A primer of drug safety surveillance: an industry perspective. Part III: Managing adverse-event data.

OBJECTIVE: To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part III of this series describes management of adverse-event data. This process involves an interplay of regulations, labeling, and product knowledge. Types of databases are defined and the scope of paper files and computerized files is discussed. Database management is discussed in terms of four processes: receipt, retention, retrieval, and review of adverse-event reports. A summary of the application of the fundamentals to the incident described in the scenario shows that knowledge of the fundamentals may be sufficient to make a substantial contribution to the health of patients and the commercial well-being of manufacturers.

DATA SOURCES: This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are listed in the appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention.

STUDY SELECTION: The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance.

DATA SYNTHESIS: The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered to facilitate communication of a review of adverse-event data for various audiences.

CONCLUSIONS: Careful drug safety surveillance is beneficial to the health of the public and the commercial well-being of manufacturers. Attention to the basic principles is essential and, as illustrated, may be sufficient to resolve some problems.