Pain Management & Prescription Drug Abuse: Maximizing Benefits and Minimizing Risks

1. Pain Management & Prescription Drug Abuse: Maximizing Benefits and Minimizing Risks Daniel P. Alford, MD, MPH, FACP, FASAM H E Woodall MD FAAFP, FAAHPM J. Paul Seale MD FAAFP, FASAM SECSAT 2011

2. Didactic Presentation • The issues • Starting Opioids • Responding to Aberrant Medication Taking Behaviors • Ongoing Management: To Continue or Discontinue Opioids

3. Which prescription medications are most likely to be abused?Commonly Abused Medications • Opioids • CNS Depressants • Benzodiazepines • Barbiturates • Muscle relaxants • Stimulants • Others • Clonidine

4. Which prescription medications are most likely to be diverted?Important Drug Characteristics • Onset of action • Intensity of effect • Trade name > generic • Cost and availability of illicit equivalent

5. Drug Seeking versusPain Relief Seeking? • There are no “pain meters” • Vital signs are not reliable • Pain is subjective to the patient • Pain is subjective to the examiner • There is no way on the first visit(s) to know for certain if the patient’s pain is real or not

6. Addiction (4 Cs) Prescription Drug Misuse Aberrant Medication Taking Behaviors No Concerning Behaviors Opioid Use Patterns in Patients with Chronic Pain

7. Addiction is… • A clinical syndrome presenting as… • Loss of Control • Compulsive use • Continued use despite harm • Craving • Not equal to physical dependence Aberrant Medication Taking Behaviors Savage SR et al. J Pain Symptom Manage 2003

8. Aberrant Medication Taking Behavior A spectrum of patient behaviors that may reflect misuse: • Health care use patterns (e.g., missed appointments) • Signs/symptoms of overuse (e.g., intoxication) • Emotional problems/psychiatric issues • Getting meds from others or buying on the street • Lying and illicit drug use • Problematic medication behavior (e.g., noncompliance) Implications • Concern comes from the “pattern” or “severity” • Differential diagnosis Butler et al. Pain. 2007

9. What is the Addiction Risk? • Published rates of abuse and/or addiction in chronic pain populations are 3-19% • Known risk factors for all types of addiction are good predictors for problematic prescription opioid use • Past cocaine use, h/o alcohol or cannabis use • Lifetime history of substance use disorder • Family history of substance abuse • History of legal problems • Tobacco dependence • History of severe depression or anxiety Ives T et al. BMC Health Services Research 2006 Reid MC et al JGIM 2002 Michna E el al. JPSM 2004 Akbik H et al. JPSM 2006 Liebschutz JM et al. J Pain 2010

10. Opioid Efficacy in Chronic Pain • Most literature surveys & uncontrolled case series • RCTs are short duration <4 months with small sample sizes <300 pts • Mostly pharmaceutical company sponsored • Pain relief modest • Modest to no functional improvement • Not all chronic pain is opioid responsive Balantyne JC, Mao J. NEJM 2003 Martell BA et al. Ann Intern Med 2007 Eisenberg E et al. JAMA. 2005

11. Mu Receptor >100 polymorphisms in the human MOR gene Mu receptor subtypes Not all patients respond to same opioid in same way Not all pain responds to same opioid in the same way Incomplete cross-tolerance between opioids Variability in Response to Opioids

12. Serious Opioid-Related Consequences • Addiction: SAMHSA estimates 980,000 opioid addicts in 2010 • Opioid-related visits to Emergency Rooms—305,885 visits in 2008 • Opioid-related fatalities (accidental or intentional overdoses)—14,459 deaths in 2007 MMWR June 18, 2010; MMWR August 20, 2010

13. Can Long-term Opioids Increase Pain Sensitivity? (in some patients) • Some patients obtain pain relief when tapered off opioids • Animal studies chronic opioids increased pain sensitivity • Methadone maintenance pts w/ increased pain sensitivity • ? neuroadaptation to chronic opioids • Opioid withdrawal mediated pain • Opioid-induced hyperalgesia Li X et al. Brain Res Mol Brain Res 2001 Doverty M et al. Pain 2001 Angst MS, Clark JD. Anesthesiology 2006

14. Withdrawal-Mediated Pain Comfort Opioid Concentration Pain Pain Pain Pain Withdrawal opioid opioid opioid opioid

15. How Much Opioid is Too Much? • Compared with patients receiving 1-20 mg/d p.o. of morphine equivalents, patients receiving 50-99 mg/d had a 3.7-fold increase in overdose risk • Patients receiving 100 mg/d or more had an 8.9-fold increase in overdose risk with a 1.8% annual overdose rate • Morphine equivalent doses over 120 mg/d doubled the risk of substance-related health services utilization encounters (withdrawal, intoxication, overdoses) Dunn KM et al. Ann Intern Med 2010 Braden JB et al. Arch Intern Med 2010

16. Exploit Synergism NEJM 2005; 352:1324-34

17. Prior to Prescribing Opioids… • Determine diagnosis: are opioids indicated? • Character of pain and functional assessment • Adequate trial of non-opioid options • Risk assessment for misuse of opioids • Screen for mood disorders/mental illness • Screen for alcohol/substance use • Determine if potential benefits outweighs potential risks • Treatment planning • Goals and expectations • Adjuvant meds and therapies • Monitoring plan that matches risk profile

18. Assessment: The Six A’s • Analgesia • Activities • Affect • Adjuncts • Adverse effects • Aberrant behavior • From: Chronic Nonmalignant Pain in Primary Care, RP Jackman and B S Mallett,AFP 2008; 78: 1155-1162

19. Analgesia • What number best describes your pain on average in the past week? 0 = no pain 10 = worst pain imaginable • What number describes your level of pain control in the past week? 0 = can’t tell any difference 10 = perfect

20. Affect • Are you having depression or anxiety? • Or if they have underlying depression or anxiety have them rate it on a 0-10 scale. • What number best describes how, during the past week, pain has interfered with your enjoyment of life? 0 means does not interfere 10 means completely interferes

21. Activities What number best describes how, during the past week, pain has interfered with your general activity? 0 means does not interfere 10 means completely interferes

22. Adjuncts • Nonopioid drugs • Exercise with flexibility training • Nondrug treatments • PT • Complimentary Therapies • CBT • Injections • Pumps

23. Adverse Effects • CONSTIPATION • Nausea • Sedation • Decreased Cognition

24. Aberrant Medication Taking BehaviorsThe Spectrum of Severity • Requests for increase opioid dose • Requests for specific opioid by name, “brand name only” • Non-adherence with other recommended therapies (e.g., PT, behavioral therapy) • Running out early (i.e., unsanctioned dose escalation) • Resistance to change therapy despite adverse effects (e.g. over-sedation) • Deterioration in function at home and work • Non-adherence with monitoring requests (e.g. pill counts, urine drug tests) • Multiple “lost” or “stolen” opioid prescriptions • Illegal activities – forging scripts, selling opioid prescription, buying drugs from illicit sources Note: most of these behaviors are identified over time

25. PRACTICE SESSION on assessment: ROLE PLAY # 1

26. Potential Benefits Analgesia Function Quality of life Potential Risks Toxicity/side effects Functional impairment Physical dependence Abuse/addiction Overdose Increase pain sensitivity Opioid AnalgesicsBenefit/Risk Discussion

27. The Risk-Benefit Framework:Judge the opioid treatment, not the patient • NOT… • Is the patient good or bad? • Does the patient deserve opioids? • Should this patient be punished or rewarded? • Should I trust the patient? RATHER… Do the benefits of opioid treatment outweigh the untoward effects and risks for this patient (or society)?

28. Opioid Test/Trial • We lack strong accurate predictors: • Who will experience lasting benefit from chronic opioid analgesics • Who will be harmed by chronic opioid analgesia • We do have good evidence that a 3-6 month trial is safe (with no contraindications) • If not continued past the point of obvious failure

29. Discussing Opioid Trial Discuss opioids as really imperfect treatments for chronic pain Offer all prescriptions/changes as a “test”of the medication What can patient realistically expect to do with this treatment that s/he cannot do now? Focus on goals for next visit Jointly decide how to measure benefit

30. Measuring Benefit SMART goals Specific Measurable Action-oriented Realistic Time-sensitive Remind patient Pain unlikely to go away completely Need to manage the problems that pain causes

31. Discussing Opioid Trial Clearly link continuation of opioids to demonstration of benefit Helps patient set more realistic expectations. Decreases need to prove that pain is terrible. No “I still have pain, so I still need [X]” Yes “My meds allow me to do X, so it is worth it to me to keep taking them.”

32. Clarify Side Effects, Risks & Responsibilities • Side effects (short and long term) • physical dependence, addiction • sedation, constipation, impaired driving • Risk of drug interactions or combinations • Risk of unintentional or intentional misuse • abuse, addiction, death • Legal responsibilities • disposing, sharing, selling Paterick et al. Mayo Clinic Proc. 2008

33. Encourage Patient Responsibility Encourage the patient to look out for early signs of harm Am I safe to drive or operate heavy machinery? Am I having trouble controlling the use of my medication?

34. Opioid Monitoring: Why Do We Do It? Patient safety issue Designed to help protect patient from getting harmed by medications. Statin-LFT monitoring analogy. A standard policy used with all patients set level of monitoring to match risk.

35. “Universal Precautions” used to detect aberrant behaviors • Agreements (“contracts”) • Urine Drug Testing • Pill Counts • Prescription Monitoring Programs • Phone follow up .

36. Agreements (Contracts) • Educational and informational, articulating rationale and risks of treatment • Articulates monitoring (pill counts, etc) and action plans for aberrant medication taking behavior • Takes “pressure” off provider to make individual decisions (Our clinic policy is…) • Limitations: • Efficacy not well established • No standard or validated form • No evidence they are detrimental Fishman SM, Kreis PG. Clin J Pain 2002; Arnold RM et al. Am J of Medicine 2006 Starrels JL et al. Ann Intern Med 2010

37. Monitoring: Urine Drug Tests • Evidence of therapeutic adherence • Evidence of non-use of illicit drugs • Know limitations of test and your lab • Know a toxicologist/clinical pathologist • Consider Medical Review Officer (MRO) training • Efficacy not well established • Helpful strategies… • If I send your urine right now… • Your urine was positive, can you tell me about it? Starrels JL et al. Ann Intern Med 2010 Heit HA, Gourlay DL. J Pain Symptom Manage 2004 Standridge JB et al. Am Fam Physician 2010

38. Monitoring: Pill Counts • Confirm medication adherence • Minimize diversion • Important: know what the pills look like • Helpful strategies… • 28 day (rather than 30 day) supply if insurance allows • “forgot pills”, schedule return visit with in a week • Unsanctioned dose escalation is unacceptable

39. PRACTICE SESSION: ROLE PLAY # 2

40. IDENTIFYING AND ADDRESSING ABERRANT BEHAVIORS

41. Aberrant Medication Taking BehaviorsThe Spectrum of Severity • Requests for increase opioid dose • Requests for specific opioid by name, “brand name only” • Non-adherence with other recommended therapies (e.g., PT, behavioral therapy) • Running out early (i.e., unsanctioned dose escalation) • Resistance to change therapy despite adverse effects (e.g. over-sedation) • Deterioration in function at home and work • Non-adherence with monitoring requests (e.g. pill counts, urine drug tests) • Multiple “lost” or “stolen” opioid prescriptions • Illegal activities – forging scripts, selling opioid prescription, buying drugs from illicit sources

42. Aberrant Medication Taking BehaviorsDifferential Diagnosis • Inadequate analgesia – “Pseudoaddiction”1 • Disease progression • Opioid resistant pain (or pseudo-resistance)2 • Withdrawal mediated pain • Opioid-induced hyperalgesia3 • Addiction • Opioid analgesic tolerance3 • Self-medication of psychiatric and physical symptoms other than pain • Criminal intent - diversion 1 Weissman DE, Haddox JD. 1989; 2 Evers GC. 1997; 3 Chang C et al 2007

43. Approaching Patient with Aberrant Medication-taking Behavior • Non-judgmental stance • Use open-ended questions • State your concerns about the behavior • Examine the patient for signs of flexibility • Is the patient focused more on the opioid or pain relief • Discuss the need for increased monitoring Passik SD, Kirsh KL. J Supportive Oncology 2005

44. Continuation of Opioids Assess and document benefits and harms To continue opioids: There must be actual functional benefit Benefit must outweigh observed or potential harms You do not have to prove addiction or diversion – only assess Risk-Benefit ratio

45. Not Enough Benefit? Reassess factors affecting pain. Re-attempt to treat underlying disease and co-morbidities. If aberrant behaviors are present, start by increasing monitoring If no or few aberrant behaviors, consider escalating dose as a “test”. No effect = no benefit, hence benefit cannot outweigh risks – so STOP opioids. (Ok to taper and reassess.)

46. PRACTICE SESSION: ROLE PLAY # 3

47. Discontinuation StrategyDiscussing Lack of Benefit • Stress how much you believe / empathize with patient’s pain severity and impact. • Express frustration re: lack of good pill to fix it. • Focus on patient’s strengths. • Encourage therapies for “coping with” pain. • Show commitment to continue caring about patient and pain but without opioids

48. Discontinuation StrategyDiscussing Lack of Benefit • Stress that some patients experience improvement in function and pain control when chronic opioids are stopped • Make it clear that you are not discharging the patient but discontinuing an ineffective treatment • Taper patient slowly to prevent opioid withdrawal • Schedule close follow-ups during and after taper.

49. Exit StrategyDiscussing Possible Addiction • Give specific feedback on what previous behaviors raise your concern for possible addiction • You may have to agree to disagree on your diagnosis • Benefits no longer outweighing risks. • “I cannot responsibly continue prescribing opioids as I feel it would cause you more harm than good.” • Always offer referral to substance abuse treatment. • Stay 100% in “Benefit/Risk of Med” mindset.

50. Tapering Opioids • Decrease by 10-20% each week • Pill formulations may dictate amount of drop in dose • Rate of decrease determined by circumstances of withdrawal • Allow supply of short acting medications to treat “breakthrough” symptoms • Build up alternative pain treatment modalities • Comfort medications