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Pharmacovigilance: methods, recent developments and future perspectives

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Abstract

Background

Pharmacovigilance, defined by the World Health Organisation as ‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem’ plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug’s adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes, both at a regulatory and a scientific level, are being developed with the aim of strengthening pharmacovigilance. On a regulatory level, these include conditional approval and risk management plans; on a scientific level, transparency and increased patient involvement are two important elements.

Objective

To review and discuss various aspects of pharmacovigilance, including new methodolgical developments.

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Authors and Affiliations

  1. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, ’s-Hertogenbosch, The Netherlands

    L. Härmark & A. C. van Grootheest

  2. Department of Pharmacy: Pharmacotherapy and Pharmaceutical Care, University of Groningen, Groningen, The Netherlands

    A. C. van Grootheest

Authors
  1. L. Härmark
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  2. A. C. van Grootheest
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Correspondence to L. Härmark.

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Härmark, L., van Grootheest, A.C. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 64, 743–752 (2008). https://doi.org/10.1007/s00228-008-0475-9

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  • DOI: https://doi.org/10.1007/s00228-008-0475-9

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