2198条儿童肿瘤科医嘱超说明书用药分析

Analysis on 2 198 Medical Orders with Off-Label Medication in Department of Pediatric Oncology

目的:探讨中山大学附属肿瘤医院(以下简称"该院")儿童肿瘤科超说明书用药情况,为临床合理用药提供参考。方法:回顾性调研2018年第4季度该院儿童肿瘤科用药医嘱,参照国家食品药品监督管理总局批准的最新药品说明书,结合患儿性别、年龄、药物种类和超说明书类别,对超说明书用药情况进行统计分析,并针对部分高频次的超说明书用药进行循证医学证据收集。结果:共收集该院儿童肿瘤科病历234份,医嘱2 198条;其中,超说明书用药医嘱1 297条(占59.01%);性别、年龄段及药物类别对超说明书用药发生率的影响不大。1 297条超说明书用药医嘱中,超适应证用药医嘱441条(占34.00%),超适宜人群用药医嘱512条(占39.48%),超剂量用药医嘱165条(占12.72%),超频次用药医嘱144条(占11.10%),超给药途径用药医嘱31条(占2.39%),禁忌证下用药医嘱4条(占0.31%)。列举了7种高频次的超说明书用药,其中4种有高级的相关证据支持,2种证据级别不高,1种证据不足。结论:该院儿童肿瘤科超说明书用药发生率较高,但无理由超说明书用药发生率低,临床应加强超说明书用药的管理,杜绝不合理的超说明书用药。

OBJECTIVE:To probe into off-label medication in department of pediatric oncology in a certain oncology hospital (hereinafter referred to as “this hospital”),so as to provide references for clinical rational medication.METHODS:Medical orders in the fourth quarter of 2018 were retrospectively investigated,by reference to the latest dispensatory approved by China Food and Drug Administration,medical orders of off-label medication were analyzed according to children’s genders,ages,types of drugs and off-label medication,evidence-gathering evidence-based medicine was conducted on some high-frequency off-label medication.RESULTS:A total of 234 pieces of medical history in department of pediatric oncology in this hospital were collected,including 2 198 medical orders;of which 1 297 were off-label medication (59.01%);gender,age,and types of drugs had little effect on the incidence of off-label medication.In the 1 297 cases of medical orders,441 (34.00%) were over-indications,512 (39.48%) were inappropriate patients,and 165 (12.72%) were overdose medication,144 (11.10%) were over-frequency medication,31 (2.39%) were improper administration route and 4 (0.31%) were under contraindications.Seven high-frequency off-label medication were listed,four of which were supported by advanced evidence,two were lower and one was lack of evidence.CONCLUSIONS:The incidence of off-label medication in department of pediatric oncology is relatively high,but the incidence of unreasonable off-label medication is relatively low,administration on off-label medication needs to be strengthened,and unreasonable off-label medication should be eliminated.