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乙烯基醇:固定剂量组合药物的风景中未被注意到的威胁
Alemayehu L Duga1,2, Mosoka P Fallah1, Albert Figueras2
1Africa Centres for Disease Control and Prevention, Addis Ababa, Ethiopia.
Journal of public health in Africa
|May 13, 2025
概括
药物中的二乙烯糖醇 (DEG) 和乙烯糖醇 (EG) 污染,特别是不合理的固定剂量组合 (FDC),是全球健康问题. 加强监管监督和质量控制对于防止未来事件和确保患者安全至关重要.
科学领域:
- 制药科学 制药科学
- 公共卫生 公共卫生
- 化学安全 化学安全
背景情况:
- 自2022年9月以来,在全球范围内不断出现的制药产品中二乙烯糖醇 (DEG) 和乙烯糖醇 (EG) 污染事件.
- 很大一部分受污染的产品是固定剂量组合 (FDC),其有效性的证据不足.
- 导致非理性FDC流行的因素包括低生产成本和监管漏洞.
研究的目的:
- 突出与制药中的DEG和EG污染相关的公共卫生风险.
- 强调需要对非理性FDC的营销许可重新评估.
- 倡导加强药品制造业的质量控制和监管框架.
主要方法:
- 报告的污染事件和受影响的药品的审查.
- 分析导致非理性固定剂量组合流行的因素.
- 评估当前的监管和质量保证标准.
主要成果:
- 自2022年9月以来,在9个国家连续7次报告了DEG/EG污染事件.
- 至少有14种被确定为固定剂量组合 (FDC) 的受影响产品.
- 证据表明,缺乏安全性和有效性数据的非理性FDCs的广泛营销许可.
结论:
- 不合理的FDC中受污染的DEG/EG对患者的安全构成重大风险.
- 对于缺乏有效性证据的FDCs的营销许可证,需要紧急重新评估.
- 加强制药品质量控制,监管框架和遵守世卫组织建议对于防止未来污染事件至关重要.
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