One Method for the Systematic Evaluation of Adverse Drug Experience Data within a Pharmaceutical Firm

Post-marketing surveillance of drug adverse experience incidents constitutes a major interest for physicians, pharmaceutical firms and federal regulatory bodies alike. The development and operation of a total information system for the management of adverse experience data related to a single pharmaceutical firm’s commercial products is described. Data is carefully collected from clinical investigations, visits and correspondence with practicing physicians and from the published medical literature. Each such alleged incident is carefully medically reviewed. Thereafter, the data is reported to the United States Food and Drug Administration (FDA) and entered into an internal data bank. Computer management of the data for information retrieval and trend analysis was accomplished in a rapid and economical fashion by the use of commercially available computer programming packages. This approach, combining meticulous data collection, computer management of files and links to the firm’s FDA reporting system offers a flexible, thorough approach operative within the economic constraints naturally inherent within a single corporation.

Die Überwachung des Auftretens von Nebenwirkungen nach Einführung eines Arzneimittels ist in gleicher Weise für Ärzte, pharmazeutische Firmen und staatliche Kontrollstellen von größtem Interesse. Es werden Entwicklung und Anwendung eines umfassenden Informationssystems zur Handhabung von Erfahrungsdaten über Nebenwirkungen der Handelspräparate einer einzelnen pharmazeutischen Firma beschrieben. Die Daten werden sorgfältig aus klinischen Prüfungen, Besuchen und Schriftverkehr mit praktizierenden Ärzten sowie medizinischen Publikationen zusammengestellt. Jeder angebliche Vorfall wird sorgfältig medizinisch überprüft. Anschließend werden die Daten der amerikanischen Food and Drug Administration (FDA) gemeldet mul in einer internen Datenbank gespeichert. Die Verwendmag kommerziell erhältlicher Computerprogramme ermöglichte eine rasche und wirtschaftliche Computerbearbeitung der Daten zur Informationsrecherehe und Trendanalyse. Die Kombination von genauester Datenerfassung, Computerbearbeitung der Datensammlung und Verbindung zum firmeneigenen FDA-Meldesystem bietet eine bewegliche, umfassende Methode, die innerhalb der in einer Einzelfirma vorhandenen wirtschaftlichen Grenzen anwendbar ist.

Key-Words

Drug Adverse Effects - Information Retrieval System - Food and Drug Administration Reporting - Trend Analysis

Schlüssel-Wörter

Arzneimittel-Nebenwirkungen - Informations-System - Berichte an die Food and Drug Administration - Trendanalyse

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