The WHO Programme for International Drug Monitoring
Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
During the 1968 16th World Assembly the 16.36 called for “a systematic collection of information on serious adverse drug reactions during the development and particularly after medicines have been made available for public use”. This led to the formation of the WHO Programme for International Drug Monitoring (PIDM).
WHO promotes PV at the country level. Initially the PIDM consisted of 10 countries members. As of February 2015, 120 countries have joined the PIDM, and in addition 29 associated members are awaiting for full membership. click here for List of WHO programme members
WHO PIDM members states submit reports of adverse reactions associated with medicinal products, known as individual case safety report (ICSR) to the WHO global database, VigiBase.
VigiBase is managed and maintained by the WHO Collaborating Centre for International Drug Monitoring, the Uppsala monitoring Centre.
In October 2014, there were over 10 million reports of adverse reactions in VigiBase. Data in VigiBase is recorded in a structured and comprehensive way to allow the detection of potential medicine safety hazards.
The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
In April 2015, the World Health Organization (WHO) launched www.vigiaccess.org . VigiAccess is a new web application that allows anyone to access information on reported cases of adverse events related. This aims to improve patient safety by increasing transparency and encourage the reporting of adverse effects from medicinal products.