Monitoring the World's Published Literature for Adverse Drug Experiences

Objectives of the Burroughs Wellcome Company's Product Information Section include locating, organizing, processing, storing, retrieving, and disseminating published information on the company's investigational and marketed products. Literature is collected from a wide range of international resources and integrated into a computerized INQUIRE® database called PRODBIB. PRODBIB contains bibliographic information and detailed subject indexing for over 58,000 papers. The file is utilized for answering inquiries and for generating bibliographies in support of Investigational New Drug (IND), New Drug Application (NDA), and other submissions to the FDA. In January 1982 a joint project was undertaken with the Product Surveillance and Epidemiology Department to add meaningful data from the literature to the “Adverse Reaction Reporting System,” which is a separate INQUIRE database originally designed for unpublished reports. The integration of published adverse drug experiences into this system has provided us with a unique foundation for post-marketing surveillance and systems for monitoring adverse reactions are of special interest in light of the NDA rewrite.