Grant: Operating Grant

Prescription drugs are important treatments, contributing greatly to health and quality of life. However, all medicines can cause harm as well as benefit, and harmful drug reactions are a leading cause of emergency department visits and hospitalization. Pharmaceutical sales representatives--also known as "drug detailers"--have been shown to strongly influence prescribing decisions, an influence that is often underestimated by physicians. Regulation of promotional activities aims to protect patients by ensuring that the information provided accurately reflects the scientific evidence on a drug's effects. This study examines how often sales representatives provide basic information on harmful as well as beneficial effects of medicines needed for safe prescribing, and whether this differs in different regulatory environments. We compare the situation in Canada (BC and Quebec), which has brief, general standards and a self-regulatory approach, to that in France, representing the "toughest" approach to regulation internationally, and the US, with some tighter and other weaker controls. Over 250 family physicians who see sales representatives in their normal practices were enrolled in a "real life" observational study of the information provided in sales visits, especially in relation to patient safety. To better understand physicians' experiences, opinions and educational needs in relation to study results, we are holding focus groups with participating physicians in the four sites. An in-depth policy analysis on regulation of promotion in the three countries is also being carried out, based on interviews with key informants from a range of affected sectors. The aim of this study is to identify best practices in regulation, and ultimately to contribute to better information provision to doctors and ultimately protection of patients' health.