Risk management plans and drug safety in Canada: A cross-sectional study

BackgroundHealth Canada uses risk management plans (RMPs) to identify and monitor risks associated with drugs in the postmarket phase but does not make the contents of these RMPs public.ObjectiveTo identify information about RMPs that is available in other Health Canada documents and to analyze extent of the information.MethodsA list of new active substances (NAS) approved by Health Canada between July 1, 2015 and May 5, 2025 was generated. These drugs were searched on the Summary Basis of Decision website and any information about the contents of the RMPs was copied verbatim. The information was read iteratively and grouped into themes.ResultsThere were 385 NAS approved and 381 had RMPs. For 301 the only information was that they had been reviewed by Health Canada and found to be acceptable. The information about the other 80 was typically vague and revealed little about how the information that they generated would be used to enhance safety.ConclusionHealth Canada needs to make RMPs publicly available, should explain how their implementation will be monitored and evaluated, how the information they generate will be used to enhance drug safety and should publish updates to them as necessary.