The World Medicines Situation 2011 - Pharmacovigilance and Safety of Medicines
(2011; 22 pages)

Abstract

1. Pharmacovigilance (PV) aims to improve patient safety through the detection, assessment, understanding and prevention of adverse effects and other drug related problems;

2. PV, as a discipline, has seen tremendous growth over the past decade, but in response to different needs and priorities worldwide. While ‘high-burden diseases’ have been the focus in some settings, elsewhere this growth has been driven by a demand for transparency and access to information;

3. Recent years have seen a trend towards Good Pharmacovigilance Practice (GPP), particularly in industrialized countries to assure standards and innovations in the collection, management, analysis and use of medicine safety information – with patient safety as the ultimate objective;

4. Many resource-limited countries will require additional support (technical and financial) to build PV capacity to effective levels;

5. Despite 40 years of PV, patients worldwide continue to be affected by preventable harm from medicines. It is important to analyse and learn from these events;

6. For PV to be effective there is a need for timely and responsible communication of the available evidence, involving all stakeholders;

7. Many new PV initiatives are being undertaken. But it is important that these efforts are not duplicated and that scarce resources are used wisely.

 
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