Department of Medicine, UCSF Medical Center, San Francisco, CA 94143, USA.
Postgrad Med. 2010 Nov;122(6):154-64. doi: 10.3810/pgm.2010.11.2233.
The US Food and Drug Administration (FDA) is perceived by the public as having a substantial responsibility to ensure drug safety; however, the FDA has limited resources for active surveillance and relies on voluntary reporting of adverse events and potential adverse drug reactions. Studies have shown that underreporting of adverse events and adverse drug reactions is widespread. Furthermore, a review of several studies demonstrates that most adverse drug reactions are reported by pharmacists and nurses, with physicians reporting the fewest. The hospital setting, with its clearly defined patient population observed around the clock, is an ideal setting in which to identify potential adverse drug reaction signals and to report them to either the drug manufacturer or the FDA. In this article we describe the present system for addressing adverse events, obstacles to reporting them, and the important role any hospital physician could play in reporting adverse events and potential adverse drug reactions.
美国食品和药物管理局（FDA）被公众认为在确保药物安全方面负有重大责任；然而，FDA 用于主动监测的资源有限，只能依靠对不良事件和潜在药物不良反应的自愿报告。研究表明，不良事件和药物不良反应的报告严重不足。此外，对几项研究的回顾表明，大多数药物不良反应是由药剂师和护士报告的，而医生报告的最少。医院环境具有明确界定的、昼夜观察的患者人群，是识别潜在药物不良反应信号并向药物制造商或 FDA 报告的理想环境。在本文中，我们描述了目前处理不良事件的系统、报告不良事件的障碍，以及任何医院医生在报告不良事件和潜在药物不良反应方面可以发挥的重要作用。
