对某院超说明书用药申请进行循证医学分析

目的：对某院超说明书用药申请进行循证医学分析；优化该院超说明书用药审批流程。方法：收集该院2013年至今提交药事管理与药物治疗学委员会的超说明用药申请并通过Micromedex的Thomson分级系统进行评价。结果：2013年至今该院共有28项超说明书用药申请，其中有效性等级Ⅰ（治疗有效）有22项、Ⅱa （证据支持有效）4项、Ⅱb （证据支持有效）1项、Ⅲ（治疗无效）1项；推荐等级ClassⅠ（治疗有效）0项、Class Ⅱa （证据支持有效）21项、Class Ⅱb （证据支持有效）5项、Ⅲ（治疗无效）2项；证据等级Catagory A 1项、Catagory B 22项、Catagory C 4项、No Evidence 1项。优化的超说明书用药审批流程为医师提交超说明书用药申请附证据→药学部审核重新检索证据并进行Thomson分级→提交药事管理与药物治疗学委员会→通过后提交伦理委员会审查→通过后纳入医院超说明书目录实行分级管理→患者充分知情下使用。结论：对超说明书用药申请进行循证医学分析可以为药事管理与药物治疗学委员会提供更为可靠的论证依据，有助于提高医院的超说明书用药管理水平。

Evidence-based medical analysis for the application of off-label drug use in a hospital

OBJECTIVE To provide an evidence-based medical analysis for the application of off-label drug use in our hospital and to optimize the approval process.METHODS The applications of off-label drug use were collected,which was submitted to the drug administration and drug therapy committee since 2013.Evidence-based medical analysis by the Thomson grading system of Micromedex was performed to estimate the applications.RESULTS Since 2013,our hospital had a total of 28 off-label drug use applications,including 22 items of efficacy class I (effective treatment),4 of Ⅱa (valid for evidence),1 of Ⅱb (evidence support valid),1 of Ⅲ (treatment ineffective); 0 item of recommended grade Class I (treatment effective),21 of Class Ⅱa (evidence support valid),5 of Class Ⅱb (evidence support valid),2 of Ⅲ (treatment ineffective); 1 item of evidence level catagory A,22 of catagory B,4 of catagory C,1 of no evidence.The results of the optimized approval process of the off-label drug use:doctors submitted the application with evidences → the pharmacy examined and re-retrieved evidence and performed the Thomson grading → submitted to the drug administration and drug therapy committee → submitted to the ethics committee for review → incorporated to the contents of hospital off-label drug use with hierarchical management → used after the patient was fully informed.CONCLUSION Evidence-based medical analysis of the application of the off-label drug use provides a more reliable basis for the drug administration and drug therapy committee.It will improve the hospital management level of the off-label drug use.