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从本地和跨国制药公司的患者信息传单的系统比较:评估内容质量和完整性
Abdulaziz Ibrahim Alzarea1, Azfar Athar Ishaqui2, Muhammad Zeeshan3
1Department of Clinical Pharmacy, College of Pharmacy, Jouf University, Sakaka, Saudi Arabia.
PloS one
|November 7, 2025
概括
多国制药公司的患者信息传单 (PIL) 提供比本地药物更全面的药物细节. 提高PIL质量对于患者安全和有效使用药物至关重要.
科学领域:
- 制药科学 制药科学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 患者信息传单 (PIL) 对于安全使用药物至关重要.
- 在跨国和本地制药公司之间存在PIL质量的差异.
- 评估和比较PIL的完整性和质量至关重要.
研究的目的:
- 为了比较跨国和当地制药公司的PIL的完整性和质量.
- 为了确定PIL质量在不同类型的公司之间存在差异的特定领域.
主要方法:
- 一项跨部门的比较研究评估了695个主要治疗类别的PIL (312个跨国,383个本地).
- 根据31个标准评估PIL,包括一般信息,剂量,安全性和药物相互作用.
- 统计分析包括描述性统计,t测试,奇平方测试和赔率比率.
主要成果:
- 跨国PIL在提供无活性成分,成人剂量,剂量调整 (脏,肝脏和血液透析),药物相互作用和黑盒警告等方面的信息方面表现出色.
- 在特定的剂量,毒性效应和药物不良反应报告方面,发现了有利于跨国PIL的显著差异.
- 跨国和本地PIL都充分提供了有关活性成分,禁忌和怀孕/哺乳的基本信息.
结论:
- 虽然跨国和本地PIL都提供了基本信息,但存在显著的质量差异.
- 当地PIL需要改进的领域包括非活性成分,特定剂量,剂量调整和药物相互作用.
- 通过监管措施和行业倡议标准化PIL内容是必要的,以提高患者安全和药物使用质量.
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