Opioid Agonist Therapy Guidelines For Manitoba Pharmacists

Opioid Agonist TherapyGuidelines forManitoba PharmacistsUpdated December 2020

AcknowledgementsThe College of Pharmacists of Manitoba would like to thank the following organizations andindividuals for their help and expertise in updating the “Opioid Agonist Therapy Guidelines forManitoba Pharmacists” document:Alberta College of PharmacyCollege of Pharmacists of British ColumbiaMrs. Nicole Nakatsu, B.Sc.(Pharm.)Mr. Mike Sloan, B.Sc.(Pharm.)The College would also like to recognize Dr. Lindy Lee, MD from the College of Physicians andSurgeons of Manitoba for her many years of tireless dedication and compassion for patientsstruggling with opioid addiction. Dr. Lee worked closely with the College of Pharmacists ofManitoba to help educate pharmacists and improve patient safety. Dr. Lee passed away inNovember 2014.Opioid Agonist Therapy Guidelines for Manitoba PharmacistsUpdated December 20201

ContentsAcknowledgements . 1Part One: Summary of Methadone and Buprenorphine for Opioid Agonist Therapy andAnalgesia . 5Treatment Choices .5Knowledge, Skill and Judgement .6References .7Witnessed Ingestion .7Delegation.7Deliveries .8Policy and Procedures Manual .8Labelling .8Private Area .9Equipment.9Tamper Proof Seals .9Carries .9Part Two: Introduction to Opioid Agonist Therapy .10Introduction .10Harm Reduction Philosophy .10Overview of Opioid Agonist Treatment .11Criterion for Admission to an OAT Program .11Urine Drug Screens .13Overview of Methadone for Analgesia .13Part Three: Methadone and Buprenorphine Overview.14Pharmacology of Methadone .14Adverse Effects of Methadone .15Drug Interactions with Methadone .15Drugs with additive effects . 15Opioid antagonists and partial agonists . 15QTc Interval Prolongation . 15Pharmacology of Buprenorphine and Naloxone .16Adverse Effects of Buprenorphine .17Drug Interactions with Buprenorphine .17Drugs with additive effects to the central nervous system . 17QTc Interval Prolongation . 18Dosing Considerations .18Methadone: . 18Early Stabilization Phase (0-2 weeks): . 18Late Stabilization Phase (2-6 weeks):. 19Maintenance Phase (6 weeks ): . 19Buprenorphine:. 19Opioid Agonist Therapy Guidelines for Manitoba PharmacistsUpdated December 20202

Choosing between Methadone and Buprenorphine . 22Tapering.23Methadone: . 23Buprenorphine:. 23Split Dosing (Methadone only) .23Pregnancy.24Breastfeeding .25Treatment of Acute Pain .25Overdose .26Chronic Viral Infections and OAT .27Required and Recommended Readings .27Part Four: Implementing Opioid Agonist Therapy in Pharmacy Practice.29Including OAT in your Pharmacy Practice .29Policy and Procedures Manual .29Education and Training .29Pharmacist - Practitioner Communication .31Methadone and Buprenorphine Approvals for Prescribers .31M3P Prescription Program .32New Patient on Opioid Agonist Therapy .34Methadone Stock Solution .34Diluting Methadone .34Storage .36Pharmacy Storage and Security .36Labelling of Prescription Bottles .37Inventory Records .37Billing .37MY, MZ, and Interaction Codes Caution.38Witnessed Ingestion .38Positive Identification . 38Daily Witnessed Ingestion . 39Intoxicated Patients . 40Refusing methadone or buprenorphine administration . 40Overdose due to dosing error . 40Documentation . 41Guest Doses .41Take Home Doses (Carries).42Storage of Carries . 43Documentation for non-childproof caps . 43Warning Labels . 43Destruction of Empty Methadone Bottles . 44Diversion .44Vacation Supply (Methadone) .45Counselling .45Opioid Agonist Therapy Guidelines for Manitoba PharmacistsUpdated December 20203

Replacement Doses .45Vomited Doses.46Missed Doses .46OAT in Hospital .48Continuation of Care . 48Hospital Prescribers . 49Initiating OAT in hospital . 50Provision of OAT within the Hospital. 50Discharge from Hospital . 50Transfer of Custody to Hospitals, Prisons, and Community Health Facilities .51Incarceration .52Part Five: Appendices .54Appendix A: Manitoba Health, Healthy Living and Seniors: Methadone ReimbursementProcedure and Questions and Answers .54Appendix B: Clinical Opiate Withdrawal Scale.61Appendix C: Sample Pharmacist – Patient Agreement.62Appendix D: Facsimile Transmission of Prescriptions Template .63Appendix E: Sample Emergency M3P Documentation (methadone for analgesia) .64Appendix F: Sample Ingestion and Carrier Log .65Opioid Agonist Therapy Guidelines for Manitoba PharmacistsUpdated December 20204

Part One: Summary of Methadone and Buprenorphine for OpioidAgonist Therapy and AnalgesiaMethadone and buprenorphine are both used for opioid agonist therapy (OAT) and analgesia inadults. These guidelines will focus on the use of methadone and buprenorphine for OAT but willvery briefly discuss the use of methadone for pain management.Treatment Choicesa. OAT: Health Canada has approved several commercially available methadoneoral liquid concentrates for opioid agonist therapy.The following products are to be used when patients are prescribed methadonefor opioid use disorder:Methadose 10mg/ml oral liquidDIN 2394596Methadose Sugar Free 10mg/ml oral liquidDIN 2394618Metadol-D 10 mg/ml oral concentrateDIN 2244290 Generic product formulations of methadone oral liquid are also available for usein Canada. Interchangeability and coverage of these products on the provincialformulary differ from province to province. Currently, these generic products arenot covered by Manitoba Health, Seniors and Active Living. Please see theManitoba Health, Seniors and Active Living website for more information.Health Canada completed a safety review which examined how patients respondwhen they are switched from one methadone-containing product to another forthe treatment of opioid dependence. The review found that there may be a linkbetween switching methadone-containing products and the risk of lack of effectwhich may present as withdrawal symptoms. Information on the issue can befound here: deration should be given to what brand the patient has been receiving andit may be necessary in some cases to avoid changing the formulation, if possible.If the patient receives a different methadone formulation, the patient andprescriber should be made aware and arrangements for monitoring andmanagement should be in place. Early withdrawal symptoms can lead to a failureto remain in treatment and subsequent problematic substance use, which maylead to serious harm.Methadone powder in preparation of an oral solution can no longer be used nowthat commercially available products are available.Please see Appendix A for the information sent to pharmacists from ManitobaHealth, Seniors and Active Living regarding the methadone reimbursementprocedure.Opioid Agonist Therapy Guidelines for Manitoba PharmacistsUpdated December 20205

Further Dilution of Methadone:Methadose 10mg/ml oral liquid (red, cherry flavour) does not require furtherdilution. However, it may be diluted further if deemed necessary by thepharmacist or prescriber.Methadose Sugar Free 10mg/ml oral liquid and Metadol-D 10 mg/ml oralconcentrate must be diluted further with a suitable crystalline diluent to a totalvolume of 60 to 100mL final volume. Dilution of the unflavored formulation withdistilled water is not appropriate.Buprenorphine is also indicated for opioid agonist therapy in adults with opioiduse disorder. Buprenorphine is available in combination with naloxone as 2 mgand 8 mg sublingual tablets in a 4:1 ratio (buprenorphine:naloxone).Buprenorphine alone is available only through Health Canada via the SpecialAccess program.b. Analgesia: Metadol is a commercially available product indicated for painmanagement by Health Canada. Methadone compounded into a capsuleformulation is not a benefit through the Provincial Drug Program.Please see Appendix A for the information sent to pharmacists from ManitobaHealth, Seniors and Active Living regarding the methadone reimbursementprocedure for methadone for pain management.Knowledge, Skill and JudgementPharmacists must be knowledgeable in all aspects of methadone and/or buprenorphine usewhen involved in the care of patients with opioid use disorder. Section 18 of the PharmaceuticalRegulation states that a member may only engage in the aspects of pharmacy practice that heor she has the requisite knowledge, skill and judgment to provide or perform and that areappropriate to his or her area of practice.a. OAT: The expectation is that the pharmacist will be knowledgeable in the use ofmethadone and buprenorphine for OAT. At least one pharmacist at eachpharmacy shall have specialized training in OAT. If this is not possible (i.e. first 6months) a “trained” pharmacist shall function as a mentor from another locationin the interim until a pharmacist at that site has taken the training. Thepharmacist with specialized training at a pharmacy is responsible for training allpharmacists who will be dispensing methadone and/or buprenorphine. For furtherinformation on the accepted training programs, please see the section on“Education and Training”.b. Analgesia: Where methadone is used for pain, the expectation is that thepharmacist will be knowledgeable in the use of methadone for analgesia.Specialized training should be considered for use of methadone for analgesia ina similar manner to methadone used for opioid use disorder. A suggestedresource is the free, online, accredited course, “Methadone for Pain in PalliativeCare”. For more information, please see www.methadone4pain.ca.Opioid Agonist Therapy Guidelines for Manitoba PharmacistsUpdated December 20206

ReferencesPharmacists must have onsite or readily available references and treatment guidelines whendispensing methadone or buprenorphine for harm reduction

The College would also like to recognize Dr. Lindy Lee, MD from the College of Physicians and Surgeons of Manitoba for her many years of tireless dedication and compassion for patients struggling with opioid addiction. Dr. Lee worked closely with the College of Pharmacists of Manitoba to help educate pharmacists and improve patient safety. Dr.