Abstract
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.
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References
American Journal of Health-System Pharmacy. ASHP guidelines on adverse drug reaction monitoring and reporting. Am J Health Syst Pharm. 1995;52:417–9.
Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. J Am Med Assoc. 1999;281(9):824–9.
Leape LL. Reporting of adverse events. N Engl J Med. 2002;347(20):1633–8.
Barwick DM. Quality comes home. Ann Intern Med. 1996;125(10):839–43.
Solberg L, Moaser G, McDonald S. The three faces of performance measurement: improvement, accountability, and research. Jt Comm J Qual Improv. 1997;23(3):135–47.
Classen DC, Pestotnik S, Evans SM, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. J Am Med Assoc. 1997;277(4):301–6.
Bates DW, Spell N, Cullen DJ, Burdick N, Laird NM, Petersen LA, et al. The costs of adverse drug events in hospitalized patients. Adverse events prevention study group. J Am Med Assoc. 1997;277(4):307–11.
Cohen MR. Why error reporting systems should be voluntary. Br Med J. 2000;320(7237):728–9.
Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(Supplement 3):C40–4.
US Food and Drug Administration. What is a serious adverse event? www.fda.gov/medwatch/report/DESK/advevnt.htm.
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.
Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration: your report can make a difference. J Gen Intern Med. 2003;18(1):57–60.
Cobert BL. Manual of drug safety and pharmacovigilance. Boston: Jones and Bartlett Publishers; 2007.
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.
Lawton R, Parker D. Barriers to incident reporting in a healthcare system. Qual Saf Health Care. 2002;11(1):15–8.
Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL. The incident reporting system does not detect adverse drug events: a problem for quality improvement. Jt Comm J Qual Improv. 1995;21(10):541–8.
Barach P, Smith BJ. Reporting and preventing medical mishaps: lessons from non-medical near miss reporting system. Br Med J. 2000;320(7237):759–63.
Green CF, Mottram DR, Rowe PH, Pirmohamed M. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51(1):81–6.
Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ. Influence of pharmacists’ attitudes on adverse drug reaction reporting: a case-control study in Portugal. Drug Saf. 2006;29(4):331–40.
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.
Sweis D, Wong IC. A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf. 2000;23(2):165–72.
van Grootheest AC, Mes K, den Berg LTW. Attitudes of community pharmacists in the Netherlands towards adverse drug reaction reporting. Int J Pharm Pract. 2002;10(4):267–72.
Generali JA, Danish MA, Rosenbaum SE. Knowledge of and attitudes about adverse drug reaction reporting among Rhode Island pharmacists. Ann Pharmacother. 1995;29(4):365–9.
McArdle D, Burns N, Ireland A. Attitudes and beliefs of doctors towards medication error reporting. Int J Health Care Qual Assur. 2003;16(7):326–33.
Uribe CL, Schweikgart SB, Pathak DS, Marsch GB, Fraley RR. Perceived barriers to medical-error reporting: an exploratory investigation. J Healthc Manag. 2002;47(4):263–74.
Inman WHW, editor. Assessment of drug safety problems. 3rd ed. Hamilton: McMaster University Library Press; 1978.
Wakefield DS, Wakefield BJ, Uden-Holeman T, Borders T, Blegen M, Vaughn T. Understanding why medication errors may not be reported. Am J Med Qual. 1999;14(2):81–8.
Kessler DA, Kennedy DL. MedWatch: FDA’s new medical products reporting program. J Clin Eng. 1993;18(6):489–92.
Biriell C, Edwards RI. Reasons for reporting adverse drug reactions—some thoughts based on an International review. Pharmacoepidemiol Drug Saf. 1997;6(1):21–6.
Irujo M, Beitia G, Bes-Rastrollo M, Figueiras A, Hernandez-Diaz S, Lasheras B. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf. 2007;30(11):1073–82.
Hazell L, Shakir SAW. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.
Eland IA, Belton KJ, van Grootheest AC, Meiners AP, Rawlins MD, Stricker BH. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol. 1999;48(4):623–7.
Bäckström M, Mjörndal T, Dahlqvist R, Nordkvist-Olsson T. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol. 2000;56(9):729–32.
Scott HD, Thacher-Renshaw A, Rosenbaum SE, Waters WJ Jr, Green M, Andrews LG, et al. Physician reporting of adverse drug reactions. Results of the Rhode Island Adverse Drug Reaction Reporting Project. J Am Med Assoc. 1990;263(13):1785–8.
Acknowledgments
We gratefully acknowledge Abiola Oladapo, Michelle Rascati, Ayoade Adeyemi, Haesuk Park and Busuyi Olotu for helping in stuffing the survey materials prior to posting.
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This study was funded by a fellowship from the United States Pharmacopeia.
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No conflict of interest.
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Gavaza, P., Brown, C.M. & Khoza, S. Texas pharmacists’ opinions on reporting serious adverse drug events to the Food and Drug Administration: a qualitative study. Pharm World Sci 32, 651–657 (2010). https://doi.org/10.1007/s11096-010-9420-y
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DOI: https://doi.org/10.1007/s11096-010-9420-y