Health Canada originally approved the drug Mifegymiso®, a two-drug combination product that provides a non-surgical option for early abortion, in July 2015. Mifegymiso® became available to the Canadian public in January 2017.
Details initially provided by the manufacturer and Health Canada regarding requirements for physician dispensing and patient ingestion of the medication were unclear and there was concern that patient access to care could be impaired. As such, both the Ontario College of Pharmacists (OCP) and the College of Physicians and Surgeons of Ontario (CPSO) expressed concerns to Health Canada that these requirements were outside of the normal distribution system for medications in Ontario and would be challenging to operationalize. Although physicians in Ontario can dispense drugs according to the CPSO’s Dispensing Drugs policy, only a small number of physicians dispense medications as part of their practice.
Direction from Health Canada was included in the original version of this statement. Specifically, Health Canada indicated that distribution of the medication outside of what is approved in the product monograph would be considered off-label use. On November 7, 2017, Health Canada released a Health Product Risk Communication for Mifegymiso® which updates the Product Monograph and Risk Mitigation Plan. These updates extend the gestational age requirement, update the dispensing requirements and remove the requirement for mandatory education and registration with the manufacturer.
This statement has been updated to reflect these changes
There are three possible ways Mifegymiso® can be dispensed according to Health Canada.
- Patients can take the prescription to a pharmacy of their choice and receive the medication directly from the pharmacist;
- Patients can take the prescription to a pharmacy of their choice and have the medication delivered to the physician’s office; or
- Physicians can sell and dispense the medication to the patient in accordance with CPSO’s Dispensing Drugs policy.
Administering and Ingesting Mifegymiso®
Initial direction provided in the product monograph when Mifegymiso® became available included a requirement for the medication to be administered under the supervision of the prescriber. Health Canada has since removed this wording, instead requiring that the patient take the medication as directed by their health professional.
Determining details of medication therapy is a treatment decision between the physician and patient.
Communication between Physicians, Patients and Pharmacists
When dispensing Mifegymiso®, the pharmacist must be aware of and understand the dispensing option the physician and patient determined would be appropriate. Given this, it is the physician’s responsibility to clearly indicate the dispensing option on the prescription, along with clear directions for ingestion. This is to ensure no confusion exists for the patient and the pharmacist.
As is the case with any medication, the pharmacist has the responsibility to confirm with the physician if the prescription is unclear.
It is the professional responsibility of a physician to ensure that they have sufficient knowledge, skills and judgement to competently prescribe any medication and supervise patient care. An education program has been developed by the Society of Obstetricians and Gynaecologists of Canada, the College of Family Physicians of Canada, and the Canadian Pharmacists Association. The course is available through the e-learning portal of the Society of Obstetricians and Gynaecologists of Canada.