Health Canada Update (November 7, 2017)
News Article (January 12, 2016):
Dispensing Mifegymiso in BC
There are three ways Mifegymiso® can be provided to patients who are prescribed the drug. Options include:
- Patients can take the prescription to a pharmacist of their choice and have the drug delivered to the physician’s office to take, which is consistent with the product monograph, or
- Patients can take the prescription to a pharmacist of their choice and take 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 of Physicians and Surgeons standard on Sale and Dispensing of Drugs by Registrants, the drug can be sold, dispensed and taken by the patient in the physician’s office.
Patients will need to have informed consent discussions with their physician about how and where they intend to take Mifegymiso®. Physicians will 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.
On November 7, 2017, Health Canada implemented changes regarding the prescribing and dispensing of Mifegymiso. Updates included indicating mifegymiso can be dispensed directly to patients by a pharmacist or a prescribing health professional, and allowing the drug to be prescribed up to nine weeks (63 days) into a pregnancy, rather than the previous limit of seven weeks (49 days). Directions for use remain the same. Patients should take the medication as directed by their health professional, either at a health facility or at home.
Previously the product monograph referenced the patient receiving the medication directly from their physician, although pharmacists in BC were able to dispense Mifegymiso® directly to the patient, which aligns with provincial legislation, and the College of Physicians and Surgeons professional standard, Sale and Dispensing of Drugs by Registrants.
The Mifegymiso® package contains two boxes: one box contains 1 tablet of mifepristone 200mg, which when taken initially, blocks progesterone production in the uterus. This is followed one to two days later by the contents of the second box: 4 tablets of 200 mcg misoprostol taken buccally, which will induce contractions and cause a miscarriage.
The College’s Code of Ethics requires all pharmacy professionals to practice only within the scope of their education, training and competence. Pharmacists and Pharmacy Technicians need to be aware of the limitations of their knowledge and expertise and refer as necessary and appropriate.
The College does not require pharmacy professionals to undertake additional training for the dispensing of Mifegymiso®.
While the manufacturer of Mifegymiso®, Celopharma, previously required pharmacists to complete the Medical Abortion Training Program to order the drug, training is no longer mandatory. Celopharma still encourages pharmacists to take the training provided through the Society of Obstetricians and Gynaecologists of Canada prior to ordering the drug. See Health Canada's Health Product Risk Communication for MIFEGYMISO released on May 18, 2017 for more information.
Medical Abortion Training Program
The College of Family Physicians of Canada, Canadian Pharmacists Association, and Society of Obstetricians and Gynaecologists of Canada collaborated on developing a Medical Abortion Training Program. The program is designed for both physicians and pharmacists and consists of six online modules that review scientific evidence on medical abortion. It is intended to train health-care professionals on the safe use of Mifegymiso® and to register trained physicians and pharmacists for the distribution of Mifegymiso®.
- MIFEGYMISO (mifepristone and misoprostol tablets) - Updates to Product Monograph and Risk Management Plan
- Medical Abortion Training Program
- Canadian Abortion Providers Support
- More information on Mifegymiso® from Health Canada
- College of Physicians and Surgeons of BC – Prescribing Mifegymiso® will require clear and concise communication between physicians, patients and pharmacists