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Pharmacovigilance indicators: Desiderata for the future of medicine safety

Pharmacovigilance: Critique and Ways Forward, Page: 99-114
2016
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Book Chapter Description

The thalidomide tragedy highlighted an unacceptable harm and potential risks of taking medicines [1]. This resulted in a global resolve that such a tragedy should never occur again, and all machinery to achieve this was put in place in the more developed countries in a rather systematic manner. This initial and prompt response ultimately resulted in the establishment of the WHO Programme for International Drug Monitoring (PIDM) schemes [2]. The initial focus was on suspected adverse drug reactions however over time the scope broadened to include other medicine-related problem. The occurrences regarding issues on medicinal safety after the thalidomide experience underscore the need for continuous watchfulness. The nomenclature has become more embracing and issues bordering on medicines safety coined “pharmacovigilance.".

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