27. Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative

  1. Elizabeth B. Andrews PhD, MPH, FISPE4 and
  2. Nicholas Moore MD, PhD, FRCP(Edin), FISPE5
  1. Ryan M. Carnahan1,
  2. Carlos J. Bell2 and
  3. Richard Platt3

Published Online: 4 APR 2014

DOI: 10.1002/9781118820186.ch27

Mann's Pharmacovigilance

Mann's Pharmacovigilance

How to Cite

Carnahan, R. M., Bell, C. J. and Platt, R. (2014) Active Surveillance: The United States Food and Drug Administration's Sentinel Initiative, in Mann's Pharmacovigilance (eds E. B. Andrews and N. Moore), John Wiley & Sons, Ltd, Oxford, UK. doi: 10.1002/9781118820186.ch27

Editor Information

  1. 4

    Vice President, Pharmacoepidemiology and Risk Management, RTI Health Solutions, Research Triangle Park, NC, USA

  2. 5

    Professor of Clinical Pharmacology, Service Hospitalo-Universitaire de Pharmacologie, Bordeaux, France

Author Information

  1. 1

    Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA

  2. 2

    Office of Medical Policy, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, MD, USA and US Public Health Service, Silver Spring, MD, USA

  3. 3

    Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA

Publication History

  1. Published Online: 4 APR 2014
  2. Published Print: 1 APR 2014

ISBN Information

Print ISBN: 9780470671047

Online ISBN: 9781118820186

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Keywords:

  • Sentinel;
  • Mini-Sentinel;
  • Food and Drug Administration;
  • surveillance;
  • active surveillance;
  • administrative data;
  • claims data;
  • distributed data;
  • adverse effects;
  • drug safety

Summary

The Sentinel Initiative is the active surveillance component of the postmarket safety surveillance system of the Food and Drug Administration (FDA). Mini-Sentinel is a pilot program building the foundation for the Sentinel System. It is a collaboration between the FDA, academic institutions, and data partners that uses a distributed data system to allow analysis of data from health plans and other sources across a network of participating sites. This chapter provides an overview of the Sentinel Initiative, with a focus on Mini-Sentinel.