Uppsala Monitoring Centre

The principal function of the Uppsala Monitoring Centre is to manage the international database of ADR reports received from National Centres. In 2002 this database held nearly three million case reports. The majority of national contributing centres have easy electronic access to these. The UMC has established standardized reporting by all National Centres and has facilitated communication between countries to promote rapid identification of signals.
A sophisticated Bayesian confidence propagation neural network (BCPNN) programme was created in 1998, which partly automates the signal detection system, and provides earlier alert signals than previous methods.The effectiveness of this system depends on:

• the size of the database
• the quality of the reports received from the contributing centres
• the timeliness of such reporting
• an active and reliable reporting culture within participating countries.

An international advisory panel of clinical experts determines the validity and clinical importance of the signals generated. In recent years the UMC has expanded its role as a communications and training centre and clearing-house for information on drug safety. Through

• mail discussion groups,
• website development,
• newsletters
• annual National Centre meetings,

The UMC team, in collaboration with the WHO, facilitates and encourages the international collaboration, which was identified in 1972 as being vital for the success of pharmacovigilance. The terminologies developed within the WHO programme for coding adverse reactions and medicines have been widely adopted by National Centres, manufacturers and drug regulators. In recent years, the introduction of a new terminology known as MedDRA (Medical Dictionary for Drug Regulatory Activities) has replaced the World Health Organization Adverse Reaction Terminology (WHO-ART) in developed countries. WHO-ART remains the mainstay of communicating adverse reactions in most developing countries within the International Programme.

Another project at the UMC is the creation of an ADR monitoring system for herbal and traditional medicines.While the UMC has achieved much in improving the activities, support and recognition of individual National Centres, much more could still be done in providing training and encouraging expertise at a national level. There needs to be better consultation and communication between developed and developing countries when discussions on international harmonization of pharmacovigilance issues are taking place. More effective communication of information is being promoted and encouraged through the WHO International Drug Monitoring Programme and the UMC. They are working towards playing a more pro-active role in working together with countries in addressing specific safety concerns and establishing a system that would make possible an evaluation of safety concerns of international importance by a supranational body of experts.