基于中成药说明书【不良反应】完善的临床药学服务策略

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

中成药说明书【不良反应】承载着中成药潜在风险的关键信息,可为中成药临床安全合理应用提供强而有力的指导。由中华中医药学会《上市中成药说明书安全信息项目修订技术规范不良反应》(T/CACM1370.2-2021)引发思考,针对目前中成药说明书【不良反应】存在的内容缺失、更新不及时、表述模糊等问题,从拓展中成药不良反应信息来源、跟进中成药不良反应信息、规范撰写形式三方面完善【不良反应】。基于中成药说明书【不良反应】信息完善的内容,中成药相关药学服务的开展需遵循“中医药理论指导”和“合理用药”的原则,参照防范不良反应发生为重点的药学服务路径,开展中成药风险监测、风险评估、风险防范及相应的不良反应救治。通过中成药说明书【不良反应】的完善,提供临床药学服务策略思考,为中成药临床用药提供参考,助力中成药的安全应用。

The section of“adverse drug reactions”in Chinese patent medicine instructions contains the critical information of the potential risk of Chinese patent medicine,which can provide strong guidance for safe and rational application of Chinese patent medicine.This paper is derived from the Technical Specifications for Revising Safe Information Items in the Marketed Chinese Patent Medicine Instructions-Adverse Drug Reaction(T/CACM 1370.2-2021)of China Association of Chinese Medicine.The section of“adverse drug reactions”can be improved by expanding the information source of adverse reactions of Chinese patent medicine,following up the information of adverse reactions and standardizing the writing form in view of lack of content,untimely updates and vague statements.The pharmaceutical care of Chinese patent medicine should follow the principles of“theoretical guidance of traditional Chinese medicine”and“rational drug use”,which refers to a pharmaceutical care path focusing on the prevention of adverse reactions,and carrying out risk monitoring,assessment,prevention,and treatment with Chinese patent medicine.The improvement of the section of the“adverse drug reactions”in Chinese patent medicine instructions and the strategics of providing clinical pharmaceutical care is conducive to the clinical use of Chinese patent medicine and thus improves the safety of Chinese patent medicine.