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- Title
How Should Regulators and Manufacturers Prevent Avoidable Deaths of Children From Contaminated Cough Syrup?
- Authors
Nallathambi, Kavitha; Cadwallader, Amy B.
- Abstract
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.
- Subjects
DRUG adulteration; HEALTH literacy; PATIENT safety; GLYCERIN; DIZZINESS; HEADACHE; EDEMA; CHILD mortality; EXCIPIENTS; QUALITY control; MEDICAL supplies; SUPPLY chains; HEPATOMEGALY; UNITED States. Food &; Drug Administration; PHARMACEUTICAL industry; COUGH; GLYCOLS; VOMITING; TACHYCARDIA; QUALITY assurance
- Publication
AMA Journal of Ethics, 2024, Vol 26, Issue 4, p289
- ISSN
2376-6980
- Publication type
Article
- DOI
10.1001/amajethics.2024.289