2198条儿童肿瘤科医嘱超说明书用药分析
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摘要
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.
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.
引文
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[11] 陈邵阳,苏娜,朱阳慧,等.某三甲医院呼吸内科门诊处方中超药品说明书用药情况分析[J].中国医院药学杂志,2017,37(22):2300-2303.
[12] Lee JH,Byon HJ,Choi S,et al.Safety and Efficacy of Off-label and Unlicensed Medicines in children[J].J Korean Med Sci,2018,33(37):e227.
[13] Bellis JR,Kirkham JJ,Nunn AJ,et al.Adverse drug reactions and off-label and unlicensed medicines in children:a prospective cohort study of unplanned admissions to a paediatric hospital[J].Br J Clin Pharmacol,2013,77(3):545-553.
[14] 邓斌,洪晓丹,姚秋燕,等.4例超说明书用药致医疗纠纷的典型案例分析[J].中国医院药学杂志,2018,38(1):88-91.
[15] 杜博冉,冯欣,史湘君,等.超说明书用药司法判例中的药学分析[J].中国药学杂志,2018,53(21):1876-1880.
[2] 李亚昙,贾琳,滕亮.国内外儿科超说明书用药近况的系统评价[J].中国医院药学杂志,2016,36(23):2114-2119.
[3] 万正兰,林米花.抗肿瘤药超说明书使用调查分析[J].中国医院药学杂志,2013,33(12):1003-1004.
[4] NCCN.NCCN Clinical Practice Guidelines in Oncology:Soft Tissue Sarcoma(Version1.2009)[EB/OL].(2018-12-19).https://www.nccn.org/patients/guidelines/sarcoma/index.html.
[5] Sugita J,Mastushita T,Kashiwazaki H,et al.Efficacy off folinic acid in preventing oral mucositis in allogeneic hematopoietic stem cell transplant patients receiving MTX as prophylaxis for GVHD[J].Bone Marrow Transplant,2012,47(2):258-264.
[6] 于英莉,董小晶,王林海.亚叶酸钙治疗胰腺癌化疗致反复口腔溃疡32例及护理分析[J].中国药业,2015,24(5):50-51.
[7] 徐瑞华,姜文奇,管忠震,等.临床肿瘤内科学[M].北京:人民卫生出版社,2014:878-879.
[8] 李亚昙,贾巍,滕亮.新疆某“三甲”医院儿科住院患儿超说明书用药情况调查与分析[J].中国药房,2016,27(32):4493-4496.
[9] 向晓琴,何莉梅,何苗,等.我院2017年门诊患儿超说明书用药情况调查分析[J].中南药学,2018,16(12):1789-1792.
[10] 杨李娜,黄献川,陈宜锋.某院儿科住院患者超说明书用药情况调查分析[J].福建医药杂志,2018,40(2):118-120.
[11] 陈邵阳,苏娜,朱阳慧,等.某三甲医院呼吸内科门诊处方中超药品说明书用药情况分析[J].中国医院药学杂志,2017,37(22):2300-2303.
[12] Lee JH,Byon HJ,Choi S,et al.Safety and Efficacy of Off-label and Unlicensed Medicines in children[J].J Korean Med Sci,2018,33(37):e227.
[13] Bellis JR,Kirkham JJ,Nunn AJ,et al.Adverse drug reactions and off-label and unlicensed medicines in children:a prospective cohort study of unplanned admissions to a paediatric hospital[J].Br J Clin Pharmacol,2013,77(3):545-553.
[14] 邓斌,洪晓丹,姚秋燕,等.4例超说明书用药致医疗纠纷的典型案例分析[J].中国医院药学杂志,2018,38(1):88-91.
[15] 杜博冉,冯欣,史湘君,等.超说明书用药司法判例中的药学分析[J].中国药学杂志,2018,53(21):1876-1880.