某院国家组织药品集中采购中选药品与参比制剂药品说明书中贮藏条件研究

Comparative Study of Storage Conditions of Bid-Winning Drugs in the National Centralized Drug Procurement and Reference Preparations in a Hospital

目的 为国家组织药品集中采购(简称集采)中选药品的正确贮藏提供参考。方法 参照2020年版《中国药典(二部)》凡例中药品贮藏条件的相关规定,梳理医院2019年12月至2021年10月第1-5批中选药品与参比制剂药品说明书中的贮藏条件,统计并比较其封闭性、光照、温度及有效期的差异。结果 共收集相同通用名的中选药品和参比制剂药品说明书280份,涉及药品140种,其中片剂87种(62.14%)、注射剂27种(19.29%)、胶囊剂14种(10.00%)。140种中选药品中,52种(37.14%)的贮藏条件要求高于参比制剂,分别是封闭性38种(73.08%)、光照19种(36.54%)、温度15种(28.85%);99种(70.71%)中选药品的有效期短于参比制剂。结论 部分中选药品贮藏条件要求高于参比制剂,多数中选药品有效期短于参比制剂,导致实际贮藏存在较大安全风险。医疗机构应重视药品的贮藏与养护条件,生产厂家应重视药品有效期的标注,保证药品质量;同时,加强对患者的用药教育,保障临床用药安全、有效。

Objective To provide a reference for the correct storage and quality of bid-winning drugs in the National Centralized Drug Procurement(NCDP).Methods According to the relevant provisions of the drug storage conditions in the Explanatory Notes of the Chinese Pharmacopoeia(Edition 2020,Volume Ⅱ),the storage conditions in the instructions of the first to fifth batches of bid-winning drugs and reference preparations in the hospital from December 2019 to October 2012 were sorted out,and the differences in the closure,light,temperature and validity period were counted and compared.ResultsA total of 280 drug instructions of bid-winning drugs and reference preparations with the same generic name were collected.A total of 140 kinds of drugs were involved,including 87 kinds of tablets(62.14%),27 kinds of injections(19.29%) and 14 kinds of capsules(10.00%).Among 140 bid-winning drugs,52 kinds(37.14%) required higher storage conditions than the reference preparation,including 38 kinds(73.08%) with sealing property,19 kinds(36.54%) with light,and 15 kinds(28.85%) with temperature.A total of 99 kinds(70.71%) of bid-winning drugs have a shorter validity period than the reference preparations.Conclusion The storage conditions of some bid-winning drugs are higher than those of reference preparations,and the validity period of most bid-winning drugs is shorter than that of reference preparations,which leads to great safety risks in the actual storage of drugs.Medical institutions should pay attention to the storage and maintenance conditions of drugs,and manufacturers should pay attention to the labeling of the drug validity period to ensure the quality of drugs.Meanwhile,the medication education of patients should be strengthened to ensure the safety and effectiveness of clinical medication.