药物流行病学杂志2024,Vol.33Issue(1) :19-27.DOI:10.12173/j.issn.1005-0698.202304099

美国、欧盟和我国监管部门对药品获益-风险沟通管理与实践的研究

National competent authority regulation and practice of drug benefit-risk communication in the United States,European Union and China

张伊楠 吴汀溪 赵志刚
药物流行病学杂志2024,Vol.33Issue(1) :19-27.DOI:10.12173/j.issn.1005-0698.202304099

美国、欧盟和我国监管部门对药品获益-风险沟通管理与实践的研究

National competent authority regulation and practice of drug benefit-risk communication in the United States,European Union and China

张伊楠 1吴汀溪 1赵志刚2
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作者信息

  • 1. 首都医科大学附属北京天坛医院药学部(北京 100070)
  • 2. 首都医科大学附属北京天坛医院药学部(北京 100070);首都医科大学药学院临床药学系(北京 100069)
  • 折叠

摘要

更加安全地用药在于每个人的持续意识和警惕,对药品的获益-风险信息沟通是这一过程的重要支撑.国外对药品获益-风险沟通的探索起步相对较早.查阅美国、欧盟药品监督管理部门网站发现,美国和欧盟已形成了较为完善的沟通管理与实践体系,制定了策略计划和指南,以多种工具和途径向医疗专业人员、患者、公众沟通,主要内容包括药品法定信息、新的风险信息、潜在安全信号等.我国相关立法中已涉及到药品获益-风险,但相关指南与具体实施细则尚且缺乏,循证沟通研究与沟通工具相对不足.可以借鉴其他国家经验,加强法规落实,构建沟通体系,发展科学证据,评估沟通成效,完善沟通工具,减少信息壁垒,最终支持患者和医疗专业人员能够做出关于药物治疗的明智决策.

Abstract

Safer drug use relies on the sustained vigilance and continual awareness of all individuals,and drug benefit-risk communication plays a pivotal role in facilitating this process.Foreign exploration on drug benefit-risk communication started relatively earlier.Upon scrutinizing the websites of drug regulatory authorities in the United States and Europe Union,it appears that these regions have established comprehensive communication regulation and practice systems,developed strategic plans and guidance,and communicated with healthcare professionals,patients and the public via various tools and channels,mainly including drug statutory information,new safety information,potential safety signals,etc.In China,drug benefit-risk communication is involved in the legislation,but the relevant guidelines and specific implementation rules are still lacking,and the evidence-based communication research and communication tools are relatively insufficient.We could learn from the experience of other countries,which involves enhancing regulatory implementation,establishing a communication framework,developing scientific evidence,assessing communication effectiveness,refining communication tools,and diminishing information barriers,in order to ultimately support patient and health care professionals to make informed decisions about medication.

关键词

药品获益-风险沟通/安全沟通/药品安全信息/药物警戒

Key words

Drug benefit-risk communication/Safety communication/Drug safety information/Pharmacovigilance

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基金项目

中国药品监督管理研究会立项课题(2022-yy-010)

出版年

2024
药物流行病学杂志
中国药学会 武汉医药(集团)股份有限公司

药物流行病学杂志

CSTPCD
影响因子:0.746
ISSN:1005-0698
参考文献量42
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