Fact: Every country that has authorized any formulation of Mifegymiso has independently required physician oversight similar to that required by Health Canada. No formulation of Mifegymiso is available in any country 'over-the-counter'.
The approach used by Health Canada to approve Mifegymiso and establish conditions of use are comparable to the approaches used by the USA, Europe and Australia health authorities. No other country requires fewer medical appointments than Canada.
The evidence submitted to support the approval of Mifegymiso did not demonstrate that it can be used safely outside of a physician's supervision. As a responsible and evidence-based regulator, Health Canada could not authorize new approaches for Mifegymiso without clear scientific proof that it could be done safely.
Health Canada remains open to receiving and reviewing information submitted by the company to modify the terms of the marketing authorization. As well, once the product is on the market, additional information will continue to be gathered to inform future decisions.
Fact: Mifepristone is not available in the United States or Europe in retail pharmacies. Australia's rules do provide for pharmacists to dispense the drug. However, unlike in Canada, this access is limited by varying Australian state and territorial laws, and practices with respect to abortion.
Fact: None of the jurisdictions that have authorized any combination of Mifepristone/Misoprostol make it available "over the counter".
Unlike the non-prescription drug "Plan B", which is available on retail pharmacy shelves across Canada, Mifegymiso is not intended to prevent pregnancy.
Mifegymiso is a prescription drug with serious potential risks requiring physician oversight. The need for medical supervision is based on strong evidence for good health and safety outcomes. It is estimated that up to 1 in 20 women who use this drug will require a follow-up surgical procedure because their pregnancy is not successfully terminated.
Fact: Medical exams are required prior to use to manage potential risks to patients. Ectopic pregnancy (outside the uterus) cannot be confirmed without an ultrasound and the use of the drug with an ectopic pregnancy could be fatal. Risks could be also considerably higher if the drug was taken by a woman whose pregnancy was farther along than she thought. This could include failure to completely abort, leading to a partially retained pregnancy and/or very heavy prolonged bleeding. Serious infections can also occur after use of the drug.
Health Canada's requirement for medical exams prior to administration of the drug is in line with other jurisdictions where combinations of mifepristone/misoprostol have been approved.
Fact: Risks associated with the use of Mifegymiso cannot be managed effectively solely by education or warning statements on the label. In order to be used safely and effectively, patients are required to attend appointments at a medical clinic at certain stages in treatment. An ultrasound examination is needed to determine how far along the pregnancy is and to rule out an ectopic pregnancy (pregnancy outside the uterus). This cannot be accomplished by means other than office visits.
Patients must also have ready access to medical care following treatment in the event of adverse reactions or in case follow-up surgery is required. Discussions on safe use of the product rest between the physician and the patient, including appropriate follow-up measures for individuals.
The requirement for a medical appointment prior to the use of Mifegymiso is consistent with other jurisdictions where combinations of mifepristone/misoprostol have been approved.
Fact: The risks are not lower than surgical abortion. In some cases, the risks of infection, heavy bleeding and other adverse events may be higher with the medication and some women may require a surgical procedure if complications arise.
In Canada, a death occurred during a clinical trial for mifepristone. In the United States, there have been over 2200 serious adverse reactions and 14 deaths associated with the formulation of the drug authorized there. It is estimated that up to 1 in 20 women who use this drug will require a follow-up surgical procedure because their pregnancy is not successfully terminated.
Fact: Mifegymiso is a prescription drug with serious potential risks requiring physician oversight. The requirement for medical supervision means that the doctor must provide the medication to the patient directly, and have further discussions regarding the effects and possible risks. Medical supervision is required, however, it is not mandated that the medication be swallowed in front of the physician. The requirement for supervision ensures that the woman has access to emergency follow up treatment if required.
Canada's rules also allow the administration of the second drug, misoprostol, in a medical clinic or at home. By contrast, in most other countries where this combination has been approved the administration of both drugs must occur in a doctor's office or other clinical setting.
Fact: As with any medication, a prescription for Mifegymiso can be filled by a pharmacist. Physicians are not required to order the medication themselves or stock it in their offices. It is simply delivered to the doctor's office instead of being picked up by the patient, similar to how patients currently access some vaccines and fertility treatments.
Medical pregnancy termination carries risks for women. Health Canada's decisions regarding drug products are focused on ensuring the health and safety of Canadians. The reason that the risk management approach for Mifegymiso includes physician-only dispensing, collection of patient information and mandatory follow up is to help reduce risks to patients. This is supported by strong evidence; in other jurisdictions where Mifegymiso is approved, similar approaches to protecting patients from potential risks are being employed.
Fact: Doctors are not required to order the medication themselves or stock it in their offices. The prescription can be filled by a pharmacist as with any other medication. It is simply delivered to the doctor's office instead of being picked up by the patient. This is similar to how some patients access vaccines and fertility treatments.
Fact: Health Canada approved the drug and established conditions of use based on the scientific evidence and proposed risk management strategy provided by the company. Health Canada also consulted with medical associations and other stakeholders.
Fact: The company's application to Health Canada for authorization of Mifegymiso was for the termination of pregnancy up to 49 days, which was granted in July of 2015.
The company may apply to Health Canada at any time with additional evidence to support an indication for use later in pregnancy. Health Canada would then review the new application.
Fact: The delay in product availability is due to other factors and is not the responsibility of Health Canada. It is up to the company to advise Health Canada when the product is available for prescribing.
Fact: Health Canada reviewed the safety and efficacy of mifepristone in the same way as all other medications and on similar timelines. This is fully explained in the Summary Basis of Decision.
Health Canada only begins its review for market authorization after an application is received.
Fact: Mifegymiso is a prescription drug with serious potential risks requiring physician oversight. The need for medical supervision is based on strong evidence for good health and safety outcomes. For example, it is estimated that up to 1 in 20 women who use this drug will require a follow-up surgical procedure because their pregnancy is not successfully terminated. Health Canada has put in place requirements that will help ensure that women have access to medical services in case of a serious adverse event taking place.