评估西班牙儿童非标签处方中的强制性声明辅助剂
Irene Lizano-Díez1,2, Itziar Aldalur-Uranga1, Antonio J Braza3,4
1Clinical Pharmacy and Pharmaceutical Care Unit, Department of Pharmacy and Pharmaceutical Technology, and Physical Chemistry, Faculty of Pharmacy and Food Sciences, University of Barcelona, Av. Joan XXIII, 27-31, Barcelona, 08028, Spain.
Scientific reports
|July 19, 2025
概括
儿童患者面临的危险来自有害的辅助剂在成人药物使用非标签. 在22种强制声明辅助剂 (EMD) 中,有9种具有严重的伤害风险,特别是在幼儿中.
科学领域:
- 药理学 药理学是指药理学的学科.
- 儿科医学 儿科医学
- 药品安全 药品安全
背景情况:
- 儿科患者经常接受针对成人的非标签药物.
- 这些非标签处方由于潜在有害的辅助物质而带来风险.
- 强制声明的辅助剂 (EMDs) 需要对儿科安全进行审查.
研究的目的:
- 在经常处方的儿科非标药物中识别强制声明的辅助物质 (EMD).
- 评估这些EMD在18岁以下的个人中所带来的安全风险.
- 突出儿童药物配方安全性的未满足需求.
主要方法:
- 一个回顾性,观察性,基于西班牙初级保健 (2004-2005,2017-2020) 的基于人口的研究.
- 分析了4,922,984个非标签处方,使用全国专有数据库.
- 对37种药物 (口服,局部,吸入) 进行审查,以评估EMD的成分和危害.
主要成果:
- 新生儿和婴儿 (<5岁) 占非标签处方的近50%,面临显著的EMD风险.
- 在22个EMD中,有9个被评为"严重"的伤害,6个被评为"中度"的伤害;没有一个被评为"没有伤害".
- 口服配方经常超过欧洲药物管理局 (EMA) 的,,醇,甘醇和甜味剂的值.
结论:
- 在儿童中使用非标签药物存在有害EMD的重大风险,特别是在年轻人群中.
- 需要紧急干预,以减轻儿科口服配方中的EMD风险.
- 将EMD风险警告集成到处方系统和监测不良事件中,对于儿童安全至关重要.
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