PHARMACOEPIDEMIOLOGY

This new edition includes several major new developments since the publication of the fourth edition in 2005. Among them are the following: - Legislative reforms in the US including the Sentinel Initiative, a national, integrated, electronic system for monitoring medical product safety, and the Medicare Prescription Drug, Improvement, and Modernization Act - Increasing use of Risk Evaluation and Mitigation Strategy (REMS) as required by the US FDA as part of the approval process for a new product, or for an approved product when new safety information emerges. - Vaccine Safety Data Link is much more widely used for signal identification about vaccine adverse events. - New HMO and other Commercial databases and new Canadian health databases have become available for pharmacoepidemiology research. - Increased availability and use of Electronic Health Records as a data source for pharmacoepidemiology research and as a tool for changing prescribing behaviour. - Molecular biology techniques are being increasingly applied within pharmacoepidemiology. - Increasing use of large simple clinical trials in pharmacoepidemiology and new methodological tools and concepts, e.g., instrumental variables, immortal time bias, and others. - Comparative Effectiveness Research is a new rapidly expanding type of research, which builds very closely on pharmacoepidemiology.