Serious adverse drug events reported to the food and drug administration, 1998-2005
Serious adverse drug events reported to the food and drug administration, 1998-2005
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DOI：
10.1001/archinte.167.16.1752
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发表时间：
2007-09-10
影响因子：
--
通讯作者：
Furberg, Curt D.
中科院分区：
文献类型：
--
作者：
Moore, Thomas J.;Cohen, Michael R.;Furberg, Curt D.
背景：美国食品和药物管理局自 1998 年起开始运行不良事件报告系统。该系统收集直接提交给该机构或通过药品制造商提交的所有药物不良事件自愿报告。方法：利用已发表的供研究使用的摘录，我们分析了 1998 年至 2005 年向美国食品和药物管理局报告的所有严重药物不良事件和用药错误。结果：从 1998 年至 2005 年，报告的严重药物不良事件有所增加2.6倍，从34 966增加到89 842，致命药物不良事件增加2.7倍，从5519增加到15 107。报告的严重事件增加速度是同期门诊处方总数的4倍。在每年报告 500 起或更多病例的药物子集中，与安全戒断相关的药物占 1999 年该组报告事件的 26%，到 2005 年下降到不到 1%。对于 13 种新生物技术产品，报告的严重事件增长了 15.8 倍，从 1998 年报告的 580 起增加到 2005 年的 9181 起。这一增长受到相对较少药物的影响：298 起已确定的 1489 种药物 (20%) 占 467 809 起事件 (87%) 中的 407 394 起。结论：这些数据显示，在研究期间，报告的与药物治疗相关的死亡和严重伤害显着增加。结果强调了这一公共卫生问题的重要性，并说明需要改进系统来管理处方药的风险。
Background: The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers.Methods: Using extracts published for research use, we analyzed all serious adverse drug events and medication errors in the United States reported to the Food and Drug Administration from 1998 through 2005.Results: From 1998 through 2005, reported serious adverse drug events increased 2.6-fold from 34 966 to 89 842, and fatal adverse drug events increased 2.7-fold from 5519 to 15 107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005. For 13 new biotechnology products, reported serious events grew 15.8-fold, from 580 reported in 1998 to 9181 in 2005. The increase was influenced by relatively few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of the 467 809 events (87%).Conclusions: These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.