我院静脉用细胞毒性药品说明书对比分析  

Comparative analysis of instructions for intravenous cytotoxic drug in our hospital

作　　者：刘海 LIU Hai(Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation for Cancer Medicine,Guangzhou 510060,China)

机构地区：[1]中山大学肿瘤防治中心药学部,华南肿瘤学国家重点实验室,肿瘤医学协同创新中心,510060

出　　处：《中国现代药物应用》2022年第10期179-182,共4页Chinese Journal of Modern Drug Application

摘　　要：目的 通过分析本院静脉用细胞毒性药物的说明书,为进一步完善药品说明书,促进药品说明书更加科学化、合理化和规范化提供参考。方法 收集本院40种静脉用细胞毒性药物的说明书,对其基本内容、其他项目内容完整性进行分析;同时对8组同一药品的进口药与国产药的说明书进行对比分析。结果 40种说明书存在不同程度的差异,其中基本内容中药物过量、特殊人群用药标注率低。标注详细度方面,特殊人群用药、药物相互作用、毒理作用标注较简单。项目完整性方面只有输注溶媒标注率为100.0%,输注速度、每支所需溶媒剂量(配置方法 )、配置浓度、配置后储存的标注有不同程度的缺失。同一药的进口药与国产药的说明书对比中,国产药的说明书往往存在完整性、规范性和科学性较差等问题。结论 建议药监部门加强药品说明书的监管力度,重视药品说明书的修订,使药品说明书更加严谨、规范、科学,能更好的服务于临床与患者。Objective To analyze the instructions for intravenous cytotoxic drugs in our hospital, so as to further improve the drug instructions and promote the more scientific, rational and standardized drug instructions.Methods The instructions of 40 kinds of intravenous cytotoxic drugs in our hospital were collected, and the basic contents and the completeness of other items were analyzed. At the same time, the instructions of imported drugs and domestic drugs of 8 groups of the same drug were compared and analyzed. Results There were different degrees of differences in the 40 instructions, including the basic content of drug overdose, special populations with a low labeling ratE_(2) in terms of labeling details, the medication for special populations, drug interactions,toxicological effects were relatively simplE_(2) in terms of project integrity, only the labeling rate of infusion solvent was 100.0%, and infusion rate, required vehicle dose per vial(dispensing method), dispensing concentration,labeling for storage after dispensing were missing to varying degrees. In the comparison between imported drugs and domestic drug instructions of the same drug, domestic drug instructions often had some problems, such as poor integrity, standardization and scientificity. Conclusion It is suggested that the drug regulatory department should strengthen the supervision of drug instructions and pay attention to the revision of drug instructions, so as to make the drug instructions more rigorous, standardized and scientific, and better serve the clinic and patients.

关 键 词：药品说明书 国产药品 进口药品 

分 类 号：R95[医药卫生—药学]