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中国医药导刊 ›› 2022, Vol. 24 ›› Issue (1): 92-98.

• 智慧监管 • 上一篇    下一篇

互联网医院药品平台的药物警戒体系研究

王广平1,陈博2   

  1. 1.上海市药品和医疗器械不良反应监测中心,上海 200040; 2.上海康荐信息科技有限公司,上海 200237
  • 收稿日期:2021-11-26 修回日期:2021-10-29 出版日期:2022-01-28 发布日期:2022-01-28
  • 基金资助:
    中国药品监督管理研究会2021年度研究课题[项目名称:药品良好监管体系规范(GRP)的建设原则和框架研究];2020年度浙江省哲学社会科学规划课题(项目编号:20NDJC221YB;项目名称:大数据战略下浙江省药品高质量发展协同共治路径研究)

Pharmacovigilance System of Internet Hospital Drug Platform

  1. 1. Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring, Shanghai 200040, China; 2. Shanghai Kangjian Information Technology Co., Ltd., Shanghai 200237, China
  • Received:2021-11-26 Revised:2021-10-29 Online:2022-01-28 Published:2022-01-28

摘要: 当前互联网医院药品销售新业态和“双通道”电子处方流转新常态已初见端倪,构建互联网医院药品销售药物警戒体系,以保证患者用药安全和合法权益。药品网络销售新业态存在处方真实性、药师审核和物流配送等风险,以及网络治理的复杂性问题;同时,需要明确药品网络销售中平台经营者、互联网医院、实体药店、医师、药师和物流配送各方的职责和义务,以及明确“双通道”模式下的互联网医院与定点零售药店的权责划分。依托于互联网医院的第三方药品平台,通过互联网复诊、电子处方和药师处方审核三要素进行质量管理,实现了双重的网络销售查对核实机制。本研究总结互联网医院的药品销售方式和风险,基于对互联网医院药品平台流程、网络销售监管制度和相关主体职责的分析,构建了三维空间结构的互联网医院药品平台药物警戒体系,并提出了互联网医院药品平台药物警戒信息机制、监管部门协调、提升智慧监管手段和信息化共享平台建设等建设路径。

关键词: font-size:medium, ">互联网医院;网络销售;药品平台;电子处方;药物警戒

Abstract: At present, the new format of drug sales in internet hospitals and the new normal of "Dual-channel" e-prescription has become a trend. Pharmacovigilance system for the drug sales in internet hospital can ensure the medication safety and legitimate right of patients. The new form of internet drug sales has serval risks such as the prescription authenticity, pharmacist review, logistics & distribution, which exist the complexity of network governance.It is necessary to clarify the responsibilities and obligations of platform operators, internet hospitals, physical pharmacies, doctors, pharmacists and logistics enterprise in online drug sales. And the division of rights and responsibilities of the internet hospitals and the retail pharmacies under the "Dual-channel" policy.Relying on the third-party drug platform of the internet hospital, the dual verification mechanism has been realized through the quality elements control of online sale through the internet follow-up consultation, e-prescription, and pharmacist prescription review. This study summarized drug sale model and risk in internet hospitals.Based on the analysis of the internet hospital drug platform process, the supervision system and related primary responsibilities of online sales, the paper constructed the pharmacovigilance system for the internet hospital drug platform which had three-dimensional structure. Finally, the author proposed the construction path of pharmacovigilance platform information mechanism, regulatory authorities coordination, smart regulatory improvement, and information sharing platform.
 

Key words: font-size:medium, ">Internet hospital; Online sale; Drug platform; Electronic prescription; Pharmacovigilance

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