The WHO Programme for International Drug Monitoring is a worldwide collaboration of more than 150 countries whose aims are the safer use of medicines for patients everywhere and building a global culture of patient safety.
The WHO Programme for International Drug Monitoring is an active, progressive partnership, serviced and supported by UMC.
The establishment of the WHO programme followed the thalidomide disaster of 1961. The discovery that severely malformed babies were being born to mothers who had taken a supposedly “safe” sleeping pill during pregnancy, abruptly ended an age of uncritical trust in medicines. It caused worldwide outrage. In 1962, a proposal was made at the World Health Assembly that an international system for monitoring the adverse effects of medicines, based on reports from national agencies, should be established to prevent such a tragedy ever happening again.
In 1963, during the 16th World Health Assembly, a 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. After a pilot project in the USA, an international database was established at WHO headquarters in Geneva in 1971.
In 1978, this database, now known as VigiBase, moved to Uppsala, since when it has been managed by UMC, alongside the broader activities of the WHO programme. Members of the programme submit reports of suspected adverse effects associated with medicinal products to VigiBase. These are known as individual case safety reports (ICSRs). UMC then reviews and analyses this international data and shares its results and conclusions with member countries.
More than 130 countries are full members of the WHO programme, and 20 more are associate member countries in the early stages of establishing their pharmacovigilance systems, and preparing themselves for full membership.
UMC is one of four officially designated collaborating centres within the WHO Programme for International Drug Monitoring. UMC is responsible for managing the technical and scientific aspects of the WHO’s worldwide pharmacovigilance network. These activities are carried out following WHO policy and in close liaison with headquarters in Geneva. They include:
UMC shares WHO’s vision of improved health for all, but UMC is organisationally and professionally distinct from WHO itself.