AERS is a relational safety database that operates as an internationally compatible system in full accordance with the International Conference on Harmonization initiatives. The fundamental piece of information stored in AERS is the Individual Safety Report (ISR), which contains all of the information contained on the MedWatch form (FDA form 3500 or 3500A). This database allows for increased efficiency in receiving and recording adverse event reports. In addition, it provides faster access for FDA reviewers who analyze the data from these reports.
A search of the AERS database was conducted for all adverse events with a patient outcome of death coded as "Drug Maladministration." "Drug Maladministration" is a Medical Dictionary for Regulatory Activities term used to index medication error events in the AERS database.
FDA receives both U.S. and foreign reports of adverse events from manufacturers that have a drug application filed with FDA. Thus, we included both domestic and foreign reports in this analysis. The deaths that occurred between January 1, 1993 and December 31, 1998 were reviewed. This defined six-year time period was chosen because FDA first began coding for medication errors during the latter part of 1993.
We reviewed and classified each report independently to determine whether a death was thought to be related to a medication error (expected event with no significant confounding factors and a positive temporal association), possibly related (expected event with some confounding factors, weaker temporal association, or incomplete data), or unrelated (no association with an error could be established). The medication error team discussed those cases that were difficult to classify independently and reached a consensus for each one. Each report was categorized according to the Taxonomy of Medication Errors, developed by NCCMERP and adopted by FDA, and analyzed by (1) event or setting of the error, (2) patient outcome, (3) product information, (4) personnel (by professional category) involved, (5) type of error, (6) causes of error, and (7) contributing factors. In addition, patient demographics (e.g., age, gender, and geographic location of the reporter) and the year the information was reported were captured.
Am J Health Syst Pharm. 2001;58(19) © 2001 American Society of Health-System Pharmacists
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