基于中成药说明书“警示语”完善的临床药学服务策略

Strategies for clinical pharmaceutical care based on the improvement of“warnings”in Chinese patent medicine instructions

药品说明书警示语项是各国药监机构保障药品安全的重要组成部分。梳理欧美、大洋洲、亚洲6个代表国家药品监管机构中药品说明书警示语项相关的12部法律法规及指南规范,对比其表达方式及格式要求,为中成药说明书警示语项的完善提供依据,并由《上市中成药说明书安全信息项目修订技术规范警示语》(T/CACM 1370.6-2021)引发思考,针对我国中成药说明书警示语项存在的标识不全等临床问题,提出说明书修订及完善思路。探讨基于警示语项完善的临床药学服务策略,提出以“重点关注、研究跟进、国际借鉴”为原则,开展全流程的临床药学服务,对医师、药师、护士、患者提供最直接的用药指导,保障临床安全合理用药,提升临床药学服务水平。

The“warnings”section in medicine instructions is an important part that all national drug regulatory agencies use to ensure drug safety.This paper sorted out 12 laws,regulations and guidelines related to the“warnings”of drug instructions in 6 representative countries in Europe,America,Oceania,and Asia,and compared their expression and format requirements to provide reference for the improvement of the“warning”terms in the instructions of Chinese patent medicines.Technical Specification for Revision of Safety Information in the Marketed Chinese Patent Medicine Instructions-Warnings(T/CACM 1370.6-2021)provided enlightenment for revising and improving the instructions in terms of the problems such as incomplete labelling of the“warnings”.We explored the strategy of clinical pharmaceutical service based on“warning”terms,and proposed to carry out the whole process of clinical pharmaceutical service based on the principles of“monitoring,follow-up research,and international reference”,and provide the most direct medication guidance for physicians,pharmacists,nurses,and patients to ensure the safe and rational medication in clinical practices,and to improve the quality of clinical pharmaceutical care.