An introspective case study examining the barriers faced by healthcare providers when reporting adverse events to MedWatch

Abstract

The Food and Drug Administration’s MedWatch is the program for reporting serious adverse events. Due to several barriers, there is a gap between the number of self-reported events and the actual number of events that occur. The aim of this research was to gauge the perspective of varying healthcare providers regarding barriers that prevent effective reporting of adverse events to MedWatch. Interviews were conducted with physician assistants, pharmacists, nurses, and physicians. Data analysis was performed during this qualitative case study utilizing interviews and focus groups. Barriers identified included: difficulty in linking ADEs to a specific drug, lack of education, lackadaisical attitude toward reporting, lack of time, lack of knowledge of reporting vehicles, fear of punitive retribution, cumbersome paperwork, and failure to know which ADEs to report. The objectives of this research were to improve healthcare provider adverse event reporting as well as to improve the current educational directives and vehicles for reporting.