Controlled Substances, Buprenophine, Methadone

The College’s Opioid Policy specifies that pharmacists dispensing methadone for Opioid Agonist Treatment (OAT), also known as methadone maintenance treatment (MMT), must be in compliance with the Key Requirements for Methadone Maintenance Treatment (MMT) Dispensing Fact Sheet, which states: 

“Community pharmacies must inform the College within seven days of starting to dispense MMT and of any changes in this information, using the approved Methadone Dispensing Notification Form.” 

Notification is required to help the College fulfill its mandate to protect the public. All pharmacies undergo routine assessments every one to four years, depending on the activities performed at the pharmacy and the risk of harm those activities pose to the public. A community pharmacy dispensing methadone will be evaluated according to the operational assessment criteria more often than a pharmacy which does not. 

Pharmacies dispensing methadone as an opioid analgesic for pain or buprenorphine/naloxone are not required to notify the College. 

The College’s expectations for buprenorphine/naloxone dispensing for Opioid Agonist Treatment (OAT) can be found in the Opioid Policy. This includes practicing in accordance with CAMH’s Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder. 

Additional resources are available in the Opioid and Opioid Use Disorder Practice Topic such as the CRISM National Guideline for the Clinical Management of Opioid Use Disorder. 

Although the Opioid Policy does not mandate formal training as a prerequisite for dispensing buprenorphine/naloxone, the College lists continuing education opportunities on its website as a tool to assist with professional development. 

As with any medication, pharmacists are relied upon to ensure they have the necessary knowledge, skills and judgment to provide OAT in a safe and effective manner. 

The College’s Opioid Policy sets out expectations for pharmacists dispensing all opioids, which includes methadone for pain or analgesia. 

Pharmacists should adhere to the most recent clinical practice guidelines and the appropriate standards of practice to ensure best patient outcomes for individuals on opioid therapy. The Opioids and Opioid Use Disorder Practice Topic provides easy access to numerous resources to support pharmacy professionals in safe opioid dispensing. 

Pharmacy professionals who accept prescriptions for any drug from an out of province prescriber should refer to the College’s Cross-Jurisdictional Pharmacy Services Policy. In addition, pharmacists should be familiar with the College’s Opioid Policy prior to dispensing any methadone prescriptions, and have the required reference Opioid Agonist Maintenance Treatment: A Pharmacist’s Guide to Methadone and Buprenorphine for Opioid Use Disorder (CAMH).  

Collaboration with the prescriber may be required to ensure methadone prescriptions are written in accordance with Ontario MMT policies as well as the Narcotic Safety and Awareness Act requirements. If a pharmacy professional is unsure of the scope of practice and prescribing authority of another regulated health professional, they should contact the individual’s regulatory body for clarification. 

There may be more than one way to dispense a prescription to ensure the patient receives the correct drug, dose and total quantity, such as in the situation you describe. The College cannot provide a specific answer on the action the pharmacist should take; it is the registrant’s responsibility to assess the prescription and decide the best course of action based on all the information at their disposal. 

In situations where a specific dose or strength indicated on a prescription does not exist, is unavailable, or is not the most appropriate option for the patient, the pharmacist, in exercising their professional judgment, may choose to use available dosage forms to make up the prescribed strength/dose. Alternatively, the pharmacist may choose to contact the prescriber for clarification — either in writing or verbally — when presented with a prescription that is ambiguous or the intent of the prescriber is not clear. 

Depending on the specific scenario, it may be important to ascertain if there was a clinical reason for prescribing a particular strength or dosage form. If there are different options, what does the patient prefer? Or, if the drug does not exist in a given strength, is it possible an error was made in the name of the drug or the dose? 

When deciding whether or not it is appropriate to split the tablets prior to dispensing, pharmacy professionals should apply their knowledge to determine whether or not the medication is amenable to splitting (e.g. scored or not, accuracy of resulting dose, stability, tablet integrity) and keep the patient’s health outcomes, best interest and safety in mind. 

Documentation of one’s rationale is important, in addition to documentation of dialogue with the patient, their understanding of the changes, and their informed consent. Pharmacy professionals are encouraged to reach out to their peers for timely guidance with practice-related questions as well, to leverage their practical experience and get advice on how they approach situations like this, assess the prescription, and exercise professional judgement.