我院超说明书用药的分级管理研究
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篇名: 我院超说明书用药的分级管理研究
TITLE:
摘要: 目的:促进临床超说明书用药的规范管理。方法:综合考量超说明书用法偏离标准操作的程度和风险程度,将我院超说明书用药分为3种情况进行审批分级及知情同意分级;对分级管理后的情况和效果进行评价。结果:我院制订的分级情况包括偶然或者小剂量超出说明书标示的用法(第1种)、常规性改变用法用量或给药途径等的用法(第2种)以及超适应证用药存在禁忌的用法(第3种);审批相应分级为医师再确认签名、医务科审批、药事会和伦理委员会审批;知情同意则分级为签署知情同意书、知情告知并记录在病历中、口头告知。从2014年2月我院正式启动超说明书用药审批流程起至2016年6月止,共收到13个科室的51份超说明书用药申请,其中16份属于审批的第2种情况,35份属于审批的第3种情况。最终42份超说明书用药通过了审批,9份未获审批。已获审批的超说明书用法在用药过程中未发生新的/严重的药品不良反应/事件;未发现未获审批的超说明书用药继续使用的情况。结论:我院超说明书用药的分级管理办法可操作性强,较大程度地改善了临床医师超说明书用药不规范的现象。
ABSTRACT: OBJECTIVE: To promote the normative management of clinical off-label drug use. METHODS: The degree of deviation from the drug instructions and the risk degree were comprehensively considered, and the off-label drug use were classified into three different situations for classifying approval and informed consent classifying; situation and effects after classifying were evaluated. RESULTS: The classifying included occasional or small amount off-label use on dosage and drugs solvent (the first), regular off-label use on route or administration (the second) and super-indications drug use with contraindications (the third). The approval was classified as follows as confirmed with signature by doctor, approved by medical department, approved by pharmaceutical committee and ethics committee accordingly; informed consent classifying were signing informed consent, informing and recording in medical record, informing orally. Off-label drug use approval process was officially initiated from Feb. 2014 to Jun. 2016 in our hospital, 51 off-label drug use applications from 13 clinical departments were received, with 16 items belonging to the second situation, 35 items belonging to the third. Finally 42 applications were approved and 9 were not. No relevant new/serious adverse drug reactions / events occurred in process of the approved off-label drug use. And no off-label drug use not approved was found to continue to be used in our hospital. CONCLUSIONS: Classification management methods for off-label drug use in our hospital have shown high operability, improved the off-label drug use behavior of physicians.
期刊: 2017年第28卷第10期
作者: 王颖,谭湘萍,司徒冰
AUTHORS: WANG Ying,TAN Xiangping,SITU Bing
关键字: 超说明书用药;分级管理;审批;知情同意
KEYWORDS: Off-label drug use; Classification management; Approval; Informed consent
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