Canadian Guideline for Opioids for Chronic Non-Cancer Pain. Speaker Disclosure. Objectives. Canadian Guideline for Opioids for Chronic Non-Cancer Pain

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1 Canadian Guideline for Opioids for Chronic Non-Cancer Pain John Fraser Community Hospital Program North Sydney April 12, 2018 This speaker has been asked to disclose to the audience any involvement with industry or other organizations that may potentially influence the presentation of any educational material. Receiving evaluations is critical to the accreditation process. After the program, please provide feedback at: (North Sydney) (Antigonish) (Inverness) Speaker Disclosure College of Physicians and Surgeons of Nova Scotia College of Physicians and Surgeons of Newfoundland Labrador Atlantic Mentorship Network No commercial interests Objectives 1. Describe the recommendations of the Canadian Guideline for Opioids for CNCP. 2. Apply the Guideline recommendations in the clinical setting. 3. Identify patients requiring review of their opioid management. 4. Conduct patient-centred opioid tapering. Canadian Guideline for Opioids for Chronic Non-Cancer Pain Strong recommendations (4) Weak recommendations (6) Best practice statements (3) Expert guidance statements (10) Strong Recommendations All or almost all fully informed patients would choose the recommended course of action Recommendation is appropriate for all or almost all individuals 1

2 Weak Recommendations Majority of informed patients would choose the suggested course of action, but an appreciable minority would not Different choices will be appropriate for individual patients Clinicians should help patients arrive at a decision consistent with their values and preferences Best Practice Statements Common sense practice Supported by indirect evidence Associated with large net benefit Expert Guidance Statements Provides direction in areas for which there is either: no published evidence insufficient evidence to justify a formal recommendation Canadian Guidelines 2010 Process of opioid prescribing 24 recommendations Tools and practice information 2017 Do s and Don ts 10 recommendations 13 guidance statements Case #1 34 year old woman 9 years low back pain (9/10) Radiation down back of left leg (electric, numb) 2 year old and 4 year old at home Physiotherapy for 1 month: no benefit Nortriptyline 25 mg od: stopped after 4 days due to side effects Requesting opioid therapy for pain relief to be able to care for children 1. Optimize Non-Opioid Therapy Benefits of opioids roughly equivalent to other pharmacotherapies Risks of opioids greater Addiction 5.5% Overdose 0.1% Risk increases with higher doses (0.23% > 100 OME) Diversion 2

3 Optimize Non-Opioid Therapy Physical therapies Physiotherapy Chiropractic Massage Psychologic Pain self management Relaxation Mindfullness Optimize Non-Opioid Therapy Pharmacotherapy TCA Gabapentinoids SNRI Interventional Opioids for Chronic Pain Little evidence for the use of opioids in many common chronic pain problems: fibromyalgia headaches mechanical back pain osteoarthritis irritable bowel syndrome chronic pelvic pain Opioids for Chronic Pain Almost all RCT s less than 12 weeks Almost all RCT s for non-opioid therapies are also less than 12 weeks Reserved for patients with severe pain that is refractory to other treatments Krashin et al, 2013, Curr Rheumatol Rep Ballantyne, 2015, Phys Med Rehabil Clin N Am Case #2 32 year old man Chronic neuropathic leg pain following inguinal hernia repair Binge drinker 12 beers a day, about one month out of three Plans to stop Failed trials of non-drug therapy Failed trials of TCA, SNRI, pregabalin, gabapentin Requesting opioid therapy 3. No Opioid with Active Addiction 8.9% risk of developing opioid addiction Increased risk fatal overdose (from 0.1% to 0.46%) Rate of overdose increases with higher doses Continue non-opioid pain management Refer to addiction services 3

4 Case #3 54 year old man Chronic HIV-related neuropathic pain Failed non-opioid trials Cocaine addiction 10 years daily inhaled use In full remission for 6 months 5. No opioid with a history of addiction Increased risk of fatal overdose (from 0.1% to 0.38%) Risk of overdose increases at higher doses Case #4 54 year old man Chronic HIV-related neuropathic pain Failed non-opioid trials Alcohol addiction 5 years daily use 10 beers In full remission for 30 years CP with History of Addiction Majority no opioid therapy Minority Benefits may outweigh risks Get second opinion Addiction and Chronic Pain 5.5% risk overall 8.9% risk with active addiction Addiction and Chronic Pain 5.5% risk overall 8.9% risk with active addiction Risk with No history History, in remission Active 4

5 Abuse and Addiction in CNCP Addiction in CNCP 24 studies CNCP on opioid therapy n=2,507 average 26 months exposure 0.19% develop opioid abuse or addiction in the absence of a past history of addiction Meta-analysis Opioid therapy over 6 months for CNCP oral, transdermal and intrathecal 17 studies, n=3,079 Signs of addiction in 0.05% Fishbain et al, 2008, Pain Med Noble et al, 2008, J Pain Symptom Manage Addiction in CNCP Systematic review CNCP on opioid therapy > 6 months 26 studies (25 case series, 1 RCT) n=4,893 Signs of opioid addiction 0.27% Addiction risk in CNCP Systematic review 17 studies Available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing addiction Noble et al, 2010, Cochrane Review Minozzi et al, 2013, Addiction Opioid Addiction in CP Opioid Addiction in CP Active addiction 8.9% History, in remission (4.4%) No history 0.17% Active addiction NNH = 11 History, in remission (NNH = 23) No history NNH = 588 Total 5.5% 5

6 Case #5 37 year old woman Chronic phantom limb pain Failed trials of TCA, gabapentin, pregabalin, SNRI Active schizophrenia Requesting morphine 4. Stabilize Active Mental Illness before Opioid Therapy 8.0% risk of developing addiction Increased risk of fatal overdose (from 0.1% to 0.15%) risk of overdose increases at higher doses Case #6 37 year old woman Chronic phantom limb pain Failed trials of TCA, gabapentin, pregabalin, SNRI Chronic depression due to constant severe pain Requesting morphine Stabilize Active Mental Illness before Opioid Therapy If considering opioid therapy, screen for mental illness Anxiety Post-traumatic stress disorder Depression 2. Opioid Trial Persistent problematic pain despite optimized non-opioid therapy, start trial of opioid therapy Reduction in pain (11%) Improvement in function (10%) Opioid Trial Screening (risk assessment) Addiction history Mental illness screening Urine drug screen Prescription Monitoring Program (PMP) or Drug Information System (DIS) 6

7 Opioid Risk Tool Substance Use History 10 item self administered Family history substance abuse Personal history substance abuse Age Preadolescent sexual abuse Psychological disease Each drug class (alcohol, benzodiazepines amphetamines, cocaine, opioids, marijuana, hallucinogens, solvents) Have you ever used? first use regular use (duration, frequency, amount, route) current use (last use) Consequences of drug use (harms) Treatment Urine Drug Screening Before initiation After initiation according to risk and aberrant behaviours Be aware of test used and its limitations Interpret carefully Informed Consent Treatment agreement Risks Benefits Expectations Terms of prescribing Goals functional Opioid Trial Only one prescriber Avoid driving when titrating dose Avoid benzodiazepines very rarely Opioid Trial Initial opioid Not methadone, fentanyl Not meperidine, pentazocin (ever) Initiate with lowest dose available Dispense at a frequency depending on risk Daily or weekly if necessary No more than 1 month at a time 7

8 Opioid Trial SR vs IR unclear Tamper-resistant products May reduce risk of altering route Patch returns May reduce diversion Naloxone Benefits with chronic pain unclear May be useful with high risk or high dose 7. Restrict Opioid Dose to 50 mg Oral Morphine Equivalent With new patients, limit dose to 50 mg OME or below Increased risk of fatal overdose 0.1% < 20 mg OME 0.14% 20 to 49 mg OME 0.18% 50 to 99 mg OME Some patients may be willing to accept the increased risk above 50 mg OME Restrict Opioid Dose to 50 mg Oral Morphine Equivalent If there is no pain reduction or functional improvement at 50 mg OME Consider the possibility of a failed opioid trial 6. Restrict Opioid Dose to 90 mg Oral Morphine Equivalent With new patients, limit dose to 90 mg OME Dose-dependent increase in the risk of fatal opioid overdose: 0.1% <20 mg OME 0.14% 20 to 49 mg OME 0.18% mg OME 0.23% 100 mg OME No benefit pain or function No increased risk of addiction Restrict Opioid Dose to 90 mg Oral Morphine Equivalent Restrict Opioid Dose to 90 mg Oral Morphine Equivalent Some patients may gain important benefit over 90 mg OME Refer for second opinion 90 mg OME should be viewed as a maximum for most patients who are being started on opioid therapy DO NOT use 90 mg OME as a target for tapering patients currently on high doses When tapering, treat the patient, not the number 8

9 Monitoring Outcomes Function ADL s Sleep Patient-defined functional goals Pain Monitoring Adverse effects Falls Cognitive dysfunction Sedation Sleep apnea Hyperalgesia Depression Hypogonadism Monitoring UDS Aberrant behaviours Less serious More serious Less Serious Aberrant Behaviours Requests dose increases Requests early refills Unsanctioned dose increases Requests specific opioids Misses appointments Requests Rx for travel Requests faxed Rx Using for non-pain symptoms Non-adherence to other treatment More Serious Selling opioids Stealing opioids Forging prescription Injecting/snorting Non-medical sources Illicit drug use Presents intoxicated Lost prescriptions Drug-related crime Aberrant Behaviours Opioid Trial Less Serious Pseudo-addiction Tolerance Pseudo-tolerance Hyperalgesia Failed Opioid Trial Opioid withdrawal Chemical coping More Serious Addiction Diversion Adequate trial 3 to 6 months Discontinue opioid with failed trial: No significant reduction in pain or improvement in function (50 to 90 OME) Presence of significant complications BUT: multiple less serious aberrant behaviours is more serious 9

10 8. Opioid Rotation with Persistent Pain or Side Effects May be useful with some patients May be part of tapering process idmanager/documents/opioid_manager_s witching_opioids.pdf Opioid Rotation 1. Calculate equivalent dose 2. Divide by 2 to get target dose 3. Rotate in one or more steps 4. Titrate Hydromorphone 18 mg bid to Morphine 1. Calculate OME Hydromorphone 18 mg bid to Morphine 2. Divide by 2 to get target 18 x 2 = x 5 = 180 OME = 90 OME Equivalency tables not exact Most patients can reduce total OME by 25% to 50% through rotation Hydromorphone 18 mg bid to Morphine 3. Rotate in one or more steps If OME < 50 OME, rotate in one step If OME > 50 OME, rotate in 2 or 3 steps Target = 90 mg morphine 2 steps Reduce HM by ½, add ½ morphine 1. HM 18 mg am, morphine 45 mg pm 2. Discontinue HM, morphine 45 mg bid Hydromorphone 18 mg bid to Morphine 3. Rotate in one or more steps If OME < 50 OME, rotate in one step If OME > 50 OME, rotate in 2 or 3 steps Target = 90 mg OME 3 steps Reduce HM by 1/3, add 1/3 morphine 1. HM 12 mg bid, morphine 15 mg bid 2. HM 6 mg bid, morphine 30 mg bid 3. Discontinue HM, morphine 45 mg bid 10

11 Hydromorphone 18 mg bid to Morphine 4. Titrate Some patients will be stable at 50% reduction Most patients will require up-titration to stabalize Usually need to titrate to ~ 25% reduction Do not titrate above original dose Case #7 54 year old man Moderately severe lumbar spinal stenosis Non-surgical Nortriptyline 25 mg qhs Gabapentin 800 mg tid Hydromorphone SR 24 mg q8h IR 4 mg qid Function: improved Not employed, does some volunteer work 3 days/wk Walks 20 minutes a day Helps with some housework 9. Current Patient > 90 OME Taper to Lowest Effective Dose Some patients are likely to experience significant increase in pain or decrease in function that persists for > one month after a small dose reduction Tapering may be paused and potentially abandoned in such patients Case #8 54 year old man Moderately severe lumbar spinal stenosis Non-surgical Nortriptyline 25 mg qhs Gabapentin 800 mg tid Hydromorphone SR 12 mg q8h Function Working full time as accountant Exercises 30 minutes a day Active social life Helps with all housework Current Patient > 90 OME Taper to Lowest Effective Dose High dose opioid therapy associated with: Overdose Falls Sedation Cognitive dysfunction Sleep apnea Hyperalgesia Depression Opioid Dose and Mortality OME Mortality (95% CI) 20 mg reference 50 to 99 mg 1.92 ( ) 100 to 199 mg 2.04 ( ) 200 mg 2.88 ( ) Gomes et al, 2011, Arch Int Med 11

12 Prescription Opioid Non-fatal Overdose Systematic review, 24 articles OME Increased risk % deaths from patients receiving opioids within guidelines (90%) Opioids and Sleep Disorders Literature review OAT (6 studies) and chronic pain (16 studies) CNCP Sleep disordered breathing % general Central sleep apnea 17-80% <10% Obstructive sleep apnea 20-39% 5-15% Elzey et al. Pain Physician. 2016;19: Hassamal et al. Am J Addict. 2016;25: Opioids and Sleep Disorders Each 100 mg OME increases rate of: Central apneas by 29% Obstructive apneas by 10% Opioid Induced Hyperalgesia Increased sensitivity to pain resulting from opioid exposure hyperalgesia, allodynia diffuse, poorly defined pain beyond the preexisting pain distribution not explained by disease progression Hassamal et al. Am J Addict. 2016;25: Chang et al, 2007, Med Clin N Am Current Patient > 90 OME Taper to Lowest Effective Dose Benefits of tapering Clearer thinking More energy More alert More functional Improved QoL Indications for Tapering Failed trial 50 to 90 OME with insignificant reduction in pain or improvement in function Failed titration One or two dose increases do not result in reduced pain or increased function Complications Intolerable side effects Non-adherence to treatment plan that results in increased risk of serious complication Pain condition resolved Dose > 90 OME Patient request 12

13 Process of Tapering Engage patient in process Discuss risks of high doses and benefits of taper Give some control to patient Decision to taper not negotiable Process of taper is negotiable which medication first rate of taper occasional breaks Tapering from High Doses GOAL: lowest effective dose Benefit vs Harm 1. What are the current outcomes? Functional Pain 2. Are there any complications? Tapering from High Doses 1. What are the current outcomes? If the current function is poor and/or the pain is poorly controlled FAILED TRIAL GOAL: Taper off Case #9 54 year old man Moderately severe lumbar spinal stenosis Non-surgical Nortriptyline 25 mg qhs Gabapentin 800 mg tid Hydromorphone Function In bed most of the day Does no housework Excruciating pain SR 24 mg q8h IR 4 mg qid Tapering from High Doses Case #10 2. Are there any complications? Overdose Sleep apnea Falls Hyperalgesia Sedation Depression Cognitive dysfunction GOAL: taper until no complication May be to zero If not zero, reassess outcomes when tapered 54 year old man Moderately severe lumbar spinal stenosis Non-surgical Nortriptyline 25 mg qhs Gabapentin 800 mg tid Hydromorphone SR 24 mg q8h IR 4 mg qid Function: improved Not employed, does some volunteer work 3 days/wk Walks 20 minutes a day Helps with some housework Spouse reports: poor memory, sleeps every afternoon since dose was increased 13

14 Tapering from High Doses 1. What are the current outcomes? Good functional outcome Adequate pain control 2. Are there any complications? No complications GOAL: lowest effective dose NOT 90 mg OME Case #11 54 year old man Moderately severe lumbar spinal stenosis Non-surgical Nortriptyline 25 mg qhs Gabapentin 800 mg tid Hydromorphone SR 24 mg q8h IR 4 mg qid Function Working full time as accountant Exercises 30 minutes a day Active social life Helps with all housework No complications Principles of Tapering Process of Tapering Client centred Rate of taper Outcome of taper (client, not number) Length of taper Short term opioid therapy: days to weeks Long term opioid therapy: months to years No longer than ¼ time on opioids Start at 5% a week Monitor closely for withdrawal and pain Adjust rate of taper as needed decrease amount and/or frequency of dose reduction Process of Tapering If tapering causes significant increase in pain decrease in function opioid withdrawal 1. Stabilize maintain dose for a period increase dose sometimes 2. Resume taper Process of Tapering Provide alternative strategies for pain management Consider opioid rotation 14

15 Process of Tapering With a patient who has good outcomes and no complications If significant increase in pain or decrease in function persists > 1 month Consider abandoning taper Do not destabilize Goal is maximum function, minimum harm Goal is NOT a number If considering abandoning taper with dose > 200 mg OME, get second opinion Refer to Multidisciplinary Program if Challenging Taper alternative is a coordinated multidisciplinary collaboration that includes several health professionals (primary care physician, nurse, pharmacist, physical therapist, chiropractor, kinesiologist, occupational therapist, addiction specialist, psychiatrist, psychologist) Main Points Prescribe opioids only after failed trials of non-pharmacologic therapy and non-opioid pharmacotherapy Main Points Define risk before prescribing opioids Personal history of addiction Family history of addiction History of mental illness History of childhood trauma Main Points Do not prescribe opioids to patients with active substance use disorder Main Points For new patients Consider 50 mg OME as trial dose Consider 90 mg OME as maximum dose Although some patients may benefit from higher doses after second opinion 15

16 Main Points For current unstable patients on doses > 90 OME Poor outcomes (failed trial) Taper off Complications Taper until complication resolved Reassess outcomes Main Points For current stable patients on doses > 90 OME (good outcomes, no complications) Try to taper to lowest effective dose Maximum benefit with minimum harm Stop taper if patient destabilizes Do not use 90 mg OME as target Resources Opioid tapering tool Opioid tapering- Information for patients %20Patient%20Information%20(english).pdf Canadian Guideline for Opioids for Chronic Non-Cancer Pain Nova Scotia Prescription Monitoring Program Medical Consultant Atlantic Mentorship Network Pain & Addiction John Fraser