Registrar’s message—prescribing Mifegymiso will require clear and concise communication between physicians, patients and pharmacists

Following a lengthy drug approval process, Health Canada agreed to allow physicians to begin prescribing Mifegymiso earlier this year. At that time, Health Canada also established strict conditions of use for this drug, including the requirement that physicians provide the first dose of Mifegymiso directly to the patient.

Both the College of Physicians and Surgeons of BC and the College of Pharmacists of BC expressed concerns that the conditions imposed by Health Canada would be challenging to operationalize since most BC physicians are not legally authorized to sell and dispense medication, therefore creating a potential barrier to access.

After corresponding with Health Canada, the two colleges were advised that it is within the purview of a practitioner and pharmacist to prescribe and dispense a drug in a manner that falls outside the recommended uses and conditions of use set out in the product’s label that is approved by Health Canada. Such practice is considered “off label” by Health Canada. As with any other off label practice, the physician and pharmacist would be held accountable for these decisions as a matter of professional responsibility.

There may be some confusion once Mifegymiso is available on the market as the product monograph will reference the patient receiving the medication directly from their physician. Physicians who choose to issue a prescription to the patient for pharmacist dispensing will need to indicate this instruction very clearly on the prescription, and ensure that both the patient and the pharmacist are aware.

Professional expectations of physicians who choose to prescribe Mifegymiso:

  1. As set out in the regulations for the practice of medicine, and the College’s professional standard, Sale and Dispensing of Drugs by Registrants, physicians are not permitted to sell and dispense drugs to their patients unless they have been authorized by the Board of the College of Physicians and Surgeons of British Columbia to do so.
  1. Mifegymiso is a drug with serious potential risks and physicians who prescribe it are expected to be competent with the use of the drug, and are encouraged to take appropriate training to effectively guide their patients.
  1. Physicians must have informed consent discussions with their patients about how and where they intend to take Mifegymiso. Patients will have two options:
     
    1. They can take the prescription to a pharmacist of their choice and have the drug delivered to the physician’s office for ingestion, which is consistent with the product monograph, or
       
    2. They can take the prescription to a pharmacist of their choice and ingest the drug at home as directed by the physician, with no requirement to have the ingestion witnessed.

If the prescribing physician is authorized to dispense in accordance with the College standard, the drug can be sold, dispensed and ingested by the patient in the physician’s office.

  1. Given the range of options, it is the physician’s responsibility to clearly indicate which option the patient has selected on the prescription, and what the directions are for consumption, so that both the patient and the pharmacist are aware, and no confusion exists. 

Please refer to the College’s professional standard, Sale and Dispensing of Drugs by Registrants, for more information on obtaining authorization to sell and dispense drugs.

More information from Health Canada can be accessed here.

Heidi M. Oetter, MD
Registrar and CEO