53. An Historical Perspective of the Future of Pharmacovigilance

  1. Elizabeth B. Andrews PhD, MPH, FISPE2 and
  2. Nicholas Moore MD, PhD, FRCP(Edin), FISPE3
  1. Nicholas Moore

Published Online: 4 APR 2014

DOI: 10.1002/9781118820186.ch53

Mann's Pharmacovigilance

Mann's Pharmacovigilance

How to Cite

Moore, N. (2014) An Historical Perspective of the Future of Pharmacovigilance, in Mann's Pharmacovigilance (eds E. B. Andrews and N. Moore), John Wiley & Sons, Ltd, Oxford, UK. doi: 10.1002/9781118820186.ch53

Editor Information

  1. 2

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

  2. 3

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

Author Information

  1. Department of Pharmacology, INSERM U657, CIC-1401, University of Bordeaux, Bordeaux, France

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:

  • adverse drug reactions;
  • drug safety;
  • pharmacovigilance methods

Summary

Previous scandals concerning drug safety resulted in the initial laws governing the quality of medicines, but pharmacovigilance really started with the case reports of phocomelia attributed to thalidomide. This chapter describes the early days and the development of pharmacovigilance methods and explains about proper drug use to avoid adverse reactions. Spontaneous reporting would identify adverse drug reactions that could justify or mandate regulatory action, but it can be affected by a number of biases, such as relative overreporting, notoriety bias, contraindication bias, or dilution bias. As these biases and difficulties with spontaneous reports became apparent, the progress in the availability of large or very large scale population databases made it feasible to test hypotheses, so that the problem of underreporting or exposure denominators could be taken care of. Finally, the chapter discusses the proper drug use to avoid adverse reaction.