摘要
目的分析本院新型抗肿瘤药物的超说明书用药合理性,为临床合理用药提供科学依据,规范本院新型抗肿瘤药物超说明书用药行为。方法提取2018年5月~2019年4月本院所有使用新型抗肿瘤药物的用药信息7521例,整理出所有超说明书用药信息包括药品名称、说明书用法、临床超说明书用法、超说明书用药例数及占比。结果本院新型抗肿瘤药物共计26个药品,4个药品(1590例)出现超说明书用药。临床使用中有2个药品(6种超说明内容,1541例,占97.16%)未通过药事管理委员会及伦理委员会审议,未收录在本院《超说明书用药目录(2018版)》。超目录使用的利妥昔单抗注射液的2种超说明书内容(7例,占0.44%)和重组人血管内皮抑制素注射液的3种超说明书内容(1533例,占96.66%),均有国内外循证医学证据支持,视为合理用药;重组人血管内皮抑制素注射液超说明书应用于复合型肺小细胞癌(1例,占0.06%),证据不足,视为不合理用药。结论超说明书用药在法律层面是不受保护的,临床使用存在一定的风险性。医师应规范超说明书用药行为,在医院的监管力度和药师实时干预下,三者通力合作,共同保障患者的用药安全,规避超说明书用药的法律风险。
Objective To analyze the rationality of the off-label drug use of novel antineoplastic drugs in our hospital,to provide a scientific basis for clinical rational drug use,and to standardize the novel antineoplastic drug use in our hospital.Methods Totally 7521 cases of novel antineoplastic drug use in our hospital from May 2018 to April 2019 were collected,and the off-label use of drug information the drug name,label usage,off-label clinical usage,proportion and case number of off-label drug use.Results Totally 26 novel antineoplastic drugs were used in our hospital,and 4 drugs(1590 cases)had off-label usage.Two drugs clinically used(6 types of off-label usage in 1541 cases,accounting for 97.16%)were not reviewed by the Pharmacy Management Committee and the Ethics Committee,and were not included in our hospital’s Off-label Use Catalogue(2018 Edition).Two types of offlabel(7 cases,0.44%)of rituximab injection and 3 types of off-label of recombinant human endostatin injection(1533 cases,96.66%)were supported by evidence-based medical evidence home and abroad,and were considered rational drug use.Recombinant human endostatin injection super-instruction was applied to composite small cell lung cancer(1 case,0.06%).With insufficient evidence,this case was regarded as irrational drug use.Conclusion Off-label drug use is not protected legally due to certain risks in clinical use.Physicians should standardize the offlabel use of medications.Concerted efforts should focus on the safety of patients’medications.
作者
宁婷婷
廖靖萍
于西全
宋洪涛
郭燕珊
NING Ting-ting;LIAO Jing-ping;YU Xi-quan;SONG Hong-tao;GUO Yan-shan(Department of Pharmacy,The 900th Hospital of the Joint Logistics Team,Fuzhou 350025;College of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350025)
出处
《中南药学》
CAS
2020年第2期306-310,共5页
Central South Pharmacy
关键词
新型抗肿瘤药物
超说明书用药
循证医学
novel antineoplastic drug
off-label use of drug
evidence-based medicine
