The majority of physicians who operate in clinics do not have access to ultrasound machines on-site. The mandatory ultrasound requirement will therefore require multiple appointments, likely at different locations. This has the potential to result in delays in administering Mifegymiso within the 7-week gestation period. In their April 2016 Medical Abortion guidelines, the Journal of Obstetrics and Gynaecology in Canada provides alternative means to confirm gestational age and rule out ectopic pregnancy when ultrasound is not available to the physician. The article notes that “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.”
“While Health Canada’s original Summary Basis of Decision included a requirement for physician supervising patient’s ingestion of the first dose of the Mifegymiso package, it has since eased this restriction. In Health Canada's own words: “In Canada, patients are not required to take either drug in front of their doctor. The product monograph is worded to allow physicians to determine what is best for the individual patient. 'Under the supervision of' is intended to give the prescriber the option to observe directly, delegate to another staff or to direct the patient as appropriate."
Action Canada for Sexual Health and Rights still considers the current wording as falling short of what we wish to see as it leaves the decision of where the ingestion must happen with doctors instead of clearly putting it in the hands of patients. We call on Health Canada to clarify its language to clearly put the decision in the hands of patients.
In addition, it came to our attention that the current packages of Mifegymiso include an outdated product monograph and consent form which contain an incorrect directive instructing physicians to observe patients during the ingestion of the first dose. Click here to see our alert about the outdated Mifegymiso Product Monograph
Health Canada does not require patients to be observed during the ingestion of the Mifepristone pill.
Many stakeholders have noted that only a small number of physicians dispense drugs as a part of their practice. The now eased physician-only dispensing requirement from Health Canada made the dispensing of Mifegymiso more heavily regulated than medications in the Controlled Substances Act. There were concerns about how access to the medications could by impaired by this restriction. In response, the colleges of physicians and pharmacists in Ontario and British Columbia have expressed concerns to Health Canada that these requirements were outside of the normal distribution system for medications and would make dispensing Mifegymiso challenging. This requirement also has the potential to prevent the incentivization of physicians, particularly if they are in rural areas and do not have access to the necessary resources and infrastructures to stock medication on site.
Since coming under critique, Health Canada confirmed on May 18th 2017 that Territorial and provincial professional bodies representing physicians and pharmacists determine distribution systems. Indeed, having pharmacists dispense Mifegymiso directly to patients falls within the scope of a physician's ability to prescribe off-label. In the words of the Ontario College of Pharmacists, "the product monograph is not a legally binding document. 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 used off-label."
Action Canada for Sexual Health and Rights welcomes the announcement made on May 18th addressing the barriers imposed on the distribution of Mifegymiso.
Pharmacists and Physicians who are not currently abortion providers who wish to prescribe and/or dispense Mifegymiso have been required to take a 6-hour training (3 hours for physicians who are currently providers). No other similar drug requires this amount of training. Since physicians might be prevented from stocking the drug or without the required infrastructure to stock Mifegymiso themselves, it was of great concern that this requirement made it harder for pharmacists and pharmacy chains to stock Mifegymiso which limits the availability of the drug for prescribers.
Following that training, prescribers and pharmacies are added to a confidential directory of registered prescribers and dispensers. This confidential directory can undermine effective referrals as prescribers may be unable to find a dispensing pharmacy in their region, as well as it creates a situation where pharmacists need to verify that physicians are registered to prescribe Mifegymiso.
To remedy this gap in information, Action Canada for Sexual Health and Rights hosts a public directory of providers that have consented to have their information made public to assist both prescribers and the public to have access to Mifegymiso. It is being continually updated as more providers consent to have their information posted on the directory.
As of May 2017, Health Canada no longer requires pharmacists to complete the previously mandatory training program. In an announcement made on May 18th, Health Canada confirmed the removal of that restriction. The announcement also alludes to Health Canada easing the requirement for physicians to complete the mandatory training program in order to prescribe Mifegymiso. We encourage Health Canada to clearly remove this barrier.
Evidence from other countries (including the United States) indicates that Mifepristone can safely be used beyond the mandated 49 days of gestation. In March 2016, the United States Food and Drug Administration revised its approval of Mifeprex, the American equivalent of Mifegymiso, to terminate pregnancies of up to 70 days.
Currently, the price tag for Mifegymiso hovers between $300 and $450 so, for many individuals who must pay out of pocket, this continues to put medication abortion out of reach.
Action Canada for Sexual Health and Rights has therefore been calling on all provincial and territorial governments as well as all relevant ministries operating programs covering federal patients to promptly ensure that the cost of medication abortion is covered under public health care. On April 20th 2017, the CADTH Canadian Drug Expert Committee made its final recommendation on the newly approved abortion pill. The expert committee recommended provincial and territorial cost reimbursement of Mifegymiso.
Currently, only three provinces have pledged universal coverage for Mifegymiso: New Brunswick, Alberta and Ontario. The Non-Insured Health Benefits will also be covering the costs of the abortion pill for First Nations people living on reserves and Inuit people. It is not yet clear when the combination of pills will effectively be available for free to those with provincial health insurance in these provinces or to NIHB patients.
While we welcome the news from these three provinces and the NIHB, there is still no widespread cost coverage for Mifegymiso. People in British Columbia, Saskatchewan, Manitoba, Quebec, the Northwest Territories, Nunavut, the Yukon, Nova Scotia, Prince Edward Island and Newfoundland and Labrador are still expected to pay out of pocket. The same is true for Federal patients, including some categories of refugee claimants eligible for the Interim Federal Health program, people who are incarcerated with a sentence of more than two years, serving members of the Canadian Forces and eligible veterans, First Nations people living on reserves and Inuit individuals covered by the Non-Insured Health Benefits. Some private insurers may offer coverage for the medication through their policy, but for the remaining individuals with no private insurance or who are not on some form of social assistance, they are required to pay for the medication themselves.