• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2021, Vol. 38 ›› Issue (6): 499-503.

• 监管科学与应用 • 上一篇    下一篇

建设我国药品使用风险管理体系的探讨

 孙雪林1,钱东方2,张亚同1*,童刚2,叶京云2,胡欣1   

  1. 1. 北京医院药学部 国家老年医学研究中心,中国医学科学院老年医学研究院,药物临床风险与个体化应用评价北京市重点实验室,北京 100730; 2.北京北方医药健康经济研究中心,北京 100021
  • 收稿日期:2021-08-30 修回日期:2021-11-19 出版日期:2021-12-28 发布日期:2021-12-28
  • 基金资助:
    国家重点研发计划(项目名称:老年多病共患及合理用药的评估、干预、综合管理方案与技术研究及其实施效果评价;项目编号:2020YFC2009000/2009001);中国药品监督管理研究会课题支持

Discussion on the Construction of Risk Management System of Drug Use in China

  1. 1.Department of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Assessment of Clinical Drugs Risk and Individual Application Key Laboratory,Beijing 100730, China; 2.Beijing North Medical Health Economic Research Center, Beijing 100021, China
  • Received:2021-08-30 Revised:2021-11-19 Online:2021-12-28 Published:2021-12-28
  • Contact: Tong YaZhang E-mail:zyt2002888@hotmail.com

摘要: 2021年5月出台的《药物警戒质量管理规范》已于2021年12月1日起执行,目前各医疗机构对于符合本院情况的药品使用风险管理体系建设仍处于探索阶段。药品使用风险管理是指药品上市后,对药品的遴选采购、贮存、配制、处方和患者使用的全过程中可能出现的风险进行识别、评估和管理的全过程管控,其体系建设应在执行相关规范的基础上构建符合实际情况的具体模式。本文通过探讨药品使用风险管理体系目标和策略、管理机制、风险信号的识别、评估与交流,构建医院药品使用风险管理体系的基本框架,分享我院药品风险管理经验,为促进药品安全有效地使用提供科学指导,为我国药品使用风险管理提供参考和思路。
    

关键词: font-size:medium, ">药品;风险管理;体系建设;风险信号;评估

Abstract:  The National Medical Products Administration issued "Good Pharmacovigilance Practices", which had implemented on December 1 2021. However, medical institutions are still exploring for the construction of drug use risk management systems suitable for each hospital. Drug use risk management refers to the whole control process of identifying, evaluating and managing the risks that may occur in each process of drug selection, procurement, storage, preparation, prescription and patient use post-marketed. The construction of the system should be constructed on the basis of the implementation of relevant specifications and should be conforming to the actual situation. This article discusses the goals and strategies of the drug use risk management system, the management mechanism, and the identification, evaluation and communication of risk signals. By exploring the above content, this article constructs the basic framework of the hospital drug use risk management system, shares our hospital′s drug risk management experience, provide scientific guidance to promotes the safe and effective use of drugs, and provide references and ideas for the drug use risk management in our country.

Key words: Drugs, Risk management, System building, Risk signal, Assessment

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