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

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.