2015 American Academy of Neurology

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2 Prescribing Opioids for Pain in the Era of Changing Pain Management Guidelines Miroslav Misha Bačkonja, MD Department of Neurology University of Wisconsin, Madison Department of Neurology University of Washington, Seattle Worldwide Clinical Trials, Morrisville NC

3 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of Physicians (ACP), 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), International Nurses Society on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training (SECSAT). 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. 5H79TI025595) 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 by the U.S. Government.

4 Dr. Backonja has received personal compensation for employment through WorldWide Clinical Trials, and for consulting with Biogen, Celgene, and WEX Pharma. This presentation may include information on unlabeled use of products. There is no commercial support for this series to disclose. AAN will be providing webinars free of cost, for CME. This material has been reviewed by the lead Clinical Expert on the PCSS-O grant, co-faculty, and AAN staff. Webinars will be available on-demand for participants unable to make the live event American Academy of Neurology

5 Accreditation Statement The American Academy of Neurology Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. AMA Credit Designation Statement The American Academy of Neurology Institute designates this live activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity American Academy of Neurology Slide 5

6 Objectives Discuss some of the critical pharmacological properties of opioids as analgesics Review issues and concerns that need to be addressed before and at the time of initiating opioid prescribing Discuss strategies for discontinuation of treatment with opioids 2016 American Academy of Neurology Slide 6

7 Putting Things Into Perspective > 100 million suffer from pain > $ 600B in Economic impact CDC Surge in opioid overdose deaths Institute of Medicine Report Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research.

8 *Updated 2017

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14 Practical Issues and Questions What to prescribe to patients with chronic pain when everything used in pain management works equally not that well? When and how to prescribe opioids analgesics, to develop and implement treatment plan with opioids, and when and how to discontinue opioids.

15 Efficacy of Opioid Analgesics for NP Evidence from Randomized Clinical Trials Authors conclusions There was insufficient evidence to support or refute the suggestion that morphine has any efficacy in any neuropathic pain condition.

16 ~20% remained at 3 years ~40% discontinued: SE s Mean dose: 56mg/d Range: mg/d

17 When and how to prescribe long-term opioid therapy for chronic pain? Pain is severe and it is interfering with daily functioning and cannot be treated with other modalities Address concern and side effects There are no contraindications: uncontrolled comorbidities - specifically psychiatric: anxiety, insomnia, depression, bipolar disorder allergy known addiction

18 Case Study 1: The Good 37 y.o. roofer suffered traumatic injury to his left eye which after multiple surgical attempts to save it, lead to enucleation. He had severe sharp pain in his left orbit reminiscent of the pain from original injury, which was diagnosed as phantom eye pain. He was prescribed codeine/apap 60/500mg QID with good pain relief for duration of 3-4 hours, after which his pain would worsen, then he had to slow down. He was switched to morphine 30mg ERT PO BID, experiencing improvement almost no pain with no side effect. He has been able to continue working full time as a roofer.

19 Concerns about Opioids Adverse effects: numerous most are persistent Long-term efficacy: not well demonstrated numerous AEs Societal issues: abuse addiction diversion

20 Acute Opioid Analgesic Therapy Adverse effects Respiratory depression opioid naive patients most at risk close monitoring is critical to prevent overdose Systemic Psychological Cognitive GI GU Pain dry mouth, pruritis sedation vs. elation/energizing mental clouding nausea, vomiting, constipation urinary retention opioid induced hyperalgesia

21 Acute Opioid Analgesic Therapy Adverse effects Hormonal female amenorrhea male low testosterone female and male negative effect on bone health Immune Neurological multiple but not all well defined opioid induced hyperalgesia (OIH) myoclonus

22 Acute Opioid Analgesic Therapy Adverse effects Psychological sedation, depression misuse, abuse addiction GI GU Most serious constipation, nausea urinary retention overdose death

23 Why not to prescribe opioids overdose Adverse effects uncertainty about long term efficacy elation constipation sedation addiction Adverse effects hypogonadism sleep disorders opioid induced hyperalgesia dry mouth Adverse effects abuse distraction from engaging in non-drug therapies

24 Chronic Opioid Analgesic Therapy Goals of Pain Therapy More Likely to Succeed It is crucial to establish realistic treatment goals: Partial pain relief - cure of pain desired but not realistic Improved coping skills relaying on opioids as a sole pain management strategy is not an acceptable coping skill Improved function and QOL Duration and end of therapy to be establish at the start Goals should be written down

25 Initiating opioid long-term analgesic therapy Indication chronic pain not relieved with specific therapies e.g. neuropathic pain not relieved by neuromodulators or MSK pain not relieved by TCAs/SNRIs and physical therapy modalities; physical therapy modalities; psychological approaches (cognitive behavioral therapy, mindfulness meditation..); stimulation therapy (spinal cord stimulation)

26 Initiating opioid long-term analgesic therapy Prerequisite treatment goals identifying the criteria for success have to be spelled out: treatment goals: acceptable degree of analgesia, improvement of function and QOL plan includes non-drug therapies as a goal monitoring (including urine testing) and frequent reassessment of the plan plan for discontinuation ongoing documentation Pain treatment agreement should be the check-list and reminder what needs to take place when prescribing opioids

27 Discontinuing opioid long-term analgesic therapy Plan for discontinuation: periodic (every few week) assessment of analgesia and function when treatment goals are not met how are non-drug therapies utilized in most cases discontinuing opioids could be done safely on outpatient basis using slow taper down ongoing documentation

28 Case Study 2: The Bad 45 y.o. attorney suffered trauma to his lower back during bicycle race. He had decompression and spinal fusion surgery. In spite of successful surgery he had persistent severe aching pain in his back, sharp pain shooting down his left leg and burning pain in his left leg and foot; he was diagnosed with radicular low back pain. After series of spinal injections that provided modest short lived improvements in shooting pain. He started a course of physical therapy, which he continued at home on his own. He was prescribed gabapentin, nortriptyline and morphine 60 mg ERT TID.

29 Case Study 2: The Bad 45 y.o. attorney with radicular low back pain (continued) He reported that morphine ERT provided best pain relief and within 2 months dose increased to 150 mg PO TID, because a bit more pain relief allowed him to sleep. He consistently called early each month with report that he ran out because he had another episode of breakthrough pain. He returned to work and had difficulties keeping his work schedule. After multiple recommendations for evaluation by a psychologist he did see one who identified that patient was treating his anxiety and panic attacks by escalating dose of morphine and sometimes just for kicks. Morphine was tapered down and discontinued.

30 Patients with chronic non-cancer pain have pain flare-ups, not breakthrough pain!!!

31 Chronic Opioid Analgesic Therapy(COAT) How are opioids similar? Short-acting: fentanyl, morphine, hydrocodone, oxycodone, oxymorphone, hydromorphone, tramadol, tapentadol Long-acting (by design): morphine, fentanyl, oxycodone, oxymorphone, hydromorphone, tapentadol Also by their properties: methadone, levorphanol Combination preparations: hydrocodone/apap ; oxycodone/apap, oxycodone/asa All of them are opioids/analgesics, same side-effect profile Each individual patient has different tolerability of any of these opioids = opioids are same, patients are not

32 Chronic Opioid Analgesic Therapy(COAT) How are opioids different? Short-acting: half-life of 2-3 hours, analgesia 2-4 hours Caveat: anticipate uneven pain relief for patients who have pain 24/7, also can precipitate anxiety, withdrawals Long-acting: half-life of 8-24/72 hours and up to 7 days designed for patients with chronic stabile pain Caveat: onset of analgesia is delayed by 2-4+ hour if dosed for acute pain, plus overdose Methadone: long half life hours, complex metabolism, prolongation of QTc, cheap but dangerous Caveat: difficult to titrate, tends to accumulate and to lead to overdose

33 Opioid Rotation Most commonly relevant in acute pain setting, such as at discharge of patients home from hospitals Opioid equianalgesic tables: danger!!! outdated, without scientific foundation Should be done by an experienced pain physician Decrease the current opioid to the lowest tolerated dose before switching to lowest dose of new opioid

34 Discontinuing Long-term Opioids WHEN AND HOW TO START DISCUSSION ABOUT DISCONTINUING OPIOIDS: 1) When opioids are started patients is informed that there is a great likelihood that the opioid will be discontinued when: a. Pain is less severe/disruptive or pain is worse (OIH) b. Pain is not controlled after 2-4 weeks of opioid Rx c. Side effects, in particular psychological, are severe d. Function is not improved or it is more impaired 2) Once one or more of the above clinical points are reached, patient is reminded that time to discontinue the opioid therapy is reached. Reminding patients about non-opioid meds and other pain treatment modalities, i.e. exercise, relaxation

35 Discontinuing Long-term Opioid Analgesic Therapy TITRATING DOWN AND DISCONTINUING OPIOIDS: (not a detox detox refers to acute discontinuation in addicts) Decrease the dose: as fast as by 5-10% per day or as slow as by 5% per week (especially for methadone) Anticipate and monitor for withdrawal symptoms opioid withdrawals are uncomfortable, not as dangerous! If necessary treat withdrawal symptoms with clonidine

36 Patient Outcomes in Dose Reduction or Discontinuation of Long-Term Opioid Therapy: A Systematic Review. Frank JW, Lovejoy TI, Becker WC, Morasco BJ, Koenig CJ, Hoffecker L, Dischinger HR, Dobscha SK, Krebs EE. Ann Intern Med Jul 18. doi: /M Conclusion Very low quality evidence suggests that several types of interventions may be effective to reduce or discontinue longterm opioid therapy and that pain, function, and quality of life may improve with opioid dose reduction.

37 Case Study 3: The Ugly 26 y.o. nursing student had an open abdominal surgery after unsuccessful laparoscopic procedure for the removal of a large idiopathic pancreatic cyst. Following this surgery she was left with severe neuralgia along surgery scar, episodic stabbing pain and N/V that would take her breath away, making her incapacitated for a few hours, thought episodes would last between half an hour to 2 hours. Episodes occurred infrequently, 1-2 per week and as frequently as 2-3 times per day. Her pain was dramatically relieved with 15mg of oxycodone and more quickly with transbuccal fentanyl 200mcg at the onset of her pain.

38 Case Study 3: The Ugly 26 y.o. nursing student abdominal pain (continued) After consultation with her PC physician, her care was transferred to Student Health Services with the plan that prescriptions will be provided by that service. She was to continue regular pain clinic follow-up. At 9 months follow-up alerted by primary care service about declining function it was found that patient s dose of transbuccal fentanyl escalated to 1200mcg 4-6 times per day she was obtaining from private clinic of her parents where she presented forged clinic notes. It was also found that she was injecting heroin she bought from friends.

39 Differential Diagnosis of Aberrant Drug-Taking Behavior Self-treatment of psychiatric comorbidities (anxiety, bipolar d., PTSD, existential anguish) Opioid addiction in susceptible individuals Unrecognized neuro-psychiatric disorders (encephalopathy, i.e. TBI, personality disorder) Criminal intent ( patient dealers ) Recreational drug use

40 Concurrent Pain, Opioid Use Disorder and Addiction By current diagnostic criteria* most of the patients with chronic pain treated could easily satisfy those criteria for opioid use disorder Pain and addiction can and do co-exist in a number of patients, requiring multidisciplinary assessment and treatment approach *In order to make the diagnosed two or more of eleven criteria must be present in a given year

41 How to Treat Aberrant Drug-Taking Behavior Comprehensive assessment Treat pain using multimodal approach Identify and treat psychiatric co-morbidities Flare-ups are treated with flare-up management, not with short-acting opioids Inquire about possibility of addiction and diversion (starting with simple questions: How do you take your pain medicines? Do you give your pain pills to anybody?...)

42 Opioid Use Disorder and its Most Severe Form Addiction (4 C s) Control - Loss of Control Compulsive Use Craving Consequences - Use Despite Harm Consensus Statement on Pain and OpioidsASAM, APS, AAPM, April

43 Concurrent Pain and Addiction Patients at risk of opioid addiction: genetically vulnerable individuals who experience elation rather than sedation => patient education Treatment of addiction should be provided by addiction specialists and or in specialized drug addiction centers Treatment with Buprenorphine provides analgesia in patients with these comorbidities; requires training and certification, not licensing

44 Treating Chronic Pain in Current Social and Medical Environment - Chronic pain is a common clinical challenge - Current pharmacological therapies have a limited efficacy and as pharmacothrapy opioids are in most guidelines a third line therapy - Non-pharmacological modalities are recognized as important components of multimodal and multidisciplinary pain management that need to be tailored to individual needs of each patient

45 Questions?

46 Thank you