基于HIS的哨点医院药物警戒系统的研究与应用  

Research and Application of the Sentinel Hospital Pharmacovigilance System Based on HIS

作　　者：舒婷[1] 陈文戈[1] 侯永芳[2] 陈冠全 周克雄 张业象[4] 

机构地区：[1]广东工业大学机电工程学院,广州510090 [2]国家食品药品监督管理总局药品评价中心,北京100045 [3]广州市品毅信息科技有限公司,广州510095 [4]广东省药品不良反应监测中心,广州510080

出　　处：《中国药房》2017年第25期3468-3471,共4页China Pharmacy

基　　金：2015年国家食品药品监督管理总局药品评价中心委托项目(No.0702-1641CITC5D03);2015年广东省科技计划项目(No.2015A030401061);2016年广州市科技计划项目(No.2017010160232);2016年越秀区科技计划项目(No.2016-GX-024)

摘　　要：目的:介绍哨点医院药物警戒系统的研究与应用情况,为我国医院药物警戒工作的开展提供技术参考。方法:构建一套基于医院信息系统(HIS)的哨点医院药物警戒系统,并介绍其结构和功能,分析其应用效果。结果:依托医院业务信息管理平台、数据中心建立的哨点医院药物警戒系统,主要功能有药品数据规整、药品不良反应(ADR)辅助上报、主动监测、药物警戒信息查询、监测预警与统计分析,实现了医院ADR的快速上报与主动监测。该系统已在20家哨点医院上线应用,上线后医院ADR报告数量明显上升。某样本哨点医院自2016年初使用该系统后,与2015年比较,2016年上报的ADR报告增长了120.6%。此外,该系统改善了ADR报告的上报流程;规范了ADR上报人员的操作及填写,缩短了上报时间,提高了上报人员的工作效率。结论:哨点医院药物警戒系统的建立与应用极大地提高了医院ADR监测管理水平,对进一步加强我国医院药物警戒工作具有重要意义。OBJECTIVE： To introduce the research and application of sentinel hospital pharmacovigilance system, and provide technical reference for hospital pharmacovigilance working in China. METHODS： A sentinel hospital pharmacovigilance system based on hospital information system was established, the architecture and functionality were introduced and its effects were ana- lyzed. RESULTS： The sentinel hospital pharmacovigilance system formed by hospital business information management platform and data center. Its main functions included drug data arrangement, the auxiliary reporting of ADR, active monitoring, pharmaco- vigilance information inquiry, monitoring and warning and statistical analysis, which successfully achieved the rapid reporting and active monitoring of hospital ADR. The system had applied in 20 sentinel hospitals, and the ADR reporting quantity was obviously increased after applying the system. Compared with 2015, ADR reporting in a sample sentinel hospital was increased 120.6% since it used the system in early 2016. Besides, the system had improved the ADR reporting process, operation and input standard for the ADR reporter, shortened the reporting time and improved the efficiency of the reporting staff. CONCLUSIONS： The establish- ment and application of sentinel hospital pharmacovigilance system has greatly improved the hospital ADR monitoring management level, and it is of great significance to further strengthen the pharmaovigilance in China.

关 键 词：哨点医院 药物警戒系统 医院信息系统 药品不良反应监测 

分 类 号：R95[医药卫生—药学]