Safe and Competent Opioid Prescribing

MILITARY Military Safe and Competent Opioid Prescribing Education (M-SCOPE) Program Safe and Competent Opioid Prescribing For Providers Working with Veterans and Military Service Personnel Daniel P. Alford, MD, MPH, Course Director Boston University School of Medicine and Boston Medical Center Karen H. Seal, MD, MPH San Francisco VA Medical Center and the University of California, San Francisco Emily Sachs, PhD San Francisco VA Medical Center and the University of California, San Francisco Tracy Lin, PharmD San Francisco VA Medical Center and the University of California, San Francisco 1

Module 2 Previously, in Module 1: John, our 42 year-old Iraq veteran with severe chronic low back pain from a combat injury on high dose opioids is requesting refills on this first visit We learned about opioid efficacy and safety and the potential benefits of multimodal approaches to chronic pain This first visit with John continues... 2

Module 2 Agenda Partnering and educating patients The VEMA (Validate, Educate, Motivate, Activate) model Universal Precautions in pain management Assessing pain, function and opioid misuse Determining appropriateness of opioid treatment Starting (or continuing) an opioid trial Re-assessing and adjusting opioid therapy Communicating effectively with patients 3

Facing the Challenge: Partnering and Educating 4

Validate, Educate, Motivate, Activate (VEMA) Validate Real pain Patient s experience and efforts Motivate Assist patient Educate toward Realistic readiness for expectations change From: I will fix it. to I will assist you in improving your functioning and QOL. Activate Collaborative goal-setting 5

Conversation Tips: VEMA Validate Validate Educate Motivate Activate 6

Opioid Management Clinical Practice Guideline (CPG) February 2017 7

Universal Precautions: Step 1 ASSESSMENT History, Exam, and Work-Up The Four A s of Pain Assessment: Analgesia Activity Level Physical and psychosocial functioning Adverse Effects Aberrant Behaviors 8

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Shows recent MRI of a bulging disk at L5-6 Otherwise physically healthy Had a bad experience with PT in the Army Epidural injections = minimal benefit Tried acetaminophen, ibuprofen, gabapentin and cyclobenzaprine without benefit 9

Building Trust Provider Issues Assume patient fears you think pain is not real or not very severe After you take a through pain history Show empathy for patient experience Educate patient about need for accurate pain scores to monitor therapy Validate that you believe pain is real Discuss factors which worsen pain and limit treatment (i.e. substance abuse, mental health) Believing a patient s pain complaint does not mean opioids are indicated 10

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Assess: Analgesia and Activity Level PEG Scale Assessment In the past week: Pain on average? 0 No pain Does not interfere 1 2 3 4 5 6 7 8 9 10 As bad as you can imagine Pain interfered with Enjoyment of life? 0 0 1 2 3 4 5 6 7 8 9 10 Completely interferes Pain interfere with General activity? Does not interfere 1 2 3 4 5 6 7 8 9 10 Completely interferes 11

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Assess: Analgesia and Activity Level PEG Scale Assessment In the past week: Pain on average? 0 No pain 1 2 3 4 5 6 7 8 9 10 As bad as you can imagine Pain interfered with Enjoyment of life? 0 Does not interfere 0 Does not interfere 1 2 3 4 5 6 7 8 9 10 Completely interferes Pain interfere with General activity? 1 2 3 4 5 6 7 8 9 10 Completely interferes 12

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Pain/Functional Assessment Summary Constant 8/10 LBP which shoots down legs; worsens with activity Pain negatively impacting mood, relationships, and QOL Current pain regimen helps a lot yet worsening pain and function; no adverse med effects 13

Assessing Risk Assess: Aberrant Behaviors and Risk for Adverse Outcomes Assess for Risk of Addiction/Misuse Opioid Risk Tool (ORT) is useful for predicting risk for aberrant drugrelated behaviors Obtain data from state prescription drug monitoring programs Obtain urine drug tests Assess for Risk of Adverse Outcomes Medical conditions in which opioids can exacerbate symptoms Co-prescription of benzodiazepines or other CNS depressants Acute psychiatric symptoms, suicidality 14

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Denies illicits (past/current); denies supplementing Drinks 1-4 beers a night to relieve pain but does not have a drinking problem PTSD diagnosis; clonazepam, no therapy Frequent nightmares, tired next day Avoids leaving home Denies suicidal ideation 15

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Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Opioid Risk Tool (adapted) Family history of substance abuse Female Male Alcohol q1 q3 Illegal drugs q2 q3 Prescription drugs q4 q4 Personal history of substance abuse ü Alcohol q3 q3 Illegal drugs q4 q4 SCORING 0-3 Low Risk 4-7 Mod Risk >7 High Risk Prescription drugs q5 q5 Age between 16-45 years q1 q1 History of preadolescent sexual abuse q3 q0 Psychological disease Webster LR, Webster RM. Pain Med. 2005 Nov-Dec;6(6):432-42. ü ADHD, OCD, bipolar, schizophrenia q2 q2 ü Depression, PTSD, anxiety q1 q1 17

Urine Drug Tests One data point that can provide info on: Limitations: Medication adherence Use or non-use of illicit drugs Urine concentrations vary with fluid intake and other PK variables Risk of false negatives due to high detection thresholds Risk of false positives due to cross reactions Risk of adulteration Unexpected findings should be sent for confirmation by gas chromatography/mass spectrometry (GC/MS) Reisfield GM, et al. Bioanalysis 2009 Aug;1(5):937-52. 18

Why Drug Test? Self-reported drug use among pain patients unreliable o Fleming MF, et al. J Pain 2007. o Fisbain DA, et al. Clin J Pain 1999. o Berndt S, et al. Pain 1993. Behavioral observations detects only some problems o Wasan AJ, et al. Clin J Pain 2007. o Katz NP, et al. Anesth Analg 2003. May improve adherence (e.g., decreased illicit drug use) o Pesce A, et al. Pain Physician 2011. o Starrels J, et al. Ann Intern Med 2010. o Manchikanti L, et al. Pain Physician 2006. Evolving standard of care o Chou R, et al. J Pain 2009. o Tescot AM, et al. Pain Physician 2008. o FSMB 2013 Gary M. Reisfield, M.D. International Conference on Opioids, June 11, 2012 19

Discussing Urine Drug Tests Review personal & public health risks of opioids Explain that urine drug screens are ordered for ALL patients who are prescribed opioids Set frequency of monitoring to match risk At least q6 months; more frequently if higher risk 20

Pill Counts Intended to: Confirm medication adherence Minimize diversion Strategy 28 day supply (rather than 30 days) Prescribe so that patient should have residual medication at appointments Ask patient to bring in medications at each visit For identified risks or concerns, can request random call-backs for immediate counts 21

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) ORT score is 5: moderate risk for opioid misuse Younger age and untreated PTSD increase risk for opioid misuse as well as adverse outcomes Clonazepam and EtOH increase risk for adverse outcomes Poor sleep may exacerbate pain Not exercising or using other non-opioid strategies UDT (+) for benzodiazepines as expected PDMP (-) for outside prescriptions as expected 22

Universal Precautions: STEP 2 DETERMINING APPROPRIATENESS OF OPIOID THERAPY Has patient failed a reasonable trial of non-opioid medication? Does patient have any absolute or relative contraindications to prescribing opioids? Do the benefits of opioids outweigh risks? 23

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Dr. Seal reviewed risks with John Agrees to Mental Health referral to further assess PTSD and EtOH use Agrees to taper off clonazepam under psych supervision and cut down on the drinking Agrees to more frequent monitoring 24

Use a Health-Oriented, Risk-Benefit Framework NOT Is the patient good or bad? Does the patient deserve opioids? Should this patient be punished or rewarded? Should I trust the patient? RATHER Judge the opioid treatment NOT the patient Nicolaidis C. Pain Med. 2011 Jun;12(6):890-7. 25

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Long h/o opioid therapy, currently in withdrawal Failed many non-opioid trials Moderate risk for misuse; some risk for adverse events Protective factors; agreeable to risk mitigation steps No absolute contraindications 26

Use of Opioid Therapy While opioids should never be first-line therapy for chronic pain, if they are used, it is critical to understand how to use them to maximize benefit and minimize harm. 27

Universal Precautions: STEP 3 STARTING A TRIAL OF OPIOID THERAPY Principles of Choosing Opioids Patient Education: Setting Expectations Opioid Pain Care Agreement 28

Choosing Opioids: Choose options that best meet your patient needs individualize treatment 29

Opioid Choice Immediate Release (IR/SA) Morphine Hydrocodone Hydromorphone Oxycodone Oxymorphone Tramadol Codeine Extended Release / Long-acting (ER/LA) Morphine Hydrocodone Hydromorphone Oxycodone Oxymorphone Tramadol Methadone Fentanyl transdermal Buprenorphine transdermal 30

IR/SA Opioids When to Consider No opioid tolerance/opioid naïve Intermittent or occasional pain Start with non-opioid and non-pharmacologic modalities for breakthrough pain 31

ER/LA Opioids When to Consider Opioid tolerance exists Constant, severe, around-the-clock pain is present To stabilize pain relief when patient using multiple doses IR/SA opioids 32

Theoretical Concern with IR/SA Opioids Opioid Concentration Increased Side effects Comfort Withdrawal Opioid Withdrawal-Mediated Pain Pain Pain Pain Pain Opioid Opioid Opioid Opioid 33

Theoretical Benefit of ER/LA Opioids Opioid Concentration Increased Side effects Comfort Withdrawal Opioid Opioid 34

Exploit Synergism Morphine, Gabapentin, or Combination for Neuropathic Pain 7 Score for Pain Intensity 6 5 4 3 2 1 Dosage (mg) 2500 2000 1500 1000 500 Gabapentin 50 40 30 20 10 Morphine 0 Baseline With Placebo Gabapentin Morphine Combination 0 Single Agent Combination 0 Single Agent Combination Gilron I, et al. N Engl J Med. 2005 Mar 31;352(13):1324-34. 35

Conversation Tips: VEMA Educate Validate Educate Motivate Activate 36

Opioids and Unrealistic Expectations Patients often have unrealistic expectations that Opioids always equal chronic pain relief therefore more opioids equal more pain relief Which often results in unsanctioned dose escalation or continued requests for higher doses Need to re-educate: Realistic goals Potential severe risks and harm with opioids Alford DP. JAMA. 2013 Mar 6;309(9):919-25. 37

Patient Education Set Realistic Patient Expectations Goal Education Pain Reduction Total pain relief is unlikely Goal with meds is to take the edge off and reduce the pain by 30-50% Improve Function Focus on: functioning, quality of life Minimize SEs/Risk Educate about potential SEs and risks Opioid therapy is a trial 38

Tool for Providers Educating Patients 39

Opioid Pain Care Agreement 40

Opioid Pain Care Agreement 41

Opioid Pain Care Agreement (OPCA) Mutually agree on: Pain management goals Opioid & non-opioid and non-pharm strategies Monitoring Frequency of follow-up visits (Q1-4 weeks after dose adjustments, Q6 months otherwise) Response to aberrant behavior Fishman SM, Kreis PG. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S70-5. Arnold RM, Han PK, Seltzer D. Am J Med. 2006 Apr;119(4):292-6. 42

Opioid Pain Care Agreement (OPCA) Agreement also emphasizes: One prescriber, one pharmacy Use only as directed Refill/renewal policies No diversion, sharing or selling Safe storage; protect from theft Fishman SM, Kreis PG. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S70-5. Arnold RM, Han PK, Seltzer D. Am J Med. 2006 Apr;119(4):292-6. 43

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Given Taking Opioids Responsibly Signed Opioid Pain Care Agreement Agreed to UDT at return and at least 2x/year Sleep hygiene reviewed Importance of mental health f/u reinforced Agreed to PT referral Agreed to follow-up in four weeks New ER/LA morphine 30 mg TID IR/SA oxycodone 5 mg Q8h PRN pain Add: diclofenac 75 mg BID Prior ER/LA morphine 60 mg TID IR/SA oxycodone 10 mg Q6h PRN pain 44

Care Coordination Collaboration with psychiatry PTSD Inappropriate benzo treatment Drinking Request of psychiatry: Taper benzo Monitor drinking, consider Substance Abuse Treatment Consider SNRI Good mood management is good pain management Invite further collaboration 45 45

Universal Precautions: STEP 4 RE-ASSESSMENT AND ADJUSTMENT Review four A s Repeat monitoring strategies Follow up on referrals Analgesia Activity Level Adverse Effects Aberrant Behaviors PEG Scale Urine Drug Tests Pill Counts 46

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) John walks in 3 weeks later, out of meds Self-increased morphine and oxycodone Increased drinking Rates pain as 8/10; QOL and functioning unchanged Missed PT appt, never started NSAID Finds PTSD therapy helpful Requests increase in MS Contin to match old dose PCP brings wife in; finds additional risk Intoxication, benzo, suicidal ideation 47

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Aberrant Medication Taking Behaviors Differential Diagnosis Pain Relief Seeking Disease progression Poorly opioid responsive pain Withdrawal mediated pain Opioid analgesic tolerance Opioid-induced hyperalgesia Pain Relief and Drug Seeking Likely most common scenario e.g. pain with comorbid addiction, patient taking some for pain and diverting some for income Drug Seeking Addiction Other psychiatric diagnosis Criminal intent (diversion) Alford DP. JAMA. 2013 Mar 6;309(9):919-25. 49

Lack or Loss of Benefit Reassess multiple factors affecting pain Re-attempt to treat underlying cause of pain and co-morbidities Avoid increasing opioids in setting of aberrant behavior Consider adding or increasing adjuvant medications or treatments for synergy 50

Tapering Strategies A slow taper is recommended for patients who exhibit opioid physical dependence (in cases of diversion or OD risk, may just need to stop) A dose reduction of 20-50% of the original dose per 1-2 weeks is usually well tolerated Consider using adjuvant medications for pain during taper 51

Tapering Care Package Clonidine 0.1 mg PO q4-6h PRN sweating, tremors, or agitation (off label) NSAIDs for aches and pains Antidiarrheals (e.g. loperamide, bismuth) Antiemetics (e.g. prochlorperazine, ondansetron) Anti-histamines (e.g. hydroxyzine, diphenhydramine) or trazodone for insomnia DO NOT ADD BENZOS! 52

Conversation Tips: VEMA Motivate Validate Educate Motivate Activate 53

Discussing Concerns Stay in the Risk/Benefit mindset: Do not have to prove addiction/diversion. Re-Assess risk-to-benefit ratio. When benefits no longer outweigh risks, may need to discontinue opioids I cannot responsibly continue to prescribe opioids because I feel that they are causing you more harm than good. You may not reach agreement: I hear what you re saying. Unfortunately we may have to agree to disagree on this. Rupture is sometimes part of the treatment relationship. Emphasize that you will not abandon your patient: I remain committed to working with you to manage your pain. Offer referrals: I can bring in a colleague of mine. Consider medication-assisted treatment (i.e., methadone, buprenorphine) for severe opioid dependence 54

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Dr. Seal refuses to prescribe more opioids and suggests the following: An opioid taper and adding medications to alleviate withdrawal symptoms Non-opioid medications for pain Substance abuse treatment John is not happy 55

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Conversation Tips: VEMA Activate (Goal Setting) Validate Educate Motivate Activate 57

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Self-management goals: Track daily dosing Take supportive meds PRN and track Coordinate w/ mental health; bring wife to discuss taper and EtOH Practice relaxation daily Reinforce at follow-up 58

Case Study: John 42 year-old Iraq veteran with chronic low back pain (LBP) Debrief Difficult, yet common, scenario Use of the risk-benefit framework Discontinue opioids if lack of benefit and/or apparent harm Keep the door open for the patient to receive nonopioid treatments for chronic pain 59

Module 2 Summary Use a comprehensive pain and opioid risk assessment Educate patients and individualize plan of care Monitor patients for benefits and harm Aberrant medication taking behavior can indicate poor pain control, or drug-seeking, or both Document your decision-making process 60