Texas pharmacists’ opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study
- 163 Downloads
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.
KeywordsADR-reporting Adverse drug events Drug safety Pharmacovigilance Pharmacy United States
We gratefully acknowledge Abiola Oladapo, Michelle Rascati, Ayoade Adeyemi, Haesuk Park and Busuyi Olotu for helping in stuffing the survey materials prior to posting.
This study was funded by a fellowship from the United States Pharmacopeia.
Conflicts of interest
No conflict of interest.
- 1.American Journal of Health-System Pharmacy. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health Syst Pharm. 1995;52:417–9.Google Scholar
- 4.Barwick DM. Quality comes home. Ann Intern Med. 1996;125(10):839–43.Google Scholar
- 10.US Food and Drug Administration. What is a serious adverse event? www.fda.gov/medwatch/report/DESK/advevnt.htm.
- 11.US Department of Health and Human Services. MedWatch—The FDA safety information and adverse event reporting program (Form 3500). 2009. http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf.
- 13.Cobert BL. Manual of drug safety and pharmacovigilance. Boston: Jones and Bartlett Publishers; 2007.Google Scholar
- 14.Office of Drug Safety. Office of Drug Safety annual report. Center for Drug Evaluation and Research, Food and Drug Administration. http://www.fda.gov/cder/Offices/ODS/annrep2001/annualreport2001.htm (2001). Accessed 18 May 2008.
- 20.Houghton J, Woods F, Davis S, Coulson RA, Routledge PA. Community pharmacist reporting of suspected ADRs: attitudes of community pharmacists and general practitioners in Wales. Pharm J. 1999;263(7071):788–91.Google Scholar
- 26.Inman WHW, editor. Assessment of drug safety problems. 3rd ed. Hamilton: McMaster University Library Press; 1978.Google Scholar