热不稳定的药物。冷链故障操作规程

L. Periáñez Parraga, A. Gómez-Lobón, I. Gamón Runnenberg, R. Seco Melantuche, O. Delgado Sánchez, F. Puigventós Latorre
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引用次数: 5

摘要

目的建立冷链故障处理的标准操作规程。方法选择医院药品指南中包含的耐高温药品。我们对现有文献进行了回顾,将每种药物分类为给定的类别,并为每种药物制定了干预方案。结果共审查了254种药物(162种有效成分)。分类为:A类(25°C稳定≥28天):65种药物;B组(25℃≥7天):47种药物;C(25℃≥48 h): 30药;D(25℃下48 h): 47种药物;E(不稳定>8°C): 12种药物;F(批次依赖)22种药物。31种药物未被分类。干预方案包括建立一个系统来监测有关产品,如果它们超过了每一类产品所规定的时间或温度限制,就将它们丢弃或送回实验室。本研究的目的是在发生冷链故障时更快地进行干预。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Thermolabile Drugs. Operating Procedure in the Event of Cold Chain Failure

Objective

To establish a standard operating procedure in the event of cold chain failure.

Method

We selected thermolabile drugs included in the hospital's pharmaceutical guide. We performed a review of the available literature, classifying each drug into a given category with an intervention protocol for each one.

Results

We reviewed 254 drugs (162 active ingredients). Categories were: A (stable ≥28 days at 25 °C): 65 drugs; B (≥7 days at 25 °C): 47 drugs; C (≥48 h at 25 °C): 30 drugs; D (<48 h at 25 °C): 47 drugs; E (unstable >8 °C): 12 drugs; F (batch-dependent) 22 drugs. Thirty-one drugs were not classified into any category.

The intervention protocol consisted of establishing a system to monitor the products concerned, and discarding or returning them to the laboratory if they were to exceed the time or temperature limit indicated for each category.

Discussion

The aim of this study is to make intervention quicker in the event of cold chain failure.

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