药品说明书中药品使用期限标注情况的调查与分析

Investigation and Analysis of Labeling Utilization Period in Package Inserts

目的:为规范临用现配制剂和多剂量包装制剂在使用过程中的期限管理提供参考。方法:对我院2017年在用药品说明书进行整理,对其中临用现配制剂和多剂量包装制剂说明书中使用期限的标注情况进行调查和分析。结果:我院2017年在用药品共1047种。其中,临用现配制剂357种,多剂量包装制剂194种。在357种临用现配制剂说明书中,标注使用期限的109份,占30.53%;在194种多剂量包装制剂说明书中,标注使用期限的共26份,占13.40%。结论:尽管我国在《化学药物(原料药和制剂)稳定性研究技术指导原则》中要求临用现配制剂和多剂量包装制剂应根据其具体的临床使用情况进行稳定性试验,但目前在说明书中标注使用期限相关信息的药品比例仍较低。建议药品监督管理部门以及药品生产企业积极加强对《化学药物(原料药和制剂)稳定性研究技术指导原则》中有关要求的落实,逐步完善临用现配制剂和多剂量包装制剂说明书中使用期限的相关信息。

Objective： To provide references for the regulation of utilization period management of reconstituted or diluted products and multi-dose dosage forms. Methods： Package inserts of medicinal products used in our hospital in 2017 were sorted out. The utilization period information in the package inserts of reconstituted or diluted products and multi-dose dosage forms were investigated and analyzed. Results： A total of 1047 kinds of medicinal products were used in our hospital in 2017, among which there were 357 kinds of reconstituted or diluted products and 194 kinds of multi-dose dosage forms. Among the 357 reconstituted or diluted products, there were 109 package inserts labeling utilization period, accounting for 30.53%. Among 194 multiple-dose dosage forms, there were 26 package inserts labeling utilization period, accounting for 13.40%. Conclusion： According to ＂the Technical Guidance to Stability Testing of Chemical Drugs＂ in China, the stability testing should be taken for reconstituted or diluted products and multi-dose dosage forms based on their specific clinical use. At present, there is only a small number of products labeling the utilization period and other information in the package inserts. It is suggested that the drug regulatory department and pharmaceutical manufacturers should promote the implementation of the relevant requirements according to the ＂the Technical Guidance to Stability Testing of Chemical Drugs＂, and gradually improve the relevant information about utilization period of reconstituted or diluted products and multi-dose dosage forms.