Lessons Learned from the MMA/BOLIM Chronic Pain Project ME Ass’n of Psych Physicians April 30, 2010 Noel J. Genova, MA, PA-C

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

“Table of Contents” 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). Emerging issues (from chart reviews and Integrated Pain Mgt Conference Group).

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

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

Initial Objectives, cont’d Assist prescribers in use of the Prescription Monitoring Program. Discuss methods for urine drug screening. 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).

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.

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.

The Problems are On-Going Drug-related deaths in Maine were again higher than MVA-related deaths in 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.

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

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

Methadone Related Deaths 2005 Larger Circle indicate higher rates NYT

Where Pain Relievers Were Obtained Non-medical Use among Past Year Users Aged 12 or Older 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%

BENZOS May be used by psychiatrists in pts treated for chronic pain with COT. Implicated in many drug-related deaths, esp in combo with methadone. Many pts on benzo + stimulant from psychiatry, + COT + prn butalbital. Methadone clinics do not report to the PMP. Consider drug testing adult pts on any chronically used controlled med.

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. 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.

Urine Drug Testing 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. Interpretation of results can be tricky— develop a relationship with your lab.

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”). 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. Psychiatry may be able to help PCPs on this issue.

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

Barriers to Best Practices 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. Local culture which equates treatment of pain with use of opioid medication. Lack of reimbursement for the time needed to treat pts comprehensively.

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 Appendices regarding Screening and Brief Intervention for Addiction are especially useful and important.

2009 Guideline (cont’d) Addresses Efficacy and Risk Assessment “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. Monitoring process not evidence-based, but may reveal a community standard.

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

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). These conditions may have psychiatric component. Psych can help PCPs.

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

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

Recommendations Be sure to document efficacy of high-dose opioids. Screen for misuse and/or addiction. Be aware of the possibility of opioid- induced hyperalgesia. Be Careful With Benzos and Other Controlled Substances! Psychiatry + Primary Care may = Polypharmacy.

Discontinuing Opioid Meds May be indicated if med not effective. 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. Some pts want to D/C med. Condition may have improved or resolved (e.g. after surgery).

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.

Discontinuing Opioid Meds Taper can be slow (~10%/week), or rapid. See March, 2006; Kral, Lee A. Buprenorphine can be used if the pt does not tolerate discontinuation of COT. Certificate needed if med used for opioid addiction, but not if used for chronic pain. DEA is concerned about mislabelling pts as chronic pain. Document carefully!

Buprenorphine If used for pain, Dx must be clearly indicated on Rx. Efficacy for pain relief controversial. In Maine, has “street value”. If used for opioid addiction, and the pt has a chronic pain condition, may want to consult with a specialist in pain management.

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

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

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

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:

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.

Recommendations Review definitions of addiction, dependence, and tolerance. 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. Psychiatry can help PCPs and med team.

Medical Marijuana Legal in some states, including Maine. May be useful for chronic pain. Proponents note its safety, esp. compared to COT. It can be a drug of abuse. Little research on this Schedule I drug. No psych dx’es currently included in certification list in ME.

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

Recommendations for Physicians 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 not certify pt for use if not comfortable in doing so.

“Soft” indications for COT 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. No place for COT for tx of chronic H/A.

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; Chou R and Huffman L; Meds for Acute and Chronic LBP; same issue;

Recommendations 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. Consider tapering and/or D/C’ing COT if pt not doing well. Work with COT prescriber on taper strategy.

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

Questions? Comments? Thank you for your attention. Noel J. Genova, MA, PA-C MMA/BOLIM Chronic Pain Project tel: