Pharmacist reporting of serious adverse drug events to the Food and Drug Administration

Objective: To identify barriers to and facilitators of pharmacist reporting of serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). Method: Two focus groups consisting of practicing pharmacists were held in Austin, TX, in 2009. The following open-ended questions were used in the focus groups: (1) What do you think would make it easier to report serious ADEs to the FDA? (2) What do you think would make it more difficult to report serious ADEs to the FDA? A content analysis was performed on the generated transcripts. Results: 13 pharmacists practicing in hospital and community settings in Texas participated. Pharmacists identified 27 barriers to and facilitators of reporting serious ADEs to FDA. Lack of patients' complete medical histories and lack of time were the barriers most frequently cited. Knowledge and awareness of ADEs and ADE reporting emerged as important factors that would facilitate reporting serious ADEs to FDA. Conclusion: These findings highlight the factors that facilitate and/or inhibit pharmacist reporting of serious ADEs to FDA. Improved knowledge of ADEs and ADE reporting would facilitate reporting behaviors, while lack of time, lack of complete patient medical histories, and lack of compensation issues serve as important barriers to reporting. Interventions are needed to address these factors.