Minimum Requirements for a Functional Pharmacovigilance System
(2010; 2 pages)

Abrégé

Pharmacovigilance (PV) is defined as the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”1. It is a very important medical discipline to prevent drug-related adverse effects in humans, ensure patient safety and promote the rational use of drugs.

PV is well established in most industrialized countries but its practice in low and middle income countries is variable with some countries having absolutely no systems at all whilst a few have systems comparable to the best in industrialized countries. In view of the importance of pharmacovigilance to all countries, the World Health Organisation, upon request from the Global Fund against AIDS, TB and Malaria (Global Fund) and key multilateral and technical agencies, has embarked upon an extensive and wide ranging consultative process to produce a Pharmacovigilance Strategy for use by all countries that are seeking to advance PV systems, through the Global Fund and similar health initiatives. The process includes the identification of (and the specifications for) the minimum requirements for PV.

The current document describes the minimum requirements for any national PV system and sets out what needs to be done as a minimum to ensure that a national PV system exists and is able to provide some measure of assurance for and security of medicines safety. Such a system is expected to be sustainable with guaranteed funding and with a key focus on patient safety.

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