肿瘤专科医院超说明书用药评价体系的构建与应用评价

Construction and application evaluation of off-label drug use evaluation system in cancer hospital

目的为加强肿瘤专科医院超说明书用药的规范化管理提供参考。方法构建超说明书用药评价体系,规范我院药品目录外药品超说明书使用的申请、审批、备案流程。比较我院该评价体系构建前(2021年10月1日-2022年9月30日)和构建后(2022年10月1日-2023年9月30日)的超说明书用药申请量、占比、病种类别和药品类型变化;并统计药学部筛选出的具有高级别循证证据支持的用药条目。结果我院超说明书用药申请总数量逐步增加,从2021年第4季度的306份增长至2023年第3季度的3828份。该评价体系构建前1年,共有超说明书用药申请4482份;该评价体系构建后1年,共有超说明书用药申请11840份。该评价体系构建后,未备案的超说明书用药比例较上一年度同期显著降低(P<0.05)。其中,消化系统肿瘤、头颈肿瘤2个病种及放射性药物未再见有未备案的超说明书用药申请;淋巴瘤、乳腺肿瘤和泌尿生殖系统肿瘤3个病种,细胞毒类药物和新型抗肿瘤类药物的未备案超说明书用药申请量降幅均超过70%。我院药学部共筛选出19种药品相关的27条具有高级别循证证据支持的超说明书用药条目,其中25条为超适应证用药。结论肿瘤专科医院超说明书用药评价体系的建立有助于临床抗肿瘤药物的合理应用和细化管理。

OBJECTIVE To provide reference for strengthening the standardized management of off-label drug use in cancer hospitals.METHODS The evaluation system for off-label drug use was established to standardize the application,approval,and filing process for off-label drug use in our hospital.The changes in off-label drug application quantity,proportion,disease category and drug category in our hospital were compared before(October 1st,2021-September 30th,2022)and after(October 1st,2022-September 30th,2023)the establishment of the evaluation system;drug items supported by high-level evidence screened by pharmacy department were analyzed statistically.RESULTS The number of off-label drug use applications in our hospital had gradually increased,from 306 pieces in the fourth quarter of 2021 to 3828 pieces in the third quarter of 2023.In the year before the construction of the evaluation system,there were a total of 4482 applications for off-label drug use,and in the year after the construction of the evaluation system,there were 11840 applications for off-label drug use.After the construction of the evaluation system,the proportion of unregistered off-label drug use significantly decreased,compared to the same period last year(P<0.05).Among them,there were no unregistered applications for offlabel drug use for digestive system tumors,head and neck tumors,and radioactive drugs;lymphoma,breast tumors,urogenital system tumors,cytotoxic drugs and new anti-tumor drugs all had a decrease of over 70%in unregistered off-label drug applications.Twenty-seven off-label drug use items related to 19 drugs supported by high-level evidence were screened by the pharmacy department of our hospital,among which 25 items were drug use beyond indication.CONCLUSIONS The establishment of off-label drug use evaluation system in cancer hospital is helpful to the rational use and refined management of clinical anti-tumor drugs.