运输前批量测试在确保良好的药品质量方面的作用
1American Enterprise Institute, 1150 Seventeenth Street, NW, Washington, DC 20036, USA.
MalariaWorld journal
|June 10, 2024
概括
由世卫组织批准的制造商生产的基于美素的组合疗法 (ACT) 的质量几乎是未经批准的产品的五倍. 然而,一些已批准的ACT仍然存在质量问题,需要对捐赠者进行批量测试.
科学领域:
- 药品质量保证 药品质量保证 药品质量保证
- 全球卫生药物采购全球卫生药物采购
- 抗疟疾药物的有效性
背景情况:
- 捐赠机构优先考虑由严格监管机构或世卫组织预资格计划批准的药物.
- 尽管获得批准,但美国总统疟疾倡议已经退还了质量不佳的批准药物.
- 本研究调查了经批准和未经批准的制造商的基于美素的组合疗法 (ACT) 的质量.
研究的目的:
- 为了比较世卫组织批准的ACT与未经批准的制造商的ACT的质量.
- 为了确定捐赠者获得的抗疟疾药物的政策改进.
- 确保发展中国家抗疟疾药物的有效性和安全性.
主要方法:
- 秘密购物者从14个发展中国家的药房收集了1203个ACT样本.
- 用Minilab®协议选样品以检测不合格,退化或假冒产品.
- 使用高性能液体染色学进一步分析可疑产品.
主要成果:
- 在1203个ACT中,684个来自世卫组织批准的制造商,519个来自未经批准的制造商.
- 在经批准的产品中,2.6%的产品和12.5%的未经批准的产品中发现了不符合标准的ACT (不足的活性成分).
- 经过认可的制造商的ACT表现明显更好,但质量问题仍然存在.
结论:
- 经世卫组织批准的制造商的ACT显示性能比未经批准的近五倍.
- 已批准的ACT中很大一部分仍不含足够的活性药物成分.
- 捐助者,比如美国总统疟疾倡议,应该对所有采购的抗疟疾药物实施批量测试,以确保质量.
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