J. Mark Bailey, DO, PhDProfessor
Neurology and Anesthesiology
PAIN MEDICINE: STATE REGULATION AND
INTERPROFESSIONAL COLLABORATION
Disclosures
Dr. Bailey has nothing to disclose
OBJECTIVESAt the conclusion the learner will be able to:
Provide examples of how state pain regulations impact the practice of medicine
Effectively respond to new regulations, including state-mandated continuing medical education topics such as opioid-prescribing
Identify information resources available to practitioners regarding appropriate pain practice
Encourage a better understanding of state and federal laws/regulations for the prescribing and dispensing of controlled substance for all health care providers and promote interprofessional communication that helps address misuse and diversion.
CHRONIC PAIN DEFINITIONS
• Greater than 3 months ”Classification of pain". In Weiner, R.S. Pain management: A practical guide for clinicians (6 ed)
• Greater than 12 months Pain management: an interdisciplinary approach. Elsevier. p. 93
• Pain that extends beyond the expected period of healing Bonica's management of pain (3 ed.). Lippincott Williams & Wilkins. pp. 18–25.
PREVALENCE
Heart Disease
Stroke
Cancer
Diabetes
Total
Chronic Pain
25.8 million
16.3 million
7 million
11.7 million
60.8 million
116 million
http://www.painmed.org/patient/facts.html#incidence
COSTS
The total annual cost of health care due to chronic pain ranges from $560 billion to $635 billion which combines the medical costs of pain care and the economic costs related to disability days and lost wages and productivity.
Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011.
PAIN TREATMENT HISTORY
Too Little?2000
Too Much?2014
THEN …• Prior to 2000, there was a growing public
perception that pain was being medically undertreated.
• In late 2000, Congress passed into law a provision that declared the ten-year period that began January 1, 2001, as the Decade of Pain Control and Research.
• Also in 2000, JCAHO released new standards for the assessment and management of pain in the facilities they accredit and certify. (5th vital sign)
… AND NOW
“Deaths from prescription painkillers have reached epidemic levels in the past decade. The number of overdose deaths is now greater than those of deaths from heroin and cocaine combined.”
CDC Vital Signs November 2011
OPIOIDS SOLD 2010
Automation of Reports and Consolidated Orders System of the DEA, 2010
OPIOID OVERDOSE DEATHS
National Vital Statistics System, 1999-2008; Automation of Reports and Consolidated Orders System of the Drug Enforcement Administration, 1999-2010; Treatment Episode Data Set, 1999-2009
REGULATIONS IN THE TREATMENT OF CHRONIC
PAIN
Types of Regulations& Guidelines
Federal Regulations
State Regulations
Best Practices Guidelines
Federal Regulations
Risk Evaluation & Mitigation Strategy
Under the Food and Drug Administration Amendments Act of 2007, the FDA has the authority to require a manufacturer to develop a REMS when further measures are needed to ensure that the drug’s benefits outweigh its risks.
http://www.er-la-opioidrems.com/IwgUI/rems/home.action
Many Drugs have REMS
Opioids• Long-acting / Extended Release• Transmucosal IR Fentanyl Preps• Buprenorphine Oral Preps for Dependence
Androgel
Chantix
Vigabatrin
…many others.
Each REMS is Different
www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111350.htm#Current
ER/LA Opioid REMS
Components Include:• Prescriber Training• Patient Counseling Document • Medication Guides • Assessment and Auditing• Adverse Event Reporting
http://www.er-la-opioidrems.com/IwgUI/rems/home.action
Prescriber Training
Voluntary at present
Closely follows FDA ‘Blueprint’
Available at many professional / society meetings
AOA participation in CORE*REMS
State Regulations
24 | © CO*RE 2013
Office of the Inspector General. South Carolina Lacks a Statewide Drug Abuse Strategy. May 2013. http://oig.sc.gov/Documents/South%20Carolina%20Lacks%20A%20Statewide%20Prescription%20Drug%20Abuse%20Strategy.pdf
State of South Carolina. Executive Department. Office of the Governor. Executive Order No. 2014-22 (Establishing the Prescription Drug Abuse Prevention Council). March 2014. http://oig.sc.gov/Documents/South%20Carolina%20Lacks%20A%20Statewide%20Prescription%20Drug%20Abuse%20Strategy.pdf
In 2010
South Carolina ranked 23rd highest per capitaIN BOTH PRESCRIPTION OPIOID PRESCRIPTIONS & OVERDOSE DEATHSAs a result, the Governor’s Prescription Drug Abuse Prevention Council was established in 2014
SC Reporting & Identification Prescription Tracking System
(SCRIPTS)
25 | © CO*RE 2013
• Can provide prescribers w/ their patient’s prescription history to:
• Identify “doctor shoppers” who go to multiple doctors• Intervene to help abusers & keep excess prescription drugs off the street
• Prevent potential drug interactions
Office of the Inspector General. South Carolina Lacks a Statewide Drug Abuse Strategy. May 2013. http://oig.sc.gov/Documents/South%20Carolina%20Lacks%20A%20Statewide%20Prescription%20Drug%20Abuse%20Strategy.pdf
SCRIPTS is substantially underutilized• Use is voluntary• Only 22% of South Carolina physicians were registered in 2013 • Much fewer actually use it for prescribing decisions
New 2014 AL RegulationsWho is a Pain Specialist?
A physician practice which advertises or holds itself out to the public as a provider of pain management services; OR
A physician practice which dispenses opioids; OR
A physician practice with greater than fifty percent of the patients being provided pain management services; OR
A physician practice in which any of the providers of pain management services are rated in the top ten percent of practitioners who prescribe controlled substances in Alabama, determined by the Alabama Prescription Drug Monitoring Database on an annual basis. (These physicians will receive a notification letter from the Board)
THESE DO NOT APPLY TO THE TREATMENT OF ACUTE PAIN
http://www.albme.org/painserv.html
New 2014 AL RegulationsRegistration as a Pain Specialist w/ State Board
A completed application
Proof of a current Drug Enforcement Administration (DEA) registration
Proof of an Alabama Controlled Substance Certificate (ACSC)
Proof of a current registration with the Alabama Prescription Drug Monitoring Program (PDMP)
The results of a criminal background check ($65)
The disclosure of any controlled substances certificate or registration denial, restriction or discipline imposed on the registrant, or any disciplinary act against any medical license of the registrant
Payment of the initial registration fee ($100.00)
A certification listing the current name of the physician who serves as the medical director
The physical address of each location where pain management services are provided
A list of all physicians who work at the practice location, including the name of the physician who will serve as the medical director
TN Pain RegulationsEffective January 1, 2012, all pain management clinics in Tennessee must be registered with the State.
Tennessee state law defines a pain management clinic as a privately-owned facility in which a medical doctor, an osteopathic physician, an advanced practice nurse or a physician assistant provides pain management services to patients, a majority of whom are issued a prescription for, or are dispensed, opioids, benzodiazepine, barbiturates, or carisoprodol, but not including suboxone, for more than 90 days within a 12-month period.
‘Pain management clinic’ shall also mean any privately-owned, facility or office which advertises in any medium for any type pain management services and in which one or more employees or contractors prescribe controlled substances.
TN Pain Regulations
TN law specifically limits pain clinics to accepting checks or credit cards. NO CASH! (except for co-pays)
Treatment of CA pain and benzos for mental health are excluded from pain clinic determinations.
Urine drug testing with confirmation is required prior to the outset of chronic opioid therapy and at least twice per year.
TN Non-Pain Medicine Specialist:All providers who wish to treat patients requiring less than 120 milligram morphine equivalent daily dose (MEDD) shall:
• Hold a valid Tennessee license issued by their respective board through the Department of Health and a current DEA certification.• Attend Continuing Education pertinent to pain management as directed by their governing board.
All providers who wish to treat patients requiring more than 120 MEDD for greater than nine months shall:
• Obtain at least one annual consultation with a Pain Medicine Specialist. Patients with more complicated cases may require more frequent consultation.
TN Pain Medicine Specialist:
Subspecialty certification in Pain Medicine under the boards of, Anesthesia, Neurology, Psychiatry and Physical Medicine & Rehabilitation OR diplomate status by 7/1/2016
An unencumbered Tennessee license
The minimum number of CME hours in pain management to satisfy retention of ABMS certification.
Any exceptions to this must be approved by the respective health related licensing and regulatory board.
Current pain medicine specialists who are qualified to take the specialty exam may continue to practice as a pain medicine specialist until 7/1/16, when diplomate status will be required.
FL Definition – Pain Clinic
Any publicly or privately owned facility that:• Advertises for pain-management services• In any month, the majority of patients seen
are prescribed opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic non-malignant pain
FL Controlled Substance Prescribing
Amendment effective 7/1/12: a licensed physician under chapter...459(osteopathic),...who prescribes any controlled substance, as defined in §893.03, for the treatment of chronic nonmalignant pain must:
Designate himself or herself as a controlled substance prescribing practitioner on the physician’s practitioner profile
Comply with the requirements of the State Board
Use counterfeit-resistant prescription blanks
http://www.flsenate.gov/Laws/Statutes/2011/Chapter456/
FL Controlled Substance Prescribing
Report to State Board quarterly:
• How many new and return patients treated for chronic nonmalignant pain.
• Number of patients discharged due to drug abuse
• Number of patients discharged due to drug diversion
• Number of patients treated from out of stateAnnual Onsite Inspection
Best PracticesStandard of Care
Federation of State Medical Boards
State Medical Board Recommendations• Closely follow FSMB
Pain Organizations Recommendations
FSMB Model Policy
• Pain management is important and integral to the practice of medicine
• Use of opioids may be necessary for pain relief• Use of opioids for other than a legitimate medical purpose
poses a threat to the individual and society• Physicians have a responsibility to minimize the potential for
abuse and diversion• Physicians may deviate from the recommended treatment
steps based on good cause• Not meant to constrain or dictate medical decision-making
FSMB, Federation of State Medical Boards
Recommended ElementsPatient Information about Opioids
Medication Agreement
Opioid Consent Form
Intake forms with appropriate elements
Documented Abnormality
Opioid Risk Assessment
Rx Drug Monitoring Program Use
Documented Treatment Plan
Drug Screening Policy / Practices
Discharge letter (when/if necessary)
PRINCIPALS FOR SAFE OPIOID PRESCRIBING
Risk assessment for misuse
Assess for comorbid mental disease
Addiction referral if indicated
Caution with opioid conversions
Avoid combining opioids and benzos
Start methadone at very low doses
Assess for sleep apnea
Reduce dose during respiratory illness
Avoid using ER/LA for acute or post-op
Webster, L.W. Pain Medicine 2013: 14: 959 – 961.
41
PDMPs: Requirements for Prescribers to Register
YesNo
1
2
3
4
1Alabama: only physicians w/ or seeking pain management registration required to register. 2Virginia: effective 7/1/2015. 3Ohio: effective 1/1/2015. 4Maine: automatically registered upon obtaining/renewing professional license.
PDMPs: Substances Monitored
Schedule IISchedule II-IIISchedule II-IVSchedule II-V
PHARMACY ISSUES
PHARMACY ISSUES
In 2013, physicians were becoming aware that Rx they had written (usually opioids) were not being filled.
Some pharmacies required ‘medical information’ (diagnosis codes, imaging / lab results, date of last exam) or even direct physician communication before filling Rx.
This resulted in some patients not getting the medications they required in a timely fashion – even though they had an entirely proper Rx.
PHARMACY ISSUESThe AMA House of Delegates adopted policy stating that a pharmacist who makes inappropriate queries on a physician's rationale behind a prescription, diagnosis or treatment plan is interfering with the practice of medicine.
AOA asked to participate in a stakeholders workgroup, led by the NABP, and included representatives from the AMA, several large pharmacy chains and the DEA
Guidelines currently being formulated for both prescribers and dispensers
SHARED RESPONSIBILITYPharmacists also accountable for improperly prescribed / dispensed medications
DEA mandates on pharmacies “include assessing whether prescriptions for controlled substances were written for a legitimate medical purpose in the usual course of professional practice”
A pharmacist cannot dispense a controlled substance unless he/she concludes that the prescription meets these criteria
PHARMACY ISSUES
The U.S. DEA has reached an $80 million settlement with Walgreens Pharmacies after the company violated rules about dispensing analgesics. According to the DEA, Walgreens pharmacies in Florida violated record-keeping and dispensing rules. The pharmacies continued to fill suspicious oxycodone orders and Rx that were not for legitimate medical use.
2014 AMA HOD
“If the problem isn't resolved, the AMA will advocate for regulatory and legislative solutions to prohibit pharmacies from denying medically necessary treatments, the policy states.”
“There are doctors, and there are pharmacists. My responsibility is to write a prescription; it's
the pharmacist's responsibility to fill it” comment from one of the participants
STAKEHOLDERSAmerican Academy of Family Physicians
American College of Emergency Physicians
American Medical Association
American Osteopathic AssociationAmerican Pharmacists Association
American Society of Anesthesiologists
American Society of Health-System Pharmacists
Cardinal Health
CVS Health
Healthcare Distribution Management Association
National Association of Boards of Pharmacy
National Association of Chain Drug Stores
National Community Pharmacists Association Pharmaceutical Care Management Association
Purdue Pharma L.P.
Rite Aid
Walgreen Co
POSSIBLE ACTIONS
Education for physicians / pharmacists concerning mutual roles
Development of clinical ‘vignettes’ for appropriate physician / pharmacists interactions
Expansion of PDMP Interconnect program to ALL states
Naloxone kits to patients prescribed chronic opioids and their families
SUMMARYChronic pain is a widespread, and expensive medical problem.
Because of skyrocketing opioid overdose deaths, many new regulations are in place.
It’s getting harder to comply with the plethora of recommendations / regulations; particularly when writing ER/LA opioids.
There are unexpected ramifications of these regulations. The AOA is actively involved in finding appropriate solutions.
CONTACT INFORMATION
UAB Highlands1201 11th Avenue SouthSuite 400Birmingham, AL 35205
(205) 930-8300 office(205) 930-8301 fax
[email protected]/neuropain