E-DRUG: Global storage conditions for medicines
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'Must not be stored above 25oC'
This storage instruction has begun to appear on tablet packages from many manufacturers, some of them large generic companies. An adverse effect of this instruction is that some patients in Norway put their tablets in the fridge in the summer heat. Fridges have high humidity, are often crowded and dirty and full of fungus, and are definitely within sight and reach of children.
The big problem is not that the storage instruction is misinterpreted. The problem is that neither WHO nor medicine authorities do require or recommend manufacturers to make medicines that can be stored at higher temperatures. Medicine storage regulations are not in harmony with the living conditions of people in warm countries.
ICH test conditions are 24oC/60%RH until claimed shelf life, and 40oC/75%RH for typically 6 months. Manufacturers will not test at high temperatures or long periods if there is no money in it, or if they are not forced to.
We need medicines that can be stored at 35 or 40oC for a long shelf life without damage.
A lot of today's medicines can probably stand that challenge, but the evidence for that is not there yet.
The World Health Organisation, WHO, the International Committee of Harmonisation, ICH, the International Pharmaceutical Federation, FIP, and regulatory authorities in all countries - unite and solve this problem!
Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
www.lyftingsmo.no
"Stein Lyftingsmo" <stein@lyftingsmo.no>