Construction of the management index system for the management of off-label drug use in the hospital based on Delphi method

LIU Li; Zebi; Danzenglaji; LIU Rui; WANG Feng; HU Yang; ZUO Wei

doi:10.6039/j.issn.1001-0408.2025.17.17

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Construction of the management index system for the management of off-label drug use in the hospital based on Delphi method

更新时间：2025-09-29

- Construction of the management index system for the management of off-label drug use in the hospital based on Delphi method
- ZHONGGUO YAOFANG Vol. 36, Issue 17, Pages: 2182-2186(2025)
- 作者机构：
  
  1.西藏自治区人民医院药学部，拉萨　850000
  2.西藏自治区人民医院医务处，拉萨　850000
  3.中国医学科学院北京协和医院药剂科，北京　100730
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.17.17
  CLC： R95
- Received：19 February 2025，
  
  Revised：2025-07-10，
  
  Accepted：10 July 2025，
  
  Published：15 September 2025
- 稿件说明：
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刘莉,泽碧,旦增拉吉,等.基于德尔菲法构建医院超说明书用药管理指标体系[J].中国药房,2025,36(17):2182-2186.

LIU Li,Zebi ,Danzenglaji ,et al.Construction of the management index system for the management of off-label drug use in the hospital based on Delphi method[J].ZHONGGUO YAOFANG,2025,36(17):2182-2186.
刘莉,泽碧,旦增拉吉,等.基于德尔菲法构建医院超说明书用药管理指标体系[J].中国药房,2025,36(17):2182-2186. DOI： 10.6039/j.issn.1001-0408.2025.17.17.

LIU Li,Zebi ,Danzenglaji ,et al.Construction of the management index system for the management of off-label drug use in the hospital based on Delphi method[J].ZHONGGUO YAOFANG,2025,36(17):2182-2186. DOI： 10.6039/j.issn.1001-0408.2025.17.17.

摘要

目的

构建医疗机构超说明书用药管理指标体系，为西藏地区医疗机构超说明书用药管理提供参考。

方法

基于法规、文献资料检索和小组讨论等方法初步建立超说明书用药管理指标体系框架，再通过“问卷星”手机小程序以德尔菲法对西藏自治区人民医院的10名来自医学、药学、医院管理等领域的专家进行两轮函询，对函询结果进行整理、修订和统计，形成最终的指标体系。

结果

两轮专家函询问卷的有效回收率均为100%，判断系数均为0.93，熟悉程度均为0.74，专家权威系数均为0.84，肯德尔协调系数分别为0.278、0.308（

＜0.001），满分率均不低于20%。最终构建的超说明书用药管理指标体系包括一级指标3个（超说明书用药分级管理办法、超说明书用药监督管理模式和超说明书用药管理级别量化评估体系），二级指标14个（如管理级别划分和知情同意要点等），三级指标52个（如普通使用级、限制使用级、特殊使用级等）。

结论

基于德尔菲法构建的超说明书用药管理指标体系切合医院工作实际，满足专家积极程度、权威程度和意见一致性等各项标准。

Abstract

OBJECTIVE

To establish a management index system for off-label drug use in medical institutions， offering a reference for the improvement of the management of off-label drug use in medical institutions from Xizang region.

METHODS

The framework of the management index of off-label drug use was initially developed based on regulations， literature retrieval and group discussion. Then，two rounds of Delphi consultation were conducted via the “Wenjuanxing” mobile mini-program involving 10 in-hospital experts from the fields of medicine， pharmacy， and hospital management. The consultation results were then sorted， revised and statistically analyzed， the final index system was established.

RESULTS

The questionnaire recovery rates of the two rounds of expert consultation were both 100%. The judgment coefficients were both 0.93， the familiarity degrees were both 0.74， and the authority coefficients were 0.84 in both rounds. Kendall’s coordination coefficients were 0.278 and 0.308， respectively （

＜0.001）， and

the full score rates in both rounds were no less than 20%. The final management index system for off-label drug use in the hospital was established， including 3 first-level indicators（off-label drug use graded management regulations， off-label drug use supervision model， off-label drug use management level quantitative assessment system）， 14 second-level indicators （such as management level classification and key points of informed consent， etc.）， and 52 third-level indicators（such as general use level， restricted-use level， and special-use level， etc.）.

CONCLUSIONS

The management indicators for off-label drug use developed in this study， which are established based on Delphi method， are aligned with practical needs of hospital operations and meet the standards of expert enthusiasm， authority， and consistency.

关键词

Keywords

references

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