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2004 March Report of the Auditor General of Canada
Exhibit 2.9—Options available to Health Canada to improve post-market surveillance
Sentinel systems (U.S.)—An active surveillance system which currently collects adverse events information from approximately 180 sentinel health care facilities (select health care facilities that volunteer to participate fully). Once fully implemented this program will include 250 sentinel facilities.
Liaison officers (UK)—A network of surveillance officers that are stationed in each hospital with responsibility for actively collecting adverse-events information and providing that information to the Medicines and Healthcare Products Regulatory Agency.
Active surveillance systems (Canada)—Health Canada is currently piloting an active surveillance system for pediatric drugs. Health Canada has developed arrangements with specific health care professionals and facilities that deal with children to have them actively collect information on adverse drug events and submit it to Health Canada.
Registries (Sweden)—Registries are data bases where clinicians provide data regarding patients who have the clinical conditions of interest. Data includes diagnosis and history, treatment, and related variables. Patient outcomes are monitored with a view to establishing the relationship between treatment and outcomes.
Environmental scanning (UK)—A regular and active scan of relevant domestic and international media.
Inspection of manufacturers' post-market surveillance systems (U.S.)—Inspection to ensure: that manufacturers are operating post-market surveillance systems that are adequate to identify adverse events; and that manufacturers are reporting all serious adverse events to the government.
Integrated adverse-events reporting systems (Canada)—Canada will use the U.S. Adverse Events Reporting System software to create its own database for Canadian adverse events. The Canadian database will be supplemented by de-identified U.S. data (data that contains no personal information) on a regular basis through downloads of the U.S. data.
Source: U.S. Food and Drug Administration, UK Medicines and Healthcare Products Regulatory Agency, Health Canada