Heat and medicines' stability

Question

Hello,

Lots of medicines’ preservation mentions (as such as for Creon or Colimycin) recommend to keep these at a temperature not exceeding 25°C.
Now for several days even weeks, in this period of heat, temperature often exceeds 30°C.
Worse, during strolls outside or during car journeys, we sometimes curl 35-40°C.
Do our medicines remain stable in these conditions? Cordially

Answer

Hello,

In case of strong heat, recommendations for medicines’ preservation are available on the French website of the French Agency of Sanitary and Safety Health Products (AFSAPS). You will find these on-line recommendations by copying the following link: http: // www.afssaps.fr/Infos-de-securite/Recomm andations/Bon-usage-des-medicaments-en-case-de-vague-de-chaleur-Mise-au-point / % 28language%29/fre-FR 28language%29/fre-F.

In summary, before any authorization of launch on the market, medicines are subjected to stability assays in standardized and internationally recognized conditions, that give duration and condition of their preservation. The particular conditions of preservation appear on the medicines’ packaging: "medicines to be kept between +2°C and 8°C" or "medicines to be kept at less than 25°C or 30°C.

Certain medicines have no particular preservation mentions. In this case, preservation at room temperature prevails (continental climate temperature). In case of heat exposure, either during a phase of heat wave, or during a transport in conditions where the temperature is uncontrolled, the following recommendations can be made:
• medicines to be kept between 2 and 8 ° C must be transported in conditions which respect the cold chain (cooled isothermal packaging), but without provoking the product freezing;
• medicines to be at less than 25 or in 30°C, as well as medicines to be kept at room temperature, must not be exposed for such a long time to high temperatures such as those frequently raised in cars’ safes or cockpits exposed in the sun. It is, as a safety precaution, recommended to transport them in a not cooled isothermal packaging.

I hope that these advices will be useful for you, sincerely

Harriet Corvol

01.09.2011