Grant: Project Grant

Medicines provide important health benefits but can also lead to harm, and are a major cause of emergency department visits and hospitalization. Much of this harm is preventable through appropriate use of the safest available treatment option. When new safety concerns arise, Health Canada and other national regulatory agencies put out warnings to health professionals and the public, with the aim of supporting safer medicine use and avoiding situations that can lead to harm. When and how warnings are issued can differ considerably between countries, but no research has compared the effectiveness of different approaches. This study compares safety advisories on medicines in Canada, the United States, the European Union (United Kingdom and Denmark), and Australia from 2005 to 2016. The focus is on new safety concerns for which the decision to communicate, methods used, or key messages differ between countries. We will develop a database of advisories on serious safety concerns in the five countries from 2005 to 2016. At a population level, we examine whether recommended changes to prescribing, other health-related behaviours, and health outcomes have occurred to a greater extent in countries with safety advisories than in those without advisories, The study also includes policy analysis and interviews with clinicians and patient groups to better understand factors that enhance the effectiveness of safety advisories and how awareness and medicine use are affected. The aim of the study is to identify best practices in regulatory risk communication on medicines, in terms of effects on medicine prescribing and use, and ultimately on public health.