中国药房2017，Vol.28Issue(10)：1306-1310,5.DOI:10.6039/j.issn.1001-0408.2017.10.03
我院超说明书用药的分级管理研究
Study on the Classification Management of Off-label Drug Use in Our Hospital
摘要
Abstract
OBJECTIVE:To promote the normative management of clinical off-label drug use. METHODS:The degree of devi-ation from the drug instructions and the risk degree were comprehensively considered,and the off-label drug use were classified in-to 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 pharmaceu-tical committee and ethics committee accordingly;informed consent classifying were signing informed consent,informing and re-cording 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 ad-verse 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 hos-pital have shown high operability,improved the off-label drug use behavior of physicians.关键词
超说明书用药/分级管理/审批/知情同意Key words
Off-label drug use/Classification management/Approval/Informed consent分类
医药卫生引用本文复制引用
王颖,谭湘萍,司徒冰..我院超说明书用药的分级管理研究[J].中国药房,2017,28(10):1306-1310,5.基金项目
广东省科学技术厅科技发展专项资金项目(No. 2016A020218013) （No. 2016A020218013）
广州医科大学青年科研项目(No.2014A22) （No.2014A22）
