中国医院超说明书用药调查与对策研究

Investigation and countermeasure research of off-label use of drugs in Chinese hospital

目的调查中国医院超说明书用药的基本情况。方法用学术会议现场、Web网络、E-mail三种访问调查法,对不同级别医院的医务人员进行随机问卷调查,收集国内超说明书用药实例,并进行分析研究。结果纳入调研分析的医院1163家(三级617家、二级463家、一级83家),收集到涉及405种药品的756例超药品说明书用法。71.88%医院允许超说明书用药,仅32.07%医院出台了超说明书用药管理规定。三级医院回答有超说明书用药管理制度及定期召开相关会议频次与一、二级医院比较差异有统计学意义(P<0.01)。不同职称与学历药师对超说明书用药的认知差异有统计学意义(P<0.01)。结论规范医院(尤其二级及以下)超说明书用药管理迫在眉睫,亟需有关部门密切合作出台国家层面的超药品说明书应用指导原则或管理规范。

Objective To investigate the baseline data on off-label medication specification for clinical doctors or management department in hospitals. Methods Random questionnaire survey was implemented on various grades medical workers in hospitals by the conference,E-mail and web network. The usage practices of domestic off-label medicine were collected and analyzed. Results Totally 756 cases of off-label usage on 405 drugs from 1163 hospitals（617 tertiary referral center,463 secondary,83 primary） were investigated. Among the investigated hospitals,71. 88% hospitals allow the off-label usage,only 32. 07% hospitals established the off-label medicine manual management regulations.The tertiary referral center hospitals established the drug management system and the regular meeting on off-label medicine usage,while the secondary and primary hospitals insufficient relevant practice,the difference between them have statistical significance（P〈0. 01）. Relevant statistical significance also existed in pharmacists with various background of professional qualifications and academic diplomas（P〈0. 01）.Conclusion Standardizing the instructions on off-label medication management is urgent for domestic hospitals,especially for the secondary and below hospitals. It is necessary to established national level application guidelines or management specification on off-label drug usage.