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Practical Approaches to Opioid Prescribing: Working Within the Guidelines Adapted from Dr. Brenda Lau MD, FRCPC, FFPMANZCA, MM Learning Objectives Incorporate the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain and apply elements into a busy practice Help you effectively utilize supporting tools such as the › Brief Pain Inventory (BPI) and the › Opioid Risk Tool (ORT), and Implement improved opioid monitoring practices, including documenting the › 6 A’s and using the Opioid Manager* › Weaning guidelines 2 The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain What is it? › An evidence-based guideline with 24 recommendations outlining how to use opioids to treat patients with CNCP Why was it developed? › Existing treatment information and guidelines were found to be outdated Why was it necessary? › To improve the safety and care of CNCP patients being treated with opioids, and to safely manage potential side effects (including addiction) and the risk of opioid misuse http://nationalpaincentre.mcmaster.ca/opioid/, 3 The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain Available at: http://nationalpaincentre.mcmaster.ca/opioid/ 4 The Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain CNCP = Chronic Non-Cancer Pain *Courtesy of: “Toronto Rehabilitation Institute” Available at: http://nationalpaincentre.mcmaster.ca/opioid/ 5 Effects of Chronic Pain on the Patient Physical Functioning Moods Mobility Depression Impaired Immununity Anxiety Sleep disturbances Anger Fatigue Irritability Loss of appetite Social Functioning Diminished social relationships (family/friends) Societal Consequences Health care utilization Disability Decreased sexual function/intimacy Loss of work days or employment Decreased recreational and social activities Substance abuse Ashburn MA, et al. Lancet. 1999;353:1865-1869. Harden RN. Clin J Pain. 2000;16:S26-S32. Agency for Health Care Policy and Research. Clinical Practice Guideline No. 9. 1994. Meyer-Rosberg, K et al. Eur J Pain. 2001;5:379-389. Zelman D, et al. J Pain. 2004;5:114. Manchikanti L, et al. J Ky Med Assoc. 2005;103:55-62. Hoffman NG, et al. Int J Addict. 1995;30:919-927. 6 Deciding to Initiate Opioid Therapy – Cluster 1 Pain is moderate to severe Pain has significant impact on function and QOL Non-opioid pharmacotherapy has been tried and failed Opioids indicated for specific pain condition Opioid risk assessment has been done & documented Informed consent (goals, risks, benefits, AEs, complications …) Patient agreeable to have opioid use closely monitored (UDS, treatment agreement, freedom of information …) Responsible prescribing of opioids 7 Opioid Risk Tool & Checklist 8 Universal Precautions in Pain Medicine 1. Diagnosis with appropriate differential 2. Psychological assessment › Including risk of addictive disorders 3. Informed consent › Verbal v. written/signed 4. Treatment agreement › Verbal v. written/signed 5. Pre trial assessment of pain/function and goals 9 Content of a Treatment Agreement One prescriber (include name) One dispensing pharmacy (include name) Will comply with safe/secured storage of opioid; Will comply with no driving while titrating No sharing/selling of opioid; No accepting of any opioid medications from anyone else Will not change the dose or frequency of taking the medication without consulting the doctor Strict rules with respect to medication loss, early refills, possible abuse or diversion (e.g. Dr._________ will not prescribe extra medication for me. I will have to wait until the next prescription is due.) Strict rules with respect to concomitant usage of other sedating medications, OTC/prescription opioids, recreational drugs (e.g. 222’s, Tylenol® #1 …) Will comply with scheduled office visits and consultations Will comply with pill/patch counts and random UDS when requested, and with limited quantity of opioid dispensed per prescription Adverse effects, medical complications and risks (including addiction) of opioids understood Freedom of information permitted Understanding and agreement that if there is no demonstrable improvement in functionality, the physician reserves the right to wean patient off his/her opioid medications. Understanding that if these conditions are broken, Dr. _______ may choose to cease writing opioid prescriptions for me Patient’s Signature Physician’s Signature Date Date 10 Universal Precautions in Pain Medicine 6. Appropriate trial of opioid therapy › +/- adjuvants › Replace short-acting opioid with long-acting opioid at equivalent dose › Limit the number of pills/patches that a patient may have at one time 7. Reassessment of pain score and level of function 8. Regular assess the “Six A’s” of pain medicine › Analgesia › Activities › Adverse effects › Ambiguous drug taking behaviur › Accurate medication record › Affect 9. Periodically review Pain Diagnosis and co morbid conditions including addictive disorders 10. DOCUMENT, DOCUMENT, DOCUMENT (Passik 2000) 11 Conducting an Opioid Trial Summary – Cluster 2 Start low, go slow › Titrate to “optimal dose” › Remember safety issues when selecting opioids, including altered pharmacokinetics (e.g. liver/kidney) &/or drug interactions › Comprehensive review before nearing the “watchful dose” Document progress / opioid effectiveness Monitor adverse effects, medical complications, risks › Opioid Manager* › 6 A’s If risks outweigh benefits, then: switch, taper ± discontinue *Courtesy of: “Toronto Rehabilitation Institute” Available at: http://nationalpaincentre.mcmaster.ca/opioid/. 12 Opioid Manager 13 Goals Guide Treatment Options Psychological Chronic pain self-management programs Physical / Rehabilitative Goals Complementary and Alternative Medicine Medical Pharmacological Interventional Adapted from Jovey RD, 2008 14 The Analgesic Toolbox Nonopioid Acetaminophen, ASA, COXIB, NSAID Opioid Buprenorphine transdermal system, codeine, fentanyl transdermal system, hydromorphone, morphine, oxycodone, tramadol Choice exists between IR (immediate release) and CR (controlled release) formulations for many agents 15 Basis for Opioid Selection Selection Criteria: Current /past efficacy and side effect profile of short-acting opioid Convenience and compliance potential Cost (coverage by drug plan or ability to pay) Patient preference History of abuse/misuse/diversion (screen) Concomitant health conditions necessitating adjustments in dosage and/or dosing interval of some opioids (e.g., morphine or codeine in renal failure) Compromised oral route Evidence of molecule efficacy for different pain characteristics Chou R et al, 2009; Gardiner-Nix; Wisconsin Medical Journal, 2004 ; Jovey RD et al, 2002 16 Opioids: Initial Dose and Titration Opioid Start Dose Codeine 15-30mg q4h CR Codeine 50mg q12h Tramadol + Tylenol 1 tab q4-6h prn (4/d) CR Tramadol Zytram XL 150mg Tridural 100mg Ralivia 100mg IR Morphine 5-10mg q4h prn up to 40mg /d CR Morphine 10-30 mg q12h Convert to CR when reaching Minimum time interval for increase 100mg daily 1 week 15-30mg/day (600mg/d) 2 days 50mg/d (300mg q12h) 1 week 1-2 tab q4-6h prn (8/d) 1 week (400mg/d) 2 days 5 days (300mg/d) (300mg/d) 1 week 5-10mg/d Min 2 d 5-10mg/d 3 tabs 20-30mg Suggested dose increase (max) 17 Opioids: Initial Dose and Titration Opioid Start Dose Convert to CR Minimum when time interval reaching for increase IR Oxycodone 5-10mg q6h prn up to 30mg/d CR Oxycodone 10-20mg q12h up to 30mg/d 1 week 5mg/day Min 2 days 10mg/d 1 week 1-2 mg/d CR 3mg q12h up Hydromorphone to 9mg/d Min 2 days 2-4mg/d OROS 8mg OD Hydromorphone 2 days 25-100% of starting dose IR 1-2mg q4-6h Hydromorphone prn up to 8mg/d 20mg daily Suggested dose increase (max) 6mg Maalis-Gagnon, Elafi Altlas 2010 18 PO Opioid Analgesic Equivalence table Morphine 10mg Codeine 60mg Oxycodone 7.5mg (O:M= 2:1 acute 1.5:1 chronic) Hydromorphone 2mg(H:M=5:1) Meperidine 100mg Methadone Variable Transdermal fentanyl 25ug/h = 60-134 mg 37ug/h = 135-179mg 50ug/h = 180-224mg 62ug/h = 225-269mg 75ug/h = 270-314mg 100ug/h = 360-404mg 19 When to Stop Opioid Therapy When patient: Does not realize meaningful pain relief from therapy Has adverse reactions to opioids, such as depression or respiratory depression Does not achieve reasonable therapeutic goals such as improved physical or social functioning, even with effective pain relief Ballantyne JC et al, 2003; Benyamin R et al, 2008; Chou R et al, 2009; Porreca F et al,2009; Slatkin NE, 2009 20 Tapering Opioid Therapy Discuss with the patient and other responsible persons who may be helpful. Patients with aberrant behaviour or addiction may refuse to comply and leave treatment, seeking opioids elsewhere. › Controlled withdrawal from opioids is not dangerous › May experience discomfort, anxiety, restlessness, nausea, sweating, etc. Reassure patient of alternative plan for pain control. Document discussions and provide a written treatment plan If the patient is taking a sedative or benzodiazepine, these should be maintained Ballantyne JC et al, 2003; Chou R et al, 2009 21 Key Learning Points 2010 National Opioid Use Guidelines (NOUG) serve to improve the responsible use of opioids in Canada When considering the use of long-term opioid therapy, screening for addiction risk must be a part of the assessment process Improvement in function as measured with the BPI is a key factor supporting the continuation of CR opioids in CNCP Management of CNCP is multi-modal using non-opioid medications, interventional techniques and self-management strategies. 22 Opioid Tapering Protocol Use controlled-release products for 24 hour coverage Decrease by 10% of total daily dose ( ranging from every day to) every 1 to 2 weeks. Once one-third of original dose is reached, decrease by 5% every 2 to 4 weeks. Hold the dose when appropriate: The dose should be held or increased if the patient experiences severe withdrawal symptoms, a significant worsening of pain or mood, or reduced function during the taper Taper can usually be completed between 2 weeks… to 4 months. http://nationalpaincentre.mcmaster.ca/opioid 23 Distinguishing between dependence, tolerance & addiction Physical dependence: withdrawal syndrome arises if drug abruptly discontinued, dose substantially reduced, or antagonist administered May start after two weeks of regular use Withdrawal symptoms: Early: agitation, anxiety, insomnia, muscle aches, tears, runny nose, sweating, yawning Late: nausea, vomiting, abdominal cramping, diarrhea, dilated pupils, goose bumps 24 Distinguishing between dependence, tolerance & addiction Tolerance: greater amount of drug needed to maintain therapeutic effect, or loss of effect over time Pseudoaddiction: behavior suggestive of addiction; caused by undertreatment of pain (e.g., increased focus on obtaining medications or “drug seeking,” “clock watching,” use of illicit drugs, or deception) American Pain Society (2006). 25 Distinguishing between dependence, tolerance & addiction Addiction (psychological dependence): a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: (the 4 C`s of addiction) impaired control over drug use compulsive use continued use despite harmful consequences 26 Addiction risk with chronic opioid therapy Between 4% and 26% of patients have an opioid use disorder One out of ten misuse opioids by: intentional oversedation, concurrent alcohol use for pain relief, hoard medications, increase dose on their own, borrow opioids from others Andrea Furlan www.support PROP.org Ballantyne J and LaForge S Opioid dependence and addiction during opioid treatment of chronic pain Pain 129 (2007) 235–255 27 Addiction risk of opioids for chronic pain A comprehensive systematic review to assess the incidence and prevalence of dependence syndrome (ie, addiction) associated with opioid therapy for pain relief in adults with and without a previous history of substance abuse Of 2,871 potentially relevant studies identified (excluding duplicate studies), data were extracted from 17 investigations that qualified for inclusion, involving a total of 88,235 patients Minozzi et al. found that the incidence of addiction reported across the various studies ranged from 0% to 24% (median 0.5%), while prevalence ranged from 0% to 31% (median 4.5%). However, there was a great amount of variation among the studies, or heterogeneity, in terms of design, definitions of addiction, data collection, and other factors, so a data metaanalysis could not be conducted. Overall, the researchers rated the evidence as being of very low quality Authors conclusion :“The available evidence suggests that opioid analgesics for chronic pain conditions are not associated with a major risk for developing dependence 28 [addiction].” Thank You Questions?