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.
In 1968, during the 16th World Assembly the 16.36 resolution 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 country level. Initially the WHO PIDM members consisted of 10 countries. As of January 2016, 123 countries have joined the WHO PIDM, and in addition 28 associate members are awaiting full membership. List of WHO programme members
WHO PIDM Member States submit reports of adverse reactions associated with medicinal products, known as Individual Case Safety Reports (ICSRs) to the WHO global database, VigiBaseTM.
VigiBase is managed and maintained by the WHO Collaborating Centre for International Drug Monitoring, known as the Uppsala Monitoring Centre. In October 2014, there were over 10 million reports of adverse reactions in VigiBase. Data in VigiBase are recorded in a structured and comprehensive way to allow the detection of potential medicinal 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 to assess the risk-benefit profile of medicines.
In April 2015, the World Health Organization (WHO) launched VigiAccessTM. VigiAccess is a new web application that will allow anyone to access information and encourage the reporting of adverse effects from medicinal products.