safe & effective management of chronic 11/8/2014 pain · safe & effective management of...

Safe & Effective Management of Chronic

Pain

11/8/2014

2014 MA ACP Annual Scientific Meeting 1

Safe & Effective Management of Chronic Pain:A Primary Care Core Competency

November 8, 2014

Christopher W. Shanahan, MD, MPH, FACP

Assistant Professor of Medicine

Boston University School of Medicine

Boston Medical Center

Certified: Internal Medicine (ABIM) & Addiction Medicine (ASAM )

No Conflict of Interest

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Learning objectives

• Understand the scope, etiology, & consequences of the

U.S. prescription opioid epidemic.

• Understand rationale for & methods to:

• Risk assess patients prior to treating pain with opioid

medications.

• Monitor benefit & risk associated with pain

management using opioid medications.

• Refer or discontinue opioid medications.

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The Problem…Under-treatment of pain

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Opiophobia

Addiction / Diversion ↑ Safety / Liability ↑Quality of Care ↓

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Opioid sales, opioid-related deaths & opioid treatment admissions

Warner et al. 20115

Drug overdose deaths by major type in U.S., 1999-2011

National Vital Statistics System 2014. 6


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Source for Most Recent Nonmedical use (Past year users > 11 yo) 2012-2013

Where Pain Med Rx’s were obtained…

9SAMHSA, OAS, NSDUH data , 2013

Where are all these meds coming from?

•Legitimate Provider Prescriptions: •common source misused/diverted opioids

•Doctor shopping: •~ 0.7% of pts on opioids.

•a/w ↑mortality.

•Drug dealers also obtain Rx’s from physicians. •ED & Day surgery opioid prescriptions a

significant source of misused opioids

Cicero TJ, et.al. J Drug Issues. 2011; Rigg KK, , et.al. Drugs. 2012.

McDonald DC, , et.al. PLoS One. 2013; Jena AB, , et.al. BMJ. 2014.

Peirce GL, , et.al. Med Care. 2012; Chapman CR, Korean Pain J. 20138

Factors leading to ↑ risk of overdose death

• 1/1/07 -12/31/11 (5 years)

• 30% Tennessee population

filled opioid Rx each year.

Risk Factor Adjusted Odds Ratio 95% CI

4 or more prescribers 6.5 5.1 - 8.5

4+ pharmacies 6.0 4.4 - 8.3

more than 100 MMEs 11.2 8.3-15.1

Persons w/ 1+ risk factor comprise 55% of all OD deaths

↑ risk of opioid-related OD death a/w:

Gwira Baumblatt, JAMA 2014

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Chronic Pain and the Unexpected

• 66 yo ♂ here for follow-up Primary Care.

• Hx: Longstanding T2DM, HTN, OSA and Severe diabetic neuropathy

confirmed by Neurology.• Ibuprofen & Acetaminophen tried with no or limited effect.

• Pt still requesting treatment for lower extremity pain.

• New meds prescribed:

• Oxycodone (5 mg) / APAP (325 mg). 1 tab po qid X 28 days; Disp: #112.

• Gabapentin 300 tid (tapered start).• FU visit in 1 month.

• 12 days later patient calls:

• Out of pain medication & requesting oxycodone refill.

• Took more pills than Rx’d b/o inadequate pain relief.

• Pain is 12/10.• Not taking gabapentin because “Doesn’t do anything”.

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Goals

•Goal 1: Avoid / Mitigate this situation.

• Set expectations - Informed consent

• Assess for risk.

•Goal 2: Maximize Benefit (Safety & Quality of Care).

• Pain management plan,

•Goal 3: Minimize risk.

• Prepare for the unexpected.

• Establish monitoring plan.

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Setting expectations - Informed consentSet Expectations:

• “Pain free” is not a realist expectation.

• Treatment as a “Trial” – Reserving the right to stop the medications if response is inadequate or unsafe.

Patient Responsibilities:• Communication if unacceptable levels of post-operative pain,

Medication Disposal, No sharing.

Discuss Benefits & Risks Opioids (Focus: Safety)• Benefits

• Pain relief, Increased function, Quality of Life.

• Risks• Side effects: physical dependence; sedation.• Misuse, abuse, addiction, overdose, death.

• Drug interactions. Paterick et al. Mayo Clinic Proc. 200812

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Pre-prescribing opioid risk assessment

1. Screen for Risk Substance Use

• Single Item Drug & Alcohol

2. Check Massachusetts Prescription Medication

Program (PMP)

3. Use Opioid Risk Tool (ORT)

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Single item drug & alcohol risk screening Drug

• “How many times in the past year have you used an illegal drug or

used a prescription medication for non-medical reasons?”• If asked to clarify meaning of “non-medical reasons”, add "for instance

because of the experience or feeling it caused"

• �� = Response >0 100% sens., 74% spec. for Drug Use Disorder93% sens. & 94% spec. for Past-year Drug Use

Alcohol (NIAAA): • “Do you sometimes drink beer wine or other alcoholic beverages?

How many times in the past year have you had 5 (4 for women) or

more drinks in a day?”

• �� = Response >0 82% sens., 79% spec. for Alcohol Use Disorder

Smith PC, et.al. 2010.

NIAAA. Clinicians Guide to Helping

Patients Who Drink Too Much, 2007.

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Massachusetts Prescription Medication Program (PMP)

• A secure website supporting

safe prescribing & dispensing.

• A licensed prescriber or

pharmacist may obtain

authorization, to view the

prescription history of a patient for the past year.

• MA Online PMP assists state &

federal agencies address prescription drug diversion

…supports ongoing, specific

controlled substances-related

investigations.

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http://www.mass.gov/eohhs/gov/commissions-and-initiatives/vg/Ca

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Before Prescribing: The Opioid Risk Tool (ORT)♂ ♀

Family History of Substance Abuse Alcohol 3 1

Illegal Drugs 3 2

Prescription Drugs 4 4

Personal History of Substance Abuse Alcohol 3 3

Illegal Drugs 4 4

Prescription Drugs 5 5

Age (Mark box if 16 – 45) 1 1

h/o Preadolescent Sexual Abuse If present 0 3

Psychological Disease h/o ADD, OCD, Bipolar, Schizophrenia 2 2

Depression 1 1

Total

LR Webster, 2005 16

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Pain management planning• Non-opioid pain medications

• Adjunct Medications to Opioids.

• Acetaminophen / NSAIDS (Naprosyn).• Tylenol with Codeine.

• Adjunct analgesics: Gabapentin, Amitriptyline.

• Local measures (heat / cold / massage, etc.).

• Non-medication based Therapies.

• Physical Therapy / Counseling / Optimize transportation & housing.

• Plan for unexpected outcomes• Develop & implement policies.

• Discuss policy pre-operatively with patient when consenting.

• Instruct patient when, how, & who to contact.• Establish specific strategies for:

• Treatment escalation.

• Dealing w/ aberrant medication taking behaviors.

J Barden J, et.al. Cochrane Reviews 2004

CJ Derry et.al. Cochrane Reviews 2009

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“Ran out meds early” is a symptom.

1. With patient• Review treatment agreement & Policies.

• Reset expectations.

2. What is going on? What is the diagnosis?• Unfounded patient expectations?

• Inadequate pain-management?

• Progression of disease?

• New disease process?

• Misuse? Addiction? Diversion?

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4 yrs later: Managing chronic pain

• Pt (70 yo) stable on MS Contin 60 mg bid. (~3.5 ys.).

• Today: Monthly Follow-up visit for refills.

• Patient reports:

• Pain manageable. (PEG = 5 → 5).

• Feeling more anxious (PEG = 3→ 7).

• Less active. (PEG = 4→ 9).

• Increasingly forgetful.

• Recently fell & hit head.

• Despite repeated attempts, unable to taper opioid -

Pt states “is the only pain med that works”.

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Risk - Benefit Framework

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Unintended consequencesNot all meds taken → Increased risk for Diversion

→Misuse, abuse, addiction, overdose, death

Assessing benefit

PEG (Pain, Enjoyment, General activity) scale (0-10)

1. What number best describes your Pain on average in the past week?

(No pain (0) - - - - - - - - - - - - - - Pain as bad as you can imagine (10))

2. What number best describes how, during the past week, pain has interfered with your Enjoyment of life?

(Does not interfere (0)- - - - - - - - - - - - - - Completely interferes (10))

3. What number best describes how, during the past week, pain has interfered with your General activity?

(Does not interfere (0) - - - - - - - - - - - - - - Completely interferes (10))

Krebs EE, et al. J Gen Intern Med. 200921

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Aberrant medication-taking behaviors

o Requests for increase opioid dose.

o Requests for specific opioid by name, “brand name only”.

o Non-adherence w/other recommended therapies (e.g., PT).

o Running out early (i.e., unsanctioned dose escalation).

o Resistance to change therapy despite AE (eg. over-sedation).

o Deterioration in function at home and work.

o Non-adherence w/monitoring (e.g. pill counts, UDT).

o Multiple “lost” or “stolen” opioid prescriptions.

o Illegal activities – forging scripts, selling opioid prescription.

Spectrum: to Flags

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Monitoring Aberrant BehaviorsThe Screener & Opioid Assessment for Patients with Pain (SOAPP)® helps determine required monitoring for patients on long-term opioid therapy

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0 1 2 3 4

1. How often do you have mood swings?

2. How often do you smoke a cigarette within an hour after you wake up?

3. How often have any of your family members, including parents and grandparents, had a problem with

alcohol or drugs?

4. How often have any of your close friends had a problem with alcohol or drugs?

5. How often have others suggested that you have a drug or alcohol problem?

6. How often have you attended an AA or NA meeting?

7. How often have you taken medication other than the way that it was prescribed?

8. How often have you been treated for an alcohol or drug problem?

9. How often have your medications been lost or stolen?

10. How often have others expressed concern over your use of medication?

11. How often have you felt a craving for medication?

12. How often have you been asked to give a urine screen for substance abuse?

13. How often have you used illegal drugs (for example, marijuana, cocaine, etc.) in the past five years?

14. How often, in your lifetime, have you had legal problems or been arrested?

0 = Never, 1 = Seldom, 2 = Sometimes, 3 = Often, 4 = Very Often

A score of 7 or higher is considered positive.©2009 Inflexxion, Inc.

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Urine Drug Testing (UDT): Key to opioid prescribingWhy to do it:

• Provides objective information supporting safety (patient & public).

• Demonstrates med adherence. Is patient using the Rx?

• Shows substances that patient shouldn’t be using?

• Helps prevent abuse if pts know drug tests will occur.

How to Discuss UD Testing with Patients:• Some providers feel awkward discussing UDT’ing.

• Frame as a personal & public health safety issue.• Remind patients that:

• Opioid are dangerous & Providers can’t tell which pts will develop problems.

• Its the Standard of care for treatment with these medications.

• You monitor all your patients: Universal Precautions (No singling out).

When to Perform Urine Drug Testing:• No clear standard: Regular scheduled basis vs. Random.

• Implement when concerns arise (e.g. aberrant behavior). 24

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When to refer•Possible addiction or misuse.

• Addiction Specialist.• Substance Abuse Treatment Program.

•Assistance with or discomfort with prescribing high

levels of chronic opioids.• Pain Specialist.

•Assistance w/ tapering / discontinuing high doses of

opioid.• Addiction Specialist.• Substance Abuse Treatment Program.

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When to discontinue: Risks > Benefits

DO NOT have to prove diversion/addiction to stop opioid therapy.

Absolute Indications for Stopping Opioid Therapy.• No benefit identified. • Harms from treatment.

• Cannot keep medications safe. • Unable / unwilling to comply w/ required monitoring.• Active addiction (unstable).• Illegal activity / medication diversion.

• Violent / abusive behaviors → practice staff/clinicians.Relative Indication for stopping opioid therapy

• Clinical judgment required (excl. absolute indication for stopping).

• Risks of opioid treatment outweigh potential benefits.26

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Online toolswww.myTOPCARE.org

• Before Starting Opioids• Starting Opioids• Continuing Opioids• Stopping Opioids

www.scopeofpain.com• Live Conferences• Online Training (FREE)• Videos• Patient Ed Resources• Practice posters• ER/LA Opioid Analgesics Info• Patient Prescriber Agreements• Assessment & Monitoring Tools• Resources / Guidelines / Bibliography 27


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Treating Chronic Pain - In a Nutshell

• Establish an etiology of the pain.• Establish realistic Goals of Care.

• Consider & use all modes of pain management.• Use online tools to assess risk of treatment with opioids.• Set expectations in the context of Informed Consent.• Start Low - Go Slow.

• Adopt a trial mindset based on outcomes.

• Monitor: • Functional Goals (PEG).• Urine Drug Testing & Pill Counts (Scheduled & Random).

• Refer if outside comfort zone (Pain or Addiction).

• Discontinue opioids when Risks > Benefits. • Judge the treatment not the patient. 28

Summary•Screen and assess Risk for all patients for risk of

substance misuse / abuse.

•Provide Informed Consent & Set Expectations.

•Perform ongoing monitoring.

•Make a diagnosis when the unexpected occurs.

•Discontinue opioids when Risks > Benefits.

•Access resources a/o ask for help.

•Judge the treatment not the patient.29

Thank You30


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DSM-5 - Substance use disorder

Presence of at least 2 of 11 criteria clustered in four groups:• Impaired control:

1. taking more or for longer than intended

2. unsuccessful efforts to stop or cut down use

3. spending a great deal of time obtaining, using, or recovering from use

4. craving for substance.

• Social impairment:5. failure to fulfill major obligations due to use

6. continued use despite problems caused or exacerbated by use

7. important activities given up or reduced because of substance use.

• Risky use:8. recurrent use in hazardous situations

9. continued use despite physical or psychological problems that are caused or exacerbated by

substance use.

• Pharmacologic dependence:• (10) tolerance to effects of the substance

• (11) withdrawal symptoms when not using or using less.* 31

# of criteria met:

A general measure

of severity:mild (2–3 criteria)

moderate (4–5 criteria)

severe (6 or more

criteria)

* Persons prescribed meds

such as opioids may exhibit these 2 criteria, but would not

necessarily considered to

have a substance use disorder.

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All to prevent…Addiction

• A primary, chronic, neuro-biologic disease, with genetic, psychosocial, and environmental factors influencing its

development and manifestations

• A clinical syndrome presenting as…

•Loss of Control

•Compulsive use

•Continued use despite harm

•Craving

Aberrant

MedicationTaking Behaviors

Savage SR et al. J Pain Symptom Manage 2003

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Risk of addiction• Published rates of substance abuse and/or addiction in

chronic pain populations are 3-19%

• Risk factors for addiction to any substance are good predictors for problematic prescription opioid use:

• Past cocaine use, h/o alcohol or cannabis use

• Lifetime h/o substance use disorder

• H/o severe depression or anxiety

• FMHx of substance abuse, a h/o legal problems, drug &

alcohol abuse

• Tobacco dependence Ives T et al. BMC Hlth Svcs Rsch 2006

Reid MC et al JGIM 2002 Michna E el al. JPSM 2004

Akbik H et al. JPSM 200633

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More than they need…

• Study: Oral surgeons’ opiate Rx practices after 3rd molar

extraction. • > 20% of surgeons Rx’d a higher # of pills than considered

necessary.

• Study: Pt’s opioid use s/p OutPt upper extremity surgery• Pts recv’d avg ~30 pills (OC, HC, or propoxyphene). • Used only 14 of those pills at most.

• Mean # pills consumed by pts: ~10 pills. (1/3 of # Rx’d!!) • Patients receiving more opioids than needed to manage

post-surgical pain.

Bates C, et.al. J. Urology. 2011; Fischer B, et.al. Addiction. 2014.

Rodgers J, et.al. J. of Hand Surgery. 2012.

Mutlu I, et.al. J. of Oral & Maxillofacial Surgery. 2013 34

…and more likely to keep taking them.

•Despite for Short-term care of acute pain,•Narcotic Rx immediately post surgery a/w

eventual long-term use.• Pts Rx’d Opioids w/in 7 d of day Sx: 44% more likely

continue long-term vs patients not prescribed.

•Longitudinal cohort s/p Surgery (n-172): • Despite ↓ pain & ↑ function > 50% continued opioid

pain meds.

• Of Pts not previously Rx’d opioids prior to Sx - 20%

continued opioid pain meds > 1 year. 35

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