中国药物警戒 ›› 2021, Vol. 18 ›› Issue (2): 164-169.
DOI: 10.19803/j.1672-8629.2021.02.14

• 安全与合理用药 • 上一篇    下一篇

新生儿超说明书用药现状分析与风险对策

江永贤1, 蒲欣瑜2, 陈文文1, 陶婉君1, 陈娟1, 李根1,*   

  1. 1电子科技大学医学院附属妇女儿童医院,成都市妇女儿童中心医院,四川 成都 611731;
    2成都医学院,四川 成都 610000
  • 收稿日期:2019-11-25 修回日期:2021-02-26 出版日期:2021-02-15 发布日期:2021-02-26
  • 通讯作者: *李根,男,本科,主任药师,医院药学。E-mail：lgzyc@163.com
  • 作者简介:江永贤,女,硕士,主管药师,药物警戒。

Countermeasures Against Risk of Neonatal Off-label Drug Use

JIANG Yongxian1, PU Xinyu2, CHEN Wenwen1, TAO Wanjun1, CHEN Juan1, LI Gen1,*   

  1. 1Department of Pharmacy, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China,Chengdu Sichuan 611731, China;
    2Chengdu Medical College, Chengdu Sichuan 610000, China
  • Received:2019-11-25 Revised:2021-02-26 Online:2021-02-15 Published:2021-02-26

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摘要： 目的 对某院新生儿科住院患儿超说明用药状况进行回顾性分析,查找用药风险因素,为降低用药风险以及促进医院优化超说明书用药政策提供基础数据。方法 利用等数分配法随机抽取新生儿科病例及其医嘱作为研究对象,统计且分析患儿基本信息和超说明书发生率、用药类型、使用情况和药品不良反应/事件的发生率。结果 2018年该院新生儿科超说明书用药人次发生率为98.13%、医嘱发生率为65.48%,每位患儿超说明书用药品种数（11.9±1.5）个。超说明书发生率较高的主要为造影剂类药物（100.00%）、血液和造血系统用药（96.03 %）、呼吸系统用药（95.38 %）。超说明书用药情况通常包含未提及新生儿用法（61.89 %）、超适应证给药（15.83 %）以及超剂量范围（8.66 %）。超说明书用药导致药品不良/事件为55.56%。结论 该院新生儿住院患者超说明书用药发生率高,涉及品种广泛。医院应该完善超说明书用药备案管理机制,做好患者知情同意工作,保障超说明书用药风险应急措施和日常监控。

关键词: 新生儿, 住院患儿, 超说明书用药, 用药分析, 风险分析

Abstract: Objective To retrospectively analyze off-label medications among neonatal inpatients in our hospital in 2018, and to identify the risk factors for drug use so as to provide data for reducing the risk of drug use and optimizing off-label drug use policies in our hospital. Methods Neonatological cases and related doctors' instructions in 2018 were randomly chosen using the method of equal number distribution. The basic information of the patients, incidence of off-label instructions, types of drugs used, and the incidence of adverse events were statistically analyzed. Results Based on the number of children and the number of medication orders, the incidence of off-label drug use was 98.13% and 65.48% respectively. The average number of off-label drugs used per child was 11.9±1.5. The most common drugs that were used off-label were contrast agents (100.00%), followed by hematopoietic drugs (96.03%), and respiratory drugs (95.38%). Off-label use of drugs often involved drugs whose usage for newborns was not mentioned (61.89%), over-indication drugs (15.83%) and over-dose drugs (8.66%). The proportion of adverse events caused by off-label drug use was 55.56%. Conclusion The incidence of off-label drug use among newborns in our hospital is high, involving a wide range of varieties, Therefore, hospitals should improve the documentation of off-label drug use, ensure informed consent of patients, and work out emergency measures and monitor the risk of off-label drug use daily.

Key words: newborn, hospitalized children, off‐label use, drug analysis, risk analysis

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