Safe & Effective Management of Chronic Pain in Primary Care Settings

1. Safe & Effective Management of Chronic Pain:
A Primary Care Core Competency
Lemuel Shattuck Hospital Addiction Conference
March 2, 2015
ChristopherW. Shanahan, MD, MPH, FACP
Assistant Professor of Medicine
Boston University School of Medicine
Boston Medical Center
Certified: Internal Medicine (ABIM) & Addiction Medicine (ASAM )
No Conflicts of Interest
1

2. 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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3. The Problem…Under-treatment of pain
3

4. Opiophobia
Addiction / Diversion ↑ Safety / Liability ↑Quality of Care ↓
4

5. Opioid sales, opioid-related deaths &
opioid treatment admissions
Warner et al. 2011
5

6. Drug overdose deaths by major type in U.S., 1999-2011
National Vital Statistics System 2014. 6

7. 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

8. 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

9. 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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10. Hold On….
Are Opioids even any good for Chronic,
Non-Cancer Pain??
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11. 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
11
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

12. Treatment of
Chronic Non-
cancer Pain
using Opioids
Insufficient
Evidence
12
Chou R
Ann Intern
Med. 2015

13. 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 forCNP 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)
• “TheTragedy 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. 13

14. 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.
14
Chou R J Pain. 2009

15. Chronic Pain and the Unexpected
• 66 yo ♂ here for follow-up Primary Care.
• Hx: LongstandingT2DM, 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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16. 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

17. 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. 2008 17
Case

18. 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 RiskTool (ORT)
18
Case
Don’t Forget!!!!
What you are treating?
Establish pain etiology.

19. 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 Disorder
93% 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. CliniciansGuide to Helping
PatientsWho DrinkToo Much, 2007.
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20. 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/
Case

21. Before Prescribing:The Opioid RiskTool (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 SexualAbuse If present 0 3
Psychological Disease h/o ADD, OCD, Bipolar, Schizophrenia 2 2
Depression 1 1
Total
LRWebster, 2005 21
Case
http://mytopcare.org/udt-calculator/opioid-risk-tool/

22. 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 basedTherapies.
• PhysicalTherapy / 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
22
Case

23. “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? 23
Case

24. 24
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

25. Risk - Benefit Framework
25
Case
Unintended consequences
Not all meds taken → Increased risk for Diversion
→ Misuse, abuse, addiction, overdose, death

26. 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. 2009
26
Case

27. 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
27
Case

28. Monitoring Aberrant Behaviors
SOAPP® Screener & Opioid Assessment for Patients with Pain
helps determine required monitoring for Pts 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.
Case
PLR = 2.90 [1.91 -4.39]
NLR =0.13 [0.05 -0.34])

29. Urine DrugTesting (UDT): Key to opioid prescribing
Why 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 UDTesting 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 DrugTesting:
• No clear standard: Regular scheduled basis vs. Random.
• Implement when concerns arise (e.g. aberrant behavior). 29
Case

30. 30
Urine DrugTesting is ComplicatedCase

31. When to refer
•Possible addiction or misuse.
•Addiction Specialist.
•SubstanceAbuseTreatment Program.
•Assistance with or discomfort with prescribing high
levels of chronic opioids.
•Pain Specialist.
•Assistance w/ tapering / discontinuing high doses of
opioid.
•Addiction Specialist.
•SubstanceAbuseTreatment Program.
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Case

32. When to discontinue: Risks > Benefits
DO NOT have to prove diversion/addiction to stop opioid therapy.
Absolute Indications for Stopping OpioidTherapy.
• 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

33. 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?
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Case

34. 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 StudyV:
Established Patient with Evidence of Illicit Drug Use
34
Case

35. Online tools
www.myTOPCARE.org
• Before Starting Opioids
• Starting Opioids
• Continuing Opioids
• Stopping Opioids
www.scopeofpain.com
• Live Conferences
• OnlineTraining (FREE)
• Videos
• Patient Ed Resources
• Practice posters
• ER/LA OpioidAnalgesics Info
• Patient PrescriberAgreements
• Assessment & MonitoringTools
• Resources / Guidelines / Bibliography 35

36. 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 OpioidTherapy
• 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 DrugTesting & 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.

37. ThankYou
37