期刊
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
卷 64, 期 8, 页码 743-752出版社
SPRINGER HEIDELBERG
DOI: 10.1007/s00228-008-0475-9
关键词
drug regulation; drug safety; intensive monitoring; pharmacovigilance; spontaneous reporting; transparency
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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