Adverse Drug Reactions Monitoring

An international system for monitoring adverse reactions to drugs using information derived from Member States was established in 1971. WHO Headquarters is responsible for policy issues while the operational responsibility for the programme rests with the WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, (the UMC), in Sweden. The system started with 10 countries that had already established national systems for spontaneous adverse reaction reporting and who agreed to contribute data. For an effective international system to become operative, a common reporting form was developed, agreed guidelines for entering information formulated, common terminologies and classifications prepared and compatible systems for transmitting, storing and retrieving and disseminating data were created. The adverse drug reactions database in Uppsala currently contains over three million reports of suspected adverse drug reactions.