A Successful Global Drug Safety System: The Hoffmann-La Roche Experience

Abstract

While premarketing clinical trials detect the majority of drug-related adverse events (AEs), they are not capable of detecting all possible reactions. Through postmarketing surveillance activities, voluntary reports of adverse events are reported to pharmaceutical companies and the Food and Drug Administration (FDA) where they are analyzed for trends and signals. Hoffmann-La Roche has developed a truly global drug safety system, in which all local centers funnel adverse event reports to one global processing center where they are coded onto a single, centralized database. This organization draws cases from all exposed patient populations worldwide and is able to develop corporate opinions on safety issues. In order to evaluate the customer impact of the new system, a survey was conducted of 1000 health care providers who had contacted the United States Roche Drug Safety Department during 1997. Survey results indicated overwhelming satisfaction with the Roche service, and also suggested that the presence and quality of such interactions can affect patient care and prescribing habits.