Pharmacovigilance: methods, recent developments and future perspectives
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- Härmark, L. & van Grootheest, A.C. Eur J Clin Pharmacol (2008) 64: 743. doi:10.1007/s00228-008-0475-9
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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.
To review and discuss various aspects of pharmacovigilance, including new methodolgical developments.