For place in therapy and treatment goals we look first to Canadian consensus guidelines, to ensure consistency with current Canadian medical opinion. (s3.2) In the absence of Canadian guidelines we can consider US or North American guidelines. In the absence of those, we can consider international guidelines. When an international guideline is being submitted, we require authoritative support that the International guidelines are endorsed by a recognized Canadian health professional organization representing this therapeutic area.
In the scenario described above where guidelines lower in the aforementioned hierarchy are being used over the available US guidelines, evidence must be provided to support that these guidelines are a true reflection of Canadian practice. A letter from the recognized Canadian health professional organization for the particular therapeutic area is required to clearly support that the international guidelines are endorsed and more widely used by Canadian HCPs than the recent American guidelines (i.e. An official statement from the organization (not a personal letter from a KOL) on official letterhead demonstrating that it has been vetted by the entire group).
With respect to off-label content, guidelines cannot be used to support advertising content which extend beyond a product’s monograph, even in unbranded advertising. Off-label uses should not be mentioned.
