Appalachian College of Pharmacy, Oakwood, VA 24631 College of Pharmacy, The University of Texas at Austin, 1 University Station A190, Austin, TX 78712, USA.
Br J Clin Pharmacol. 2011 Jul;72(1):143-52. doi: 10.1111/j.1365-2125.2011.03944.x.
To investigate the influence of pharmacists' attitudes on intention to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA).
This cross-sectional study used a mail survey to collect data from hospital and community pharmacists practicing in Texas, United States. Three and 16 items were used to measure intention and attitudes, respectively, using a seven-point bipolar scale. Pharmacists' demographic and practice characteristics, and past reporting were also measured.
The response rate was 26.4% (n= 377/1500 pharmacists). Most pharmacists intended (n= 297, 78.8%) to report serious ADEs that they will encounter to the FDA through MedWatch. Overall, pharmacists held favourable attitudes towards reporting serious ADEs (mean = 24.5, SD = 6.7, possible range 1-49, neutral = 16). Pharmacists intending to report serious ADEs had more favourable attitudes than those who did not (P < 0.001). About 90% of the pharmacists believed that reporting serious ADEs would improve patient safety. However, 72.6% indicated that reporting serious ADEs was time consuming and over half (55.5%) of the respondents believed that reporting serious ADEs disrupted the normal workflow. Non-intenders held stronger beliefs that ADE reporting would disrupt the normal workflow and was time consuming compared with intenders. Years of experience, number of hours worked and practice setting were associated with pharmacists' attitudes towards reporting (P < 0.05).
Most pharmacists held moderately favourable attitudes and high intentions toward reporting serious ADEs to the FDA. This study's findings contribute to an increased understanding of individual factors that influence pharmacists' attitude and intention towards reporting serious ADEs to the FDA.
调查药师对向美国食品和药物管理局（FDA）报告严重药物不良事件（ADE）的态度的影响。
本横断面研究采用邮件调查的方式，从美国德克萨斯州的医院和社区药师中收集数据。使用七点双极量表，分别使用 3 项和 16 项条目来衡量意图和态度。还测量了药师的人口统计学和实践特征以及过去的报告情况。
回复率为 26.4%（n=377/1500 名药师）。大多数药师（n=297，78.8%）打算通过 MedWatch 向 FDA 报告他们将遇到的严重 ADE。总体而言，药师对报告严重 ADE 持有利态度（均值=24.5，SD=6.7，可能范围 1-49，中立=16）。打算报告严重 ADE 的药师比不打算报告的药师态度更为积极（P <0.001）。约 90%的药师认为报告严重 ADE 会提高患者安全性。但是，72.6%的人表示报告严重 ADE 很耗时，超过一半（55.5%）的受访者认为报告严重 ADE 会扰乱正常工作流程。非意向者比意向者更强烈地认为 ADE 报告会扰乱正常工作流程并很耗时。工作年限、工作时间和实践环境与药师对报告的态度相关（P<0.05）。
大多数药师对向 FDA 报告严重 ADE 持有较为有利的态度和较高的意向。本研究的结果有助于更深入地了解影响药师向 FDA 报告严重 ADE 的个体因素。
