Improving safety and efficacy of opioid prescribing for pain in primary care

1. <?xml version="1.0"?><AllQuestions /> <?xml version="1.0"?><AllResponses /> <?xml version="1.0"?><Settings><answerBulletFormat>Numeric</answerBulletFormat><answerNowAutoInsert>No</answerNowAutoInsert><answerNowStyle>Explosion</answerNowStyle><answerNowText>Answer Now</answerNowText><chartColors>Use PowerPoint Color Scheme</chartColors><chartType>Horizontal</chartType><correctAnswerIndicator>Checkmark</correctAnswerIndicator><countdownAutoInsert>No</countdownAutoInsert><countdownSeconds>10</countdownSeconds><countdownSound>TicToc.wav</countdownSound><countdownStyle>Box</countdownStyle><gridAutoInsert>No</gridAutoInsert><gridFillStyle>Answered</gridFillStyle><gridFillColor>255,255,0</gridFillColor><gridOpacity>50%</gridOpacity><gridTextStyle>Keypad #</gridTextStyle><inputSource>Response Devices</inputSource><multipleResponseDivisor># of Responses</multipleResponseDivisor><participantsLeaderBoard>5</participantsLeaderBoard><percentageDecimalPlaces>0</percentageDecimalPlaces><responseCounterAutoInsert>No</responseCounterAutoInsert><responseCounterStyle>Oval</responseCounterStyle><responseCounterDisplayValue># of Votes Received</responseCounterDisplayValue><insertObjectUsingColor>Red</insertObjectUsingColor><showResults>Yes</showResults><teamColors>Use PowerPoint Color Scheme</teamColors><teamIdentificationType>None</teamIdentificationType><teamScoringType>Voting pads only</teamScoringType><teamScoringDecimalPlaces>1</teamScoringDecimalPlaces><teamIdentificationItem></teamIdentificationItem><teamsLeaderBoard>5</teamsLeaderBoard><teamName1></teamName1><teamName2></teamName2><teamName3></teamName3><teamName4></teamName4><teamName5></teamName5><teamName6></teamName6><teamName7></teamName7><teamName8></teamName8><teamName9></teamName9><teamName10></teamName10><showControlBar>All Slides</showControlBar><defaultCorrectPointValue>0</defaultCorrectPointValue><defaultIncorrectPointValue>0</defaultIncorrectPointValue><chartColor1>187,224,227</chartColor1><chartColor2>51,51,153</chartColor2><chartColor3>0,153,153</chartColor3><chartColor4>153,204,0</chartColor4><chartColor5>128,128,128</chartColor5><chartColor6>0,0,0</chartColor6><chartColor7>0,102,204</chartColor7><chartColor8>204,204,255</chartColor8><chartColor9>255,0,0</chartColor9><chartColor10>255,255,0</chartColor10><teamColor1>187,224,227</teamColor1><teamColor2>51,51,153</teamColor2><teamColor3>0,153,153</teamColor3><teamColor4>153,204,0</teamColor4><teamColor5>128,128,128</teamColor5><teamColor6>0,0,0</teamColor6><teamColor7>0,102,204</teamColor7><teamColor8>204,204,255</teamColor8><teamColor9>255,0,0</teamColor9><teamColor10>255,255,0</teamColor10><displayAnswerImagesDuringVote>Yes</displayAnswerImagesDuringVote><displayAnswerImagesWithResponses>Yes</displayAnswerImagesWithResponses><displayAnswerTextDuringVote>Yes</displayAnswerTextDuringVote><displayAnswerTextWithResponses>Yes</displayAnswerTextWithResponses><questionSlideID></questionSlideID><controlBarState>Expanded</controlBarState><isGridColorKnownColor>True</isGridColorKnownColor><gridColorName>Yellow</gridColorName></Settings> <?xml version="1.0"?><AllAnswers /> Improving safety and efficacy of opioid prescribing for pain in primary care William C. Becker, MD, FASAM Instructor Section of General Internal Medicine Yale University School of Medicine

2. Disclosure I have no potential or actual conflict of interest related to this presentation.

3. Learning objectives • To understand terminology related to use of opioids for chronic non-cancer pain • To appreciate the prevalence of chronic non-cancer pain, opioid prescribing and adverse events related to opioids • To review fundamental components of effective management of chronic non-cancer pain • To understand practical techniques for improving safety and efficacy of opioid prescribing for pain

4. Chronic Pain • Pain lasting most of the day during most days for > 3 months • Point prevalence in U.S. adults: 15-20% • Lifetime prevalence in U.S. adults: 50-75% • Pain is most often-reported symptom in office visits after URI • Multi-faceted disorder that, by definition, has bio- psycho- social components

5. Prescription opioids • Full opioid receptor agonists used to treat pain (acute and chronic) • e.g. morphine, oxycodone, hydrocodone, methadone, codeine, hydromorphone, fentanyl

6. Reward pathways

7. Adverse effects of opioids Addiction: compulsive substance use despite harm = DSM-IV dependence, at least 3 of the following: • Tolerance • Withdrawal • Greater amounts/longer period than intended • Persistent desire/unsuccessful efforts to cut down • Inordinate amount of time obtaining, using, or recovering • Important social, occupational or recreational activities given up or reduced due to substance use • Use continued despite knowledge of having a persistent or recurrent physical or psychological problem likely caused or exacerbated by substance Incidence in opioid treatment for pain:~2% per year Contrast with: “Physiologic Dependence”

8. Adverse effects, continued • Misuse  Use other than how prescribed: • To get high • More than prescribed • Selling, trading = “diversion”

9. Adverse effects, continued • “Drug-seeking Behavior”  requests for opioid medications for the purpose of getting high • “Aberrant Behaviors”  among patients on opioids for chronic pain, behaviors that may be indicative of misuse or addiction • Early refills • Frequent phone calls • Doctor shopping • Prescription forgery

10. Adverse effects, cont’d • Constipation • Nausea • Itching • Dizziness • Clouded mentation • Sedation • Falls • Overdose • Death

11. Annual sales of Rx opioids and unintentional overdose death1990 - 2006 Source: Paulozzi, CDC, Congressional testimony, 2007

12. How did we get here? • 1990s • Under-treatment of pain • Pain as the 5th vital sign • Pain as a human rights issue • Early data that opioid risks were low, some of which intentionally minimized • Interwined cultural and medical trend towards “a pill for what ails ya’”

13. Juggling? Balancing BENEFITS HARMS

14. Case 57 M w/ chronic low back pain for 15 years after being thrown out of a jeep • Worked as officer in NHPD until 50 • Lives with wife and 3 daughters, active in community • Admits to cocaine and speed for 1-2 years 25 years ago • Pain has been worsening and interferes with functioning • Dx based on hx/PE/MRI: spinal stenosis • You prescribe NSAIDS, capsaicin, physical therapy • After 8 weeks pt still experiencing significant pain that is negatively affecting function; you start opioids (MSContin 15 mg TID titrated to 30 mg TID) to good effect: improved pain and function • One month later, routine UDT positive for cocaine

15. What do you do now? We’ll get to that discussion but also… What should you have done in the first place?

16. Practical techniques for improving efficacy and safety of opioid prescribing

17. Where it all begins Comprehensive approach to high-quality management of chronic pain • Empathize, partner with the patient • Perform a complete history and physical • Set functional goals • Utilize shared decision-making • Employ multi-modal treatment plan • Employ rational polypharmacy When using opioids: • Follow the harm/benefit paradigm • Perform frequent monitoring, reassessment and DOCUMENTATION

18. Empathize/Partner with your patient “Identification with and understanding of another person's situation or feelings” Pain Loss of Function Depression Stress

19. Breaking the cycle • “You’ve been through a lot.” • “My goal is help *you* manage this better” – EMPOWER the patient to be the locus of control/change • “Your pain will not go away entirely. Our goal is to get better control of it.” • “Moving, stretching, activity will help you reach your goal.” • “Uncontrolled pain makes mood worse, bad mood makes pain worse – have to work on both.”

20. Complete history and physical • Region/systems involved • Quality of pain • Temporal characteristics • Degree of intensity • Time since onset This is the biological approach…. necessary but not sufficient

21. Biopsychosocial Model of Pain Overall functional status

22. Tumors Fractures Infection Cauda Equina Syndrome Addiction Suicidality Don’t Miss the Red Flags • ‘B’ symptoms: fever, weight loss, night sweats, malaise • Sudden focal neurologic symptoms • Acute worsening of chronic pain • Failing to thrive

23. Complete history and physical, cont’d Full standard exam plus: • Focus on function – • Watch the patient walk • Ask the patient to transition from seated to standing position • Ask the patient to stand on the floor, flex the back, extend the back

24. Set Functional Goals Functional Status: • What’s a typical day like? • What’s the most active thing you do? • Do you ever stay in bed all day? • Do you get any exercise? • How have these things changed over the past weeks/months/years? What would you (realistically) like to be able to do?

25. Utilize Shared-Decision Making • Uncontrolled chronic pain is found more often in patients who • Are passive • Catastrophize • Perceive an external locus of control • Counteract these by requiring the patient to make decisions and set goals with you.

26. Employ multi-modal approach Behavioral therapies SELF CARE SELF EFFICACY Pharmacologic treatment Physical activity

27. Employ Rational Polypharmacy • Anti-nociceptive agents • NSAIDs • Acetaminophen • Opioids • Anti-neuropathic agents • Anti-convulsants • Tricyclics • Anti-depressants

28. When Using Opioids, Follow the Harm/Benefit Paradigm CONTINUE IF BENEFIT OUTWEIGHS HARM. DISCONTINUE IF HARM OUTWEIGHS BENEFIT. Perform frequent monitoring, re-assessment and DOCUMENTATION

29. Initiating opioid treatment: When? When functional goals have not been achieved with non-opioid therapies (acetaminophen, ibuprofen, lidocaine, capsaicin, TCAs, gabapentin, physical therapy) New patient already on opioids

30. Initiating opioid treatment: Who? Active addiction (alcohol, illicit drugs, prescription medications) is a contraindication Risk factors for misuse that should prompt closer follow up but do not necessarily preclude opioid therapy Younger age Personal history of substance abuse Illicit, prescription, alcohol, smoking Family history of substance abuse Legal history (DUI, time in jail) Mental health disorders Patient who is showing engagement with process

31. Initiating opioid treatment: How? Therapeutic trial in the harm/benefit paradigm Set specific, functional goals Refer back to those goals to assess benefit Which medication? Long/short acting Strength Formulation Abuse potential

32. Informed consent Communication of risks, potential benefits, goals/expectations, and treatment and monitoring plans Written agreements or ‘contracts’ Educate patient about safe opioid use Clearly define acceptable behavior

33. Opioid treatment agreements Tone is important: “This is so you know what to expect from us and what we expect from you” “This is about keeping you safe” “We do this for all patients”

34. What should be in your OTA? What patient can expect of the practice: A good faith effort to manage patient’s pain What practice can expect of patient: No unsanctioned dose escalation No early refills No replacement for lost or stolen prescriptions Single prescriber Safeguard meds and no sharing Keep regular appointments Follow-through with referrals and adjuvant treatment No use of illicit drugs or non-prescribed controlled substances Urine drug testing Whom/When to call for refill If agreement not followed, may taper opioids off and/or refer to addiction treatment

35. Monitoring: the 5 A’s Analgesia – 11- pt Numeric Rating Scale Activities of daily living (function) – ‘Your goal was to get back in your walking routine. How is it going?’ Adverse effects: constipation, sedation, etc – ASK! Addiction/overuse – Is the patient oversedated? Does pt think he is addicted? Does the patient use other illicit drugs? Adhering to the treatment agreement

36. CT prescription monitoring program www.ctpmp.com Log of every scheduled medication filled in any Connecticut pharmacy Sortable by patient 1-2 week lag time

37. Urine drug testing Identifies more misuse than self-report or physician impression Which test to order? Immunoassay is screen Gas chromotography/mass spectroscopy for confirmation – would recommend doing this any time you get an unexpected result Always ask and document recent intake before sending test

38. How to discuss UDT “This is our routine practice.” “We want to ensure your safety.”

39. UTox8 • Federal “5” • Marijuana • Cocaine • Opiates • PCP • Amphetamine/ • methamphetamine • Plus • Methadone • Benzodiazepines • Barbiturates

40. Interpreting UDT • Common errors: • Standard Utox8 does not include oxycodone or fentanyl: you must include tests of medications patient is prescribed • In most cases, oxycodone will NOT cause opiate assay to be positive; however, it can in high doses. Therefore, you MUST do confirmatory testing • Hydrocodone metabolizes to hydromorphone so pt who takes hydrocodone may frequently have + hydromorphone on opiate GC/MS.

41. Responding to problems • Reassess • Document findings and plan • Structured risk management • Short courses and follow-up • Frequent UDT and/or pill counts • Referral to pain or addiction specialist • Taper off opioids

42. Stay in the harm/benefit paradigm • Explain how patient’s behavior or the outcome of the treatment is not in line with the treatment agreement. • Firm but empathic -- you will still work with pt on pain treatment and primary care • Pt is not bad; treatment is not effective, not safe, not appropriate. • Benefits no longer outweighing harms. “Cannot responsibly continue prescribing opioids as I feel it would cause you more harm than good.”

43. Case 57 M w/ chronic low back pain for 15 years after being thrown out of a jeep • After 8 weeks pt still experiencing significant pain that is negatively affecting function; you start opioids (MSContin 15 mg TID titrated to 30 mg TID) to good effect: improved pain and function • One month later, routine UDT positive for cocaine

44. What was done/should have been done in advance • Comprehensive approach to high-quality management of chronic pain • Treatment agreement: discussion with pt about risk and benefits • “Fair warning” that UDTs would be done • “Fair warning” that + UDT might mean discontinuing opioids • Practice-wide decision about how treatment agreement violations handled

45. What to do now? • Get GC/MS confirmation of any unexpected result • (if confirmed) Talk to patient, reveal result of test, ask him why he used • Show empathy but do not allow patient to dispute results • Show empathy but do not allow patient to shift blame: ‘I did it because my pain was out of control/you are not treating my pain’ • Based on practice policy, either begin opioid taper or ‘second chance’ with close monitoring (1-2 week follow up with UDT) • Consider addiction referral based on your assessment

46. Opioid Management: Summary If prescribed, opioids for chronic pain must be part of a comprehensive pain management plan Treatment agreements are useful to keep everyone on the same page Patients must be monitored for the 5 As Know the tools available to you for monitoring and how to use them Opioids should be continued when effective and safe, discontinued if ineffective or unsafe Use this harm/benefit paradigm to help you communicate with patient Document

47. Thank you

48. Managing opioids in Primary Care Brief Visits Complicated Patients Resources not meeting demand Fear of feeding into addiction/ safety problems Fear of Litigation Joint Commission Mandate to Manage pain Desire to relieve suffering Patient Expectations

49. Bibliography • Caudill-Slosberg et al. Pain (2004) • Davis WR, Johnson DB. Prescription opioid use, misuse, and diversion among street drug users in New York City. Drug and Alc Dep. 2008;92:267-276. • Fleming MF et al. J Pain. 2007 • Katz NP. Patient Level Opioid Risk Management. PainEDU.org Manual. 2007 • Olsen Y et al. J of Pain (2006); • Passik J Opi Manage 2005 • R.K. Portenoy, “Opioid Therapy for Chronic Nonmalignant Pain: Current Status,” in H.L. Fields and J.C. Liebeskind, eds., Progress in Pain Research and Management (Seattle: IASP Press, Vol. 1, 1994): at 267. • Monitoring the Future • National Survey of Drug Use and Health • Drug Abuse Warning Network • TEDS • Zacny JP, Galinkin JL. Psychotropic drugs used in Anesthesia Practice: Abuse Liability and Epidemiology of Abuse. Anesthesiology. 1999;90(1):269-288.

50. Addiction (Abuse/Dependence) Prescription Drug Misuse Aberrant Drug Related Behaviors (ADRB) A spectrum of patient behaviors that may reflect misuse Total Chronic Pain Population Adapted from Passik. APS Resident Course, 2007