Evaluation of Drug Adverse Event Intake and Reporting in a Medical Information Service

Abstract

The primary objective of this research was to evaluate the depth and quality of adverse event (AE) intake and data collection in a pharmaceutical industry-based medical information service (PIMIS). Three US-marketed drug products over a 5-year period were assessed at MedImmune, LLC. A retrospective AE case analysis in the department’s Information Request Management System (IRMS) database was conducted from August 1, 2004 to July 31, 2009. The percentage of AEs received annually and the completeness of AE data fields collected in each case according to specified work instructions were assessed. Over the 5-year period, the medical information service (MIS) received 54,340 total medical information inquiries, of which 1,462 (2.7%) were potentially reportable AE cases. Of these AE cases, 14.6% (N = 213) were identified as serious adverse events (SAEs). Overall, the MIS accounted for an average of 50.7% of the company’s US spontaneous AE reports for these three products (does not include ex-US or clinical studies). Product seasonality caused an increase in AE volume during fall and winter months. AEs were primarily reported by nursing professionals (50.8%), with the most common method of receipt by phone (81.7%). The MIS successfully collected the minimum data field elements (reporter, adverse event, drug name, and patient identifier) required for regulatory reporting in 94% of cases and, in addition, other ancillary AE data fields in up to 72% of the AE cases. The MIS improved its success rate in collecting AE data elements by 14.2% over the 5-year study period because of enhancements in staff training and collection tools utilized. Through this research, we created a benchmark for evaluating AE data quality and data collection in a PIMIS.