Please refer to Health Canada’s New Approved Monograph
It came to our attention that the current packages of Mifegymiso include an outdated product monograph and consent form which contain an incorrect directive instructing physicians to observe patients during the ingestion of the first dose. Health Canada does not require patients to be observed during the ingestion of the Mifepristone pill.
The product monograph outlines that the drug should be “administered under the supervision of the prescriber” and instructs patients to take Mifegymiso “as directed by their doctor or given to them by medical staff”. Health Canada provided clarification that the intent of the wording in the product monograph is to allow prescribers to use their discretion for each individual patient and does not mandate that the medication be ingested in the presence of the prescriber.
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."