Health Canada updates Mifegymiso Product Monograph and Risk Management Plan
The SOCG welcomes today’s notice from Health Canada which clarifies the regulations around the prescription and distribution of the abortion pill Mifegymiso. The “Updates to Product Monograph and Risk Management Plan” can be viewed here.
Mifegymiso was approved for use in Canada in January 2017. It is a combination of two drugs, mifepristone and misoprostol, and is used for the safe medical termination of early pregnancy. The Mifegymiso pill provides an important alternative to a surgical procedure for women, particularly for those who are unable to access abortion services in their area. We believe today’s announcement will improve access to the drug to women across the country.
We urge all SOGC members to review the important changes and to consider becoming prescribers. Although Health Canada no longer requires health care providers to take the SOGC online course before prescribing or dispensing, we strongly recommend the course as it provides a valuable overview of our Clinical Practice Guideline (http://www.jogc.com/article/S1701-2163(16)00043-8/abstract) for safe use of the drug.
- MIFEGYMISO is now indicated for medical termination of a developing intra-uterine pregnancy with a gestational age up to nine weeks (63 days) as measured from the first day of the last menstrual period. The previous indication was for use up to seven weeks (49 days) as measured from the first day of the last menstrual period.
- Registration of health professionals with Celopharma is no longer required in order to prescribe or dispense MIFEGYMISO.
- The MIFEGYMISO education program is not mandatory. However, MIFEGYMISO should be prescribed by health professionals with prior adequate knowledge of medical abortion and use of MIFEGYMISO or who have completed a MIFEGYMISO education program.
- The Education Program is available to all health professionals.
- MIFEGYMISO can now be dispensed directly to patients by a pharmacist or a prescribing health professional. As was always the case, patients should take the medication as directed by their health professional, either at a health facility or at home.
- Health professionals are required to do the following prior to prescribing MIFEGYMISO:
- Ensure you have adequate knowledge of the use of these medications to prescribe Mifegymiso;
- Discuss informed consent with the patient and provide the patient with the current Patient Medication Information and a completed Patient Information Card;
- Exclude ectopic pregnancy and confirm gestational age by ultrasound;
- Counsel patients on the effects and risks of Mifegymiso, including bleeding, infection, and incomplete abortion;
- Ensure that patients have access to emergency medical care in the 14 days following administration of mifepristone; and,
- Schedule a follow-up 7 to 14 days after patients take mifepristone to confirm complete pregnancy termination and monitor for side effects.
Mifepristone has been approved for use in over 60 countries around the world, including Canada, and has proven to be a safe and effective means of terminating unplanned pregnancies.