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意大利儿科实践中的非标签处方:来自全国调查的见解
Anna Arbo1, Anna Flamigni2, Giulia Zamagni2
1Institute for Maternal and Child Health, IRCCS Burlo Garofolo, 34137, Trieste, Italy. anna.arbo@burlo.trieste.it.
European journal of pediatrics
|November 29, 2025
概括
儿童医院的非标签处方是常见的,由新生儿重症监护室 (NICU) 等专业单位驱动,而不是医院规模. 改进的数字跟踪和监督提高了对更安全的儿科药物治疗的监管合规性.
科学领域:
- 儿科药理学 儿科药理学
- 医疗保健管理的管理
- 监管科学 监管科学
背景情况:
- 在儿科护理中,非标签药物处方普遍存在,原因是缺乏年龄特定的配方和数据.
- 这种做法对药物的安全性,疗效和剂量准确性构成风险,特别是在新生儿和婴儿中.
- 现有的监管监督和机构对非标签使用的认识有很大差异,对医院管理实践的数据有限.
研究的目的:
- 了解意大利医院如何管理和监管儿科护理中的非标签处方.
- 确定与监管合规和更安全的处方实践相关的因素.
- 为改善监督和促进儿童更安全的药物治疗提供信息.
主要方法:
- 从2024年11月13日到2025年1月31日,在50个意大利设施进行了一项多中心,横截面的调查.
- 数据是根据意大利儿科临床试验网络 (INCiPiT) 收集的.
- 分析的重点是机构专业化 (如NICU),医院规模,数字追踪,研究单位和监管合规性之间的关联.
主要成果:
- 非标签处方与新生儿重症监护室 (NICU) 有着强烈的关联,在同情使用拒绝后增加到50%.
- 64%的儿童病房数量少于5000个,有NICU和分娩中心.
- 25%的参与中心不知道他们的非标签处方频率.
- 具有数字追踪和专用研究单位的设施显示出更好的监管合规性和更高的同情使用批准率.
结论:
- 儿童医院的非标签处方普遍存在,并由机构专业化,特别是NICU存在,而不是医院规模驱动.
- 结构化的监督,数字基础设施和成本监测提高了监管合规性.
- 标准化程序和政策调整对于确保安全的儿科药物治疗至关重要.
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