贵州省三级医疗机构超说明书用药管理情况调查  

Status Investigation on Management of Off-label Drug Use in Tertiary Hospitals of Guizhou Province

作　　者：张瑞 阚鹏鹏 张家兴[1,2] 谢娟 陈琦[1,2] 胡鳞方 赵华叶[1] 蓝俊杰 王家雪 孙水梅 谭松松 ZHANG Rui;KAN Pengpeng;ZHANG Jiaxing;XIE Juan;CHEN Qi;HU Linfang;ZHAO Huaye;LAN Junjie;WANG Jiaxue;SUN Shuimei;TAN Songsong(Department of Pharmacy,Guizhou Provincial People's Hospital,Guiyang 550002,China;Quality Control Center,Guizhou Pharmaceutical Administration,Guiyang 550002,China;Party Group Work Department,Shougang Shuigang Hospital,Liupanshui 553000,China;Office of Health Insurance Administration,Guizhou Provincial People's Hospital,Guiyang 550002,China)

机构地区：[1]贵州省人民医院药剂科,贵阳550002 [2]贵州省药事管理质量控制中心,贵阳550002 [3]首钢水钢医院党群工作部,六盘水553000 [4]贵州省人民医院医保科,贵阳550002

出　　处：《医药导报》2024年第9期1519-1524,共6页Herald of Medicine

基　　金：国家自然科学基金地区基金资助项目(72064004);贵州省卫生健康委科学技术基金资助项目(gzwkj2021-553)。

摘　　要：目的调查贵州省三级医疗机构的超说明书用药管理状况,为制订贵州省统一的超说明书用药管理制度提供参考。方法根据相关政策法规制定超说明书用药调查问卷,内容包括填表人基本信息、医疗机构基本信息以及超说明书用药相关调研信息,以“问卷星”方式向贵州省所有84家三级医疗机构发送问卷进行调研。结果发放问卷84份,回收问卷84份,回收率100.00%。调研的84家医疗机构中,77家存在超说明书用药情况,其中只有68家(88.31%)制订了超说明书用药管理制度,65家(84.42%)超说明书用药需药事管理与药物治疗学委员会批准,42家(54.55%)限制处方医生的资质,58家(75.32%)需要患者或其家属知情同意,36家(46.75%)在患者病案中记录超说明书用药事项和原因,15家(19.48%)对超说明书用药的患者建档随访并对超说明书用药合理性进行评价,21家(27.27%)开展专项点评,30家(38.96%)建立了超说明书用药目录,58家(75.32%)有建立全省统一的超说明书用药目录的需求。结论贵州省三级医疗机构超说明书用药管理水平较低,亟需建立全省统一的超说明书用药管理制度和用药目录。Objective To investigate the current status of off-label drug use(OLDU)management in tertiary hospitals of Guizhou province and to provide baseline evidence for developing a unified administration regulation for OLDU in Guizhou province.Methods In line with the relevant policies and regulations,a questionnaire including basic information about the person filling out the form,basic information about the hospitals,and information about OLDU was developed.The questionnaire was sent to 84 tertiary hospitals in Guizhou province through the Wenjuanxing.Results A total of 84 questionnaires were distributed and recovered,with a response rate of 100.00%.Of the 84 hospitals,77 had OLDU,of which 68(88.31%)had established a management system for OLDU.Among the 77 hospitals with OLDU,65(84.42%),42(54.55%),58(75.32%),36(46.75%),15(19.48%),and 21(27.27%)hospitals respectively,required approval from the Committee on Drug Administration and Pharmacotherapy before OLDU,restricted the qualifications of doctors prescribing OLDU,required informed consent from patients or their families before OLDU,recorded the matters and reasons in the medical records of patients treated with OLDU,followed up patients in their files and evaluated the reasonableness of the OLDU,and carried out special reviews for OLDU.Only 30(38.96%)hospitals have set up a catalogue of OLDUs,and 58(75.32%)hospitals have urgent needs to set up a unified provincial catalogue of OLDUs.Conclusion The pharmacy administration level of OLDU in tertiary hospitals of Guizhou province is relatively low,so there is an urgent need to establish a unified OLDU management system and medication catalog.

关 键 词：超说明书用药 药事管理 贵州省三级医疗机构 

分 类 号：R951[医药卫生—药学]