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

• Published in: Journal of the American Pharmacists Association Vol. 51; no. 3; pp. 397 - 409a
• Main Authors: Gavaza, Paul, PhD, Brown, Carolyn M., PhD, Lawson, Kenneth A, PhD, Rascati, Karen L., PhD, Wilson, James P., PhD, Steinhardt, Mary, EdD, LPC
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-05-2011
• Subjects: Adult; Adverse drug effects; Adverse Drug Reaction Reporting Systems; Age Factors; Cross-Sectional Studies; Female; Food and Drug Administration; Health Knowledge, Attitudes, Practice; Humans; Internal Medicine; Male; medication safety; Middle Aged; patient safety; Pharmaceutical Services - organization & administration; pharmacists; Pharmacists - standards; Pharmacists - statistics & numerical data; pharmacovigilance; Surveys and Questionnaires; Texas; United States; United States Food and Drug Administration; United States; Texas; patient safety; medication safety; Adverse drug effects; pharmacovigilance; pharmacists; Food and Drug Administration
• ISSN: 1544-3191; 1544-3450
• DOI: 10.1331/JAPhA.2011.10079

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.