Stang P E, Fox J L
Pharmacy Administration, School of Pharmacy, University of North Carolina, Chapel Hill 27599.
Ann Pharmacother. 1992 Feb;26(2):238-43. doi: 10.1177/106002809202600220.
To review some of the abuses and proper uses of the Food and Drug Administration's (FDA's) spontaneous adverse-reaction reporting system, as a way of educating the reader to its strengths and limitations.
Published literature and reports based on information obtained from the FDA's database of spontaneous adverse drug-event reports.
The Freedom of Information Act has increased public access to the FDA's database of spontaneous adverse drug reaction reports. As these reports are voluntarily received and reported to the FDA, their use for comparisons of drug safety is severely limited. Despite these limitations and the FDA's caveats for use of these data, consumer advocacy groups, researchers, and various pharmaceutical marketing groups have used this source to project the incidence of adverse drug reactions.
The FDA's spontaneous adverse-event reporting system is designed to generate signals of unexpected adverse drug events. Use of the data gathered by this system to make drug safety comparisons is beyond their credible scope because many factors influence the reporting of adverse events. Researchers and peer reviewers should place these data in the proper perspective and support sound research into questions of drug safety.
回顾美国食品药品监督管理局（FDA）自发不良反应报告系统的一些滥用情况及正确用法，以此让读者了解该系统的优势与局限性。
基于从FDA自发药品不良事件报告数据库获取的信息所发表的文献和报告。
《信息自由法》增加了公众对FDA自发药品不良反应报告数据库的访问权限。由于这些报告是自愿提交给FDA的，其在药品安全性比较方面的用途受到严重限制。尽管存在这些局限性以及FDA对这些数据使用的警示，消费者权益倡导组织、研究人员和各类药品营销团体仍利用此来源来推测药品不良反应的发生率。
FDA的自发不良事件报告系统旨在生成意外药品不良事件的信号。利用该系统收集的数据进行药品安全性比较超出了其可靠范围，因为许多因素会影响不良事件的报告。研究人员和同行评审人员应正确看待这些数据，并支持对药品安全性问题进行合理研究。
