Abstract
OBJECTIVES: To determine pharmacy students' attitude toward and knowledge of reporting serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHOD: A 58-item survey questionnaire constructed to measure respondents' intention to report ADEs (3 items), attitude toward reporting ADEs (20 items), knowledge of ADE reporting (9 items), and demographic data was administered to all third-year (final-year) pharmacy students at the Appalachian College of Pharmacy. RESULTS: The majority of the 58 students who responded (91% response rate) intended (84%) and planned (85.3%) to report serious ADEs when they encounter them. Most respondents had favorable attitudes toward reporting serious ADEs to the FDA; respondents believed that reporting serious ADEs was valuable (5.6 ± 1.5, mean ± SD), good (3.0 ± 1.7), and beneficial (5.7 ± 1.5). Many students also believed that ADE reporting resulted in increased risk of malpractice, compromised relationships with physicians, broken trust with patients, disruption of the normal workflow, and was time consuming. Many students had inadequate knowledge on reporting ADEs. CONCLUSION: Although pharmacy students had strong intentions and favorable attitudes toward ADE reporting, they had inadequate knowledge of how to report serious ADEs.