The WHO Programme for International Drug Monitoring, its database, and the technical support of the Uppsala Monitoring Center

• Published in: Journal of rheumatology Vol. 28; no. 5; pp. 1180 - 1187
• Main Authors: LINDQUIST, Marie, EDWARDS, I. Ralph
• Format: Journal Article Conference Proceeding
• Language: English
• Published: Toronto, ON The Journal of Rheumatology 01-05-2001; Journal of Rheumatology Publishing
• Subjects: Adverse Drug Reaction Reporting Systems - organization & administration; Antirheumatic Agents - adverse effects; Biological and medical sciences; Clinical trial. Drug monitoring; Clinical Trials as Topic - standards; Drug Monitoring; General pharmacology; Humans; International Agencies; Medical sciences; Pharmacology. Drug treatments; Product Surveillance, Postmarketing; Program Evaluation; Rheumatic Diseases - drug therapy; Sweden; World Health Organization - organization & administration; Sweden; Human; Methodology; International system; Toxicity; Rheumatology; Diseases of the osteoarticular system; Pharmacovigilance; Chemotherapy; Treatment; Database; Clinical trial; Internet; Sanitary surveillance; WHO
• ISSN: 0315-162X; 1499-2752

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 based on interchange of adverse
reaction information between national drug monitoring centers in 60 countries. Collectively these centers provide more than
150,000 individual reports annually of reactions suspected of being drug induced. The cumulative database constructed from
these reports now comprises over 2 million records. Compatibility of different data collection systems that need to communicate
with each other has been achieved through harmonization rather than standardization. The design of the new system was driven
by the needs of existing and prospective users in terms of data fields and functionality. The data set required in the original
WHO case reports form was the lowest common denominator consistent with being useful for signal generation and evaluation.
The new database has an unlimited number of data fields. The WHO system relies on information being transferred, stored, and
retrieved in a timely and secure way. Through the use of sophisticated exchange server technology, the Internet can be used
as a transport medium for data and document transfer with guaranteed security and client authentication.