Thank you for your question.
Off-label use of a therapeutic product is basically when a product is used outside of the approved product labelling. It might be a different dosage or different route of administration, or outside of the indication for which the drug was initially approved.
The issue of off-label use is partially under the control of the physician. Sometimes it's the practice of medicine to use drugs outside of their recommended indications. The control or oversight of such off-label practice mostly resides with the provincial colleges of pharmacists and physicians who regulate the activities of their members.
In Canada it does happen sometimes, of course, in the pediatric population. There is some off-label use occurring there due to the fact that often there is a therapeutic need to handle some medical conditions. As well, there is not necessarily a solid body of knowledge that has been routed through the regulatory authorities and approved to basically grant an indication. Off-label use occurs also in certain subpopulations, such as cancer patients and AIDS patients. As I said, it's a reality that basically involves the practice of medicine.
We do, as a regulator, take action when we are aware of an off-label use that generates safety concerns, but we cannot regulate off-label use; it's outside the scope of our authority. As I said, it falls within the competencies of the different professional associations in Canada.