1. “Recognition and Management of Prescription Opioid Failure and Abuse in the Primary Care Setting” William Morris, MD Medical Director Janus of Santa Cruz

5. Chronic Pain: Burden of Disease 9 in 10 Americans regularly suffer from pain Each year approx 50 million Americans suffer from chronic pain Chronic pain is the most common cause of chronic disability Almost 1/3 of Americans will suffer from chronic pain at some point in their lives Pain: Current Understanding of Assessment, Management, and Treatments. National Pharmaceutical Council.

6. Overview Process for prescription of opioids for chronic non-cancer pain Opioid “failures” – excessive side effects – inadequate analgesia – Opioid “misuse” = opioid-related aberrant behaviors Clarification of terminology Recognizing and responding to aberrant opioid- related behaviors

7. Clinical Guidelines for Opioid Use in Chronic Pain 2010: American Society of Anesthesiologists – http://journals.lww,com/anesthesiology/Fulltext/2010/04000/Pract ice_G http://journals.lww,com/anesthesiology/Fulltext/2010/04000/Pract ice_G 2010: Drug Enforcement Agency – www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html www.deadiversion.usdoj.gov/pubs/manuals/pract/index.html uideline_for_Chronic_Pain_Management_13.aspx 2009: Institute for Clinical Systems Improvement – www.icsi.org/pain_chronic_assessment_and_management_of_143 99/pain_chronic_assessment_and_management_of_guideline.html www.icsi.org/pain_chronic_assessment_and_management_of_143 99/pain_chronic_assessment_and_management_of_guideline.html 2009: Journal of Pain – www.jpain.org/article/S1526- 5900(08)00831-6/fulltextwww.jpain.org/article/S1526- 5900(08)00831-6/fulltext 2004: Federation of State Medical Boards of the United States – www.fsmb.org/pdf/2004_grpol_controlled_substances.pdf www.fsmb.org/pdf/2004_grpol_controlled_substances.pdf 2003: Veterans Administration Guideline – www.healthquality.va.gov/cot/cot_fulltext.pdf www.healthquality.va.gov/cot/cot_fulltext.pdf

8. Summary Process for Prescription Opioids Decision Phase Implementation Phase Goals metGoals not met Outcome Phase

9. Decision Phase – Are Opioids Needed? Pain is moderate to severe Pain has significant impact on function and quality of life Non-opioid therapies have failed

10. Decision Phase- Are Opioid Benefits > Risks? Strongest risk factors for abuse – History of substance abuse personally/family – Psychiatric comorbidity: severe depression/anxiety – History of drug-related crime – Regular contact with high risk group (substance abusers) – History of Sexual abuse – preadolescent – Smokers - Ives T el al. BMC Health Services Research 2006 - Redi MC et al. JGIM. 2002 - Michna E et al. JPSM 2004 - Akbik H et al. JPSM 2006

11. Decision for Opioids - Benefit > Risk? (cont.) Risk assessment tools: www.emergingsolutionsinpain.com – Opioid Risk Tool: Webster LR and Webster RM. Pain Medicine.2005;6;432-42 – Screener and Opioid Assessment for Patients with pain – Revised (SOAPP-R): Butler et al. Journal of Pain. 2008;9:360-72 Collateral information: family, friends, physicians, pharmacists CURES report

12. Opioid Risk Tools ORT: scores to place in low, mod, high risk – Family Hx of substance abuse – Personal Hx of Substance abuse – Hx of preadolescent sexual abuse – Psych disease (depression separate) – Age, Sex SOAPP-R: 24 ?’s self admin 1-4 scale totaled – e.g: “How often do you feel bored?” – “How often have you been sexually abused?” – “How often have you felt impatient with your doctors?”

13. Controlled Substance Utilization Review and Evaluation System – “CURES” Office of state Attorney General – http://ag.ca.gov/bne/cures.php Online “Prescription Drug Monitoring Program” generates “patient activity report” Initial register online at: http//ag.ca.gov/bne/cures.php Then must submit written application with notarized copies of DEA and medical licenses, govt. issued ID

14. Decision Phase – Goals and Conditions of Opioid Rx Goals – Analgesia – Improved function: physical, social, vocational and recreational – Ask question what can patient realistically hope to be able to do that they cannot do now? Important to realize that the evidence for opioid efficacy mostly comes from survey and uncontrolled case series, therefore each patient is his/her “n of 1” trial.

15. Decision Phase – Goals and Conditions of Rx (cont.) Conditions of Rx “universal precautions” – Treatment agreement - verbal or written? – Informed consent/education – One prescriber/one pharmacy – Visit frequency – No early refills – Pill counts? – Urine tox screens?

16. Urine Drug Tests - An Objective Tool Shows patient is taking what they are prescribed and not other substances Aberrant behavior present Aberrant behavior absent total POSITIVE urine 10 (8%)26 (21%) 36 (29%) NEGATIVE urine 17 (14%)69 (57%) 86 (71%) 27 (22%)95 (78%)122 Katz NO. et al. Clinical J of Pain. 2002

17. Decision Phase – Goals and Conditions for Rx Exit plan - mutually agreed upon criteria – Lack of adequate analgesia – Lack of adequate functional improvement – Persistent, intolerable side effects – Aberrant behaviors

18. Implementation Phase Dose initiation and titration – How long is long enough? [2 months] – How much is too much? [200mg daily oral morphine equiv dose] Higher doses – refer to specialty pain clinic Ballantyne, JC and Mao, JM. Opioid Therapy for Chronic Pain. NEJM.2003;349:1943-53 Management of side effects

19. Outcomes Phase – When Goals are Met: Monthly med renewal visits – Document pain score and side effects – Treat side effects – Tox screen if indicated Comprehensive Reassessment visits Q 3-6 months The “4 A’s” – Analgesia? – Activity? – Acceptable SE profile? – Aberrant behaviors? “collateral” information remains important

20. Outcome Phase – The Dark Side of Opioids Goals not met Excessive side effects Ineffective analgesia - disease progression - tolerance - opioid resistant pain - opioid induced hyperalgesia - opioid induced toxicity Aberrant opioid-related behaviors - non-addiction - addiction

21. Opioid-induced Hyperalgesia vs. Opioid Toxicity Opioid-Induced Hyperalgesia – Anesthesia/pain literature – Setting of chronic, non-terminal pain syndromes – Continued poor pain control despite moderate opioid doses (>200mg/day) – Diffuse pain, out of previous distribution – Absence of neuroactivation – Absence of dehydration, renal failure – RX: dose reduction and opioid rotation (NMDA antagonists?) Opioid toxicity – Palliative Care/oncologic literature – Increase in pain despite rapid titration – Allodynia, hyperalgesia – Signs of neuroactivation: myoclonus, delirium – Dehydration, renal failure – RX: opioid rotation with marked reduction in dose, benzos, hydration? Lee, M et al. Pain Physician. 2011;14:145-61. Silverman, S. Pain Physician. 2009; 12:679-84

22. “Confusing Panopoly of Terms and Definitions” Addiction Habituation Dependence Substance abuse Substance dependence Substance misuse Physical dependence Psychological dependence

23. Evolution of Terminology Liaison Committee on Pain and Addiction (LCPA) – American Pain Society – American Academy of Pain Medicine – American Society of Addiction Medicine – 1991-2001 created consensus definitions

24. LCPA Consensus Definitions “Addiction” favored over “dependence” Clear separation of concepts of physical dependence, tolerance, and addiction Addiction as a chronic disease Utility of distinguishing addiction from other forms of aberrant drug behavior

25. Tolerance “a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time”

26. Physical Dependence “a state of adaptation that is manifested by a drug class specific withdrawal syndrome that can be produced by abrupt cessation, rapid does reduction, decreasing blood level of the drug, and/or administration of an antagonist.”

27. Addiction “a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving”

28. Addiction

29. Addiction

30. Addiction

31. Addiction

32. Aberrant Opioid-Related Behaviors Examples of non-addiction aberrant behaviors: – Noncompliance – Diversion – Seeking euphoria – Medical “coping” – Pseudoaddiction

33. Chronic Pain Population on Opioids Aberrant Opioid-Related Behaviors Addiction

34. Behaviors LESS indicative of addiction Anxiety over symptoms Med hoarding Taking other’s meds Requesting a specific med Openly getting meds from other providers Complaints about needing higher dose Behaviors MORE indicative of addiction Buying street drugs Illegal activities Multiple lost or stolen meds Prescription forgery Injection or snorting meds Performed sex for drugs Resistance to med change despite SEs Passik SD, et. al. Clinical J Pain. 2006;22:173-181

35. Aberrant Opioid-Related Behavior Survey Tools Addiction Behaviors Checklist Wu, et al. J. Pain Symp Manage. 2008;32(4):342-51. – Clinician considers presence of behaviors since last visit and within current visit – e.g. ran out of meds early? Reports worsening relationship with family? Current Opioid Misuse Measure Butler, et al. Pain. 2007;130:144-56. – 17 questions asked of patient with 0-4 response

36. Chronic Pain Population on Opioids Aberrant Opioid-Related Behaviors Addiction 30 - 40% 2-5%

37. Personal Observations from Dealing with Challenging Patients Assuming opioids = only way to Rx severe pain Multiple opioids of same type High doses without pain specialist input Continued dose escalation despite lack of significant improvement Absence of weighing benefit against risk Assuming aberrant behaviors = addiction

38. Having the Conversation Clearly lay out my concerns – – I first focus on lack of analgesia and side effect – Then discuss specific examples of aberrant opioid- related behaviors Present your assessment that risk of harm is greater than benefit – If I have relationship with patient, I focus on my wanting the best for them – If first visit, I focus on my ethical obligation to “do no harm” Refer back to opioid agreement if you have one

39. Having the Conversation (cont.) “It doesn’t make sense to keep doing something that is more likely to harm you than help you, does it?” I acknowledge that this is not an easy problem to deal with Don’t back them into a corner - I remind them; – My diagnosis could be wrong – I would not be offended if they transferred care to another physician – I will not abandon them.

40. Having the Conversation (cont.) I offer choice around how opioids are tapered, not if they will be tapered, with as much flexibility as is safe. Try to decide: tapering because of addiction or because of opioid side effects and/or failure? – Addiction should include in the care plan referral for recovery treatment – Addiction may require medication assisted treatment: methadone or buprenorphine

41. Insanity: doing the same thing over and over again and expecting different results - Albert Einstein

42. RECOVERY

43. janussc.org