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

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.

The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: March 20, 2014