为什么确保抗微生物药品的质量是全球必不可少的
Amy B Cadwallader1, Kavitha Nallathambi2, Carly Ching3
1Director of regulatory and public policy development at US Pharmacopeia.
质量差的抗菌药物危及全球健康,特别是在低收入国家. 本文探讨了不符合标准的抗微生物药物的风险,并提出了监管改革,以提高供应链完整性和药物质量.
科学领域:
- 制药科学 制药科学
- 全球卫生安全 全球卫生安全
- 药用化学 医学化学
背景情况:
- 劣质和伪造的抗微生物药物是一个重大的全球威胁.
- 质量差的药物会损害治疗的有效性和患者的安全性.
- 低收入和中等收入国家不成比例地受到假冒药物的影响.
研究的目的:
- 讨论与低质量的抗微生物药物相关的多方面的风险.
- 要突出低标准抗微生物药物和抗微生物药物耐药性之间的联系.
- 为改善供应链推政策和监管干预措施.
主要方法:
- 对抗微生物药物质量问题的文献综述.
- 对供应链漏洞的分析.
- 综合监管和政策建议.
主要成果:
- 质量差的抗微生物药物导致治疗失败和不良事件.
- 低质量的药物加剧了抗菌素耐药性的危机.
- 现有的供应链缺乏可靠的质量保证机制.
结论:
- 加强监管监督对于确保抗菌素质量至关重要.
- 需要进行政策改革,以建立有弹性的制药供应链.
- 国际合作对于打击低质量的药物的扩散至关重要.
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