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. 2014 May 1;38(3):169-92.
doi: 10.7399/fh.2014.38.3.1164.

[Thermolabile drugs stability faced with an accidental interruption in the cold chain]

[Article in Spanish]
I Ricote-Lobera  1 , B Ortiz-Martín  2 , S Fraile-Gil  3 , B Santos-Mena  3 , F J Hidalgo-Correas  4 , B García-Díaz  5
Affiliations
Free article

[Thermolabile drugs stability faced with an accidental interruption in the cold chain]

[Article in Spanish]
I Ricote-Lobera et al. Farm Hosp. .
Free article

Abstract
in English, Spanish

Objective: To develop an updated guide about the stability of thermolabile drugs included in the Pharmacotherapeutic Guide that,according to product information sheet, should be stored under refrigeration or freezing, when are accidentally exposed to temperatures outside the range recommended by the manufacturer.

Methods: It was reviewed the information about storage temperatures recommended in the product information sheet and the available stability data at different temperatures of thermolabile drugs included in the Pharmacotherapeutic Guide of a 400-bed hospital that, according to the manufacturer, should be stored under refrigeration or freezing. Drugs of clinical trials were excluded. Stability data were obtained from the product information sheet, the last two guides published in Spain about thermolabile drugs and through consultations to laboratories(via phone or e-mail).

Results: It was created a table with the storage temperatures recommended in the product information sheet and currently available stability data at different temperatures of 209 presentations of several drugs. Stability data were requested to laboratories in 172 cases.

Conclusions: The stability guide is a tool that facilitates decisions of pharmacists when they are faced with an accidental interruption of the cold chain, when it is necessary to know whether the drug can be used and it is not possible to contact the laboratory.

Objetivo: Elaborar una guía actualizada sobre la estabilidad delos medicamentos termolábiles incluidos en la Guía Farmacoterapéuticaque, según ficha técnica, deben conservarse bajorefrigeración o congelación, expuestos accidentalmente a temperaturasde conservación fuera del rango recomendado por elfabricante.Métodos: Se revisó la información sobre las temperaturas deconservación recomendadas en ficha técnica y los datos deestabilidad disponibles a distintas temperaturas de los medicamentostermolábiles incluidos en la Guía Farmacoterapéuticade un hospital de 400 camas que, según el fabricante, debenconservarse bajo refrigeración o congelación. Se excluyeron losmedicamentos incluidos en ensayos clínicos. Los datos de estabilidadse obtuvieron a partir de la ficha técnica, la informacióncontenida en las dos últimas guías de conservación de medicamentostermolábiles publicadas en España y a través de las consultasrealizadas a los laboratorios (vía telefónica o por e-mail).Resultados: Se confeccionó una tabla con las temperaturas deconservación recomendadas en ficha técnica y los datos deestabilidad disponibles actualmente a distintas temperaturas de209 presentaciones de distintas especialidades farmacéuticas.Se solicitaron datos de estabilidad actualizados de 172 de ellasa los laboratorios.Conclusiones: La guía elaborada constituye una herramientaque facilita la toma de decisiones del farmacéutico ante unarotura accidental de la cadena de frío, cuando sea necesarioconocer si el fármaco puede ser utilizado y no sea posible contactarcon el laboratorio fabricante.

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