E-DRUG: Global storage conditions for medicines (9)
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The question of storage instructions is a question of money, it is a question of harmonisation, and it is a question of communication.
When global manufacturers send packages labelled with storage instructions for climate zone II to the markets in climate zones IVa and IVb, it's because they don't find it necessary to use money on relevant packaging and on relevant stability studies. And the buyers and regulatory institutions in the countries in these climate zones don't have the money to pay for necessary quality.
The International Conference on Harmonization, ICH, and the World Health Organisation, WHO have discussed this question for several years, with the ASEAN countries giving their view. But the best they have come up with for climate zone IVb (hot and very humid climate) is accelerated (not long or intermediate term) testing at 40oCelcius at 75% relative humidity.
The recommended storage instruction for medicines filling the requirements for climate zone IVb is 'Do not store above 30oC'
Pharmacists are customed to get exact information and figures, and the evil of evidence is kind of reinforcing this.
Most of the label elements on the packages are accurate and not interpretable. But now we see that the storage instructions are meant to be interpreted. The public is not aware of that, and not even the pharmacists of the world. The necessary knowledge for interpretation is not widespread. And the manufacturers deny to take economic liability for medicines that has been outside the storage instruction temperature.
Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
www.lyftingsmo.no
"Stein Lyftingsmo" <stein@lyftingsmo.no>