Allowable room temperature excursions for refrigerated medications: A 20-year review

Autor:	Lucas E Orth, Amanda S Ellingson, Sara F Azimi, Joseph T Martinez, Amal A Alhadad, Brenda C Tran, Chase W Allen, Cecilia T Nguyen, Tony Duong, Jordan S Burkdoll, Jenny Yoo, Allison B Blackmer, Meghan N Jeffres
Rok vydání:	2022
Předmět:	Pharmacology Drug Stability Pharmaceutical Preparations United States Food and Drug Administration Health Policy Drug Storage Pharmaceutical Services Temperature Humans United States
Zdroj:	American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists. 79(15)
ISSN:	1535-2900
Popis:	Purpose The aim of this review was to build upon previous literature describing the maximum duration for which refrigerated medications can tolerate room temperature excursions while maintaining stability and potency. Methods During a 12-month period ending in June 2021, the prescribing information and published monographs from multiple pharmacy compendia were reviewed for all medications and biologic products approved by the US Food and Drug Administration (FDA) for human use since January 2000. Products that were subsequently withdrawn from the US market were excluded. When temperature excursion data was unavailable in published form, product manufacturers were surveyed via telephone and/or email. Acceptable storage information for all products for which storage is recommended at temperatures below room temperature (20-25 °C [68-77 °F]) was compiled and arranged in tabular format. Results Of the 705 products or formulations approved by FDA during the predefined time period, 246 were identified as requiring storage at temperatures below room temperature. After review of available prescribing information and manufacturer communications, if applicable, acceptable periods of excursion to temperatures at room temperature or higher were identified for 214 products (87%). Conclusion Information related to acceptable periods of room temperature excursion was compiled for a total of 214 products approved for US distribution since 2000. The included tables may increase patient safety and decrease medication loss or related expenditures.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::72c4400f0d67c49536f88106d127e6b7 https://pubmed.ncbi.nlm.nih.gov/35451022 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
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