中国药物警戒 ›› 2026, Vol. 23 ›› Issue (4): 438-442.
DOI: 10.19803/j.1672-8629.20250645

• 安全与合理用药 • 上一篇    下一篇

基于风险管理闭环模型构建的医疗机构药物警戒实践策略思考

许卓欣1,2,3, 张冰4,5, 张晓朦5,6, 孟敏1,2,*, 萨日娜1,2,3,4#   

  1. 1甘肃中医药大学药学院,甘肃 兰州 730000;
    2甘肃省人民医院药剂科,甘肃 兰州 730000;
    3甘肃省人民医院中西医结合实验室,甘肃 兰州 730000;
    4甘肃省人民医院岐黄学者张冰工作室,甘肃 兰州 730000;
    5北京中医药大学中药学院,北京 102488;
    6北京中医药大学中药药物警戒与合理用药研究中心,北京 102488
  • 收稿日期:2025-09-11 出版日期:2026-04-15 发布日期:2026-04-15
  • 通讯作者: *孟敏,女,博士,主任药师,天然产物活性成分与循证药学。E-mail：min_pharmacy@163.com。#为共同通信作者。
  • 作者简介:许卓欣,女,在读硕士,中药功效与安全性评价。
  • 基金资助:
    国家自然科学基金资助项目（82274117）; 国家卫健委胃肠肿瘤诊治重点实验室2025年度开放基金项目（NHCDP2025009）; 甘肃省药品监督管理局科研项目（2024GSMPA065）; 2024年度甘肃省人民医院院内科研基金项目（23GSSYC-8）; 甘肃省卫生健康委员会科研项目（GSWSQN2024-13）; 甘肃省中医药管理局高水平重点课题（GZKZ-2024-17）; 甘肃省人民医院院内科研基金项目（23GSSYF-34）; 兰州市科技计划项目（2025YJ1025）

Strategies for Pharmacovigilance in Medical Institutions Based on Closed-Loop Model of Risk Management

XU Zhuoxin1,2,3, ZHANG Bing4,5, ZHANG Xiaomeng5,6, MENG Min1,2,*, SA Rina1,2,3,4#   

  1. 1School of Pharmacy, Gansu University of Chinese Medicine, Lanzhou Gansu 730000, China;
    2Department of Pharmacy, Gansu Provincial Hospital, Lanzhou Gansu 730000, China;
    3Laboratory of Integrated Traditional Chinese and Western Medicine, Gansu Provincial Hospital, Lanzhou Gansu 730000, China;
    4Zhang Bing's Qihuang Scholar Studio, Gansu Provincial Hospital, Lanzhou Gansu 730000, China;
    5School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China;
    6Center for Pharmacovigilance and Rational Use of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 102488, China
  • Received:2025-09-11 Online:2026-04-15 Published:2026-04-15

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摘要： 目的 深入探讨医疗机构药物警戒的实践策略,为医疗机构药物警戒体系提供参考。方法 通过分析医疗机构药物警戒的现状与核心内容,剖析当前在制度建设、风险识别、管理流程中面临的挑战,并基于风险管理理念设计优化方案。结果 基于风险管理理念,提出对应的实践优化策略,构建“监测-评估-干预-反馈”闭环管理模型。结论 旨在提高医疗机构对药品风险的监测、识别、评估和反馈能力,以期为构建科学、高效的医疗机构药物警戒体系提供参考。

关键词: 风险管理, 医疗机构, 药物警戒, 药品不良反应, 药品风险管理

Abstract: Objective To explore strategies for pharmacovigilance in medical institutions in order to provide a reference for related pharmacovigilance systems. Methods By analyzing the current practices and priorities related to pharmacovigilance in medical institutions, the challenges to construction of systems, risk identification, and processes of management were investigated while schemes for optimization were devised based on concepts of risk control. Results Strategies for optimization were proposed, and a closed-loop management model was established using a “monitoring-assessment-intervention-feedback” framework. Conclusion This study is expected to improve the ability of medical institutions to monitor, identify, assess drug risks, and provide feedback.

Key words: Risk Management, Medical Institutions, Pharmacovigilance, Adverse Drug Reaction, Drug Risk Management

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