Eur J Clin Pharmacol. 2008 Aug;64(8):743-52. Epub 2008 Jun 4.

Pharmacovigilance: methods, recent developments and future perspectives.

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Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 's-Hertogenbosch, The Netherlands. l.harmark@lareb.nl

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 methodological developments.

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