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。
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.
出处
《中国药房》
CAS
北大核心
2017年第10期1306-1310,共5页
China Pharmacy
基金
广东省科学技术厅科技发展专项资金项目(No.2016A020218013)
广州医科大学青年科研项目(No.2014A22)
关键词
超说明书用药
分级管理
审批
知情同意
Off-label drug use
Classification management
Approval
Informed consent
