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Home Articles Vol 33,2024 No.1 Detail

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

Published on Dec. 04, 2023Total Views: 1131 times Total Downloads: 901 times Download Mobile

Author: ZHANG Yinan 1 WU Tingxi 1 ZHAO Zhigang 1, 2

Affiliation: 1.Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China 2.Department of Clinical Pharmacy, School of Pharmaceutical Science, Capital Medical University, Beijing 100069, China

Keywords: Drug benefit-risk communication Safety communication Drug safety information Pharmacovigilance

DOI: 10.12173/j.issn.1005-0698.202304099

Reference: ZHANG Yinan, WU Tingxi, ZHAO Zhigang.National competent authority regulation and practice of drug benefit-risk communication in the United States, European Union and China[J].Yaowu Liuxingbingxue Zazhi,2024, 33(1):19-27.DOI: 10.12173/j.issn.1005-0698.202304099.[Article in Chinese]

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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.

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