M. Lindquist et Ir. Edwards, The WHO Programme for International Drug Monitoring, its database, and thetechnical support of the Uppsala Monitoring Center, J RHEUMATOL, 28(5), 2001, pp. 1180-1187
We describe the development of an international adverse reaction database,
The operational responsibility for technical aspects of international drug
monitoring are run by the Uppsala Monitoring Center (UMC). The system is ba
sed on interchange of adverse reaction information between national drug mo
nitoring centers in 60 countries. Collectively; these centers provide more
than 150,000 individual reports annually of reactions suspected of being dr
ug induced. The cumulative database constructed from these reports now comp
rises over 2 million records. Compatibility of different data collection sy
stems that need to communicate with each other has been achieved through ha
rmonization rather than standardization. The design of the new system was d
riven by the needs of existing and prospective users in terms of data field
s and functionality. The data sec required in the original WHO case reports
form was the lowest common denominator consistent with being useful for si
gnal generation and evaluation. The new database has an unlimited number of
data fields. The WHO system relies on information being transferred, store
d, and retrieved in a timely and secure way. Through the use of sophisticat
ed exchange sen:er technology, the Internet call be used as a transport med
ium for data and document transfer with guaranteed security and client auth
entication.