Ultrasound to Confirm Gestational Age and Exclude Ectopic Pregnancy

The majority of 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 7-week gestation period, especially in regions where ultrasound services are few and far between, only accessible in hospitals, have long wait lists, etc. 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. 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.” 

Physician Observing Patient's Ingestion (resolved)

“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In addition, it came to our attention that the current packages of Mifegymiso include an outdated product monograph and consent form which contain an incorrect directive instructing physicians to observe patients during the ingestion of the first dose. Click here to see our alert about the outdated Mifegymiso Product Monograph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.

Physician-Only Dispensing (partly resolved)

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 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." Since then, five provincial governing bodies of pharmacist professionals produced guidelines in support of pharmacists and pharmacy technicians involvement in dispensing Mifegymiso directly to patients.  Those five provinces are British Columbia, Ontario, Alberta, Nova Scotia and Saskatchewan.  

Action Canada for Sexual Health and Rights welcomes the announcement made on May 18th addressing the barriers imposed on the distribution of Mifegymiso. That said, many provincial and territorial professional bodies have not yet issued clarifications in support of pharmacist dispensing, making it essential that Health Canada clarify their stance on physician-only dispensing as it is still a barrier in many regions.

Mandatory Training and Registration (resolved)

This restriction was lifted in May 2017 when the manufacturer and Health Canada made a joint announcement that clarified that training was no longer mandatory for pharmacists to order and stock Mifegymiso and for physician to prescribe the abortion pill. The announcement also communicated that pharmacists are under no obligation to monitor physicians' training or physician competence to prescribe Mifegymiso. Though Action Canada does encourage Health Canada to be clearer in their removal of these restrictions, that announcement addressed many of the concerns surrounding the earlier restrictions relating to mandatory trainings. (See below)

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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.

 

Gestational Limits

Evidence from other countries (including the United States) indicates that Mifepristone can safely be used beyond the mandated 49 days of gestation (7 weeks from the last menstrual period). In many countries, this medication is commonly used for medical abortion for pregnancies of up to ten weeks of gestation (and beyond). 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.

Physician-only prescribing

Primary care provision of mifepristone, particularly in rural and remote communities and among disadvantaged populations, carries the potential to address current disparities and health access inequity. Nurse practitioners (NPs) are trusted health professionals providing high quality primary-care services, particularly in rural and remote locations serving disadvantaged populations throughout Canada. However, although international evidence universally supports the safety and acceptability of NP provision of mifepristone , Health Canada's approval specifies physician-only prescribing and dispensing. Despite this approval, Provincial nursing practice regulators still have the authority to specify scope of practice for their registrants, but many are hesitant to oppose Health Canada’s current regulation.

In recognition to the important role other health care practitioners, like Nurse Practitioners, can play in improving access to Mifegymiso in Canada, some professional associations have issued statements in support.

The Canadian Nurses Association has publicly stated their opinion on Nurse Practitioners prescribing of Mifegymiso® and what this could mean for individual access across Canada.

The College of Nurses of Ontario is the first nursing governing body to support their NPs to prescribe Mifegymiso®. The college has stated those NPs with the knowledge, skill and judgment to prescribe Mifegymiso® and who can manage all possible outcomes are legally authorized to prescribe it. Other provinces like Alberta, are waiting for Health Canada to clarify who qualifies as 'prescriber', when it can administered and who can dispense it.

Action Canada encourages Health Canada to amend their approval to change the language from 'physicians' to 'prescribers'.