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ADE触发工具在药品不良事件监测中的应用
引用本文:张海霞,冯嘉幸,刘金春,葛卫红. ADE触发工具在药品不良事件监测中的应用[J]. 药学与临床研究, 2016, 24(5): 399-403
作者姓名:张海霞  冯嘉幸  刘金春  葛卫红
作者单位:1. 南京大学医学院附属鼓楼医院药学部,南京,210008;2. 南京中医药大学药学院,南京,210046
基金项目:南京大学医学管理研究所课题(NDYG2015005)
摘    要:目的:探索ADE触发工具在医院药品不良事件(ADE)监测中的应用。方法:根据医疗保健研究所(IHI)推出的ADE触发工具及医院具体用药情况,选择19项触发器。自医院电子病历系统随机抽取2015年第三季度出院病历共967份(肿瘤患者和18岁以下患者除外),回顾性研究患者的用药情况、检验检查指标及病程记录,对触发器显示阳性的患者进行ADE判定和分析,并进行数据统计和分析,评估各触发器信号与ADE发生的相关性。结果:967位患者中触发器阳性者达到417例次,涉及319位患者,确定33位患者发生ADE,ADE检出率为10.34%(33/319)。33例ADE中E级ADE为31例,F级为2例。同时间段医院ADE自愿上报率为0.67%(147/21897),与经触发器检出的ADE发生率相比,有统计学差异;且在医院ADE自愿上报系统中未检查到此33例ADE患者信息。结论:ADE触发工具对发现ADE具有较强的敏感性,与自愿上报系统相比,可发现更多的ADE,但触发器需要进一步修正。

关 键 词:ADE触发工具  药品不良事件  医院信息系统
收稿时间:2016-08-16
修稿时间:2016-10-13

The use of ADE trigger tool for monitoring adverse drug events
ZHANG Hai-xi,FENG Jiaxing,LIU Jinchun and GE Wei-hong. The use of ADE trigger tool for monitoring adverse drug events[J]. Pharmacertical and Clinical Research, 2016, 24(5): 399-403
Authors:ZHANG Hai-xi  FENG Jiaxing  LIU Jinchun  GE Wei-hong
Affiliation:Department of Pharmacy,the Affiliated Drum Tower Hospital of Nanjing University Medical School,Department of Pharmacy,Nanjing University of Chinese Medicine,Department of Pharmacy,the Affiliated Drum Tower Hospital of Nanjing University Medical School,Department of Pharmacy,the Affiliated Drum Tower Hospital of Nanjing University Medical School
Abstract:Objective: T o explore and optimize the use of ADE trigger tool for monitoring adverse drug events (ADEs). Methods: Nineteen triggers were selected according to ADE trigger tool designed by the Institute for Healthcare Improvement (IHI) and situation of medicine using in Nanjing Drum Tower Hospital. Discharged patients' medical records in the third quarter of 2015 from Hospital Information System (HIS) of the hospital were reviewed and examined, including information of using medicine, conventional indices and progress notes. The records with positive triggers were further reviewed in order to identify ADEs and assess the correlation between each trigger and the occurrence of ADEs. Results: A total of 967 cases were reviewed, among which 417 positive triggers (319 patients involved) were detected. Thirty-three patients were identified with ADEs, and the total positive predictive value was 10.34% (33/319). The 33 ADEs contained 31 ADEs of level E, 2 ADEs of level F. The voluntary reporting rate of ADEs in the same period was 0.67%(147/21897), comparing with the detection rate of triggers, the difference was statistically significant. These 33 ADEs were not found in the voluntary reporting system. Conclusion: ADE trigger tool has a high sensitivity of finding adverse drug events. Comparing with the voluntary reporting rate, ADE trigger tool can find more ADEs. But the triggers should be modified according the situation of the hospital.
Keywords:ADE trigger tool  Adverse drug events  Hospital information system
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