某院137个集采药品药品说明书中药用辅料标注情况分析

Labeling of Pharmaceutical Excipient Information in the Instructions of 137 Drugs Through Centralized Bidding and Procurement in a Hospital

目的为修订《药品说明书和标签管理规定》提供参考。方法选取某院2021年12月使用的集中招标采购(简称集采)药品137个,包括国家集采品规126个和省集采品规11个,查找其药品说明书标注的药用辅料信息,并与3.4.3.0版美康合理用药系统收录的原研制剂电子版药品说明书相关信息(截至2022年3月)进行比较。结果137个集采药品中,90个品规未标注药用辅料信息,包括82个口服制剂、7个注射剂和1个雾化吸入剂。与原研制剂剂型及规格相同的集采药品96个,其中集采药品与原研制剂均未标注药用辅料信息的55个(包括1个雾化吸入剂和54个口服制剂),标注一致的15个,标注不一致的26个。结论药品说明书中辅料标注的相关法律法规及技术指南体系尚需进一步完善。建议我国相关法律法规强化药用辅料的标注,以确保用药安全。

Objective To provide a reference for the revision of the Provisions on the Administration of Drug Instructions and Labels.Methods A total of 137 drugs through the centralized bidding and procurement(hereinafter referred to as centralized procurement)used in December 2012 were selected,including 126 national and 11 provincial centralized-procurement drug specifications.The pharmaceutical excipient information labeled in the the drug instructions were found out and compared with the relevant information(up to March 2022)in the electronic drug instructions of the original-patented preparations recorded in the MCDEX(V 3.4.3.0).Results Among the 137 centralized-procurement drugs,90 drug specifications were not labeled with the pharmaceutical excipient information,including 82 oral preparations,seven injections and one aerosol inhalation agent.There were 96 centralized-procurement drugs with the same dosage forms and specifications as the original-patented preparations.Among them,55 centralized-procurement drugs,like the original-patented preparations,were not labeled with the pharmaceutical excipient information(including one aerosol inhalation agent and 54 oral preparations),there were 15 centralized-procurement drugs labeled the consistent information of pharmaceutical excipients with the original-patented preparations,and there were 26 centralized-procurement drugs labeled the inconsistent information with the original-patented preparations.Conclusion The relevant laws,regulations and technical guidance system for the labeling of excipient information in the drug instructions need to be further improved.It is suggested that the relevant laws and regulations of China should strengthen the labeling of pharmaceutical excipient information to ensure the safety of drug use.