As part of the January 2015 approval process for Mifegymiso, Health Canada had recommended unnecessarily strict conditions for use of the abortion pill. These restrictions were standing in the way of realizing the drug’s potential for better access to abortion care in Canada. But now, in response to the tireless work of health care advocates (including Action Canada for Sexual Health and Rights) Health Canada has finally removed most of the restrictions that complicated access to the abortion pill!
Up until now, Mifegymiso was more regulated than controlled substances in Canada, despite decades worth of evidence from its use in over 60 countries proving how safe and effective this medication is. Mifegymiso now has federal regulations similar to other prescription drugs.
Health Canada Changes
- Language in their product monograph has been changed to “health professional” from “physician” only. This change allows for appropriate prescribing and dispensing by pharmacists, nurse practitioners, midwifery groups, etc.
- Pharmacists (or health professionals) may dispense directly to patients. This change replaces the prior restriction to “physician-only” dispensing.
- Gestational age limit has been extended to 63 days. While Action Canada called for a 70 days gestational limit, we applaud Health Canada’s decision to extend their original 49 days gestational limit. This change will positively impact access to medical abortion in Canada. The medication is FDA approved for medical abortion for pregnancies of up to 10 weeks of gestation, which providers can do off-label in Canada.
- Patients are no longer required to sign a consent form but Health Canada recommends that patients give informed consent.
- Mandated health professional training is no longer required. While the training is still available for health care professionals, the new language clarifies that it is not mandatory and indicates that health care professionals prescribing Mifegymiso "should have the appropriate knowledge" (as for all health professional care).
- Health care professionals authorized to prescribe or dispense Mifegymiso are no longer required to register with the manufacturer.
The last standing Health Canada restriction is the mandatory ultrasound required to prescribe Mifegymiso. This rule can lead to serious delays in administering Mifegymiso, can make it unavailable in many settings and/or can create a barrier to become a new Mifegymiso prescriber.
Most health care providers who operate in clinics do not have access to ultrasound machines on-site. The mandatory ultrasound requirement therefore requires multiple appointments, likely at different locations. This has the potential to result in serious delays in administering Mifegymiso within the 9-week gestation period, especially in regions where ultrasound services are few and far between, only accessible in hospitals, or have long wait lists.
In their April 2016 Medical Abortion guidelines, the Journal of Obstetrics and Gynaecology in Canada provided alternative means to confirm gestational age and rule out ectopic pregnancy when ultrasound is not available to the physician.
In the absence of readily accessible ultrasound, gestational age can be estimated using last menstrual period (LMP), clinical history, and physical examination, in people who are certain of the date of their LMP. Ultrasound is needed when uncertainty remains — Journal of Obstetrics and Gynaecology in Canada