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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (9): 882-888.

• 监管科学 • 上一篇    下一篇

外配处方管理模式下医疗机构药物警戒体系建设

陈文萍1, 王广平2, 张吉1*   

  1. 1.上海交通大学医学院附属瑞金医院,上海 200025;

    2.上海市药品监督管理局,上海 200233

  • 收稿日期:2025-06-09 修回日期:2025-08-07 接受日期:2025-11-12 出版日期:2025-09-28 发布日期:2025-11-18
  • 基金资助:
    国家药品监督管理局药品评价中心专项研究——我国药物警戒数据共享与数据交换现状与发展研究(CDR2024R01004)

Hospital Pharmacovigilance System Based on Management Model of External Prescription Dispensing

CHEN Wenping1, WANG Guangping2, ZHANG Ji1*   

  1. 1.Ruijin Hospital Shanghai Jiao Tong University School of Medicine Shanghai 200025, China
    2.Shanghai Medical Products Administration Shanghai 200233, China
  • Received:2025-06-09 Revised:2025-08-07 Accepted:2025-11-12 Online:2025-09-28 Published:2025-11-18

摘要:

外配处方管理模式是“三医”联动改革和“双通道”政策背景下具象化的数字化场景应用,能解决“双通道”政策背景下药品可及性和便利性问题,但同时也需要通过采用药品追溯码管理、加强医疗机构药物警戒体系建设、强化多部门协调机制、注重患者教育和科普宣传等多种方案、多管齐下地开展工作。其中医疗机构药物警戒体系是外配处方管理的关键性要素。外配处方管理模式下的医疗机构药物警戒体系建设,包括医疗机构质量体系和处方外配合规管理;建立健全医疗机构药物警戒体系,可从源头控制药品安全风险,并强化外配处方管理责任落实。本研究基于互联网医院药品网络销售、电子处方流转、外配处方风险和药品追溯码应用等方面的分析研究,提出外配处方管理模式下医疗机构药物警戒体系建设路径,包括专家共识制度体系、外配主体责任体系、多部门协调机制、患者用药教育与药品科普宣传等,既要合规,也要适应网络新业态新技术发展趋势,采用药品追溯码、区块链技术、全生命周期管理工具、新媒体科普技术等,推进“三医”联动数字化发展进程。

  

关键词: 外配处方, 医疗机构, 药物警戒, 药品追溯码, “三医”联动

Abstract:

The external prescription management model is a concrete digital application scenario under the background of the Three-Medical linkage reform and the Dual-channel policywhich it can solve the problems of accessibility and convenience of drugs.But at the same time it is necessary to take a variety of measures such as adopting drug traceability code management strengthening the construction of the drug vigil system in medical institutions enhancing the coordination mechanism among various departments paying attention to patient education and science popularization and so on.Among these the pharmacovigilance system in medical institutions is a critical component. The construction of the pharmacovigilance system in medical institutions under the external prescription management model includes the quality system of medical institutions and the standard management out-prescription combination which can control the risk of drug safety from the source and strengthen the implementation of the responsibility of out-prescription management.This study analyzes key aspects such as online pharmaceutical sales through internet hospitals electronic prescription circulation external prescription risks and drug traceability code applications. It proposes a framework for constructing a pharmacovigilance system within medical institutions under the external prescription management model. This includes the establishment of an expert consensus system clarification of responsibilities among external prescription stakeholders development of interdepartmental coordination mechanisms as well as initiatives for patient medication education and pharmaceutical science communication.The approach emphasizes regulatory compliance while adapting to the emerging trends of new digital business formats and technologies leveraging drug traceability codes blockchain life-cycle management tools and new media science outreach to advance the digital integration of the Three-Medical Linkage system.


Key words:  , External prescription , Medical institutions , Pharmacovigilance , Drug traceability code , Three-Medical linkage

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