Health Canada received nearly 42 thousand domestic AR reports in 2011

In 2011, the medical industry regulatory Health Canada received 41,923 domestic drug adverse reaction reports, of which 78% were considered to be serious. The Canada Vigilance Program collects reports of suspected ARs to health products (pharmaceuticals, biotechnology products, blood products and biologics, natural health products, radiopharmaceuticals, and cells, tissues and organs).

The 41,923 reports represent 28,675 AR cases. A case consists of all information describing the AR(s) experienced by one patient at one time and suspected of being related to the use of one or more health products; thus, an AR case will include an initial AR report as well as any subsequent additional information received as follow-up report(s).

In Canada, Market Authorization Holders (MAHs) are required to submit AR reports received in accordance with the requirements of the Food and Drugs Act and Regulations. MAHs are required to send, within 15 days, all reports of serious ARs that have occurred in Canada (domestic) and all reports of serious unexpected ARs that have occurred outside Canada (foreign) to the Canada Vigilance Program. In 2011, MAHs submitted 81.8% of all the domestic reports received. The remaining reports were received directly from the community and hospitals.