监管机构和制造商应该如何防止儿童因受污染的咳糖而死亡?
Kavitha Nallathambi1, Amy B Cadwallader2
1Former senior manager of global public policy at US Pharmacopeia.
AMA journal of ethics
|April 2, 2024
概括
咳糖中的受污染的糖突出了辅助剂供应链的风险. 提高透明度和质量控制对于药物安全和患者健康至关重要.
科学领域:
- 制药科学 制药科学
- 药物安全和药物监管
- 供应链管理 供应链管理
背景情况:
- 糖是药物中常见的辅助剂,对于药物输送,有效性和稳定性至关重要.
- 助剂,虽然在药理上不活跃,但是药物产品性能不可或缺的一部分.
- 基于糖的咳糖中乙烯甘醇污染的一个案例强调了潜在的风险.
研究的目的:
- 检查污染物进入制药辅助剂供应链的途径.
- 讨论助剂当前质量控制测试的作用和局限性.
- 强调在辅助剂采购方面提高透明度的伦理和临床必要性.
主要方法:
- 审查辅助剂供应链中的污染途径.
- 对制药辅助剂的质量控制测试策略的分析.
- 讨论供应链透明度的伦理和临床影响.
主要成果:
- 污染物可以通过误导性标签,故意改或人类/系统错误透到辅助剂供应链中.
- 目前的质量控制措施可能不足以检测出所有形式的辅助剂污染.
- 缺乏透明度对药物安全和患者健康构成重大风险.
结论:
- 加强质量控制和提高辅助剂供应链透明度至关重要.
- 需要采取主动措施,以防止未来出现受污染药物的事件.
- 伦理的制药实践要求在所有药物成分的采购和验证方面承担更大的责任.
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