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In addition, it came to our attention that the current packages of Mifegymiso include an outdated product monograph and consent form which contain an incorrect directive instructing physicians to observe patients during the ingestion of the first dose. Click here to see our alert about the outdated Mifegymiso Product Monograph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