监管机构和生产商应如何防止儿童死于受污染的止咳糖浆?

Kavitha Nallathambi, Amy B Cadwallader
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引用次数: 0

摘要

本评论回应了一起关于止咳糖浆中甘油受二甘醇污染的案例。甘油是药品中常用的辅料,用于改善质地和口感。辅料通常是处方药和非处方药中的药理非活性成分,对活性药物物质的输送、有效性和稳定性起着至关重要的作用。评论首先探讨了污染物是如何进入辅料供应链的。一种方式是制造商或供应商在标签上误导或故意掺假。另一种方式是人为或系统性错误。本评论随后讨论了质量控制测试,并提出了提高辅料供应链透明度的伦理和临床重要性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
How Should Regulators and Manufacturers Prevent Avoidable Deaths of Children From Contaminated Cough Syrup?
This commentary responds to a case about diethylene glycol-contaminated glycerin in cough syrup. Glycerin is a commonly used excipient in medicines to improve texture and taste. Excipients are typically pharmacologically inactive ingredients contained in prescription and over-the-counter drugs that play a critical role in the delivery, effectiveness, and stability of active drug substances. The commentary first canvasses how contaminants enter the excipient supply chains. One way is by misleading labeling or intentional adulteration by manufacturers or suppliers. Another way is by human or systemic error. This commentary then discusses quality control testing and suggests the ethical and clinical importance of increased transparency in excipient supply chains.
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