中国药物警戒 ›› 2013, Vol. 10 ›› Issue (7): 411-414.

• 药械安全性研究 • 上一篇    下一篇

住院患者药品不良事件主动监测与评估警示系统的研发

陈超1,郭代红1*,薛万国2, 刘东杰3,刘皈阳4,朱曼1   

  1. 1.解放军总医院药品保障中心/ 解放军药品不良反应监测中心,北京100853；
    2.解放军总医院信息情报所,北京100853；
    3.康联达软件有限公司,北京,100097；
    4. 解放军第一附属医院药剂药理科,北京100037
  • 收稿日期:2013-05-01 修回日期:2016-03-09 出版日期:2013-07-08 发布日期:2016-03-09
  • 通讯作者: 郭代红,女,主任药师,硕士生导师,临床药学与药事管理。 E-mail:guodh301@163.com
  • 作者简介:陈超,女,硕士,主管药师,临床药学。
  • 基金资助:
    军队十二五科技攻关面上项目,军队药品风险防控关键技术研究（项目编号CWS12J127）。

Development of Alarming System to Actively Monitor and Assess the Adverse Drug Events in Hospitalized Patients

CHEN Chao1,GUO Dai-hong1*, XUE Wan-guo2, LIU Dong-jie3, LIU Gui-yang4, ZHU Man1   

  1. 1.Department of Pharmacy, the PLA General Hospital/the PLA Adverse Drug Reaction Monitoring Center, Beijing 100853, China;
    2.Computer Center, the PLA General Hospital, Beijing 100853, China;
    3.KangLianDa Software Development Limited Company, Beijing 100097, China;
    4.Department of Pharmacy, First Affiliated Hospital of Chinese PLA General Hospital, Beijing 100037, China
  • Received:2013-05-01 Revised:2016-03-09 Online:2013-07-08 Published:2016-03-09

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摘要： 目的 探索计算机辅助筛查药品不良事件和评估预警技术,旨在弥补现行自发报告模式的不足,改善“被动监测”现状,使“实时监测”和“预防为主”的药品风险控制策略成为可能。方法 依托运行良好的军卫1 号医院信息系统,采用触发器技术原理,设计开发住院患者药品不良事件主动监测与评估警示系统,并以临床药师人工评估结果为对照,论证系统监测效果。结果 完成了药物相关性血小板减少、贫血、肝损害、肾损害4个事件的自动识别规则设计,建立了集自动监测、用药审查、辅助评估、特征分析、高危筛选为一体的关键技术路线,开发了配套软件系统,并对接医院自发报告监测管理系统,效果验证阳性预测值达69.4%。结论 本研究建立了医疗机构药品不良事件“主动监测”与“自愿报告”的联动工具型平台,为药品安全性监测工作的开展提供一种新的思路和实用性的技术工具。

关键词: 药品不良反应, 主动监测, 重点监测, 计算机辅助筛查与评估, 临床药师

Abstract: Objective To develop active surveillance and assessment system for the detection and prevention of ADE in hospitalized patients in order to make up for the deficiency of the voluntary reporting and improve the status of "passive surveillance" to "real-time monitoring". Methods The principles of triggers technology were applied to the development of the system. The accuracy of the system was evaluated by the Results of the verification of clinical pharmacists. Results Detection rules of drug-related thrombocytopenia, anemia, liver damage, kidney damage were designed. The key technical route of automatic monitoring, medication review, assistance evaluation, characteristics analysis, high-risk screening were established and the software was developed to dock with hospital voluntary reporting system. +PV was 69.4%. Conclusion The computerized survelliance and auxiliary evaluation of adverse drug events was developed, and the electronic platform with SRS of ADE linkage monitoring was established. The study providesa new way of thinking and practical technology tools in order to carry out the drug safety monitoring.

Key words: adverse drug reaction, active surveillance, intensive monitoring, computerized detection and assessment, clinical pharmacists

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