药学专业学生对不良事件报告的看法。
Pharmacy student perceptions of adverse event reporting.
机构信息
Johnson & Johnson Pharmaceutical Research and Development, LLC, Horsham, PA 19044, USA.
出版信息
Am J Pharm Educ. 2011 Sep 10;75(7):131. doi: 10.5688/ajpe757131.
OBJECTIVE
To assess US pharmacy students' knowledge and perceptions of adverse event reporting.
METHODS
To gauge pharmacy students' impressions of adverse event reporting, a 10-question survey instrument was administered that addressed student perceptions of the reporting procedures of the Food and Drug Administration (FDA) and pharmaceutical manufacturers, as well as student understanding of the Health Insurance Portability and Accountability Act (HIPAA) and its relationship to adverse event reporting.
RESULTS
Two hundred twenty-eight pharmacy students responded to the survey. The majority of respondents believed that the FDA is more likely than a pharmaceutical company to take action regarding an adverse event. There were misconceptions relating to the way adverse event reports are handled and the influence of HIPAA regulations on reporting.
CONCLUSIONS
Communication between the FDA and pharmaceutical manufacturers regarding adverse event reports is not well understood by pharmacy students. Education about adverse event reporting should evolve so that by the time pharmacy students become practitioners, they are well acquainted with the relevance and importance of adverse event reporting.
目的
评估美国药学学生对不良事件报告的知识和认知。
方法
为了评估药学学生对不良事件报告的印象，我们采用了一种包含 10 个问题的调查工具，这些问题涉及学生对食品和药物管理局（FDA）和制药商报告程序的看法，以及学生对《健康保险携带和责任法案》（HIPAA）及其与不良事件报告关系的理解。
结果
228 名药学学生对调查做出了回应。大多数受访者认为，FDA 比制药公司更有可能对不良事件采取行动。在处理不良事件报告的方式以及 HIPAA 法规对报告的影响方面存在误解。
结论
药学学生对 FDA 和制药商之间关于不良事件报告的沟通并不理解。关于不良事件报告的教育应该不断发展，以便当药学学生成为从业者时，他们非常熟悉不良事件报告的相关性和重要性。
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