Active Vaccine and Drug Surveillance

Margrét V. Bjarnadóttir () and David Czerwinski ()

Chapter Chapter 12 in Operations Research and Health Care Policy, 2013, pp 251-279 from Springer

Abstract: 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 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.

Keywords: False Alarm; Surveillance System; Heart Attack; Claim Data; Risk Increase (search for similar items in EconPapers)
Date: 2013
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DOI: 10.1007/978-1-4614-6507-2_12

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