某院集采中选/非中选品种药品说明书对比分析  

Comparative Analysis of Instructions Between Selected/Non-Selected Drugs Involved in Centralized Volume-Based Procurement in a Hospital

作　　者：杨婷[1] 张裴[1] 马祖文[1] 花晓薇 李自然 YANG Ting;ZHANG Pei;MA Zuwen;HUA Xiaowei;LI Ziran(The Fifth Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang,China 830011;Xinjiang Medical University,Urumqi,Xinjiang,China 830011)

机构地区：[1]新疆医科大学第五附属医院,新疆乌鲁木齐830011 [2]新疆医科大学,新疆乌鲁木齐830011

出　　处：《中国药业》2023年第12期14-19,共6页China Pharmaceuticals

基　　金：中国药学会科技开发中心科普项目[CMEI2022KPYJ00258]。

摘　　要：目的确保临床用药安全。方法收集医院使用的第1—5批国家集采、陕西省际联盟集采、重庆十省联盟集采中抗菌药物、神经系统药物、降糖药等的中选/非中选品种药品说明书(共44个品规,44组,88份),提取相关数据,分析并比较中选/非中选品种药品说明书的差异。结果非中选药品说明书整体标注率与中选药品相当,但内容存在差异,差异率为22.38%。其中二者警示语标示率相当(38.64%比40.91%)。中选/非中选品种药品说明书的差异项目多为效期、贮藏、注意事项、药理毒理、用法用量。6组(13.64%)中选/非中选品种药品说明书项目差异较大,差异项数≥6项的分别为注射用盐酸万古霉素(11项),注射用头孢呋辛钠(规格为0.75 g,10项),氯氮平片(10项),阿法骨化醇口服常释剂型(7项),注射用头孢呋辛钠(规格为1.5 g,6项),阿奇霉素片(6项)。结论中选/非中选品种药品说明书在规范性、严谨性与完整性方面存在差异。与非中选品种药品说明书相比,部分中选品种药品说明书存在信息更新不及时、部分条目缺失等问题。建议相关部门进一步完善药品说明书监督管理的法律与制度,提升监管效能;医师应关注特殊人群用药,为药品说明书的动态管理与更新提供充分详实的临床证据;药学人员应掌握药品说明书修订与更新信息,重视临床宣教,为临床提供足够的用药信息,确保临床用药安全。Objective To ensure the medication safety in clinical practice.Methods The instructions of selected/non-selected drugs such as antibacterial drugs,nervous system drugs and hypoglycemic drugs involved in the first to fifth batch of national centralized volume-based procurement,province-alliance centralized volume-based procurement led by Shaanxi and ten-province-alliance centralized volume-based procurement led by Chongqing in the hospital(a total of 44 specifications,44 groups,88 instructions)were collected.The relevant data were extracted,the differences in instructions of selected/non-selected drugs were analyzed and compared.Results The overall labeling rate of the instructions of non-selected drugs was similar to that of the selected drugs,but there were differences in the content,with a difference rate of 22.38%.The warning labeling rate of instructions of non-selected drugs was similar to that of the selected drugs(38.64%vs.40.91%).The different items in instructions of selected/non-selected drugs were mostly expiration date,storage,attention,pharmacology and toxicology,usage and dosage.Six groups of selected/non-selected drugs(13.64%)had a large difference in the items of the instructions,with no less than six different items,involving Vancomycin Hydrochloride for Injection(11 items),Cefuroxime Sodium for Injection(specification:0.75 g,10 items),Clozapine Tablets(10 items),alfacalcidol with regular oral dosage forms(7 items),Cefuroxime Sodium for Injection(specification:1.5 g,6 items)and Azithromycin Tablets(6 items).Conclusion There are differences in the standardization,rigor and completeness in instructions of selected/non-selected drugs.Compared with the instructions of non-selected drugs,there are problems such as delayed information updating and lack of some items in the instructions of some selected drugs.Suggestions are as follows:relevant departments should further improve the laws and regulations for the supervision and management of drug instructions,and improve regulatory efficiency;physicians

关 键 词：国家集采 联盟集采 药品说明书 用药安全 

分 类 号：R95[医药卫生—药学]