Evaluation of Spontaneous Adverse Event Reports by Primary Reporter—A 15-Year Review (1983 to 1997)

Abstract

We conducted a study to explore whether the type of reporter has any impact on the quality and type of adverse event reports collected. One thousand spontaneous reports each from seven major reporter categories (primary care physicians, consultant/specialist physicians, psychiatrists, nurses, pharmacists, other health care providers, and consumers) were randomly generated from our safety database. Among the 7000 reports reviewed, serious reports were most commonly reported by consultant/specialist physicians (30.4% of the 1000 reports) with the lowest number reported by consumers (5.7%). Allergic reactions/anaphylaxis cases were reported most commonly by both pharmacists and other health care providers (2.9% each). Interestingly, other health care providers reported more cases about drug interaction than pharmacists (3.4% vs. 1.9%) although pharmacists remained the most common type of reporter to report lack of drug effect cases (14.6%). Psychiatrists (5.2%) and pharmacists (4.6%) reported the most incidences of overdose. Addiction/drug dependence reports were rarely reported, but were most commonly reported by primary care physicians and consumers (0.7% each). Completed reports were highest among primary care physicians. The current study is limited to our experience and further research by other investigators to confirm these findings is warranted.