A worldwide adverse drug event monitoring and management system is described. Two subsidiaries encompassing over two dozen regional offices are linked by a FAX network. A common format is used for central collection and distribution of infor mation. Each regional office reformats information to comply with regulatory re porting requirements. Surveillance methods are described, coordination problems are outlined, and sources of bias in assessing incidence changes are discussed.RAPID COLLECTION, evaluation, and dissemination of adverse drug experience data are essential for both investigational and marketed drugs. These activities are required not only by regulations of the United States and many other countries but also by an increasingly competitive cli mate in which prompt assessment of ad verse reactions is required to determine the viability of investigational agents. Rapid, accurate information turnaround is more challenging in international pharmaceuti cal firms which deal with different, and often conflicting, adverse reaction termi nologies and local reporting regulations. An approach is described below which was chosen by a multinational pharma ceutical firm to meet internal and external requirements.

The analysis and dissemination of adverse reaction information for investigational drugs is described for an international pharmaceutical firm. Procedures are detailed which facilitate compliance with often conflicting international requirements for promptly reporting fatal or serious adverse reactions. Procedures include maintain ing investigator's brochure-derived adverse experience listings, using FAX machines, each programmed to send information to up to 200 clinical investigators and other selected sites, and circulating reports internally using a local area network.

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