Evaluating light-sensitive injectables: Gaps in manufacturers’ package inserts and recommendations for best practices

包装设计 包装说明书 业务 计算机科学 制造工程 工程制图 工程类 医学 药理学
作者
S. F. Lim,Shao Jin Ong,Priscilla How,Elaine Ah‐Gi Lo
出处
期刊:Proceedings of Singapore healthcare [SAGE Publishing]
卷期号:34
标识
DOI:10.1177/20101058251365298
摘要

Objectives This study aimed to compile a list of light-sensitive injectables in a tertiary hospital, determine the reasons and impacts of light protection, and suggest light protective methods. Methods Using a descriptive study design, injectables listed in the drug formulary of a tertiary academic hospital were screened for light-sensitive injectables through Package Inserts (PIs), both physical and online, for light protection information. Additional references like Micromedex, British Pharmacopoeia, United States Pharmacopeia and Trissel’s Handbook on Injectable Drugs, were consulted for verification. Where information was insufficient, manufacturers were contacted for photostability data. A literature search was conducted to suggest possible light-protective measures. Results Of 322 injectables from the formulary, 193 were identified as light-sensitive. Instructions on protective methods were found in 109 (56.5%) PIs, while 45 (23.3%) PIs mentioned the acceptable light exposure duration or stages requiring protection. Only 13 (6.74%) PIs provided the rationale for light protection. Rationales and details pertaining to light protection from PIs and other sources were presented in a table, with identified discrepancies discussed. Light protective methods were subsequently suggested. Conclusion The study highlights a lack of detailed, accessible information on light protection in PIs beyond the instruction to “Protect from light”. More comprehensive guidance on when and how to implement light protection, would improve the handling of light-sensitive injectables. Also, incorporating evidence, such as photostability studies, to validate manufacturers’ claims would empower healthcare professionals to make informed decisions, ultimately reducing the risk of photodegradation.
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