National competent authority regulation and practice of drug benefit-risk communication in the United States,European Union and China
10.12173/j.issn.1005-0698.202304099
- VernacularTitle: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
- Author:
Yinan ZHANG
1
;
Tingxi WU
;
Zhigang ZHAO
Author Information
1. 首都医科大学附属北京天坛医院药学部(北京 100070)
- Keywords:
Drug benefit-risk communication;
Safety communication;
Drug safety information;
Pharmacovigilance
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(1):19-27
- CountryChina
- Language:Chinese
-
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.
