Canada has one of the safest drug systems in the world and we at Health Canada are always looking for ways to improve it. For example, the Minister of Health recently committed to mandatory reporting of adverse drug reactions and has indicated his support for more transparency regarding clinical trials.
The CMAJ editorial on the Vioxx case and its implications for drug safety1 notes some of the difficulties inherent in postmarketing surveillance, such as extrapolating conclusions from clinical trials to real-world clinical practice and detecting signals and relating them to a specific drug. The editorial also points to areas for improvement: better mechanisms for physician reporting, active surveillance targeting serious adverse events and improved use of other databases. Health Canada agrees and looks forward to active discussion of these issues with CMAJ readers, who are on the front line of postmarketing surveillance.
However, other comments in the editorial are inaccurate. Reference to a “built-in bias toward approving drugs” and a low bar for approval of drugs for sale in Canada are incorrect and misleading. The review process in Canada is thorough; involves extensive assessment of the safety, efficacy and quality of all medications; and is in line with international standards.
It is important to continue to raise the profile of adverse event reporting within the health care community and to work together to improve the system. The cooperation of CMAJ in the publication and distribution of the Canadian Adverse Reaction Newsletter is greatly appreciated, but much more must be done. One example of Health Canada's commitment in this area is its pilot project on active surveillance (undertaken with the Canadian Paediatric Society), which brings together a network of 2300 pediatricians to collect and analyze information on adverse reactions (see www.cps.ca/english/CPSP/Studies/drugreactions.htm). In addition, we are opening 2 new centres in our system of regional adverse reaction centres to enhance our ability to promote the reporting of adverse reactions nationally.
My colleagues and I look forward to working with CMAJ as well as the key players in the drug safety process to improve on the good and safe foundation that already exists.
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