Rogers A S, Israel E, Smith C R, Levine D, McBean A M, Valente C, Faich G
Johns Hopkins University School of Medicine, Baltimore, MD.
Arch Intern Med. 1988 Jul;148(7):1596-600.
Voluntary physician reporting of adverse drug events (ADEs) in their patients remains the single most important source of information on serious and rare ADEs. Yet, substantial underreporting exists and the factors producing it are unclear. We surveyed 3000 randomly chosen physicians by mailed questionnaire to determine their knowledge about the reporting system, attitudes toward reporting, and their past behavior in reporting the ADEs they had detected. Responses numbered 1121. Only 57% were aware of the Food and Drug Administration's reporting system. While 418 physicians had detected an ADE in their practices during the previous year, only 21 physicians reported these events directly to the Food and Drug Administration. The physicians appear to appreciate the safety issues involved in prescription drug use and view reporting as a professional obligation; however, the current reporting system is considered inconvenient.
医生自愿报告其患者的药品不良事件（ADEs）仍然是有关严重和罕见药品不良事件最重要的单一信息来源。然而，存在大量漏报情况，且导致漏报的因素尚不清楚。我们通过邮寄问卷对3000名随机选择的医生进行了调查，以确定他们对报告系统的了解、对报告的态度以及他们过去报告所发现药品不良事件的行为。共收到1121份回复。只有57%的人知晓美国食品药品监督管理局的报告系统。虽然有418名医生在前一年的诊疗过程中发现了药品不良事件，但只有21名医生直接向美国食品药品监督管理局报告了这些事件。医生们似乎认识到处方药使用中的安全问题，并将报告视为一项职业义务；然而，当前的报告系统被认为不方便。
