Texas pharmacists' knowledge of reporting serious adverse drug events to the Food and Drug Administration

Abstract

Objectives: To assess Texas pharmacists' knowledge of adverse drug event (ADE) reporting to the Food and Drug Administration (FDA) and to determine demographic and practice characteristics associated with this knowledge. Design: Cross-sectional descriptive study. Setting: Austin, TX, in June and July 2009. Participants: 377 pharmacists practicing in hospital and community settings. Intervention: Survey instrument mailed to participants. Main outcome measures: Scores on an eight-item test were used to assess pharmacists' knowledge about ADE reporting to FDA. Pharmacists' demographic and practice characteristics, as well as past reporting, were also measured. Results: 1,500 surveys were mailed and 377 usable responses were obtained (26.4% response rate). Most (67.9%) pharmacists had never reported ADEs to FDA. A majority of pharmacists (65.7%) reported having inadequate knowledge about ADE reporting. Pharmacists had low knowledge scores on ADE reporting, and the pass rate for all items ranged from 56.7% to 96.0%. Pharmacists' age (r = -0.106, P = 0.042) and years of experience (-0.134, P = 0.010) were negatively correlated with knowledge levels, whereas hours worked by pharmacists was positively correlated with knowledge levels (0.130, P = 0.012). Mean knowledge levels differed by practice setting, job title, and area/setting of primary place of employment (P < 0.001). Conclusion: Texas pharmacists have knowledge gaps concerning ADE reporting to FDA. Pharmacists need more education, awareness, and training on ADE reporting, especially regarding reportable ADEs, how to report, and what constitutes a good report.