基于德尔菲法构建医院超说明书用药管理指标体系

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中图分类号R95 文献标志码A 文章编号 1001-0408（2025）17-2182-05

DOI 10.6039/j.issn.1001-0408.2025.17.17

Construction of the management index system for the management of of-label drug use in the hospital basedonDelphimethod

LIU LiΔ ，Zebi'，Danzenglaji'，LIU Rui'，WANG Feng²，HU Yang³，ZUO Wei³（1.Dept. of Pharmacy，People’s Hospital of Xizang Autonomous Region，Lhasa 850ooo，China;2. Dept. of Medical Administration，People's Hospital of Xizang Autonomous Region，Lhasa 850oo0，China; 3. Dept. of Pharmacy，Peking Union Medical College Hospital，Chinese Academy of Medical Sciences，Beijing 100730，China）

ABSTRACTOBJECTIVEToestablishamanagementindexsystem forof-labeldruguseinmedical institutions，oferinga referencefortheimprovementofthemanagementofof-labeldruguseinmedical institutionsfrom Xizangregion.METHODSThe frameworkofthemanagementindexofof-labeldrugusewasinitiallydevelopedbasedonregulations，literatureretrievaland groupdiscusion.Then，tworoundsof Delphiconsultation wereconductedviathe“Wenjuanxing”mobilemini-programinvolving 10in-hospitalexpertsfromthefieldsofmedicine，pharmacy，andhospitalmanagement.Theconsultationresultswerethensorted， revisedandstatisticallanalyzed，thefinalindexsystemwasestablished.RESULTSThequestionnairerecoveryratesofthetwo rounds of expert consultation were both 100% . The judgment coefficients were both O.93，the familiarity degrees were both 0.74， andtheauthoritycoficientswereO.84inbothrounds.Kendal'scoordinationcoeffcientswere0.278and.308，respectively（ P< 0.001），and the full score rates in both rounds were no less than 20% .The final management index system for of-label drug use in thehospitalwasetablished，cluding3fist-evelindicators（of-labeldugusegradedmanagementregulations，of-beldruguse supervisionmodel，of-labeldrugusemanagementlevelquantitativeassessmentsystem），14second-levelindicators（uchas managementlevelclasificationandkeypointsofinformedconsent，etc.），and52thid-levelindicators（suchasgeneraluselevel， restricted-uselevel，andspecial-uselevel，etc.）.CONCLUsIONSThemanagementindicatorsforof-labeldrugusedevelopedin thisstudy，whichareestablishedbasedonDelphi method，arealignedwith practicalnedsofhospitaloperationsandmetthe standards of expert enthusiasm，authority，and consistency.

KEYWORDSoff-label drug use；Delphi method；index system；Xizangregion；medical institutions

超说明书用药是指药品使用的适应证、剂量、给药途径或适用人群不在国家药品监督管理部门批准的药品说明书记载范围内的用法，又称药品说明书之外用法、药品未注册用法、药品拓展性临床应用等1。（剩余7187字）