Texas pharmacists' opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study.

OBJECTIVE

Pharmacists in the United States (U.S.) are encouraged to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA) through MedWatch. The aim of this study is to investigate the beliefs and opinions of Texas pharmacists toward reporting ADEs to the FDA.

METHODS

The comments made by pharmacists in state-wide mail survey about reporting serious ADEs to the FDA were independently content analyzed and categorized into themes by two raters. Some comments contained more than one idea and these were categorized into different themes.

MAIN OUTCOME

Beliefs and opinions of Texas pharmacists toward ADE reporting.

RESULTS

A total of 86 pharmacists provided comments on ADE reporting. Texas pharmacists had positive opinions about reporting ADEs to the FDA (e.g., important, valuable and positive). Respondents cited many constraints that impeded the reporting of ADEs: lack of time, failure to know which ADEs to report, difficulty in linking ADEs to a specific drug, lack of patient history, lack of compensation, fear of malpractice suits, limited support from employers and mistrust of the FDA. Pharmacists recommended continuing education and training to raise awareness on ADE reporting and streamlining the reporting process to enhance pharmacists' reporting behavior.

CONCLUSIONS

Despite pharmacists having positive opinions about reporting ADEs to the FDA, actual reporting may be impeded by a myriad of challenges involved in reporting ADEs. ADE reporting can be improved through addressing these challenges. Continuing education and on-the-job training on ADE reporting are imperative.