title: Regional reporting of adverse drug reactions: a new computer-based network.
abstract: The use of drugs is always accompanied by the risk of adverse drug reactions (ADRs) and adverse events (AE). Generally physicians, pharmaceutical manufacturers, and pharmacists use a paper-based form for sending spontaneous ADR and AE reports to the national drug regulatory authority. Besides underreporting, reporting lag-time and errors through data transformation are a major issue. In order to improve the current reporting situation we have set up a new computer-based, network-driven system for storing, transferring, and evaluating ADR reports. The system consists of three regional centres, one coordinating centre, and the central ADR database of the national drug regulatory authority. In the regional centres, clinical pharmacologists collect ADR data in local databases. There is a comfortable user-interface with an online help-function available. New reports are sent automatically to the Federal Agency using EUROSCAPE as a standardized electronic report form of the EU. The coordinating centre in Munich is responsible for overall performance and quality assurance. This model for a clinical health information network is of a high level of data security, is reliable and easily expandable through the use of standard tools, is fast and also inexpensive by using standard shareware products.
authors.affiliation: Pharmacoepidemiology Research Group, Department of Medical Informatics, Biometry and Epidemiology, University of Munich. wswoboda@uro.med.uni-muenchen.de
authors.forename: W J
authors.initials: WJ
authors.lastname: Swoboda
authors.forename: M
authors.initials: M
authors.lastname: Göttler
authors.forename: J
authors.initials: J
authors.lastname: Hasford