基于中国医院药物警戒系统开展药品不良反应监测的效果评价

doi:10.19803/j.1672-8629.20210011

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (10): 1136-1139.
DOI: 10.19803/j.1672-8629.20210011

基于中国医院药物警戒系统开展药品不良反应监测的效果评价

白荷荷, 聂晓静, 夏丽, 马莉, 王金萍, 彭莉蓉^*

西安市中心医院药剂科,陕西西安 710003

收稿日期:2021-01-14 出版日期:2022-10-15 发布日期:2022-10-17
通讯作者: ^*彭莉蓉,女,硕士,主任药师,医院药事管理。E-mail: 2725433862@qq.com
作者简介:白荷荷,女,硕士,主管药师,药品不良反应监测。
基金资助:
陕西省科技项目（2019JQ-984）; 陕西省科技项目（2020JQ-933）; 西安市科技项目（20YXYJ00012）; 西安市中心医院科研项目（2022YB06）

Effect evaluation of adverse drug reactions monitoring based on the Chinese hospital pharmacovigilance system

BAI Hehe, NIE Xiaojing, XIA Li, MA Li, WANG Jinping, PENG Lirong^*

Department of Pharmacy, Xi'an Central Hospital, Xi'an Shaanxi 710003, China

Received:2021-01-14 Online:2022-10-15 Published:2022-10-17

摘要/Abstract

摘要： 目的探讨医疗机构利用中国医院药物警戒系统（CHPS）开展药品不良反应（ADR）监测的工作成效。方法收集2019年1月1日至2020年12月31日本院ADR,以CHPS正式运行时间为截点,2019年收集上报的ADR为运行前组,2020年收集上报的ADR为运行后组。回顾性分析CHPS运行前后ADR监测上报情况,对ADR报告的数量、来源、类型、质量、涉及药品情况、累及系统-器官进行比较分析。结果运行CHPS前收集ADR报告 260例,运行CHPS后收集ADR报告573例,ADR报告数量增加120.38%;医护人员上报比例由13.08%增长至36.30%（P<0.001）;新的/严重的ADR报告增加363.16%,严重ADR上报比例由7.69%增长至24.43%（P<0.001）;报告规范性、药品信息完整性、报告及时性及填报效率显著提高（P<0.001）。结论 CHPS可识别、监测可疑ADR,提高ADR报告数量和质量,实现风险信号预警,为医院用药安全防控提供技术支撑。

关键词: 中国医院药物警戒系统, 药品不良反应, 效果评价, 用药安全, 回顾性分析

Abstract: Objective To study the role of the Chinese hospital pharmacovigilance system (CHPS) in the monitoring of adverse drug reactions (ADR) in medical institutions. Methods The ADR that occurred in our hospital between 2019 to 2020 were collected. The ADR reported in 2019 were assigned to the pre-operation group, while those reported in 2020 to the post-operation group based on the time the CHPS started to operate in China. The ADR reports before and after the operation of the CHPS were analyzed. The numbers, sources, types and quality of ADR reports as well as drugs and organ and systems involved were compared. Results Two hundred and sixty ADR reports were collected before the operation of the CHPS and 573 after that. The number of ADR reports increased by 120.38%. The proportion of reports by the medical staff increased from 13.08% to 36.30% (P<0.001). New/serious ADR reports increased by 363.16%. The proportion of serious ADR reports increased from 7.69% to 24.43% (P<0.001). The standardization of reports, completeness of drug information, timeliness of reports and the efficiency of reporting were significantly improved (P<0.001). Conclusion The CHPS can identify and monitor suspicious ADR, improve the quantity and quality of ADR reports, deliver risk signal warning, and provide technical support for the safety of hospital medications.

Key words: Chinese hospital pharmacovigilance system, adverse drug reaction, effect evaluation, medication safety, retrospective analysis

中图分类号:

R951
R994.11

白荷荷, 聂晓静, 夏丽, 马莉, 王金萍, 彭莉蓉. 基于中国医院药物警戒系统开展药品不良反应监测的效果评价[J]. 中国药物警戒, 2022, 19(10): 1136-1139.

BAI Hehe, NIE Xiaojing, XIA Li, MA Li, WANG Jinping, PENG Lirong. Effect evaluation of adverse drug reactions monitoring based on the Chinese hospital pharmacovigilance system[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1136-1139.

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基于中国医院药物警戒系统开展药品不良反应监测的效果评价

Effect evaluation of adverse drug reactions monitoring based on the Chinese hospital pharmacovigilance system

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