2012—2017年重庆医科大学附属第二医院超说明书用药备案情况调查分析

Investigation and Analysis of Off-Label Drug Use Record in the Second Affiliated Hospital of Chongqing Medical University During 2012-2017

目的:了解重庆医科大学附属第二医院(以下简称"我院")超说明书用药备案情况,促进超说明书用药的规范化管理。方法:汇集整理2012—2017年我院各临床科室向药学部提交的超说明书用药备案申请表及我院药事管理与药物治疗学委员会(以下简称"药事会")批准通过的超说明书用药目录总表,采用Excel软件进行统计分析。结果:2012—2017年我院共有14个临床科室提交超说明书用药备案申请124份,获批106份,通过率为85.48%;其中,风湿免疫科提交申请数与获批数均为59份,居首位,通过率达100%,其获批数占总获批数的55.66%;各临床科室提交的超说明书用药备案申请附带的循证医学证据质量比较高;106份获批的超说明书用药申请中,主要为超适应证用药(100份,占94.34%),其次为超剂量用药(5份,占4.72%),应作为超说明书用药监管的重点。结论:我院超说明书用药管理尚存在一些不合理的地方,需要进一步改进;同时,亟需国家出台相关法律法规或文件指导超说明书用药,实施更规范化的管理,规避执业风险,保障患者用药安全。

OBJECTIVE: To investigate and analyze the off-label drug use record in the Second Affiliated Hospital of Chongqing Medical University(hereinafter referred to as "our hospital"), so as to promote the standardized management of off-label drug use. METHODS: The off-label drug use record application form submitted by each clinical department of our hospital to the pharmacy department and the general table of off-label drug use list approved by the Pharmacy Administration and Drug Therapy Committee of our hospital(hereinafter referred to as "the pharmaceutical affairs committee") during 2012-2017 were summarized, and statistical analysis was conducted by using Excel software. RESULTS: During 2012-2017, a total of 14 clinical departments in our hospital submitted 124 applications for off-label drug use record, and 106 were approved, with a pass rate of 85.48%. 59 applications were submitted and approved by the rheumatology and immunology department, which too the first place, with a pass rate of 100%, accounting for 55.66% of the total number of approved applications. The quality of evidence-based medicine attached to the off-label drug use record application submitted by each clinical department was relatively high. Among the 106 approved applications for off-label drug use, the main one was over-indications(100 cases, 94.34%), followed by over-dosage(5 cases, 4.72%), which should be the focus of off-label drug use supervision. CONCLUSIONS: There are still some irrational problems in the management of off-label drug use in our hospital, which need to be further improved. meanwhile, it is urgent for the state to issue relevant laws and regulations or documents to guide off-label drug use, implement more standardized management, avoid the risk of practice, and ensure the safe medication for patients.