April 20, 2020: Important update regarding the novel coronavirus (COVID-19) pandemic
The Centre for Addiction and Mental Health (CAMH) has provided new guidance to pharmacists and prescribers for dispensing and prescribing of OAT that will assist in the provision of collaborative patient care during COVID-19 pandemic.
Published: December 2018
- Drug and Pharmacies Regulation Act R.S.O. 1990, c. H.4
- Narcotics Safety and Awareness Act, 2010, SO 2010, c. 22
- Controlled Drugs and Substances Act, S.C., 1996, c. 19
- Safeguarding our Communities Act, 2015, SO 2015, c. 33
Opioids can be effective medications in the treatment of various conditions. However, opioid use and misuse is on the rise in Ontario, resulting in a serious opioid crisis with growing numbers of opioid-related deaths. In the province of Ontario from January to October 2017, there were over 1000 opioid-related deaths, a significant rise from 20161.
Many strategies have been initiated in Ontario to help address the opioid crisis. Health Quality Ontario (HQO) has established Quality Standards addressing opioid prescribing for acute and chronic pain management, and opioid use disorder treatment to provide guidance for prescribing practices. The Ontario College of Pharmacists (the College) instituted an Opioid Strategy to address opioid related issues relevant to pharmacy practice in alignment with the College’s mandate to serve and protect the public. The College’s Opioid Strategy focuses on advancing opioid related education, harm reduction initiatives, strategies to prevent opioid use disorder, and promoting quality assurance specific to opioid security and dispensing.
Purpose and Scope
This policy outlines the College’s expectations for pharmacy professionals regarding opioids. The purpose of this policy is to promote safe and appropriate opioid use through education and training, sharing of evidence-based best practice and outlining expectations. This policy provides further direction to pharmacists regarding the NAPRA Model Standards of Practice and is applicable to any opioid therapy regardless of the indication or practice setting. This policy is not intended to be clinical in nature, or duplicate information contained in other guidelines, policies, or resource documents.
Controlled Substance: Any drug or substance found in the Schedules to the Controlled Drugs and Substances Act. This includes narcotics, amphetamines, synthetic cannabinoids, barbiturates, benzodiazepines, anabolic steroids, and other such drugs, as well as precursor chemicals2.
Diversion: Any non-intended or non-medical use of a prescribed opioid (including prescribed opioid agonist medication), or use by any individual other than the individual for whom it was prescribed3.
Harm Reduction: Policies and programs that aim to minimize immediate health, social, and economic harms associated with the use of psychoactive substances, without necessarily requiring a decrease in substance use or a goal of abstinence3.
Opioid: Substance commonly prescribed for pain management that binds and activates opioid receptors in the brain, suppressing the ability to feel pain3.
Opioid Agonist: Substance that binds to and activates mu (µ) opioid receptors, providing relief from withdrawal symptoms and cravings in people with opioid use disorder, and pain relief if used for chronic pain management3.
Opioid Use Disorder: A problematic pattern of opioid use leading to clinically significant impairment or distress that meets the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) Diagnostic Criteria for Opioid Use Disorder3.
The Opioid Policy was developed to support the College’s mandate to serve and protect the public interest and is grounded on the following principles:
- Pharmacy professionals should employ the same respectful, patient-centered, professional approaches and attitudes towards all patients receiving opioid therapy, regardless of indication.
- Pharmacy practice should be in alignment with the federal and provincial strategies and HQO Quality Standards with regards to opioids
- Pharmacists should abide by the most recent clinical practice guidelines and the appropriate standards of practice to ensure best patient outcomes for individuals on opioid therapy
- Pharmacists play an important role in ensuring appropriate access to controlled substances
- Pharmacists must abide by specific requirements when providing Opioid Agonist Treatment
A. Education and Training
Although pharmacists must be confident that they have sufficient clinical knowledge, relevant training and skills with regard to any medications, special considerations need to be made for opioid therapy. Pharmacists should have knowledge of the best evidence and relevant clinical practice guidelines specific to opioid therapy. Pharmacists should ensure they review opioid related educational material including tools on the College website to ensure they provide optimal care to all patients on opioid therapy.
Pharmacists must assess, within their scope and to the best of their abilities, whether the prescribed opioid therapy is appropriate given the clinical status of the patient. Pharmacists should use their professional judgement and consider individual patient circumstances when determining the level of assessment necessary to ensure appropriateness. Whilst conducting this assessment, pharmacists can refer to relevant College policies and guidelines, quality standards, clinical practice guidelines and evidence. Relevant resources and tools can be found on the Practice Tools section of the College’s website. The following considerations should, when appropriate, be included in the assessment:
- Complete patient history (including allergies, medical conditions, concomitant prescription and non-prescription medications (including herbals), past medication history, lifestyle factors) and clinical status of patient
- Possible alternative or adjunctive appropriate non-opioid and non-pharmacological treatment options (eg. lifestyle change, dietary change, physical therapy)
- Appropriateness of medication as prescribed (eg. reviewing dose, indication, formulation, route, frequency, quantity, duration of therapy, previous opioid use)
- Monitoring parameters (eg. adverse effects, efficacy)
- Identifying, in collaboration with prescribers, patients that are interested in and would benefit from opioid tapering
- Patient’s risk for opioid use disorder
- Narcotic Monitoring System (NMS) notifications prior to dispensing
Communication with Patients & Caregivers
Pharmacists should ensure that patients/caregivers are active participants in their care. Patients should be encouraged to ensure they have opportunities to discuss their therapy with their pharmacists. Communication should be a two-way dialogue, ensuring patient/caregiver concerns are addressed in a timely manner. Pharmacists should engage in a discussion with patients/caregivers of patients prescribed opioids to ensure patients feel supported and well informed about:
- Realistic expectations regarding outcomes/benefits from opioid therapy (i.e. improved function vs. complete eradication of pain)
- Potential adverse effects and risks associated with opioids
- Signs of substance use disorder
- Monitoring parameters to ensure continuous appropriateness of opioid therapy
- Safe storage and appropriate return and disposal of unused opioid medications
Communication with Prescribers
The pharmacist and the prescriber play an important and complementary role in the care of a patient on opioid therapy. Pharmacists should establish regular two-way communication with prescribers to ensure continuity of care, reduce risk of opioid misuse and diversion, and optimize patient outcomes.
Pharmacists must, when appropriate, actively communicate pertinent information to prescribers such as:
- Potential drug therapy problems with evidence-based recommendations and solutions
- Patients with possible substance use disorder
- Patients who would be interested in and benefit from opioid tapering or alternative therapy
- Relevant NMS alerts
As is required with all medications, pharmacists should record relevant and pertinent details with regards to opioid therapy in an accessible and standardized manner in accordance with the College Documentation Guidelines. When faced with a decision that requires professional or clinical judgement, documentation should include: the decision, the rationale for the decision, expected patient outcome and plan for monitoring and follow up. Pharmacists should also ensure documentation of rationale and response to NMS alerts. Communication with patients and other healthcare professionals surrounding the decision should also be documented.
E. Managing Therapy: Monitoring and Follow-up
In order to ensure continuity of care, pharmacists should continue to monitor and follow up with patients that are prescribed ongoing opioid therapy. Monitoring should include reassessment of appropriateness and effectiveness of opioid therapy, and reassessment of safety of therapy including identifying and addressing any adverse events the patient may be experiencing. Pharmacists should work with patients and primary care providers to develop a plan for follow-up to address any concerns. Updates should be documented and provided to prescribers with recommended next steps, as appropriate.
Tapering Opioids for Pain
Pharmacists should ensure that they have the necessary knowledge and skills, and collaborate with prescribers to ensure tapering is carried out appropriately in a patient-centered and safe manner. Patients/caregivers and families should be counselled on information pertaining to tapering such as opioid withdrawal symptoms.
F. Security and Disposal
The regulations regarding controlled substances require that pharmacists take all steps necessary to secure these drugs in their possession. This includes ensuring that the medications are accounted for, inventory is accurate, security measures are in place to minimize diversion, outdated stock is identified and removed, and medications are disposed of properly.
Pharmacists are responsible for the safety and security of all drugs, including post-consumer returns and unserviceable controlled substances, until they are destroyed. Destruction must occur on a regular basis as any accumulation may increase diversion risk. Further information can be found in the Fact Sheet – Controlled Substances: Destruction of Unserviceable Stock and Post-Consumer Returns.
Narcotic reconciliation must be conducted on a regular basis to ensure accountability and traceability of medications. Pharmacists also need to account for damaged, unserviceable or outdated controlled substances. More information can be found in the Fact Sheet – Controlled Substances: Security and Reconciliation. Any theft, forgery or loss of controlled substances must be reported to the Office of Controlled Substances within 10 days after discovery.
Pharmacy professionals must adhere to the Safeguarding our Communities Act, 2015. Specific guidelines for dispensing fentanyl patches are outlined in the Fact Sheet: Patch-for- Patch Fentanyl Return Program.
G. Harm Reduction
Naloxone is a potentially lifesaving medication indicated for use in opioid overdose. Since naloxone is classified as a Schedule II drug, pharmacists should ensure they act in accordance with NAPRA Supplemental Standards of Practice for Schedule II and III drugs when dispensing naloxone. Pharmacy professionals can refer to the Guidance for Pharmacy Professionals when Dispensing or Selling Naloxone for specific guidelines and education requirements.
Opioid Agonist Treatment (OAT)
Buprenorphine/naloxone and methadone play an important role in treatment of opioid use disorder because they are opioid agonists which cause little to no euphoria. A pharmacist should have the necessary knowledge and training to provide OAT. This includes sufficient knowledge of:
- Standards of practice, policies and legislation for pharmacists providing OAT
- Differences between types of OAT and how to assess which is most appropriate for the patient
- Opioid withdrawal signs and symptoms and management
- Opioid use disorder signs and management
- Strategies for harm reduction
Pharmacists should practice in accordance with CAMH’s Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder. Pharmacists dispensing methadone should be in compliance with the Fact Sheet: Key Requirements for Methadone Maintenance Treatment (MMT) as outlined by the College.
Recordkeeping – Robust recordkeeping and documentation processes should be in place to support accuracy of information for administered doses to ensure safety at all times especially during transitions of care (i.e. patient entering or being discharged from hospital or correctional institution, guest dosing).
Patient Agreements – A written agreement serves as best practice to outline expectations and prevent miscommunication.
Transfer of Custody – If methadone doses are transferred to a prescriber for administration, policies and procedures should be in place to ensure documentation of receipt, administration and daily reconciliation of doses.
Education and Training — Pharmacists dispensing buprenorphine/naloxone and methadone should be familiar with the principles and guidelines outlined in CAMH’s Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder. For pharmacies dispensing methadone, the Designated Manager (DM) must be trained in methadone via the CAMH Opioid Use Disorder Treatment Course or comparable course within six months of beginning a methadone practice. In addition to the DM, within one year, at least one staff pharmacist must complete these training requirements. Training must be updated at a minimum of every 5 years. Ideally all pharmacists providing buprenorphine/naloxone and methadone services should have knowledge of the best evidence and relevant clinical practice guidelines. It is the DM’s responsibility to inform all pharmacists working in a pharmacy, including relief pharmacists, if that pharmacy provides OAT services.
Appendix A: Additional Resources
- Centre for Addiction and Mental Health (CAMH) Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder
- Practice Tools on the College’s website
- College of Physicians and Surgeons of Ontario (CPSO) Advice to the Profession: Prescribing Drugs (companion resource to the Prescribing Drugs Policy)
2 Controlled Drugs and Substances Act. S.C. 1996, c. 19 (Current to April 24, 2018). Available from: http://laws- lois.justice.gc.ca/PDF/C-38.8.pdf. Accessed July 6, 2018.
3 CRISM National Guideline for the Clinical Management of Opioid Use Disorder. Available from: https://crism.ca/wp-content/uploads/2018/03/CRISM_NationalGuideline_OUD-ENG.pdf. Accessed July 6, 2018.