神经内科门诊超说明书用药现状分析

Analysis of Off-label Drug Use in Outpatient Department of Neurology

关键词:  超说明书用药  神经内科  门诊  合理用药

Key words:  off-label drug use  neurology  outpatient  rational drug use

摘要:

目的 回顾性分析郑州大学第一附属医院神经内科门诊超说明书用药情况，为超说明书用药分级管理提供参考，促进临床合理用药，保证患者用药安全。方法 对神经内科2020年6—9月的门诊医嘱进行随机抽样，以最新药品说明书为依据，分析用药医嘱是否为超说明用药，整理分析超说明书用药类型、超说明书药品种类等。根据国外说明书、国际/国内指南、专家共识和其他循证支持用法对超说明书用药进行证据级别分析，采用单因素分析对超说明书用药的相关性因素进行分析。结果 共纳入1 663张门诊处方，涉及用药医嘱3 240条，药品种类190种。其中超说明书用药处方307张(18.46%)、医嘱334条(10.31%)、药品30种(15.79%)。超说明书用药主要类型为超适应证、超用法用量2种。334条超说明书用药医嘱中有证据支持的医嘱293条(87.72%)。单因素分析结果显示，神经内科超说明书用药与药品种类有关。结论 神经内科门诊超说明书用药发生较常见，大部分超说明书用药有一定的证据支持和不可避免性，应根据证据级别加强超说明书用药的监管，保证临床合理用药。

Abstract:

OBJECTIVE To retrospectively analyze the off-label drug use in neurology outpatient department of The First Affiliated Hospital of Zhengzhou University, so as to provide reference for classification management of off-label drug use, promote rational drug use in clinic, and ensure the safety of drug use. METHODS Prescriptions of neurology outpatient department during June—September 2020 were randomly selected. According to latest drug instructions, off-label drug use of these prescriptions was analyzed, including the category of off-label drug use and incidence of off-label drug use with different category of drugs. According to foreign instructions, international/domestic guidelines, expert consensus and other evidence-based support usage, the level of evidence for off-label drug use was analyzed. Meanwhile, univariate analysis was used to explore risk factors for off-label drug use. RESULTS A total of 1 663 outpatient neurology prescriptions with 3 240 medication orders were extracted, including 190 kinds of drugs. There were 307 prescriptions(18.46%), 334 medication orders(10.31%) and 30 kinds of drugs(15.79%) for off-label use, respectively. The main types of off-label drug use were off-label indication and off-label drug frequency medication. There were 293(87.72%) medical orders supported by evidence in 334 off-label drug orders. Univariate analysis showed that off-label drug use in neurology department was related to drug type. CONCLUSION Off-label drug use is common in the outpatient department of neurology, and most has certain evidence support and inevitability, the supervision of off-label drug use should be strengthened according to the evidence levels to ensure rational clinical drug use.