A Review of Considerations in the Assessment and Treatment of Pain and Risk for Opioid Misuse Follow-up Q & A Webinar with Case Discussions

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1 A Review of Considerations in the Assessment and Treatment of Pain and Risk for Opioid Misuse Follow-up Q & A Webinar with Case Discussions Presented by: Kevin A. Sevarino, MD, PhD, PCSS-O Medical Director November 13,

2 Kevin A. Sevarino, Disclosures Shareholder in GlaxoSmithKline (<10K) Support from SAMSHA for medical directorship of PCSS-O Honoraria for lectureships in AAAP Addictions and their Treatments course. No conflicts with this presentation. Where off-label use of medication is discussed, it will be disclosed. 2

3 Planning Committee, Disclosures AAAP aims to provide educational information that is balanced, independent, objective and free of bias and based on evidence. In order to resolve any identified Conflicts of Interest, disclosure information from all planners, faculty and anyone in the position to control content is provided during the planning process to ensure resolution of any identified conflicts. This disclosure information is listed below: The following developers and planning committee members have reported that they have no commercial relationships relevant to the content of this webinar to disclose: AAAP CME/CPD Committee Members Dean Krahn, MD, Tim Fong, MD, Tom Kosten, MD, Joji Suzuki, MD; and AAAP Staff Kathryn Cates-Wessel, Miriam Giles, Sharon Joubert Frezza and Justina Andonian. All faculty have been advised that any recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in the presentation must conform to the generally accepted standards of experimental design, data collection, and analysis. Speakers must inform the learners if their presentation will include discussion of unlabeled/investigational use of commercial products. 3

4 Target Audience The overarching goal of PCSS-O is to offer evidence-based trainings on the safe and effective prescribing of opioid medications in the treatment of pain and/or opioid addiction. Our focus is to reach providers and/or providers-intraining from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators. 4

5 Educational Objectives At the conclusion of this activity participants should be able to: o Summarize two case presentations, which highlight ways on how to assess and treat patient pain, and to reflect on the possible risk for opioid misuse. o Review questions regarding prescribing opioids, and evaluating patients with possible substance use disorders or those who are at risk of developing opioid misuse. 5

6 Overview Two case presentations followed by a five minute question period for each. Review of unanswered questions from the original presentation. 6

7 Case No. 1 Suboxone for Pain A 64 year old Caucasian male presents to your psychiatric office reporting his insurance carrier no longer covers his previous PCP and his new PCP will not prescribe the pain medication he had been on before. The patient had been maintained on Oxycontin 80 mg BID and oxycodone 20 mg q4 hrs prn for several years for failed back syndrome (2 failed vertebral fusions). He is also on cyclobenzaprine 10 mg TID and diazepam 5 mg tid prn for spasms. The patient reports he has only three days left of his opioid pain medications, and the new PCP had suggested he be evaluated for Suboxone for pain management. 7

8 Case No. 1 What do you, an addiction specialist, do? 1. Tell the patient Suboxone is not used for pain and tell him you cannot accept the case. 2. Explore with the patient the reasons the new PCP was resistant to prescribing the opioid pain medications. 3. Tell the patient you d be happy to start him on Suboxone. 8

9 Case No. 1 FDA Indications for buprenorphine/naloxone products Bup/nal sublingual tablets are indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. 9

10 Case No. 1 Is it Legal to Prescribe buprenorphine/naloxone products (e.g. Suboxone or Zubsolv) for Pain Management? Yes, but it IS an off-label use. PCPs and other physicians for whom pain management is within their scope of practice can prescribe these formulations for pain WITHOUT a DEA waiver. 10

11 Case No. 1 - Considerations a. Most physicians do not know they can prescriber buprenorphine/naloxone or methadone for pain without a waiver. b. Most PCPs are not comfortable using either agent for pain management. c. As a psychiatrist, one should determine whether an opioid use disorder exists before prescribing buprenorphine/naloxone under your DEA X-number. 11

12 Case No. 1 So What do you do? 1. Tell the patient Suboxone is not used for pain and tell him you cannot accept the case. 2. Explore with the patient the reasons the new PCP was resistant to prescribing the opioid pain medications. 3. Tell the patient you d be happy to start him on Suboxone. 12

13 Case No. 1 Next Steps: 1. You cannot determine whether you can assist in this patient s pain management without a thorough history, including substance use disorder history. 2. Sending the patient away without further understanding the case may contribute to opioid-induced harms (illegal purchase, doctor shopping, overdose etc.) 13

14 Next Steps: Case No Pain management is often done poorly in this country as testified by countless people in pain and distress because of either overuse or underuse of opioids despite medical care. 4. IF you determine the PCP might appropriately manage the pain, your job is not over as you may be the only one to help this patient get adequate treatment. 14

15 Evaluation of Pain to Minimize Requirements: Opioid Misuse A medical history and physical evaluation Document nature/intensity of pain Underlying diseases/conditions Physical and psychological function History of substance abuse Documentation of presence of medical indications for controlled substance use o FSMB Model Policy for Use of Controlled Substances in Treatment of Pain 15

16 Evaluation of Pain Ask the patient about their pain listen to their answer Connect with the patient-take the time to listen to what the patient says and behavioral cues: reflective listening How is the pain experienced physically: how/when it started, location, character, better/worse, lowest/highest during day on scale of 0-10, usual severity of pain on a typical day, what s been tried, what s helped or not Effect on sleep, mood, ability to work, effect on personal life Litigation related to condition? Expectations of pain medication(s) on analgesia or recovered function? 16

17 Psychosocial Aspects of Pain Consider psychosocial contributors: Psychiatric comorbidities Non-organic signs: Widespread pain at multiple sites; somatization Demographic variables: age, gender, weight, education status, smoking status, SES Work factors: worker s comp, satisfaction at job, physical demands Maladaptive coping strategies: those who have greater fear, who catastrophize (overly focus on pain and negative thoughts regarding ability to cope) may experience pain as more severe; avoid activity that may worsen pain leading to greater disability Psychosocial factors are most strongly correlated with low back pain outcomes Chou and McCarberg,

18 Case No. 1 Key Questions So you take a history to determine: a. Is there evidence for an opioid use disorder or other substance use disorder? b. What has been the prior history of pain management? What is the nature of the pain? c. Are there co-morbid psychiatric conditions? 18

19 Screening Patients for Drug Misuse/Addiction: No group/population or setting definitively identified as likely to abuse, so use universal precautions and explore risks of misuse with all patients to receive opioid therapies However, the most reliable predictors of future abuse are family history of or individual history of a substance use disorder Some patients may resent this approach; important to explain that: SUDs are common; use of drugs with abuse liability may raise risk; SUDs are treatable and patients will benefit from treatment; all patients are screened in same manner 19

20 Use a Survey Instrument to Assess Risk of Opioid Use Administration On initial visit Prior to opioid therapy Opioid Risk Tool (ORT) Scoring 0-3: low risk (6%) 4-7: moderate risk (28%) > 8: high risk (> 90%) 20 Webster & Webster. Pain Med. 2005;6:432.

21 Identification of Prescription Narcotic Abusers Deterioration in home/work Resistance to changes in therapy Use of drug by injection or nasal route Early refills Lost/stolen prescriptions Doctor shopping (check PMP) Prescription forgery Abuse of other substances Frequent ED visits Unauthorized dose increases Seeks specific drug Nonmedical use Refuses UDS/referral to specialist 21

22 Identification of Prescription Narcotic Abusers Important to recognize that not all aberrant behaviors are equal: e.g.: running out of medication a day or two early is not the same as prescription forgery Important to try to assess the underlying cause of the aberrant behavior is the pain under-treated; is there a co-occurring mental disorder (depression/anxiety), are there other signs of misuse occurring Try to address the individual patient needs; educate patient regarding use of medications; try other approaches to pain management when indicated; if behaviors are sociopathic enforce treatment agreement which gives a means by which to stop prescribing/refer out 22

23 Case No. 1 You determine there is evidence of the patient seeking early refills by a few days each month. Your patient has not obtained outside scripts or illegal opioids. There is no personal or family history of an opioid use disorder, though a paternal uncle was an alcoholic. 23

24 Case No. 1 a. Your patient is engaged with physical therapy, though he perceives it sometimes worsens his pain. b. Your patient has been on opioids and muscle relaxants, including a current script for diazepam. He has never been on an antidepressant, anticonvulsants or topical treatments. c. On opioids your patient s pain is constant but tolerable, and he is gainfully employed. 24

25 Case No. 1 a. You find your patient is overweight and suffers from marked sleep disruption. b. Your patient meets DSM-5 criteria for a moderate major depressive episode. c. Your patient s marriage has been adversely affected by his wife s perception he s an addict because he focuses so much on his pain medication refills. 25

26 Case No. 1 a. You determine your patient does not meet criteria for a past or present substance use disorder. b. Your patient has engaged in some alternative therapies for pain management though you have ideas about other medications that might be helpful. c. Your patient has co-morbid depression, a possible sleep disorder, and possibly under-treatment of his pain. 26

27 Case No. 1 - Conclusions a. You conclude there isn t a clear reason why full agonists could not be prescribed to this patient. b. You obtain a release of information, including the specifier that drug abuse information will be discussed, and tell the patient you will discuss coordinated care with his new PCP. c. Your goals of contact discuss whether opioids will be used and why or why not, discuss safe opioid prescribing practices, discuss addressing the sleep disorder, ask if there is evidence for a neuropathic pain component, and discuss your plan to start and antidepressant such as duloxetine, venlafaxine or a TCA. 27

28 For the Patient Needing Chronic Opioid Therapy: What s the Best Path? Check urine drug screen initially and periodically: Illicit drug use highly correlated with opioid abuse/addiction Confirm use of the drug you re prescribing Point of Service vs. Clinical Lab (GC/MS confirmation) Pill Counts Periodic review: Evidence of analgesia Treat side effects Enhanced social/employment functioning Overall improved quality of life Consultation: Pain specialists Psychiatrist (co-occurring mental illness is common) Addiction specialist 28

29 Case 1 Five Minute Discussion 29

30 Case No. 2 a. You work in an integrated primary-care mental health setting and you walk a patient over to the psychiatrist. b. Your report: My patient has urine drug screen showing he has no oxycodone in his urine (prescribed Percocet), but has morphine I m not sure what s happening. Your gut is to fire the patient. c. The patient accuses the doctor of patient abandonment and tearfully sits down with the psychiatrist. 30

31 Case No. 2 a. The patient is a 35 year old CNA who suffered onset of back pain with radiculopathy 2 years ago and soon thereafter went out on disability. b. There is no clear indication for surgical intervention (per a consultation), and your patient has required increasing doses of opioids to manage chronic 10 out of 10 pain. c. Your patient has reported attempts at PT and use of gabapentin and NSAIDs have been unhelpful, and she will not try those hokey therapies like acupuncture and yoga. 31

32 Case No. 2 a. Currently you patient is maintained on Oxycontin 40 mg bid and 1-2 Percocet q6h prn (#240/month which she says runs out by the third week). b. Your patient has been consistently positive for cannabis, which she says she needs for pain control and for which she has obtained a medical marijuana card. c. Your patient is nearing conclusion of her Worker s Compensation case, and is seeking Social Security Disability for permanent disability. d. You have had a family meeting with your patient and her husband, because he has had it with her lack of involvement in child care or household chores. 32

33 Case No. 2 a. You have had to fill scripts early, with the claimant tearfully saying she tries but can t seem to cut down. b. Occasionally your patient has come up benzodiazepine positive in her urine drug screens and you have counseled her on the hazard this presents. c. The psychiatrist, with direct questioning, elicits a prior history of heroin use and a family history of drug abuse in both parents. She has a history if childhood sexual and physical, abuse. The claimant says she has had to use heroin (snorting) when she runs out of Percocet. d. Do you think this patient has an opioid use disorder? 33

34 Case No. 2 UDS Interpretation Drug Taken Common Opiate Metabolites Found in Urine by GC/MS Less Common Metabolites Heroin (DAM) 6-MAM, Morphine, Codeine Oxymorphone, Norcodeine Morphine Morphine Oxymorphone Codeine Codeine, Morphine Norcodeine Hydrocodone Hydrocodone, Hydromorphone Norhydrocodone Hydromorphone Hydromorphone Oxycodone Oxycodone, Oxymorphone Noroxycodone Poppy Seeds Codeine, Morphine Norcodeine 34

35 Case No. 2 Urine Toxicology What do the UDS results mean: 1. Most screens now include oxycodone as a separate test from natural opioids (morphine, codeine). 2. If one is prescribed oxycodone, it should be in the urine. The patient either is diverting, or runs out early. 3. One must understand opioid catabolism to decipher UDS results. 6-MAM is specific for heroin, and many compounds break down to morphine. 35

36 Use a Survey Instrument to Assess Risk of Opioid Use Administration On initial visit Prior to opioid therapy Opioid Risk Tool (ORT) Scoring 0-3: low risk (6%) 4-7: moderate risk (28%) > 8: high risk (> 90%) 36 Webster & Webster. Pain Med. 2005;6:432.

37 DSM-5 Criterea for a Substance Use Disorder A maladaptive pattern of substance use leading to significant impairment or distress, as manifested by 2 (or more) of the following within a 12-month period: 1. recurrent substance use resulting in a failure to fulfill major role obligations 2. recurrent substance use in situations in which it is physically hazardous 3. continued substance use despite having recurrent social or interpersonal problems 4. need for markedly increased amounts to achieve intoxication/ desired effect 5. markedly diminished effect with continued use of same amount (not counted for prescribed medications) 6. withdrawal (not counted for prescribed medications) 7. substance taken in larger amount/longer period than intended 8. persistent desire or unsuccessful efforts to control substance use 9. great deal of time spent to obtain, use or recover from effects 10. important activities are given up or reduced 11. use continues despite knowledge of physical/psychological problem, and 12. craving or a strong desire or urge to use the substance. 37

38 Case No. 2 Red Flags A number of red flags have been identified for use of opioids in pain control in this case: 1. High risk of aberrant behavior 2. Evidence of diversion/misuse 3. Unclear evidence pain generator requires full agonists and poor evidence of improvement in function on them 4. Psychosocial stressors contributing to pain not addressable by opioids (co-morbid diagnoses, ongoing litigation) 38

39 Case No. 2 Next Steps 1. The patient has relapsed to heroin so needs referral to substance abuse treatment. 2. Such treatment will include opioid detoxification just cutting the patient off without such referral leaves patient at risk for illegal activity, overdose etc. 3. Once acute phase of substance abuse treatment completed, a new pain management plan must be developed that almost certainly will not include opioids, unless these are for maintenance. 39

40 Case 2 Five Minute Discussion 40

41 Unanswered Question #1: How frequently is buprenorphine prescribed for pain? Unclear exact numbers jury is out regarding it s efficacy but anecdotally I have about 50% success in treating comorbid pain and opioid use disorder with the agent. In V.A. it is not approved for pain management alone and again, it is an OFF-LABEL use of the agent (this does not apply to not Buprenex or BuTrans) 41

42 Unanswered Question #2: Will I be investigated by my state s medical board or the DEA for such a use of buprenorphine for pain? Not if you are: 1. within your scope of practice to treat the condition, 2. you are licensed to prescribe schedule III controlled substances, 3. you have ruled out the presence of an opioid use disorder AND you have a prescribing waiver if you are using it to treat an opioid use disorder, and 4. you follow best practices in using any opioid to treat pain. 42

43 Unanswered Question #3: Suggestion made to do an SBIRT? Yes screening, brief intervention and referral for treatment should be done in any pain case, given the high risk of co-morbid substance abuse issues. This can be considered part of our universal precautions. Remember, SBIRT now has specific mechanisms for billing: see the Institute for Research, Education and Training in Addiction site for your state s procedures. 43

44 References American Pain Foundation. Accessed March 2010 Ballantyne J, Mao J. Opioid therapy for chronic pain. N Engl J Med. 349: Banta-Green C, Merill J, Doyle S, Boudreau D, Calsyn D. Opioid Use Behaviors, mental health and pain development of a typology of chronic pain patients. Drug and Alcohol Dependence 104: 34-42, Banta-Green C, Merrill J, Doyle S, Boudreau D, Calsyn D. Measurement of opioid problems among chronic pain patients in a general medical population. Drug and Alcohol Dependence 104: 43-49, Bohnert A, Valastein M, Bair M, et al.: Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA 305 (13): ,

45 References Boscarino J, Rukstalis M, Hoffman S, et al. Risk factors for drug dependence among out patients on opioid therapy in a large US healthcare system. Addiction 105: , Catalano R, White H, Fleming C, Haggerty K. Is nonmedical prescription opiate use a unique form of illicit drug use? Addictive Behaviors 36: 79-86, Chen Y, Sommer C. Activation of the nociceptin opioid system in rat sensory neurons produces antinociceptive effects in inflammatory pain: involvement of inflammatory mediators J.Neurosci. Res. 85 (7): Chou R, Fancuillo GJ, Fine PG, et al.: Clinical guidelines for use of chronic opioid therapy in chronic non-cancer pain. J Pain 10 (2): , Chou R, McCarburg B: Managing acute back pain patients to avoid the transition to chronic pain. Pain Manage. 1 (1): 69-79,

46 References Dunn K, Saunders K, Rutter C, et al.: Overdose and prescribed opioids: Associations among chronic non-cancer pain. Ann Int Med 152(2): 85-92, Fishman S: Responsible Opioid Prescribing; A Physician s Guide, Fleming M, Balousek S, Klessig C, Mundt M, Brown D. Substance use disorders in a primary care sample receiving daily opioid therapy. J Pain. 8: , Fu X, Zhu ZH, Wang YQ, Wu GC. Regulation of proinflammatory cytokines gene expression by nociceptin/orphanin FQ in the spinal cord and the cultured astrocytes. Neuroscience 144 (1): Gomes T, Mamdani M, Dhalla I, Paterson M, Juurlink D: Opioid dose and drug related mortality in patients with non-malignant pain. Arch Intern Med 171(7) ,

47 References Institute of Medicine: Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research Mitra S. Opioid-induced hyperalgesia: pathophysiology and clinical implications. J Opioid Manag 4(3): National Institutes of Health. New Directions in Pain Research National Survey of Drug Use and Health, SAMHSA, Rockville, MD 2006, 2010 Okuda-Ashitaka E, Minami T, Matsumura S, et al. The opioid peptide nociceptin/orphanin FQ mediates prostaglandin E2-induced allodynia, tactile pain associated with nerve injury. Eur. J. Neurosci. 23 (4):

48 References Passik S, Kirsh K. Managing pain in patients with aberrant drug-taking behaviors. J Supportive Oncology. 3(1): Skurtveit S, Furu K, Bramness J, Selmer R, Tverdal A: Benzodiazepines predict use of opioids a follow up study of 17,074 men and women. Pain Med. 11(6): Webster LR, Webster RM, Predicting abberant behaviors in opioid-treated patients: preliminary validation of the Opioid Risk Tool. Pain Med. 6(6):

49 PCSS-O Colleague Support Program and Listserv PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications. PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management. Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties. The mentoring program is available at no cost to providers. For more information on requesting or becoming a mentor visit: Listserv: A resource that provides an Expert of the Month who will answer questions about educational content that has been presented through PCSS-O project. To join pcss-o@aaap.org. 49

50 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN), and International Nurses Society on Addictions (IntNSA). For more information visit: For questions pcss-o@aaap.org Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. H79TI023439) from SAMHSA. The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement 50 by the U.S. Government.

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