中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 138-140.
DOI: 10.19803/j.1672-8629.2021.02.08

• 法规与管理研究 • 上一篇    下一篇

中国医院药物警戒系统对某省2家医院不良反应报告质量的影响

袁兴东, 徐玉茗*, 周鹃, 徐瑾, 钟长鸣, 刘志军, 张薇   

  1. 江西省药品不良反应监测中心,江西 南昌 330046
  • 收稿日期:2020-03-30 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
  • 通讯作者: *徐玉茗,男,硕士,教授级高级工程师,药品不良反应监测与评价。E-mail：jxfda@126.com
  • 作者简介:袁兴东,男,硕士,主管中药师,药品不良反应监测与评价。
  • 基金资助:
    江西省药监局科研项目（2017YX11）; 江西省药监局科研项目（2019JS33）

Influence of Chinese Hospital Pharmacovigilance System on Quality of ADR Reports in 2 Hospitals

YUAN Xingdong, XU Yuming*, ZHOU Juan, XU Jin, ZHONG Changming, LIU Zhijun, ZHANG Wei   

  1. Jiangxi Adverse Drug Reaction Monitoring Center, Nanchang Jiangxi 330046, China
  • Received:2020-03-30 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

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摘要： 目的 探讨中国医院药物警戒系统（Chinese hospital pharmacovigilance system,CHPS）对医院药品不良反应（ADR）上报的影响。方法 将安装CHPS 前后1年内医院的ADR报告分为对照组和研究组,参照《药品不良反应报告质量评估指导意见（试行）》对报告各项指标进行评分,比较2组ADR报告的数量、个例报告质量、报告整体质量、报告总得分等指标的差异。结果 研究组ADR报告总数较对照组增长41.80%,严重报告数量增长173.81%。研究组报告的完整性、规范性均显著优于对照组（P<0.01）,报告整体质量得分和报告总得分研究组分别高于对照组34.28%和21.41%。结论 CHPS能快速、方便、全面发现ADR,对医院ADR报告的数量及质量有显著提升。

关键词: 中国医院药物警戒系统, 药品不良反应, 监测哨点

Abstract: Objective To explore the influence of Chinese Hospital Pharmacovigilance System(CHPS) on the quality of ADR reports. Methods The ADR reports submitted by two hospitals before the installation of CHPS and one year later were divided into the control group and study group. The indexes of the reports were scored in accordance with the "Guidelines for Quality Evaluation of ADR Reports (Tentative)". The difference in the number of ADR reports, quality of individual reports, overall quality of the reports and the total scores of the reports was compared between the two groups. Results The total number of ADR reports in the study group was 41.80% larger than that in the control group, and the number of serious ADR reports was 173.81% larger. The difference in the integrity and standardization of the reports between the two groups was statistically significant. The overall quality score and the total score of the reports in the study group were 34.28% and 21.41% higher than those in the control group, respectively. Conclusion CHPS is able to detect ADRs quickly, easily and accurately, which can significantly improve the quantity and quality of ADR reports in hospitals.

Key words: Chinese hospital pharmacovigilance system, adverse drug reaction, monicoring sentinel

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