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Active Vaccine and Drug Surveillance

Towards a 100 Million Member System

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Operations Research and Health Care Policy

Part of the book series: International Series in Operations Research & Management Science ((ISOR,volume 190))

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.

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Notes

  1. 1.

    The Food, Drug, and Cosmetic (FD&C) Act was signed into law in 1938 and mandated premarket testing of the safety of all new drugs, as well as banning false therapeutic claims.

  2. 2.

    Rosiglitazone is an antidiabetic drug that has been suspended from the European market and is currently being prescribed in the USA under significant restrictions. Annual sales peaked at approximately $2.5 billion in 2006, but have since declined due the potential increased risk of cardiac events and stroke.

  3. 3.

    Pioglitazone is an antidiabetic drug of the same class as rosiglitazone (thiazolidinedione) and shares some of the side effects of rosiglitazone, such as increase risk of fractures in females, and it may “cause or exacerbate” congestive heart failure in some patients [64].

  4. 4.

    The family-wise error rate refers to the probability of making one or more false discoveries or type I errors among all the hypotheses being tested.

  5. 5.

    Pemoline, a drug given to treat attention-deficit hyperactivity disorder, was approved by the FDA in 1975. It was withdrawn from the USA market in 2005 and can only be prescribed in the US under an “investigational new drug application.”

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  1. Van Munching Hall, College Park, MD, 20742, USA

    Margrét V. Bjarnadóttir

  2. One Washington Square, San Jose, CA, 95192-0069, USA

    David Czerwinski

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  1. Margrét V. Bjarnadóttir
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Correspondence to Margrét V. Bjarnadóttir .

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    Gregory S. Zaric

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Bjarnadóttir, M.V., Czerwinski, D. (2013). Active Vaccine and Drug Surveillance. In: Zaric, G. (eds) Operations Research and Health Care Policy. International Series in Operations Research & Management Science, vol 190. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-6507-2_12

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