某院13种原研及国产抗肿瘤药物药品说明书的统计分析

目的:比较国产仿制与原研抗肿瘤药物药品说明书中的差异,为药品说明书完善和合理使用提供参考。方法:对13种原研和国产仿制抗肿瘤药物的27份药品说明书进行对比分析,并对其零售价格进行比较。结果:27份药品说明书中,存在的问题有适应证范围不一、用法用量不详细、不良反应内容差异、注意事项详略不一、特殊人群用药建议不一、药物相互作用详细程度不一、药物过量描述不细致、药动学不完整、贮藏没有标明温度等主要问题;27份说明书中含有静脉配液指导的有14份,占总数的82.4%,无静脉配液指导的有3份,占总数的17.6%。结论:国产仿制抗肿瘤药品说明书的内容完整程度有待提高,说明书修订更新有待加强,建议厂家和相关部门补充完善并规范药品说明书。

Analysis of instructions of 13 original and generic antitumor drugs available in a hospital

OBJECTIVE To explore the differences in the instructions of antitumor drugs, and provide a reference for the improvement and rational use of antitumor drugs.METHODS Totally 27 sets of original and generic antitumor drug instructions were compared and analyzed.RESULTS In 27 copies of the drug instructions, the existing problem included different indications, the usage not detailed, adverse reactions, special populations, drug interactions. In generic drug instructions, pharmacokinetics data were not supplied and storage conditions were not well described. There were 14 instructions for intravenous administration (82.4%) and 3 for non-intravenous administration (17.6%).CONCLUSION Generic antitumor drug instructions need to be improved and revised more frequently. It is recommended that manufacturers should improve and standardize the drug instructions.