1. Opioid Usage, Pain Management and More Lessons Learned from the MMA/BOLIM Chronic Pain Project January, 2010 Noel J. Genova, MA, PA-C

2. Learning Objectives Efficacy of chronic opioid therapy— evidence, lack of evidence, opioid- responsive conditions. Efficacy of chronic opioid therapy— evidence, lack of evidence, opioid- responsive conditions. Documentation—the “6 A’s” Documentation—the “6 A’s” Screening for misuse and addiction, and referring for treatment if appropriate. Screening for misuse and addiction, and referring for treatment if appropriate. Recognition of medication diversion. Recognition of medication diversion.

3. “Table of Contents” Description of the MMA/BOLIM Chronic Pain Project Description of the MMA/BOLIM Chronic Pain Project Initial objectives of the Project, and qualitative information found during chart review (~200 participants, ~1000 charts reviewed). Initial objectives of the Project, and qualitative information found during chart review (~200 participants, ~1000 charts reviewed). Emerging issues (from chart reviews and Integrated Pain Mgt Conference Group). Emerging issues (from chart reviews and Integrated Pain Mgt Conference Group).

4. Something for Surgical PAs Comments on pts receiving high-dose chronic opioid therapy. Comments on pts receiving high-dose chronic opioid therapy. Comments regarding pts on buprenorphine and methadone. Comments regarding pts on buprenorphine and methadone. Comments on pre-surgery screening for opioid use, and histories of addiction. Comments on pre-surgery screening for opioid use, and histories of addiction. D/C’ing opioids after surgical intervention and resolution of painful condition. D/C’ing opioids after surgical intervention and resolution of painful condition.

5. MMA/BOLIM Chronic Pain Project Started in March, 2008. Funded by Maine’s Board of Medicine, administered through Maine Medical Association. Started in March, 2008. Funded by Maine’s Board of Medicine, administered through Maine Medical Association. Intended as a service to licensees and all Maine prescribers. Intended as a service to licensees and all Maine prescribers. All visits confidential, and free of charge to the practices. All visits confidential, and free of charge to the practices.

6. Initial Objectives Raise awareness of drug-related deaths, particularly from methadone. Raise awareness of drug-related deaths, particularly from methadone. Help prescribers prevent diversion. Help prescribers prevent diversion. Teach prescribers to recognize and treat addiction. Teach prescribers to recognize and treat addiction. Review records for appropriate documentation of initial evaluation and on-going monitoring of pts on opioids. Review records for appropriate documentation of initial evaluation and on-going monitoring of pts on opioids.

7. Initial Objectives, cont’d Assist prescribers in use of the Prescription Monitoring Program. Assist prescribers in use of the Prescription Monitoring Program. Discuss methods for urine drug screening. Discuss methods for urine drug screening. Offer sample treatment agreements. Offer sample treatment agreements. Review Maine’s Chapter 11 Rules for Use of Controlled Substances for Treatment of Pain (in other states, the FSMB model rules). Review Maine’s Chapter 11 Rules for Use of Controlled Substances for Treatment of Pain (in other states, the FSMB model rules).

8. Last Year’s News Treatment of chronic, non-terminal pain with opioid medications has had the unintended consequence of increased diversion of medications, increased non- medical use of prescription medications by young people, an increase in drug-related deaths nationally, and possibly an increase in opioid misuse or addiction among patients treated for chronic pain. Treatment of chronic, non-terminal pain with opioid medications has had the unintended consequence of increased diversion of medications, increased non- medical use of prescription medications by young people, an increase in drug-related deaths nationally, and possibly an increase in opioid misuse or addiction among patients treated for chronic pain.

9. Last Year’s News, Cont’d. Risks of chronic opioid therapy (COT) include endocrine abnormalities, aggravation of pain, worsening depression, sleep disturbances (including sleep apnea) and worsening function. This is especially concerning, because the indications for the use of the therapy is increased pain relief, increased function, and overall improvement in well-being. Risks of chronic opioid therapy (COT) include endocrine abnormalities, aggravation of pain, worsening depression, sleep disturbances (including sleep apnea) and worsening function. This is especially concerning, because the indications for the use of the therapy is increased pain relief, increased function, and overall improvement in well-being.

10. The Problems are On-Going Drug-related deaths in Maine were again higher than MVA-related deaths in 2008. Drug-related deaths in Maine were again higher than MVA-related deaths in 2008. Prescribers are generally well-aware of these issues, and are looking for how to reduce risks, while continuing to treat pain effectively. Prescribers are generally well-aware of these issues, and are looking for how to reduce risks, while continuing to treat pain effectively. Non-medical use of prescription analgesics remains a serious problem among youth. Non-medical use of prescription analgesics remains a serious problem among youth.

11. Maine Drug Related vs. MVA deaths 90% caused by at least one prescription drug 78% had narcotics present Office of Medical Examiner 19972000200520062007 MVA related 192169169188183 Drug related 3460176167154

12. Deaths per 100,000 related to unintentional overdose and annual sales of prescription opioids by year, 1990 - 2006 Source: Paulozzi, CDC, Congressional testimony, 2007

13. Methadone Related Deaths 2005 Larger Circle indicate higher rates NYT 8.17.08

14. Where Pain Relievers Were Obtained Non-medical Use among Past Year Users Aged 12 or Older 2006 1 The Other category includes the sources: “Wrote Fake Prescription,” “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy,” and “Some Other Way.” Bought/Took from Friend/Relative 14.8% Drug Dealer/ Stranger 3.9% Bought on Internet 0.1% Other 1 4.9% Free from Friend/Relative 7.3% Bought/Took from Friend/Relative 4.9% One Doctor 80.7% Drug Dealer/ Stranger 1.6% Other 1 2.2% Source Where Respondent Obtained Source Where Friend/Relative Obtained One Doctor 19.1% More than One Doctor 1.6% Free from Friend/Relative 55.7% More than One Doctor 3.3%

15. Learning from the Project Use of drug screens—”I’m a doctor, not a cop”. Must screen for addiction—a treatable, potentially fatal medical condition. Use of drug screens—”I’m a doctor, not a cop”. Must screen for addiction—a treatable, potentially fatal medical condition. Alcohol abuse is often missed or ignored. Alcohol abuse is often missed or ignored. Polypharmacy with controlled substances starts insidiously, and is difficult to stop. Benzos and butalbital often used w/COT. Polypharmacy with controlled substances starts insidiously, and is difficult to stop. Benzos and butalbital often used w/COT.

16. Urine Drug Testing History of substance use and abuse very important, but not entirely accurate History of substance use and abuse very important, but not entirely accurate Studies from pain treatment centers consistently show ~40% of urines with unexpected results. Studies from pain treatment centers consistently show ~40% of urines with unexpected results. Interpretation of results can be tricky— develop a relationship with your lab. Interpretation of results can be tricky— develop a relationship with your lab.

17. Learning from the Project, Cont’d We are not trained to obtain the elements of the history, particularly in monitoring of opioid analgesics (the “6 A’s”). We are not trained to obtain the elements of the history, particularly in monitoring of opioid analgesics (the “6 A’s”). Prescribers want to learn to use the PMP. Prescribers want to learn to use the PMP. Many prescribers find confrontation of patients with aberrant behaviors to be very difficult, time-consuming, and draining. Training is needed on this issue. Many prescribers find confrontation of patients with aberrant behaviors to be very difficult, time-consuming, and draining. Training is needed on this issue.

18. The “6 A’s” Analgesia Analgesia Activity (function) Activity (function) Aberrant Behaviors Aberrant Behaviors Adverse Affects Adverse Affects Affective Aspects (mood, sleep. Remember usefulness of CBT) Affective Aspects (mood, sleep. Remember usefulness of CBT) Adjuncts (pharmacologic and non- pharmacologic) Adjuncts (pharmacologic and non- pharmacologic)

19. Barriers to Best Practices Lack of strong evidence-based studies. Lack of strong evidence-based studies. Lack of access to a full range of adjuncts, esp in rural areas. Lack of reimbursement for intensive interdisciplinary therapies. Lack of access to a full range of adjuncts, esp in rural areas. Lack of reimbursement for intensive interdisciplinary therapies. Local culture which equates treatment of pain with use of opioid medication. Local culture which equates treatment of pain with use of opioid medication. Lack of reimbursement for the time needed to treat pts comprehensively. Lack of reimbursement for the time needed to treat pts comprehensively.

20. 2009 Guideline Chou, R, Fanciullo GJ, Fine PG, et al; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain; The Journal of Pain; Vol 10, #2; February, 2009; pp. 113-130. Chou, R, Fanciullo GJ, Fine PG, et al; Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain; The Journal of Pain; Vol 10, #2; February, 2009; pp. 113-130. Appendices regarding Screening and Brief Intervention for Addiction are especially useful and important. Appendices regarding Screening and Brief Intervention for Addiction are especially useful and important.

21. 2009 Guideline (cont’d) Addresses Efficacy and Risk Assessment Addresses Efficacy and Risk Assessment “Sparse” evidence for use in chronic back pain, daily headache, and fibromyalgia. “Sparse” evidence for use in chronic back pain, daily headache, and fibromyalgia. Good appendices with tools for screening for risk of misuse or addiction, consent forms, and documentation tools. Good appendices with tools for screening for risk of misuse or addiction, consent forms, and documentation tools. Monitoring process not evidence-based, but may reveal a community standard. Monitoring process not evidence-based, but may reveal a community standard.

22. Emerging Objectives Management of patients on high-dose opioids who are not responding well. Management of patients on high-dose opioids who are not responding well. Discontinuing chronic opioid therapy. Discontinuing chronic opioid therapy. Treatment of acute pain (e.g. associated with surgery) in patients who are on buprenorphine or methadone. Treatment of acute pain (e.g. associated with surgery) in patients who are on buprenorphine or methadone. Use of medical marijuana for chronic pain. Use of medical marijuana for chronic pain.

23. Emerging Objectives (Cont’d) Substituting evidence-based treatments for COT in patients with fibromyalgia, chronic headaches and migraine, and chronic low back pain for which there is no structural cause identified (in pts who are not doing well on COT). Substituting evidence-based treatments for COT in patients with fibromyalgia, chronic headaches and migraine, and chronic low back pain for which there is no structural cause identified (in pts who are not doing well on COT).

24. Maine PAs and Schedule II Meds Maine PAs licensed by the BOLIM must apply for Schedule II prescribing authority Maine PAs licensed by the BOLIM must apply for Schedule II prescribing authority Maine PAs licensed by the Board of Osteopathic Licensure cannot prescribe Schedule II medications. Maine PAs licensed by the Board of Osteopathic Licensure cannot prescribe Schedule II medications. Some of the recommendations in this lecture may pertain more to physician and NP practice than to PA practice, but will inform the practice of PAs caring for pts with chronic pain. Some of the recommendations in this lecture may pertain more to physician and NP practice than to PA practice, but will inform the practice of PAs caring for pts with chronic pain.

25. Pts on High-Dose Opioids No real definition of high-dose opioids, but general agreement on ~200 mg/day equivalent of morphine. No real definition of high-dose opioids, but general agreement on ~200 mg/day equivalent of morphine. ~160 mg/day of oxycodone. ~160 mg/day of oxycodone. ~60-120 mg/day of methadone (extreme care must be used in dosing methadone). ~60-120 mg/day of methadone (extreme care must be used in dosing methadone). ~100 microgram q 3 days fentanyl patch. ~100 microgram q 3 days fentanyl patch.

26. High-Dose Opioids--References Ballantyne JC and Mao J; Opioid Therapy for Chronic Pain; NEJM; 349:20; Nov 13, 2003; 1943-53. Ballantyne JC and Mao J; Opioid Therapy for Chronic Pain; NEJM; 349:20; Nov 13, 2003; 1943-53. Chang G, Chen L, and Mao J; Opioid Tolerance and Hyperalgesia; The Medical Clinics of North America; 91 (2007) 199- 211. Chang G, Chen L, and Mao J; Opioid Tolerance and Hyperalgesia; The Medical Clinics of North America; 91 (2007) 199- 211.

27. Recommendations Be sure to document efficacy of high-dose opioids. Be sure to document efficacy of high-dose opioids. Screen for misuse and/or addiction. Screen for misuse and/or addiction. Be aware of the possibility of opioid- induced hyperalgesia. Be aware of the possibility of opioid- induced hyperalgesia. Strongly consider consultation with a pain specialist. Strongly consider consultation with a pain specialist.

28. Discontinuing Opioid Meds May be indicated if med not effective. May be indicated if med not effective. Consider possibility of opioid-induced hyperalgesia, which may indicate need to taper and/or D/C COT. Consider possibility of opioid-induced hyperalgesia, which may indicate need to taper and/or D/C COT. May be necessary if pt misusing the med. May be necessary if pt misusing the med. Some pts want to D/C med. Some pts want to D/C med. Condition may have improved or resolved (e.g. after surgery). Condition may have improved or resolved (e.g. after surgery).

29. Case Example A 40 yo man with chronic pain after extensive injuries sustained 15 yrs ago when he fell off a roof. He is on 480 mg of oxycodone daily, has 8/10 pain, cannot work, and his wife has asked him to leave, as he is unable to participate in family activities. A 40 yo man with chronic pain after extensive injuries sustained 15 yrs ago when he fell off a roof. He is on 480 mg of oxycodone daily, has 8/10 pain, cannot work, and his wife has asked him to leave, as he is unable to participate in family activities.

30. Discontinuing Opioid Meds Taper can be slow (~10%/week), or rapid. See www.Pain-Topics.com, March, 2006; Kral, Lee A. Taper can be slow (~10%/week), or rapid. See www.Pain-Topics.com, March, 2006; Kral, Lee A.www.Pain-Topics.com Buprenorphine can be used if the pt does not tolerate discontinuation of COT. Check with DEA, supervising physician, licensing board, and local pain specialist before initiating. Special training needed. Buprenorphine can be used if the pt does not tolerate discontinuation of COT. Check with DEA, supervising physician, licensing board, and local pain specialist before initiating. Special training needed.

31. Buprenorphine Cannot be prescribed by PAs for addiction. An act of Congress required to change the restriction. Cannot be prescribed by PAs for addiction. An act of Congress required to change the restriction. If used for pain, Dx must be clearly indicated on Rx. If used for pain, Dx must be clearly indicated on Rx. Efficacy for pain relief controversial. Efficacy for pain relief controversial. In Maine, has “street value”. In Maine, has “street value”.

32. Buprenorphine (cont’d) Is an opioid agonist. Competes with other opioids for binding sites. Can induce withdrawal, and prevent efficacy of other opioids. Is an opioid agonist. Competes with other opioids for binding sites. Can induce withdrawal, and prevent efficacy of other opioids.

33. Get Help Work with someone experienced in its use before discussing with a pt. Work with someone experienced in its use before discussing with a pt. In any surgical setting, recommend working with an anesthesiologist familiar with the med. In any surgical setting, recommend working with an anesthesiologist familiar with the med.

34. Recommendations If treating pts for non-terminal chronic pain, always have an exit strategy. If treating pts for non-terminal chronic pain, always have an exit strategy. Be prepared to discontinue COT, if indicated. Be prepared to discontinue COT, if indicated. Have a back-up plan for pts who do not do well with a standard taper. Have a back-up plan for pts who do not do well with a standard taper.

35. Acute Pain in Pts on Opioid Agonist Therapy (OAT) Why is the pt on OAT? Why is the pt on OAT? Technical expertise required to avoid risk of drug interactions. Technical expertise required to avoid risk of drug interactions. Buprenorphine may precipitate withdrawal if combined with other opioids. Buprenorphine may precipitate withdrawal if combined with other opioids. Methadone maintenance may predispose pts to opioid-induced hyperalgesia. Methadone maintenance may predispose pts to opioid-induced hyperalgesia.

36. OAT (cont’d) Reference—Alford D, Compton P, Samet J; Acute Pain Management for Patients Receiving Maintenance Methadone or Buprenorphine Therapy; Annals of Internal Medicine; 17 Jan. 2006; 144:127-134. Reference—Alford D, Compton P, Samet J; Acute Pain Management for Patients Receiving Maintenance Methadone or Buprenorphine Therapy; Annals of Internal Medicine; 17 Jan. 2006; 144:127-134.

37. Case Example 35 yo man presents for day surgery. He had not revealed that he was on methadone maintenance, and standard questionnaires in the surgical intake process did not include this piece of medical history. The pt’s post-procedure pain was difficult to control, and the pt became combative. 35 yo man presents for day surgery. He had not revealed that he was on methadone maintenance, and standard questionnaires in the surgical intake process did not include this piece of medical history. The pt’s post-procedure pain was difficult to control, and the pt became combative.

38. Recommendations Review definitions of addiction, dependence, and tolerance. Review definitions of addiction, dependence, and tolerance. Work with someone who is experienced in this situation. Work with someone who is experienced in this situation. Incorporate elements of the history that allow the pt to reveal history of addiction without feeling judged, or scared that pain control will be withheld. Incorporate elements of the history that allow the pt to reveal history of addiction without feeling judged, or scared that pain control will be withheld.

39. Medical Marijuana Legal in some states, including Maine. Legal in some states, including Maine. May be useful for chronic, non-terminal pain. May be useful for chronic, non-terminal pain. Proponents note its safety, esp. compared to COT. Proponents note its safety, esp. compared to COT. It can be a drug of abuse. It can be a drug of abuse. Little research on this Schedule I drug. Little research on this Schedule I drug.

40. Reference Ben Amar, Mohamed; Cannabinoids in Medicine: A Review of their Therapeutic Potential; Journal of Ethnopharmacology; 105 (2006) 1-25. Ben Amar, Mohamed; Cannabinoids in Medicine: A Review of their Therapeutic Potential; Journal of Ethnopharmacology; 105 (2006) 1-25.

41. Recommendations for Physicians Only physicians can certify pts for use of mj. Only physicians can certify pts for use of mj. Document indication for use, efficacy, dose, and its place in overall therapeutic plan. Document indication for use, efficacy, dose, and its place in overall therapeutic plan. Physicians should follow any advice available for certifying use. (In Maine, Maine Medical Association.) Physicians should follow any advice available for certifying use. (In Maine, Maine Medical Association.) Physicians should not certify pt for use if not comfortable in doing so. Physicians should not certify pt for use if not comfortable in doing so.

42. “Soft” indications for COT Many dx’es for use non-specific, such as “chronic pain”, chronic back pain. Many dx’es for use non-specific, such as “chronic pain”, chronic back pain. Multiple fibromyalgia-related websites browsed (Arthritis Foundation, NIH, Mayo Clinic, National Fibromyalgia Foundation). None advised use of “strong” opioid medication. Multiple fibromyalgia-related websites browsed (Arthritis Foundation, NIH, Mayo Clinic, National Fibromyalgia Foundation). None advised use of “strong” opioid medication. No place for COT for tx of chronic H/A. No place for COT for tx of chronic H/A.

43. References Chou R, Qaseem A, Snow V, et al; Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the ACP and the Am Pain Soc; Annals of Internal Medicine; 2 Oct, 2007; Vol 147, #7; 478-91. Chou R, Qaseem A, Snow V, et al; Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the ACP and the Am Pain Soc; Annals of Internal Medicine; 2 Oct, 2007; Vol 147, #7; 478-91. Chou R and Huffman L; Meds for Acute and Chronic LBP; same issue; 505-14. Chou R and Huffman L; Meds for Acute and Chronic LBP; same issue; 505-14.

44. Recommendations Review your diagnoses and treatment plans for pts with chronic pain. Review your diagnoses and treatment plans for pts with chronic pain. Discuss latest treatment options with pts. They may have changed since the current plan was put in place. Discuss latest treatment options with pts. They may have changed since the current plan was put in place. Consider tapering and/or D/C’ing COT if pt not doing well. Consider tapering and/or D/C’ing COT if pt not doing well.

45. Summary Recommendations Keep up with medical literature if you prescribe COT. It is rapidly changing. Keep up with medical literature if you prescribe COT. It is rapidly changing. Pay close attention to documentation. Pay close attention to documentation. Be aware of community standard of care. Be aware of community standard of care. Identify resources for treatment of chronic pain and addiction. Identify resources for treatment of chronic pain and addiction. Be vigilant for risk of diversion. Be vigilant for risk of diversion.

46. Questions? Comments? Thank you for your attention. Thank you for your attention. Noel J. Genova, MA, PA-C Noel J. Genova, MA, PA-C MMA/BOLIM Chronic Pain Project MMA/BOLIM Chronic Pain Project tel: 671-9076 tel: 671-9076 e-mail NoelPAC@aol.com. e-mail NoelPAC@aol.com.