policies.195 The potential impact of a flexible policy for surgical trainees is less clear since studies to date have not included a validated measure of well-being. However, a qualitative study to explore some of these findings in greater depth found that residents perceived a flexible duty-hours policy to have several advantages, including giving them the ability to scheduled time off for personal needs.196

The inconsistent evidence for any burnout-related benefits from mandated work-hour restrictions may be explained by the possibility that the potential benefits are obscured as a result of work-compression (i.e., educational requirements and patient care duties remain the same despite a reduction in work hours).

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It’s also possible that medical students may feel a sense of increased stress due to the perception of being less well prepared for clinical tasks (owing to less repetition and exposure to clinical encounters or impressions given by supervisors).

Medical school culture of detachmentMedical students may be susceptible to burnout

in part because they are exposed to cultural norms of detachment that promote emotional exhaustion and depersonalization.175 The culture of medicine can be “technocratic,” meaning it prioritizes technological progress, hierarchy, and domination and may subtly view patients as “objects,” all of which alienates physicians (or medical students) from their patients. Such habits of objectification and dehumanization of patients are modeled and communicated by physicians to medical students via medicine’s “hidden” curriculum. Patients may be referred to in a derogatory fashion and conceptualized as tasks to finish or objects from which to learn. Medical students are likely to absorb these attitudes, becoming disconnected from their patients as human beings.

Medicine’s principles-based ethics (emphasizing universal concepts such as autonomy and beneficence) may further serve to distance physicians from patients and themselves. Such an approach to ethics teaches students they can “solve” moral dilemmas from afar and ignores the personal and lived experiences of both patients and clinicians.197 Physicians effectively place themselves out of their patients’ lives by identifying themselves with heroic invincibility and their patients with illness, suffering and misfortune. While useful for assuaging the physician’s own fears of illness and death, physicians and student physicians may lose touch with their own humanity and their own selves.175 In addition, medical students are susceptible to excessive detachment because they are still learning how to modulate their emotions. Medical students becoming stuck in a detached and dissociated mode, a mode that lacks “emotional coherence” and is perpetually numbing.

Emotional detachment is reinforced by cultural norms in which medical students, like physicians, are expected to not show emotion, even while they witness a steady stream of human distress. Unfortunately, the medical culture does not acknowledge the physician’s need to experience and process feelings. A consistent suppression of feelings disconnects the medical student from life in general. The consequences of disconnection from self and life are profound, particularly for self-care (i.e., recognizing, relieving, and avoiding stressful situations; healthy eating, living, and sleeping; cultivating supportive relationships; asking for help; slowing down when one feels ill; grieving; and creating meaning from one’s experiences.) Self-care depends upon the ability to reflect, to notice one’s feelings and needs, and to remember one’s unique vulnerabilities. Importantly, self-care can help students acknowledge and seek to alleviate their distress before it becomes burnout or something worse. Unfortunately, a medical culture

which defines its physicians as heroic and invincible cannot even conceptualize a need for physician and student self-care. Students disconnected from themselves in this way may be at greater risk of burnout.

Consequences of burnout and/or depressive symptoms among medical students

Far from being a benign rite of passage, burnout can be a painful and disorienting experience and is associated with same kinds of negative consequences on health and the quality of patient care found in studies of burnout in post-licensure physicians.

Several studies have found that residents with burnout are more likely to report delivering suboptimal care or having committed a medical error, although, as previously noted, higher levels of self-reported errors among providers who are “burned out” may reflect greater levels of rumination associated with depression or depressive symptoms rather than objectively-determined levels of medical errors.198,199 For example, a study, burnout among a sample of 115 internal medicine residents found that burnout was significantly associated with self-reported suboptimal patient care practices, such as dismissing patients from the inpatient service to make the service more manageable, not fully discussing treatment options with patients, and paying little or no attention to the social or personal impact of illness on patients.200

Longitudinal studies of internal medicine residents have similarly found burnout to be an independent predictor of residents perceiving that they committed a medical error over the subsequent 3 months.199 Consistent with this, medical residents with burnout are also more likely to report greater struggles with concentrating at work, which is likely due to the fact that negative emotions can impede learning, recall, and the application of knowledge and skills.201

Burnout’s adverse effects on learning and performance are further supported by a study of more than 16,000 U.S. internal medicine residents that reported a step-wise reduction in Internal Medicine In-Training Examination (IM-ITE) scores as burnout symptoms worsened.179 In addition, in a study of 58 emergency medicine residents from six institutions, residents with burnout showed lower cumulative performance scores on high-fidelity simulation scenarios used for assessing performance.202 Thus available data strongly suggests burnout among medical students can impede the acquisition of professional knowledge and skills and thus diminish the capacity of a hospital or clinic to provide the best patient care, placing patients at risk in both the short term and the long term for suboptimal care and medical errors.

Professionalism among medical students and residents suffers with burnout as well, as it does among post-licensure physicians. In a multi-institutional study of 2,682 medical students, burnout was independently associated with self-reported unprofessional conduct, with the

potential to undermine both student competency (by cheating and plagiarism) and good patient care (by lying about aspects of the physical exam done and tests ordered, etc.).203 Evidence from that study points to the fact that medical students with burnout score lower on measures of altruism and integrity, are less likely to endorse correct attitudes about managing conflicts of interests with industry, are less likely to have correct attitudes about appropriate prescribing behaviors, and are less likely to believe that they have a personal responsibility to report impaired colleagues.203

Other studies show that medical students with burnout have lower empathy, including a multi-institutional study of 545 medical students, a single-institution study of 127 fourth-year medical students, and a national study of 1,350 Brazilian medical students.1 These findings are important because empathy during medical school predicts subsequent risk of burnout during residency.178 In a longitudinal study of internal medicine residents, reduced empathy was an independent predictor of higher odds of self-perceived error in the following 3 months (West et al., 2006).204 A study of 254 hematology–oncology fellows found high levels of burnout (over half reported at least 1 domain of burnout) and that lower levels of burnout were associated with more compassionate patient care, feeling prepared to manage one’s own feelings about a patient’s illness and death, being able to handle the emotional distress of family members, and absolving oneself of guilt surrounding the death of a patient.205

Mirroring the data from studies of physicians, much evidence demonstrates a strong association between levels of burnout in medical students and negative impacts on their personal health. Cross-sectional studies in medical students and residents show a relationship between burnout and suicidal thoughts. A multi-institutional longitudinal study of 1,321 U.S. medical students found that burnout was an independent predictor of students developing thoughts of suicide over the course of 1 year.29 Even medical students without depression were at substantially higher risk of developing thoughts of suicide if they had burnout.

In a cross-sectional study of residents training in the Netherlands30 and the United States107, suicidal thoughts were also more prevalent among residents with burnout. As in previously-discussed research on alcohol use among U.S. physicians, cross-sectional studies of learners report that burnout is associated with higher alcohol intake. For example, burnout was found to be an independent predictor of alcohol abuse and dependence in a multi-institutional study of 4,402 medical students,206 and higher emotional exhaustion and depersonalization scores were associated with greater alcohol intake in a study of 168 family medicine residents.207

Some data suggest burnout in learners may increase the likelihood of them subsequently developing poor mental health, but evidence from small studies indicates that poor mental health may not increase the likelihood of burnout.

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In a study of 218 nursing students, emotional exhaustion scores at baseline predicted psychological well-being 18 months later; however, baseline psychological well-being did not predict subsequent emotional exhaustion, suggesting that the relationship is not bidirectional.208

Concordant with those findings, a multi-institutional longitudinal study of 185 first-year internal medicine residents found no relation between past psychiatric history and the risk of burnout over the course of 1 year.191 Burnout also appears to adversely affect learners’ physical health.

A longitudinal study of 340 internal medicine residents showed a dose–response relationship between burnout and adverse risk to personal health; each 1-point decrease in a personal accomplishment score was associated with an 8 percent increase in the odds of a self-reported blood and body fluid exposure in the subsequent 3 months.27 Moreover, after controlling for fatigue, each 1-point increase in an emotional exhaustion score or a depersonalization score was associated with a 3 percent increase or 4 percent increase, respectively, in the odds of reporting any motor vehicle incident in the subsequent 3 months.

The stress associated with residency programs may also take a toll at a cellular and molecular level, which, in turn, may accelerate the aging process. A 2019 longitudinal cohort study of 250 first-year residents at 55 U.S. hospital systems during the 2015-2016 academic year evaluated associations between measures of the residency experience and saliva-measured telomere attrition.209 (Telomeres are found at the ends of chromosomes and their length decreases with each cell replication cycle. When telomeres reach a critically shortened length, cells no longer replicate and become senescent.)

The study found that mean telomere length among participants shortened significantly over the course of the internship year from 6,465 base pairs to 6,321 base pairs at the end of the year, which was a rate 6 times higher than the normal attrition rate. Longer work hours were associated with greater telomere loss (p = 0.002).209

Licensure and credentialing issuesThe need to pass national standardized

examinations to obtain licensure is a known stressor for medical students because how well they perform on these exams can significantly impact their careers. For example, a medical student’s US Medical Licensing Examination (USMLE) Step 1 score has a strong impact on that student’s chances of getting a residency within his or her desired specialty. The competition within select residency training specialty programs is steep, particularly in more desirable training locations. Although well-accepted as an enormous stressor for medical students, the way in which the USMLE Step 1 exam affects self-care behaviors and mental health has not yet been formally studied.

(Note: in 2020, the Federation of State Medical Boards and the National Board of Medical Examiners announced that the scoring of Step 1 exam will change to pass/fail from the current three-digit score, effective no earlier than January 1, 2022.)210

Those residents who take a medical leave due to illness or maternity may experience escalations of their stress as rigid training requirements constrain the time available for self-care and personal life events. In addition, state medical license boards and hospital credentialing and privileging processes commonly inquire about previous emotional problems, including help-seeking behaviors. Although such questions are well-established barriers to help-seeking for practicing physicians experiencing emotional difficulties, less is known about their role in learners’ reluctance to seek help for emotional problems.

It is likely, however, that factors such as a lack of time, a lack of confidentiality, the stigma associated with using mental health services, cost, a fear of documentation on academic record, and a fear of unwanted intervention are all major barriers to help-seeking among medical students.1 Data show that medical students are more reluctant to seek help for a serious emotional problem than the general population (and age-matched individuals).211 A 2016 review and meta-analysis of 16 longitudinal studies found that only 15.7% of medical students who screened positive for depression actually sought psychiatric treatment.10 A 2015 study found that perceived stigma likely explains why medical students with burnout do not actively seek help and, in addition, reported that faculty and peer behaviors may also influence a learner’s help-seeking,211 which underscores the urgency to eliminate barriers to help-seeking for all students and trainees.211

Schedule flexibilityHaving some degree of control over their

education and daily lives can help to reduce medical students’ stress levels. Medical students who perceive having little control over their daily schedule or life are more likely to have burnout, and among a sample of residents from 13 specialties in two hospitals, perceptions of a lack of control over office processes and schedule increased the likelihood of burnout.212 A qualitative study of 26 residents from seven specialty training programs found that schedule flexibility was more important to some residents’ sense of well-being than an overall limitation of work hours.213 Overly rigid schedules amplify the challenges of completing personal tasks, sending the message that personal needs are inconsequential, which has been found to be a major stressor more often for residents with burnout than for those without.

Quality of faculty supportThe nature of the student/faculty relationship

can play a role in burnout. In a study of more than 1,100 medical students attending five medical schools, Dyrbye and colleagues found that dissatisfaction with the level of faculty support

was an independent predictor of burnout among first- and second-year students, while perceptions of residents being cynical and the students’ dissatisfaction with the level of resident supervision were independent predictors of burnout among third- and fourth-year students.186

On the other hand, students reporting that education was a priority for faculty members was an independent predictor of “never” having burnout (i.e., not having burnout at baseline or 1 year later) and of “recovering” from burnout (i.e., having burnout at baseline but not 1 year later) in a separate multi-institutional study of medical students.203 In a study of residents training in the Netherlands, dissatisfaction with the emotional support received from supervisors was a strong predictor of emotional exhaustion and depersonalization, and this finding persisted upon multivariate analysis controlling for other factors.214 Among 684 surgery residents, greater perceptions of demands from attending physicians and lack of independence correlated with higher emotional exhaustion scores.189

Residents with burnout are also more likely to describe their relationships with supervisors as stressful. Reports of harassment and belittlement are common among medical students, particularly among women and minorities. Not surprisingly, perceptions of recurrent mistreatment by faculty or residents are associated with an increased risk of burnout among medical students.215 In a study of 395 neurosurgical residents, perceptions of working with hostile faculty was an independent predictor of burnout that persisted on multivariable analysis.216

Other studies suggest a relationship between faculty teaching behaviors and learner burnout. For example, more favorable ratings of teachers, clear and explicit teaching styles, and direct observation of goals-of-care discussions was associated with lower emotional exhaustion scores and better overall teaching quality, while more frequent observation of the residents’ skills was associated with lower depersonalization scores in a sample of hematology–oncology residents.205 Although the direction of the relationship cannot be determined from these cross-sectional studies, one longitudinal study involving 186 final-year medical students in Sweden found that positive perceptions of the first year of residency training environment, driven by supervisors who incorporated residents’ needs for education, feedback, and support, was negatively associated with the development of emotional exhaustion (measured using Oldenburg Burnout Inventory) during residency.217 Similarly, when residents perceived their relationships with supervisors to be one of mutual support and benefit—that is, the resident benefited from a supervisor’s teaching and support, and the supervisor benefited from the work done by the resident—residents had lower emotional exhaustion and depersonalization scores.218

Residents with burnout are more likely to be dissatisfied with mentoring relationships, while a study of residents in a structured mentoring program had lower burnout scores.219

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Self-care strategies among medical studentsMedical students use a range of coping and self-

care strategies (e.g., exercise, hobbies) to manage stress, and greater use of approach-oriented coping strategies (as opposed to avoidant-oriented strategies) was shown to significantly decrease the risk of burnout in a cohort of 161 medical students.220 Residents who report lacking skills to cope with stress are also more likely to report burnout.180 Exercise may be a particularly important self-care strategy. A study of 4,402 medical students found that being compliant with exercise guidelines from the Centers for Disease Control and Prevention was an independent predictor of a lower risk of burnout and higher quality of life scores.221 Smaller studies of residents have found associations between greater physical activity and both an improved quality of life and a lower risk of burnout.207 How best to teach approach-oriented coping strategies and if coping skills learned early on are transferrable to later practice both warrant additional study.

Strategies that increase a medical student’s level of social support (from peers, friends, family, or colleagues) may buffer against burnout, whereas a lack of social supports (for example, because of a need to move to a distant city for residency) is associated with higher levels of burnout.1

Organizational strategies to reduce medical student burnout

The following strategies, most of which have little or no evidence to back them up, have been suggested as ways to reduce the risk of burnout among medical students:1

• Building a culture of respect• Move to pass-fail grading• Adopt formal advisor/mentor programs• Provide students with medical scribes to help

reduce administrative load• Create more ways to link advanced practice

providers and studentsAs part of their overall well-being strategy,

some medical schools and residency programs assess learner well-being via internally or externally administered surveys or by reviewing data from Web-based self-assessment instruments completed by learners or collected nationally by external organizations, such as the Association of American Medical Colleges and ACGME. Doing so can be helpful as data suggest that program directors of residency programs underestimate the prevalence of burnout among their residents and accurately self-assessing one’s level of distress is challenging.1 Aggregated data from self-assessment instruments can provide organizations and programs with just-in-time information about the well-being of their learners and can allow for the identification of target groups or areas requiring focused attention and resources. Self-assessment can also help learners more accurately self-calibrate their own well-being, which may promote health behavior change and help-seeking behavior before distress is severe. Effective strategies for measuring learner well-being use validated measurement tools and

ensure the protection of confidentiality, the consent of learners, transparency and honesty in reporting, and the regular evaluation and improvement of learner well-being as part of broader learning environment assessments.1

One example of organizational changes aimed at reducing burnout is a set of integrated, multifaceted, preclinical curricular changes implemented at the Saint Louis University School of Medicine (see case study below).222

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 8 ON THE NEXT PAGE.

Building well-being into curriculaA number of medical schools and residency

programs have introduced curricula to raise awareness, promote self-care, and teach positive coping skills and mindfulness-based stress reduction in an effort to help learners promote their well-being. In a national study of 27 U.S. medical schools, more than half had a well-being curriculum, and most offered a variety of emotional/spiritual, physical, financial, and social well-being activities intended to promote self-care, reduce stress, and build social support for medical students.224

Resources and infrastructure varied substantially across the schools. In a 2012 survey of 212 family medicine residency directors, nearly all reported that they offered stress management lectures or workshops in addition to residency retreats and residency support groups.225 Less than one-third held seminars in mindfulness or meditation, supported athletic or mental wellness activities, or provided healthy food options.

Studies on the efficacy of curricula have primarily focused on mindfulness-based stress reduction and have used volunteer learners, with the majority reporting a reduction in burnout and stress and improvements in mood and empathy. However, most studies did not include an appropriate control group and were vulnerable to volunteer bias. Several other studies have not found measurable improvements in learners’ stress and emotional health as a result of wellness and stress management courses226 or facilitated small group discussion.227 A systematic review of the stress reduction and stress management literature targeting student nurses concluded that many work-site programs facilitated problem solving, self-management skills including relaxation and interpersonal skills, affective well-being, and work performance, although a number of design and evaluation inadequacies were identified.228

Stronger evidence is needed to support the efficacy of wellness curricula aimed at improving learner well-being, and medical schools wanting to integrate wellness curricula should carefully consider the use of existing educational sessions so as to not further overburden learners. In most situations, a menu of offerings aimed at reaching a variety of learners, rather than required experiences, is likely to be of most benefit.213,229

Supporting wellness is critically important to mitigating burnout. Burnout that begins in medical training or earlier can continue or worsen throughout the years of practice.

Given the potentially tragic consequences of burnout and the growing favorable evidence of programs that promote resident well-being, regulatory bodies, hospital systems, and training programs need to join together to usher in a new era of graduate medical education.229

Conclusions about medical student emotional distress

As this section has demonstrated, burnout and depressive symptoms among medical students and residents are common and have important personal and professional consequences, including alcohol abuse or dependence, suicidal ideation, career regret, suboptimal professional development, and, possibly, sub-optimal patient care. As with post-licensure physicians, medical school burnout can arise from a mixture of individual, organizational, and societal factors including grading schema, suboptimal clinical experiences, inadequate preparation and support, supervisor behaviors, peer behaviors, and a lack of autonomy. Although the evidence base for interventions to reduce burnout risk remain limited, existing data suggest that efforts much continue to improve the learning environment, to offer resources to promote well-being, and to support those suffering with symptoms of burnout and other mental health problems.

Individual interventions to promote well-being and reduce burnout

Interventions to prevent burnout (i.e., proactive changes) or improve the treatment or response to burnout (i.e., reactive interventions) can target different levels of the problem, ranging from the individual to the organizational, and up to the societal. Some of the factors that can promote physician burnout are out of the direct control of the clinicians who might be suffering from symptoms, such as the organizational or systems-level factors discussed in previous sections. But some key factors at an individual level can be modified, and making changes at this level can have many positive effects, not least making one less prone to burnout.

Enhancing wellnessOne model of a holistic view of personal health

and wellness, which can form the basis for individual efforts to build resilience and reduce symptoms of burnout, involves 8 inter-related dimensions of wellness:34

1. Emotional Wellness involves awareness of your emotions as they occur, expressing and processing your emotions in a productive and positive way, using the insight provided by your emotions to guide your actions, approaching life with optimism, creating interdependent relationships that involve trust and respect, and using healthy coping mechanisms.

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2. Environmental Wellness involves living and working in environments that are safe, healthy and facilitate your sense of well-being. Since our environments have a big impact on how we feel, it is important for your environment to be pleasing to you, free from exposure to toxins and in balance with the broader natural environment.

3. Financial Wellness involves accessing your financial resources and knowledge to direct financial decisions and planning. It means knowing how your investments are distributed and whether this is in alignment with your per-sonal values and desires.

4. Intellectual Wellness involves engaging in mentally stimulating activities, creativity, and expanding your personal and professional knowledge and skills. Intellectual wellness also encompasses the exploration of new ideas and information.

5. Occupational Wellness involves finding person-al satisfaction and fulfillment through work. It entails using your talents and skills to their fullest extent throughout your career as well as understanding the need for and creating a balance between work and personal time.

6. Physical Wellness involves being aware of and taking care of your body, including engaging in pleasurable physical activity and eating food that is nutritious. Physical wellness also involves obtaining regular medical check-ups, sleeping well, and living tobacco-free.

7. Social Wellness involves creating meaningful interpersonal relationships that feel support-ive and satisfying. Social wellness also involves contributing positively to one’s community.

8. Spiritual Wellness involves having a belief system that is meaningful and matches your values, establishing a life that feels purpose-ful, and being compassionate towards others.

Spiritual wellness does not necessarily mean having a religion; rather, it focuses on your ability to attribute meaning to life and the day-to-day interactions you experience.How individual physicians attempt to make

lifestyle and behavioral changes (i.e., “self care”) to achieve increased levels of health and wellness will be as unique as the physicians themselves, but may include one or more of the following components (some of which are expanded upon below):• Regular aerobic and/or strength-training

exercise• Yoga• Meditation• Balint sessions• Setting aside fixed times for connecting with

loved ones• Using stress management techniques, pro-

grams, or courses

Case Study 8Instructions: Spend 5-10 minutes reading the case study below, considering the questions that follow, and thinking about whether this type of intervention might be applicable in your setting.

Dr. Stuart Slavin, the Associate Dean for Curriculum at the Saint Louis University School of Medicine, recognized the mental health challenges facing his medical students and chose to take action by implementing a longitudinal program to improve medical student well-being and mental health at his medical school.223 Starting in 2006, he developed and implemented a simple model with three components:

1. Reduce unnecessary stressors and enhance the learning environment.2. Teach students skills to better manage their stress and encourage them to use a range of psychological and emotional support resources.3. Create more opportunities for students to find meaning in their work.Dr. Slavin believed that the following factors made his program successful:• Addressing the problem largely as one stemming from the learning environment. • Developing a deep understanding of the lived experience of students and avoiding making assumptions about what they need.• Reducing students’ cognitive load.• Addressing problematic student mind-sets through a modest resilience curriculum. • Treating students with respect and compassion. He implemented concrete changes to achieve these goals, including changing the pre-clinical grading scheme to pass/fail, reducing curriculum

hours by 10%, omitting unnecessary details from lectures, instituting longitudinal elective courses for students, and creating a mindfulness and resilience course.

Over the next decade, he and his team tracked the mental health of the students using longitudinal validated surveys and noted an 85% reduction in depressive symptoms and a 75% reduction in symptoms of anxiety among first-year medical students.

1. What kinds of validated questionnaires could one use to track depressive symptoms and anxiety symptoms among medical personnel?

2. How could such a program be implemented in your own medical school? Could such a program apply to more senior physicians, such as resident physicians and attendings?

3. To what extent should an organization be responsible for student and employee mental health? To the extent that it should be responsible, what stakeholders should be involved in the implementation of a well-being program?

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• Creating “digital-free” times when phone and computers are turned off

• Using the services of therapists or other men-tal health professionals to help with personal or relationship-related issues

• Social activities that do not revolve around alcohol or other drugs (e.g., dancing, sports, hiking, or art classes)

• Participation in spiritual groups• Exercise

Medical students and residents may have low levels of physical activity due to the demands of their training. A study of 628 residents and fellows at a large academic medical center found that only 31% met recommendations for physical activity set by the U.S. Department of Health and Human Services.230 But even modest increases in physical activity or exercise have been shown to reduce risk of burnout and enhance well-being. For example, a study that introduced a 10-min stretching exercise in the work place reduced anxiety levels and exhaustion symptoms while improving the mental and physical well-being of healthcare workers.231 Aerobic exercise has been shown to be negatively associated with depression, it helps reduce stress, and improves biological markers associated with depression and cardiovascular disease.232

In a small pilot study on 12 physicians, 12 one-hour aerobic sessions were administered for 2 or 3 days weekly to reach the required level of weekly energy expenditure of 17.5 kcal/kg measured by a calories counter.233 This was found to significantly reduce the participants’ emotional exhaustion and, to a lesser extent, their degree of depersonalization, although there was no significant change in their sense of personal accomplishment. In a study of the effects of exercise on burnout symptoms, 245 medical residents and fellows enrolled in a 12-week, team-based incentivized exercise program at the Mayo Clinic.230 Twenty-nine percent of participants reported at least weekly symptoms of burnout. At the end of the study, quality of life scores were significantly higher among those in the exercise program compared to a matched sample of peers who did not enroll (median QOL score 75 vs. 68, P<0.001), and levels of burnout were lower (24% vs. 29%) although the difference was not statistically significant.230

As previously noted, a study of 4,402 medical students found that being compliant with exercise guidelines from the Centers for Disease Control and Prevention was an independent predictor of a lower risk of burnout and higher quality of life scores.221

Mindfulness meditationMindfulness meditation is typically a self-

directed practice for relaxing the body and calming the mind through focusing on present-moment awareness.234 The emphasis is staying in the present moment, with a nonjudging, non-striving attitude of acceptance. Mindful meditation represents a complementary therapy that has shown promise in the reduction of negative stress and the extraneous factors that lead to burnout. Many studies evaluated these ‘mindfulness-based’ intervention

techniques and showed that they potentially play a role in decreasing stress and burnout, although a 2006 Cochrane systematic review and meta-analysis concluded that evidence is insufficient to support that stress management programs can help in reducing job-related stress beyond the intervention period in healthcare professionals and little evidence exists in long-term interventions with booster or refresher courses.235

A before-and-after study of 70 primary care physicians in Rochester, NY evaluated the effects of an intensive educational program that included mindful meditation, self-awareness exercises, narratives about clinical experiences, appreciative interviews, didactic material, and discussions on primary care physicians.236 Participants showed improvements in mindfulness, which was correlated with an improvement in their overall mood, empathy, measure of emotional exhaustion, personal accomplishment, and personality over the course period with sustained effects of up to 15 months.

Another pre-post study of 93 healthcare providers (physicians, nurses, psychologists) evaluated four types of formal mindfulness practices: body scans, mindful movement, walking, and sitting meditation, as well as discussions focusing on the application of mindfulness in the workplace.237 Scores on the MBI burnout scale significantly improved after the course for both physicians and other healthcare providers in the areas of emotional exhaustion, depersonalization, and personal accomplishment. Mental well-being was also enhanced, but there were no significant changes in the physical health scores.

Similarly, Shapiro et al. and Martin-Asuero et al., found that mindfulness-based stress reduction interventions effectively reduce psychological distress and negative mindsets and encourage empathy while significantly enhancing physicians’ quality of life.238,239 Mindful meditative practice can be a cost-efficient method of improving physicians’ well-being and enhancing their approach to patient-centered care.240

Balint sessionsBalint sessions are group sessions that train

doctors on how to apply a patient-centered approach with a special focus on doctor-patient relationships. They are known as a common therapeutic strategy that reduces stress and burnout symptoms. Although rigorous clinical trials are lacking, small observational studies suggest that Balint sessions may help to prevent stress and burnout, especially among medical residents.241 A qualitative study of 9 general practitioners who had attended Balint sessions for between 3 and 15 years found that participants reported increased job satisfaction, improved confidence and sense of professional identity, and increased sense of security as a result of their attending Balint therapeutic sessions.242

Another study compared the effect of a didactic problem-based program of reading assignments, lectures and discussions to an “interactive” program of similar assignments plus Balint groups and one-to-one counseling.243 It found measurable improvement in patient-centered care and self-esteem among general practitioners in both arms

and this was more pronounced in the interactive classes; however, both arms failed to decrease burnout scores.

Stress managementStress management ranges from relaxation

exercises to cognitive-behavioral and various patient-centered therapies. Evidence has shown that healthcare providers who seek help or who employ positive coping strategies tend to experience lower levels of emotional exhaustion than those who do not.244 Stress reduction programs focusing on cognitive-behavioral techniques, have been used to help prevent and treat burnout in healthcare professionals. They can be divided into programs focusing on primary, secondary, and tertiary prevention, where secondary and tertiary interventions focus on specific needs for each target group. Long-term effectiveness of these programs in preventing burnout depends on providing a combination of psycho-educational treatment combined with follow-up booster sessions and on the duration of the program, the focus on the problem, and the sustainability of the program.240

Systematic reviews evaluating stress management strategies among general medicine practitioners (GPs) reported that relaxation and cognitive-behavioral skills proved helpful, with group methods more cost-effective and more beneficial than individual counseling.245 Gardiner and colleagues evaluated the effect of 15 hours of stress management training programs on 85 Australian GPs.246 The programs focused on stress reaction, psychoeducation, relaxation techniques, and cognitive interventions. The work-related stress levels of participants significantly decreased, while their general well-being and quality of life improved over a period of 12 weeks following the course’s administration.

Skodova et al., showed that socio-psychological training could lessen the level of burnout and positively influence the personality factors that are susceptible to burnout among medical students.247 In a similar study among medical residents, Feld et al. found that an intervention program in professional development improved residents’ self-awareness and willingness to explore their feelings. This program consisted of 11 sessions of open discussions and problem solving within a flexible, group-determined set of agenda items.248 McCue et al. concluded that a single, all-day stress management workshop given to medicine and pediatric residents reduced mean levels of emotional exhaustion for as long as 6 weeks after the intervention.249 Finally, a study conducted among family medicine residents showed that their emotional exhaustion had eased as a result of a program of meditation and breathing exercises.250

Computer-based wellness interventionsAlthough the best strategy to help physicians

improve their well-being is unknown, computer-based, interactive, and individualized interventions have been shown to be an effective approach to promote behavioral change and reduce the risk of burnout.

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An interactive and individualized intervention based on the Mayo Clinic Physician Well-Being Index (MPWBI) was evaluated in approximately 1100 U.S. surgeons (84% male) in 2013.35 After answering baseline questions regarding how they believed their well-being compared with their colleagues, participating surgeons completed an online version of the MPWBI after which they received immediate, individualized feedback. Surgeons were then asked a series of follow-up questions regarding the utility of the feedback and whether they planned to make specific changes based on the information provided.

When surgeons received objective, individualized feedback on how their well-being compared with normative samples of physicians and potential personal and professional risks, they recognized the need for a change. Nearly half of the study participants indicated that they were considering making at least one change to reduce burnout, reduce fatigue, promote work-life balance, or promote career satisfaction as a direct result of the individualized feedback.35 Those with greater distress were considering a greater number of changes as a result of the feedback. The authors of this study speculated that since physicians have reached their standing by being high achievers, feedback to those in distress on how their well-being relates to peers may leverage their competitive nature and desire to be successful to help promote changes to improve their well-being.35

In 2014, West and colleagues conducted a randomized controlled trial of a 6-month intervention involving 12 biweekly one-hour meetings of self-formed groups of 6–8 academic internal medicine physicians, termed COMPASS Groups (COlleagues Meeting to Promote And Sustain Satisfaction).251 Each intervention session consisted of a brief 15-minute group discussion of an assigned topic relevant to the physician experience and drawn from prior physician well-being literature, followed by 45 min for a shared lunch or other group activity as determined by each group itself. Each participant received $20 per session for meal expenses. Control participants were wait-listed to complete their own small groups after the initial 6 months to ensure equity in study reimbursement opportunities.

The small group topics included work-life balance, medical mistakes, meaning in work, and resiliency. Participants completed surveys at baseline and then quarterly assessing overall quality of life (QOL), burnout, depression, meaning from work, social isolation, and job satisfaction.

Of 125 study volunteers, 64 and 61 participants were randomized to the intervention and control arms of the study, respectively. At baseline, no statistically significant differences were observed between the study groups for any well-being variable. Participants in the COMPASS groups experienced statistically and clinically significant improvements in multiple domains of well-being and satisfaction, including overall QOL, the depersonalization and personal accomplishment domains of burnout, meaning from work, social isolation, and job satisfaction (Table 3). The results suggest that a relatively non-intensive intervention involving self-selected physician small group meetings can be effective in promoting physician well-being, meaning from work, and job satisfaction.

Another study evaluated the effectiveness of a web-based Cognitive Behavioral Therapy program delivered prior to the start of the first year of residency in 199 interns at 2 university hospitals during academic years 2009-10 or 2011-12.252 Participants were randomized to a study group (involving 30 minutes of study each week for 4 weeks prior to internship) vs. an attention-control group who got emails with general information about depression, suicidal thinking, and local mental health providers. The PHQ-9 was used to assess suicidal ideation at 3-month intervals throughout the year. During at least one time point over the course of the internship, 12% of those in the CBT group endorsed suicidal ideation compared to 21% in the control group—in other words, those in the CBT group were 60% less likely to endorse suicidal ideation (RR 0.4, 95% CI 0.17-0.91).252

BEFORE MOVING ONTO THE NEXT SECTION, PLEASE COMPLETE CASE STUDY 9 ON THE NEXT PAGE.

Summary recommendationsA number of proposals from both individual

physicians, wellness officers, and medical organizations have been made to make progress against the array of factors involved in the current unacceptably-high levels of physician burnout. For example, Dr. Tait Shanafelt, Chief Wellness Officer at Stanford Medicine, and Dr. John Noseworthy, Chief Executive Officer at the Mayo Clinic have proposed nine strategies to reduce physician burnout that can be adapted for specific organizations:254

1. Acknowledge and assess the problem—to determine the well-being of the medical staff, one can begin by assessing any number of domains including professional satisfaction, burnout, engagement, stress, quality of life, and work/life balance. These can be used to determine a starting point and then tracked to evaluate progress.

2. Harness the power of leadership—it is clear that leaders who effectively engage their staff have a major impact on both the risk of burnout and professional satisfaction.

3. Develop and implement targeted interventions—although many drivers of burnout are known, each organization and unit within an organization will have its own culture and issues. It might be wise to start in a unit with the highest level of burnout from an institutional assessment or one that is the greatest outlier from national benchmarks

4. Cultivate community at work—this can be done by restoring formal space for physicians to gather and by providing resources and time for professional bonding and friendship. The creation of COMPASS groups (Colleagues Meeting to Promote and Sustain Satisfaction) in which six to seven colleagues at Mayo shared a meal together in the evening, paid for by the institution on a biweekly schedule, improved both belief in the meaning of work as well as symptoms of burnout.108

Table 3. Between-group changes in well-being measures after 6 months251

Outcome COMPASS group Control group

Poor QOL* -13.0 % -6.2 %

Overall QOL Score (0–10)* +0.72 +0.20

High Emotional Exhaustion -10.0 % -7.3 %

High Depersonalization* -4.4 % +2.4 %

Low Personal Accomplishment* -10.2 % +8.8 %

Overall Burnout -6.1 % -7.1 %

Positive depression screen -7.5 % -8.7 %

High Meaning from Work* -0.8 % -8.7 %

Social Isolation* -0.15 +0.38

High Job Satisfaction* +15.7 % +7.8 %

Likelihood of Leaving in Next 2 Years* +0.7 % +5.8 %* = P < 0.05 for between group comparison

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Case Study 9114

Instructions: Spend 5-10 minutes reading the case study and thinking about whether this type of intervention might be applicable in your setting, and, if so, how such an intervention might be implemented.

Mark Linzer, MD, an internal medicine doctor and Director of the Division of General Medicine at Hennepin County Medical Center (HCMC) in Minneapolis, wanted to help physicians sustain their busy workload by applying the findings from the Healthy Work Place cluster randomized trial that he led.253

Following Dr. Linzer’s suggestion, HCMC established a Provider Wellness Committee composed of physicians and advanced practice providers from 12 departments. Their goal was to support and sustain provider wellness. Within one year of implementing the Provider Wellness Committee, reports of provider burnout decreased from 33 percent to 27 percent.

All 16 departments at HCMC now have a Wellness Champion who acts as the “face of wellness” for their department and who can be approached with complaints and suggestions.

One of the committee’s first major initiatives was to transform selected physical spaces. The former Doctors’ Dining Room was renamed the Provider Dining and Wellness Center and it was transformed into a multi-purpose area open to all physicians, nurse practitioners, physician assistants, psychologists, and dentists. Space was created for exercise equipment, lockers, showers, and a dressing room to accommodate providers who exercise during the day or bike to work. The space is also used for weekly Reflection Rounds, where residents can talk in a safe and supportive environment about the challenges of practicing medicine.

A Reset Room was also created for providers who want to have a few quiet moments away from colleagues and residents, as a place they can go if they need to regroup after a traumatic encounter with a patient, or as a place to take a private phone call. The Reset Room is a serene environment modeled after a spa relaxation room.

The Provider Wellness Committee also administered an annual wellness survey comprised of 10 questions and one optional open-ended question. Survey results are shared in small meetings with the chairs of each department. Departments with low burnout rates are targeted to learn what makes them function so well. The survey findings are not shared outside of departments or used to compare one department to another. There is also no benchmarking to other organizations or departments across the country. The survey is only used to assess each department’s progress year to year.

Committee members and Wellness Champions are given paid time off to participate in the annual wellness retreat which allow members to discuss initiatives, share ideas, connect with others, and brainstorm new interventions.

5. Use rewards and incentives wisely—compensation plans that are structured to increase revenue only can have a profound negative effect by leading physicians to decrease time with patients or work longer hours. Flexibility of schedules and protected time may be a great carrot rather than monetary rewards.

6. Align values and strengthen culture—mission statements are typically altruistic but it is important to evaluate honestly institutional choices genuinely reflect the professed values and be willing to address deviant practices.

7. Promote flexibility and work-life integration—allowing physicians to adjust their schedules for seasons of life will go a long way toward helping address this driver of burnout.

8. Provide resources to promote resilience and self-care—this will only be well received as part of a larger strategy, but it is important in its own right.

9. Facilitate and fund organizational science—study changes made and try to determine those that effective and those that are not.

Linzer and colleagues presented a separate, but related, set of initiatives to prevent burnout in general internal medicine practices:255

1. Ensure that metrics for institutional success include physician satisfaction and well-being. Any system that does not measure, monitor and optimize clinician well-being and sustainability is at risk. We suggest measuring the following metrics: predictors (e.g., work control, time pressure, pace of work [chaos] and values alignment between clinicians and leaders), and outcomes (e.g., physician satisfaction, stress, burnout and intent to leave the practice). Tools for these measures and their relationships with quality of care have previously been published and short measurement tools are in development.

2. One mechanism to accomplish this work is to form a clinician wellness committee such as those at Stanford University and within the Permanente Medical Group of Kaiser Permanente. These committees are staffed with divisional champions from across disciplines. Attention to healthy eating, exercise, and efforts to minimize stress hold great promise for decreasing burnout.

3. Incorporate mindfulness and teamwork for trainees and practicing clinicians. Mindfulness, a known stress reducer, is a means for

internally accommodating to external stressors. Teamwork, such as in the Patient-Centered Medical Home (PCMH), is critically important for burnout prevention through support and sharing of clinician workload. Leaders should assure protected time for reflection, planning and relationship building and provide communication coaching for challenging situations.

4. Decrease stress from electronic health records (EHR). Strategies to address this include changing visit length to accommodate the extra work that computerized data brings, or adding “desktop” slots to daily schedules. Additional stresses have arisen from patient portals which increase after-hours communication. We propose measuring workloads, both direct (with patients) and indirect, as well as stress due to the EHR. These results should be part of an organization’s “dashboard” of clinical outcomes.

5. Address challenging work conditions in primary care clinics, especially those serving minority patients. Improving work conditions in these clinics will require leaders to provide sufficient clinical resources (supplies and equipment), room availability and access to specialists. Indeed, these “work condition quality metrics” will be useful for clinics serving all patients.

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6. Cover predictable life events with clinician “float pools.” A typical internal medicine division has 10% fewer full-time-equivalent clinicians because of predictable life events among staff. Planning for life events with float pool coverage may be cost effective, as coverage raises morale and avoids burnout and turnover.

7. Develop practice models that preserve physician work control. Many health care organizations are “standardizing” to reduce variations in physician work (e.g., requirements for specific numbers of sessions per week, patients per session, etc.). While standardization may lead to better work role definition, it also reduces flexibility and control. The “demand-control” model of job stress shows that high work demands are mitigated by work control. To preserve work control, standardization must still allow clinicians to “customize” their schedules to allow space for their other clinical and non-clinical activities.

8. Support manageable primary care panel sizes, lengthened visits and enhanced staffing ratios. One demonstration project in Seattle reduced panel sizes, lengthened visits and supported teamwork through adequate staffing. This was accompanied by a sharp drop in burnout, yet costs were neutral and quality preserved. This suggests that altering staffing ratios may reduce stress and burnout. Leaders in PCMH care have recently called for “sharing the care” with expanded primary care teams.

9. Address “career fit” so faculty have time to do what they are passionate about. We propose that it is cost effective to provide at least one half day per week for clinicians to do what they are most passionate about. Weekend, evening, and night hours present unique challenges to work-life balance, while creating opportunities to provide time off during traditional weekday working hours. Successful careers will be more likely in hospital-based medicine if academic hospitalists are effective in both “systole” (clinical work) and “diastole” (non-clinical work and time off).

10. Promote career opportunities and advancement for part-time physicians. Flexible career policies including part-time work and shared medical practices (job sharing) between two physicians are critical for enhancing work/life balance. Part-time physicians are satisfied with their careers, provide high-quality care, and are less likely to leave their jobs. The gender differences in burnout identified among US physicians are not seen in the Netherlands, where 75% of women physicians work part-time. Part-time options allow institutions to use a more flexible career life cycle approach to meet the needs of an increasingly diverse workforce and prevent burnout.

11. Prioritize physician self-care as an element of medical professionalism. Professionalism is defined by altruism and compassion in treating others. We propose that professionalism be

extended to include how physicians care for themselves. Physician distress negatively impacts both physicians and patients. Adjusting traditional views of the “diligent, hardworking, self-sacrificing” physician to also prioritize physician self-care will take strong leadership.

Conclusions

This learning activity has reviewed the complex issue of clinician emotional exhaustion, professional dissatisfaction, burnout, and depression and has summarized the evidence for its extent, its nature, and potential approaches to reducing its prevalence, which varies significantly depending on the instruments used to assess it, the criterion by which results are scored, by professional specialty, and by a host of individual and organizational factors. Briefly, current reports and guidelines about burnout suggest the following recommendations for eliminating unnecessary clinician burden and supporting professional well-being:1. Improve work environments to reduce the

risk of burnout, foster professional well-being and a healthy home/work balance, and enhance patient care. Organizations should routinely measure clinician burnout and work to eliminate factors that erode professional well-being.

2. Create positive learning environments in schools of medicine by evaluating current systems that might be contributing to burnout and by routinely assessing students and the learning environment to identify risks and potential solutions.

3. Reduce administrative burden by having health care policy, regulatory, and standards-setting entities at the federal and state levels systematically assess laws, regulations, policies, and standards to determine their effects on clinician job demands and resources as well as the effects on patient care quality, safety, and cost.

4. Enable technology solutions by including clinicians in the design and deployment of health information technology and by using human-centered design and human factors and systems engineering approaches to ensure the effectiveness, efficiency, usability, and safety of the technology. Federal policymakers, in collaboration with private sector health information technology companies and innovators, regulators, health care organizations, and clinicians, should develop the infrastructure and processes for a truly patient-centered and clinically useful health information systems.

5. Support clinicians and students by having state licensing boards, health system credentialing bodies, disability insurance carriers, and malpractice insurance carriers either not ask about clinicians’ personal health information or else inquire only about clinicians’ current impairments due to any health condition.

State legislative bodies should create legal protections that allow clinicians to seek and receive help for mental health conditions as well as to deal with the unique emotional and professional demands of their work without the information being admissible in malpractice litigation.

6. Invest in research by having federal agencies support studies examining optimal measures of occupational stress, burnout, and workplace well-being, health care system factors that contribute to distress, and tests of system-level interventions.

References for this activity can be found at references.cme.edu

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PREVENTING CLINICIAN BURNOUT

46. What is the prevalence of burnout among physicians as in the United States when assessed using a rigorous definition of burnout?A. 6%B. 16%C. 26%D. 46%

47. The estimated prevalence of suicidal ideation among physicians is approximately ____________?A. 5%B. 11%C. 15%D. 21%

48. The prevalence of suicide is significantly higher among what subpopulation of physicians, compared to the general population?A. AttendingsB. MenC. ResidentsD. Women

49. Which of the following statements most accurately describes an important aspect of burnout among physicians?A. Burnout is more common among male physicians than among

female physiciansB. Burnout is more likely to manifest as depersonalization in

women, and as emotional exhaustion in men C. Burnout is more likely among older physicians than younger

physiciansD. Burnout is more likely to manifest as emotional exhaustion in

women, and as depersonalization in men

50. Which component of physician workload has been shown to be particularly taxing and associated with higher levels of burnout?A. Dealing with terminal patientsB. Working night shiftsC. Taking calls at nightD. Dealing with difficult patients

51. According to one study, for every hour physicians spend in face-to-face time with patients, how many hours do they spend using electronic health records or doing desk work?A. 1.5 hoursB. 2 hoursC. 2.5 hoursD. 3 hours

52. Roughly what percentage of patients could be classified as “difficult” and, hence, contribute to physician stress and emotional exhaustion?A. 2-5%B. 5-10% C. 10-15%D. 15-20%

53. Although income levels are not associated with burnout, what aspect of physician compensation does appear to increase the risk of burnout?A. Tying compensation to productivityB. Tying compensation to levels of patient satisfactionC. Providing bonuses for higher numbers of procedures

completedD. Cutting salaries when required to maintain the financial viability

of a health care organization

54. Which of the following is an example of systems-level intervention to help reduce physician burnout?A. Balint sessionsB. Mindfulness meditationC. Interpersonal therapyD. Schedule changes

55. What was the goal of the AMA’s Joy in Medicine Recognition Program?A. To identify physicians who have successfully implemented

changes in their work/life balance that reduced stress and burnout

B. To bring attention to organizations trying to improve physician satisfaction and reduce burnout

C. To acknowledge hospitals that have reduced documented rates of burnout by 10% or more

D. To recognize medical school programs that enhance wellness and emotional health among students

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56. Which of the following is a component of the Patient-Centered Medical Home model that could help reduce burnout?A. Collaborative clinical decision makingB. Streamlined billing proceduresC. Electronic medical record integrationD. Care-team huddles

57. Which type of technology has been the focus of literature about the relationship of physician burnout and technology?A. Electronic Health RecordsB. Patient healthcare “portals”C. Tele-medicineD. Clinician performance-tracking software

58. What occurred in 2009 that spurred the adoption of electronic health records across the country?A. Introduction of new semiconductor chips enabling more

powerful computers and computer networks B. Congressional passage of the HITECH ActC. AMA adoption of the HITECH guidelines for effective use of

electronic health recordsD. Post-recession price drops in the costs of health-related IT

equipment and computers

59. How much time do primary care physicians typically spend using electronic health records?A. Nearly all of their working hours aside from face-to-face

patient interactionsB. Approximately one-third of their total working hoursC. About one-quarter of their total working hoursD. Roughly half of their total working hours

60. Which of the following is an example of an artificial-intelligence-based tool to facilitate better provider/patient encounters?A. Advanced MD SolutionsB. EmpowerMDC. iPatient CareD. Medics Suite

61. What is one proposed solution to the problem posed

by the increasing time demands of electronic health records?A. Medical scribesB. Automated reminders to exit EHR systemsC. Use of digital video recordings of patient encounters instead

of written recordsD. Use of artificial intelligence systems to identify errors in EHR

62. What individual-based practice has been shown to be an independent predictor of lower risk of burnout and higher quality of life among medical students?A. Regular exerciseB. Avoidance of alcoholC. Good sleep hygieneD. Mediterranean diet

63. What is the name of an intervention consisting of group trainings for doctors about using patient-centered approaches with the aim of improving the doctor-patient relationship?A. Bashur sessionsB. Bandura sessionsC. Balint sessionsD. Beck sessions

64. _______________ is an example of a discussion-group intervention aimed at reducing symptoms of burnout among internal medicine physicians.A. MD-ListenB. COMPASS groupsC. Talk About ItD. HI-QOL sessions

65. A web-based Cognitive Behavioral Therapy program has been shown to _________________?A. Increase self-reported resilience among female physicians

who screened positive for burnoutB. Reduce self-reported symptoms of depression among

physiciansC. Reduce suicidal ideation among first-year residentsD. Improve psychological wellbeing of first-year medical students

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$95 $145

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PRESCRIBER EDUCATION FOR OPIOID ANALGESICS (PG. 53)

SUICIDE ASSESSMENT & PREVENTION (PG. 92-93)

PREVENTING CLINICIAN BURNOUT (PG. 125-126)

CHILD ABUSE RECOGNITION & REPORTING IN PENNSYLVANIA

(PG. 20)

To Receive Credit: Please ensure information entered matches the information on file with the Pennsylvania State Boards of Medicine and Osteopathic Medicine. Please write legibly; failure to accurately provide this information may result in your data being non-reportable.

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LEARNER RECORDS: ANSWER SHEET & PAYMENT INFO

129PA1600CME

DCBASECTION 1 - CHILD ABUSE RECOGNITION AND REPORTING IN PENNSYLVANIA:

1. Adhere to the requirements and reporting procedures for mandatory reporting of child abuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2. Identify, assess, and document signs and symptoms of suspected child abuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3. Please identify a specific change, if any, you will make in your practice related to child abuse recognition and reporting.

4. What do you see as a barrier to making these changes?

SECTION 4 - PREVENTING CLINICIAN BURNOUT:16. Recognize symptoms of burnout in yourself and take steps to reduce your risk of burnout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17. Use technology appropriately and in ways that minimize your risk of burnout while also engaging in individual practices that improve your resilience and wellness. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18. Please identify a specific change, if any, you will make in your practice related to preventing clinician burnout.

19. What do you see as a barrier to making these changes?

DCBA

SECTION 3 - SUICIDE ASSESSMENT & PREVENTION:DCBA

11. Assess patient suicide risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12. Utilize strategies to reduce suicide risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13. Use proper evidence-based strategies for the treatment and management of patients at risk for suicide. . . . . . . . . . . . . . . . . . . . .14. Please identify a specific change, if any, you will make in your practice related to suicide assessment and prevention.

15. What do you see as a barrier to making these changes?

DCBA

5. Assess non-pharmacological, non-opioid and opioid analgesics therapies in comprehensive pain plan for patient . . . . . . . . . . . .6. Distinguish the diagnostics criteria for substance abuse disorder, including opioids, to be utilized at all stages of treatment and its impact on public health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7. Describe safety elements to address in the misuse and abuse of opioid analgesics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8. Initiate, manage and discontinue use of opioid analgesic therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9. Please identify a specific change, if any, you will make in your practice related to safe prescribing of opioid analgesics.

10. What do you see as a barrier to making these changes?

SECTION 2 - PRESCRIBER EDUCATION FOR OPIOID ANALGESICS:

20. The program was balanced, objective & scientifically valid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21. Do you feel the program was scientifically sound & free of commercial bias or influence? . . 22. How can this program be improved?

23. Based on your educational needs, please provide us with suggestions for future program topics & formats?

24. For which activities would you like to use your participation as a clinical practice improvement activity (CPIA) for MIPS? Section 1 Section 2 Section 3 Section 4 None

PROGRAM EVALUATION:If no, please explain:NoYes

LEARNER RECORDS: EVALUATIONYou must complete the program evaluation and applicable activity evaluation(s) in order to earn AMA PRA Category 1 CreditTM, MOC points, or participation in MIPS.

For each of the objectives determine if the activity increased your:

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