Opioid prescribing: Finding the Right Balance in the Face of the Opioid Epidemic.

1. Opioid prescribing: Finding the Right Balance in the Face of the Opioid Epidemic. Richard M. Sobel, M.D., D.F.A.P.A Clinical Assistant Professor, Department of Psychiatry and Human Behavior Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA Past President, Greater Philadelphia Pain Society

2. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.Inst of Med of the National Academies. 2011 _______________________________________ • The 2011 IOM report on pain outlined the following principles: • effective pain management is a “moral imperative” • pain should be considered a disease with distinct pathology • there is a need for interdisciplinary treatment approaches • there is a serious problem of diversion and abuse of opioid drugs

5. Acute Pain • Duration 3- 6 months • Causes: • Spontaneous insult or trauma • Elective or planned procedures • Treatment: • RICE (rest-ice-compression-elevation) • OTC analgesics • Limit opioids to <3 day supply • Opioid treatement not associated with patient satisfaction

8. Statistics of Chronic Pain • Point prevalence: 30% of US population1 • More frequent in women, increases with age • Impact on sleep and mood • 32% not able to work2 1. Volkow ND, McLellan RA, NEJM, 2016:374 (13)L 1253-1263 2. Portenoy RK et al. The Journal of Pain; 2004;5:317-28

9. Statistics of Opioid Prescribing • 245 million prescriptions for opioids in US in 20141 • 37% of drug overdose deaths in 2013 were attributable to pharmaceutical opioids2 • Substance abuse treatment for opioids other than heroin increased sixfold betweem 1999 and 20091 1. Volkow ND, McLellan RA, NEJM, 2016:374 (13) 1253-1263 2. Volkow ND, McLellan RA, JAMA 2011: 305 (13) 1346-1347

11. Pain Assessment

18. Opioid Use Disorder (DSM-5) A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by 2 (or more) of the following, occurring within a 12-month period: • Recurrent substance use resulting in a failure to fulfill major role obligations • Recurrent substance use in situations in which it is physically hazardous • Continued substance use despite having persistent or recurrent social or interpersonal problems • Tolerance, as defined by either of the following: • A need for markedly increased amounts of the substance to achieve intoxication or desired effect • Markedly diminished effect with continued use of the same amount of the substance (Note: tolerance is not counted for those taking medications under medical supervision such as analgesics, antidepressants, anti-anxiety medications or beta-blockers) • Withdrawal, as manifested by either of the following: • The characteristic withdrawal syndrome for the substance (refer to Criteria A and B of the criteria set Withdrawal from the specific substances) • The same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms (Note: Withdrawal is not counted for those taking medications under medical supervision such as analgesics, antidepressants, anti-anxiety medications or beta-blockers) • The substance is often taken in larger amounts or over a longer period than was intended • There is a persistent desire or unsuccessful efforts to cut down or control substance use • A great deal of time is spent in activities necessary to obtain the substance, use the substance, or recover from its effects • Important social, occupational or recreational activities are given up or reduced because of substance use • The substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance • Craving or a strong desire to urge to use a specific substance www.dsm5.org

32. http://library.fsmb.org/pdf/pain_policy_july2013.pdf

34. Clinical Guidelines

35. CDC Guidelines, as of March 2016 • Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians shouldconsider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. Ifopioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, asappropriate. • Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety

36. CDC Guidelines, as of March 2016 - cont. • Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realisticbenefits of opioid therapy and patient and clinician responsibilities for managing therapy • When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extendedrelease/long-acting (ER/LA) opioids • When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution whenprescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when consideringincreasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day

37. CDC Guidelines, as of March 2016 - cont. • Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians shouldprescribe the lowest effective dose of immediate-release opioids and should prescribe no greater quantity than needed for theexpected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven dayswill rarely be needed • Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic painor of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months ormore frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapiesand work with patients to taper opioids to lower dosages or to taper and discontinue opioids

38. CDC Guidelines, as of March 2016 - cont. • Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioidrelated harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including consideringoffering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance usedisorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present. • Clinicians should review the patient's history of controlled substance prescriptions using state prescription drug monitoringprogram (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put himor her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain andperiodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months

39. CDC Guidelines, as of March 2016 - cont. • When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy andconsider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescriptiondrugs and illicit drugs. • Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible • Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine ormethadone in combination with behavioral therapies) for patients with opioid use disorder.

40. Weaning guidelines

41. Opioid Equivalenceies

42. Risks of chronic opioids - situations requiring extra caution • Coincident use of benzodiazopines increases the risk of serious adverse events • Methadone is associated with increased risk of harm due to its unique pharmacokinetics • Women of childbearing age: risk of harm to the newborn during pregnancy and breastfeeding • Patient at risk for obstructive sleep apnea (OSA) are at increased risk for harm with the use of chronic opioid therapy. Providers should consider the use of a screening tool for OSA, and ensure patients with OSA are compliant with treatment.

43. Methadone • Can be more effective against neuropathic pain (mu-opioid agonist and NMDA receptor antagonist • Risk of QTc prolongation • EKG at baseline, 4 weeks, 6 weeks, and yearly • Be aware of other meds patient is on • Dosing - Pain relief 4-8 hrs duration, but in body 8-59 hrs, so there can be risk of accumulation. • Do not start above 10 mg q8h • Morphine --> methadone, can use 1:10 ratio • Methadone --> morphine, use 1:3 ratio

44. Morphine --> Methadone conversion1 1. Fisch and Cleeland. Managing Cancer Pain in Skeel ed. Handbook of Cancer Chemotherapy. 6thed., Phil, Lippincott, 2003, p 663)

45. Pensylvania Guidelines on the Use of Opioids to Treat Chronic Noncancer Pain • Heffley Resolution of 2014 • Work group consisting of clinicans, representatives of various state agencies, FOP, Recovery organizations, District Attorneys, State Police, Coroners Association, Pharmacists, Nurses, Pain advocacy, American Cancer Society, Organized Medicine (including PPS) • Developed first ever guidelines for Pennsylvania

46. Risk Assessment

47. Prior to initiating chronic opioid therapy • Conduct history and physical examination • Assessment of risk of substance use disorder, misuse, or addiction - ORT, CAGE, SOAPP-R