Safe & Effective Management of Chronic Pain

Safe & Effective Management of Chronic Pain:

A Primary Care Core Competency

Lemuel Shattuck Hospital Addiction Conference

March 2, 2015

Christopher W. Shanahan, MD, MPH, FACPAssistant Professor of Medicine

Boston University School of MedicineBoston Medical Center

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

No Conflicts of Interest

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Learning objectives

• Understand the 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 ↓4

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

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 Rxs (acute &

chronic pain): •common source misused/diverted opioids

•Doctor shopping:•Drug Users

•~ 0.7% of pts legitimately prescribed opioids.

•a/w ↑ mortality. •Drug dealers also obtain Rx’s from physicians.

•Opioid Rx’s from ED & Day surgery (incl. Dental & Podiatry) for acute pain- major source

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. 2013 8

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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Hold On….Are Opioids even any good for Chronic, Non-Cancer Pain??

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Context defines Pain type, Treatment goals & Overall outcomes & Risks

Acute & Post-operative Pain• Moderate to good Evidence.

• Guidelines?• Standard of Care

Chronic Non-Cancer Pain• Insufficient evidence for role of opioids

• Guidelines exist.• Standard of Care?

Cancer Pain• Role of opioids • Strong Evidence• Clear Guidelines• Standard of Care

Chou R, Ann Intern Med. 2015 The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop

Chou R et.al. Research gaps on use of opioids for chronic non-cancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009

Hegmann KT, et.al. ACOEM practice guidelines: opioids for treatment of acute, sub-acute, chronic, and postoperative pain. J Occup Environ Med. 2014

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Treatment of Chronic

Non-cancer

Pain using Opioids

Insufficient Evidence

Chou RAnn Intern Med.

 2015

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Wait, wait…. How did we get here?• Historically, under-treatment of disorders appropriate for opioid

therapy: cancer pain, pain at the end-of-life, & acute pain

• Small, non-RCT studies of safety & efficacy of opioids for chronic non-cancer pain (CNP) suggesting

moderate effectiveness.• Treatment of pain in general prioritized (5th Vital sign: American

Pain Society in 1995, JACHO, 1999)• Aggressive marketing of opioids for CNP citing these studies.• Use of opioids to treat CNMP increased & incorporated into

clinical guidelines becoming an accepted, but non-evidence-based standard of care.• Portenoy & Foley, 1986; Nyswander & Dole, 1986) • “The Tragedy of Needless Pain”, (Melzack, 1990)

• Many of the original medical proponents have been investigated for industry ties and conflicts of interest.

• Finally as overdoses and addiction explode – the clothes of the emperor are being critically considered.

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Critical research gaps in treatment of chronic non-cancer pain using opioids

• Lack of effectiveness on long-term benefits in context of known harms of opioids (incl. drug abuse, addiction, & diversion)

• Insufficient evidence for optimal approaches to risk stratification, monitoring, or initiation & titration of opioid therapy

• No evidence on: • Utility of informed consent & opioid management plans• Utility of opioid rotation• Benefits & harms of methadone or high dose opioids•  treatment of patients with chronic non-cancer pain at

higher risk for drug abuse or misuse.Chou R J Pain. 2009

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”.

Case

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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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Case

Setting expectations - Informed consent

Set 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. 200817

Case

Pre-prescribing opioid risk assessment1. 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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Case

Don’t Forget!!!!What you are

treating? Establish pain

etiology.

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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Case

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/C

ase

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

TotalLR Webster, 2005

Risk Category (Total Score)

Low Risk (0 – 3) Moderate Risk (4 – 7)

High Risk (> 8)21

Case

http://mytopcare.org/udt-calculator/opioid-risk-tool/

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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Case

“Ran out meds early” is a symptom. 1.It happens - it’s a risks of using

opioid medications - first talk with the patient.

• Review treatment agreement & clinic policy.• Reset expectations.

2.Figure it out & make a Diagnosis.• Unfounded patient expectations? • Inadequate pain-management? • Progression of disease?• New disease process? • Misuse? Addiction? Diversion?

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Case

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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 “its the only thing that works”.

Case

Risk - Benefit Framework

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Case

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. 200926

Case

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: Yellow to Red Flags

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Case

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Monitoring Aberrant BehaviorsSOAPP® Screener & Opioid Assessment for Patients with Painhelps determine required monitoring for Pts on long-term opioid therapy

 0 1 2 3

41. 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 OftenA score of 7 or higher is considered positive.

©2009 Inflexxion, Inc.

Case

PLR = 2.90 [1.91 -4.39]

NLR =0.13 [0.05 -0.34])

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).

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Case

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Urine Drug Testing is ComplicatedC

ase

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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Case

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 Indications for stopping opioid therapy• Based on clinical judgment (in absence of an absolute

indication).• Risks of opioid treatment outweigh potential benefits.

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Case

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Video Cases

https://www.scopeofpain.com/tools-resources/Case Study II, III, V:

• What is the diagnosis?

• How did the provider handle the situation?

• What issue or issues stood out for you in this case?

• What things did you take away from this case?

Case

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Video Cases

https://www.scopeofpain.com/tools-resources/Case Study II:

Assessing aberrant opioid taking behavior, increasing monitoring

Case Study III:

Addressing lack of opioid benefit and excessive risk, discontinuing opioids

Case Study V:

Established Patient with Evidence of Illicit Drug Use

Case

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

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Summary• Universal Precautions:

• Screen & assess risk for risk of substance misuse / abuse.

• Define the etiology of the pain.• Provide informed consent

• Discuss Risks/Benefits of Opioid Therapy

• Set expectations - establish realistic Goals of Care.• Consider & use all modes of pain management

• Opioids may not be of benefit and not be indicated.

• Start Low / Go Slow• Use an outcomes-oriented trial-based mindset.

• Never stop monitoring.• Functional Goals / Use the PEG.• Urine Drug Testing & Pill Counts (Scheduled & Random).

• Make a diagnosis when the unexpected occurs.• Discontinue opioids when Risks > Benefits.• Access resources a/o ask for help. 36

Judge the treatment

not the patient.

Thank You

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