NorthShore University Health System, Highland Park Hospital, 777 Park Avenue West, Highland Park, Illinois, USA.
Expert Opin Drug Saf. 2012 Mar;11(2):177-83. doi: 10.1517/14740338.2012.650165. Epub 2012 Feb 8.
The Adverse Events Reporting System (AERS) of the FDA is used to identify toxicities of drugs that are on the market. Nurse practitioners (NP) and physician assistants (PA), having an increasing role in the delivery of medical care, are also needed to participate in post-marketing pharmacovigilance. This study was performed to assess awareness and use of the AERS in voluntary reporting of drug toxicities by NPs and PAs.
A cluster sample survey was issued at the Principles of Gastroenterology for the Nurse Practitioner and Physician Assistant course in August 2010. The survey assessed familiarity with the AERS, the number of adverse events seen and the frequency of reports sent to the AERS. NP and PA responses were compared using the two-tailed Fisher's exact.
Of the 92 respondents, 67 (72%) were NPs and 24 (26%) PAs. Of the 50 (54%) respondents that reported being familiar with the AERS system, 20 (40%) incorrectly identified the methods to report using the AERS. Overall reporting of adverse events was low, particularly in respondents seeing 5-12 adverse events per year.
The study suggests that improved education regarding the importance of using AERS for pharmacovigilance is suggested for NPs and PAs. Due to the small size of the study, these data should be viewed as preliminary, pending a larger confirmatory study.
美国食品药品监督管理局的不良事件报告系统（AERS）用于识别市场上药物的毒性。执业护士（NP）和医师助理（PA）在医疗保健的提供中扮演着越来越重要的角色，也需要参与上市后药物警戒。本研究旨在评估 NP 和 PA 在自愿报告药物毒性方面对 AERS 的认识和使用情况。
2010 年 8 月，在《护士和医师助理胃肠病学原则》课程中进行了一项聚类样本调查。该调查评估了对 AERS 的熟悉程度、看到的不良事件数量以及向 AERS 发送报告的频率。使用双侧 Fisher 精确检验比较 NP 和 PA 的反应。
在 92 名受访者中，67 名（72%）是 NP，24 名（26%）是 PA。在 50 名（54%）报告熟悉 AERS 系统的受访者中，有 20 名（40%）错误地确定了使用 AERS 报告的方法。不良事件的总体报告率较低，特别是在每年看到 5-12 个不良事件的受访者中。
该研究表明，需要为 NP 和 PA 提供关于使用 AERS 进行药物警戒的重要性的改进教育。由于研究规模较小，这些数据应被视为初步数据，等待更大的确认性研究。
