142份抗肿瘤药物说明书用药信息标注情况调查与分析

目的 分析抗肿瘤药物说明书用药信息标注情况,为药品说明书规范化及临床合理用药提供参考。方法 收集现行抗肿瘤药物的药品说明书,按《药品说明书和标签管理规定》和《化学药品和治疗用生物制品说明书规范细则》,统计抗肿瘤药物说明书中常见问题,及说明书各项信息的标注情况,比较同一品种、同一剂型不同厂家的抗肿瘤药物说明书信息标注差异,统计注射用抗肿瘤药物的静脉溶液配制信息标注情况。结果 共收集抗肿瘤药物说明书142份,其中国产药物99份(口服剂35份,注射剂64份),进口药物43份(口服剂28份,注射剂15份);存在的主要问题有标注信息内容前后矛盾、文字表达不清、部分项目内容简单、汉字错误、项目缺失;进口抗肿瘤药物各项用药信息的标注率高于国产抗肿瘤药物;35组同一品种和剂型但不同厂家的药物,其说明书信息标注在适应证范围、药品不良反应、注意事项、特殊人群用药、药物相互作用及药物过量等方面存在一定差异。多数静脉注射剂溶液配制信息仅标注了推荐剂量和滴注时间,缺溶剂选择、配制浓度和注意事项,进口静脉注射剂溶液配制信息比国产注射剂完整。结论 抗肿瘤药物说明书用药信息标注存在较多问题,尤其是国产抗肿瘤药物说明书的规范化程度有待提高,国家和企业应高度重视,以促进和保障临床安全用药。

Investigation and Analysis of Drug Information Labeling in 142 Instructions of Antineoplastic Drugs

Objective To analyze the labeling situation of drug information in the instructions of antineoplastic drugs to provide scientific reference for standardization of instructions and rational drug use in clinic.Methods The instructions of current antineoplastic drugs were collected according to Regulations on the Administration of drug Instructions and Labels and Specification Rules on Instructions of Chemical Drugs and Biological Products for Therapeutic Use;the labeling of the information of each item in the instructions was analyzed.Common problems in the instructions for antineoplastic drugs were summarized.The difference of the instructions of different manufacturers of the same kind and dosage form of antineoplastic drugs were compared,and the information labeling of the intravenous solution preparation guidance of antineoplastic drugs for injection was statistically analyzed.Results A total of 142 instructions for antineoplastic drugs were collected,of which 99 were domestic(35 oral preparations,64 injections)and 43 imported(28 oral preparations,15 injections).Some common problems had been found in instructions of antineoplastic drug,such as the main annotation information content was inconsistent,the words were not clear,some items were relatively simple,Chinese characters were wrong,and the items were missing.The labeling rate of information of imported antineoplastic drugs was higher than the domestic ones.There were differences to some extent of the labeling information of the drug instructions of 35 groups of different manufacturers of the same variety and dosage form,which were mainly reflected in the scope of indications,adverse drug reactions,medication precautions,drug interactions and medication for special populations,etc.Most of the information of intravenous injection only indicated the recommended dose and drip time,while the information of solvent selection,formulation concentration and precautions were less marked.Generally,the information of intravenous injection formulation of imported injections was more complete than that of domestic injections.Conclusion There are many problems in the information labeling of anticancer drug instructions,especially the standardization of domestic antineoplastic drug specifications needs to be improved.The state and enterprises should attach great importance to promoting and guaranteeing clinical safe drug use.