Mifegymiso®

Introduction

Health Canada originally approved the drug Mifegymiso®, a two-drug combination product that provides a non-surgical option for early abortion, in July 2015. Mifegyimso® became available to the Canadian public in January 2017.

Details 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 therapy 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.

After corresponding with Health Canada, OCP and CPSO were advised that the product monograph is not a legally binding document. Health Canada went on to state that if, under the practice of medicine or pharmacy, the administration or distribution of the medication is outside of what is approved in the product monograph, the product would be considered to be used off-label.

Dispensing Mifegymiso®

Both the OCP and CPSO have confirmed there are three possible ways Mifegymiso® can be dispensed.

Options consistent with Health Canada stipulations:

  • 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.

Direct Patient Dispensing Option:

  • Patients can take the prescription to a pharmacy of their choice and receive the medication directly from the pharmacist.

It is within the scope of practice of pharmacists in Ontario to dispense medications directly to patients, therefore in alignment with provincial legislation, pharmacists are able to dispense Mifegymiso® directly to the patient.

Administering and Ingesting Mifegymiso®

The monograph outlines that the drug should be “administered under the supervision of the prescriber” and instructs patients to take Mifegymiso® “as directed by their doctor or given to them by medical staff”. Health Canada provided clarification that the intent of the wording in the product monograph is to allow prescribers to use their discretion for each individual patient and does not mandate that the medication be ingested in the presence of the prescriber. 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.

Physician Training

It is the professional responsibility of a physician to ensure that they have sufficient knowledge, skills and abilities to competently prescribe any medication and supervise patient care. A physician must ensure that they have undergone the appropriate training and has the required resources to evaluate the potential risks and benefits, and any other relevant factors specific to the situation, to ensure the drug is appropriate for the patient. A mandatory 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 free course is available to physicians and pharmacists through the e-learning portal of the Society of Obstetricians and Gynaecologists of Canada.

Update: On May 18, 2017, the manufacturer, in collaboration with Health Canada, issued a communiquĂ© to healthcare professionals to clarify the requirements and steps to follow in order to prescribe, order, stock, and/or dispense Mifegymiso®.