Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, CO.
Department of Pharmacy, Children's Hospital Colorado, Aurora, CO, USA.
Am J Health Syst Pharm. 2022 Jul 22;79(15):1296-1300. doi: 10.1093/ajhp/zxac118.
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.
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 Products that were subsequently withdrawn from the US market were excluded.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.
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%).
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.
本综述旨在在前人研究的基础上进一步探讨冷藏药物在维持稳定性和效力的前提下能够耐受室温波动的最长时间。
在 2021 年 6 月结束的 12 个月期间，审查了自 2000 年 1 月以来美国食品和药物管理局（FDA）批准用于人类使用的所有药物和生物制品的多个药房药典的说明书和已发表专论。已从美国市场撤出的产品被排除在外。当无法以已发表形式获得温度偏移数据时，通过电话和/或电子邮件对产品制造商进行了调查。编译并以表格形式排列了所有建议在低于室温（20-25°C[68-77°F]）温度下储存的产品的可接受储存信息。
在所定义的时间段内，有 705 种产品或配方获得了 FDA 的批准，其中 246 种被确定需要在低于室温的温度下储存。在审查了可用的说明书和制造商的通信（如适用）后，确定了 214 种产品（87%）在室温或更高温度下可接受的偏移时间。
为自 2000 年以来获得美国分销批准的总共 214 种产品编制了可接受的室温偏移时间段信息。所包括的表格可能会提高患者安全性，减少药物损失或相关支出。
