Active vaccine and drug surveillance: Towards a 100 million member system

Abstract

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 tradeoffs involved in surveillance, highlight some areas for future research, and frame the policy issues that designers of surveillance systems will have to address.