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

Pharmacy World & Science : PWS
Paul GavazaStar Khoza

Abstract

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. 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. Beliefs and opinions of Texas pharmacists toward ADE reporting. 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'...Continue Reading

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Citations

Jan 1, 2013·American Journal of Pharmaceutical Education·Paul Gavaza, Bihn Bui
Oct 23, 2014·Revista da Escola de Enfermagem da U S P·Fabiana Rossi VaralloPatricia de Carvalho Mastroianni

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