历年广东省药学会超药品说明书用药目录概况与分析:以抗肿瘤药品为例

目的:为抗肿瘤药物临床超说明书使用提供参考。方法:系统检索2015至2021年广东省药学会官网发布的超药品说明书用药目录(以下简称"目录"),检索时限截至2021年7月20日,重点对比历年目录中抗肿瘤药品数量、分类、Micromedex证据分级变化情况。结果:迄今纳入目录的药品共125个(以通用名计),总条目数242条,其中抗肿瘤药品28种,总条目数81条,抗肿瘤药品占目录总条目数平均30%及以上;单靶点抑制剂的品种逐渐增加:2015年版仅贝伐珠单抗和利妥昔单抗2个品种,涉及5条超说明书用药;2021年版增加至9个品种,含培唑帕尼、厄洛替尼、依维莫司、帕博利珠单抗等,涉及32条超说明书用药;历年目录同一个药品同一适应证的Micromedex分级基本不变,仅部分品种依照相关指南做了调整。结论:目录纳入药品数量持续增长,尤其是抗肿瘤药品,迫切需要规范与完善超说明书用药体系,加快药品说明书更新审核程序。

Overview and analysis on off-label drug use catalogue of Guangdong Pharmaceutical Association over the years: taking anti-cancer drugs as an example

OBJECTIVE To provide reference for the clinical off-label use of anti-cancer drugs.METHODS The catalogue of off-label drug use list (hereinafter referred to as "catalogue") published on the official website of Guangdong Pharmaceutical Association from 2015 to 2021 was searched systematically until July 20, 2021. The quantity, classification and Micromedex evidence grade of anti-cancer drugs in the catalogue over the years were compared.RESULTS A total of 125 drugs (by common names) are included in the list so far, with 242 items in total. Among them, there are 28 kinds of anti-cancer drugs, with 81 items in total; anti-cancer drugs account for 30% or more of the total items in the list on average; The varieties of single-target inhibitors are gradually increasing: in the 2015 version, only two varieties of bevacizumab and rituximab were used, involving 5 off-label drugs. In 2021 version, it was increased to 9 varieties, including pazopanib, erlotinib, everolimus and pembrolizumab, etc, and involving 32 off-label drugs. The Micromedex classification of the same drug with the same indication remains unchanged over the years, and only some varieties were adjusted according to relevant guidelines.CONCLUSION The number of drugs included in the catalogue is increasing continuously, especially the number of anti-cancer drugs is increasing year by year. It is urgent to standardize and improve the system of off-label drug use and speed up the review procedure of update of drug instructions.