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Pharmacovigilance

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Clinical Research Informatics

Part of the book series: Health Informatics ((HI))

Abstract

Pharmacovigilance is a scientific discipline concerned with the safety of drugs as used in clinical practice and whose main purpose is to balance the risk–benefit ratio to the public. This chapter discusses the progression of pharmacovigilance as a discipline from its start in the early 1960s during the thalidomide tragedy to its current status as a visible and pervasive part of the health care delivery and research. It provides an overview of the recent activities and science supporting pharmacovigilance and their informatics dependencies and implications, as well as the settings in which pharmacovigilance activities are undertaken. Major informa­tics themes related to pharmacovigilance include the design and support of drug safety data collection systems, identification of alternative data sources, methodological development to support new analyses and discovery, methods to support the use of patient-specific genetic profile data as mitigating factors, and communication of complex information to physicians, policy makers, and patients. This chapter also reviews the various methods of detecting new adverse drug reactions, including pre- and postmarketing studies, spontaneous reporting, intensive monitoring, and database studies, as well as the pros and cons of each. Both pharmacovigilance and drug safety monitoring impact the activities and workflows of clinical research, and the knowledge generated from these activities will lead to safer use of drugs in the future.

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Author information

Authors and Affiliations

  1. Mathematics and Natural Sciences, Netherlands Pharmacovigilance Centre, Goudsbloemvallei 7, 5237 MH, s-Hertogenbosch Lareb, The Netherlands

    A. C. (Kees) van Grootheest M.D., Ph.D.

  2. Department of Pharmacy, University of Groningen, s-Hertogenbosch, The Netherlands

    A. C. (Kees) van Grootheest M.D., Ph.D.

  3. Division of Informatics, Duke University School of Nursing, 311 Trent Drive, Durham, NC, 27710, USA

    Rachel L. Richesson Ph.D., MPH

Authors
  1. A. C. (Kees) van Grootheest M.D., Ph.D.
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  2. Rachel L. Richesson Ph.D., MPH
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Corresponding author

Correspondence to A. C. (Kees) van Grootheest M.D., Ph.D. .

Editor information

Editors and Affiliations

  1. College of Medicine, University of South Florida, Bruce B. Downs Blvd. 12901, Tampa, 33612-4799, Florida, USA

    Rachel L. Richesson

  2. College of Medicine, University of South Florida, Bruce B. Downs Blvd. 12901, Tampa, 33612-4799, Florida, USA

    James E. Andrews

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van Grootheest, A.C.(., Richesson, R.L. (2012). Pharmacovigilance. In: Richesson, R., Andrews, J. (eds) Clinical Research Informatics. Health Informatics. Springer, London. https://doi.org/10.1007/978-1-84882-448-5_19

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  • DOI: https://doi.org/10.1007/978-1-84882-448-5_19

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  • Publisher Name: Springer, London

  • Print ISBN: 978-1-84882-447-8

  • Online ISBN: 978-1-84882-448-5

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