Date: 04 Mar 2013

Active Vaccine and Drug Surveillance

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After the withdrawal of rofecoxib (known by the trade name Vioxx) from the US pharmaceutical market in 2004, post-approval drug safety and surveillance came under serious scrutiny. In 2008 the FDA announced the Sentinel Initiative, which includes an active surveillance system based on 100 million people’s health-care data. In this chapter we describe a number of challenges involved in active drug and vaccine surveillance and provide an overview of state-of-the-art surveillance methodologies. We also address the statistical tradeo-ffs involved in surveillance, highlight some areas for future research, and frame the policy issues that designers of surveillance systems will have to address.