Subject Insulin Stability
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WHO recommends that insulin be stored under the same conditions as vaccine,
ie 0DegC to 8 DegC. Certainly the manufacturers advise such, so if it is
not stored under the recommended conditions there will be no manufacturer
liability. Some years ago I carried out a study on the stability of drugs
during international shipment (H.V Hogerzeil, A. Battersby et al WHO/UNICEF
Study on the stability of drugs during international shipment.
WHO/DAP/91.1) This did not include insulin because it is transported by air
but it did find that ergometrine, methylergometrine and Retinol suffered
sufficient damage during shipping that they should also be transported by
air.
As with vaccines the exposure to high temperature produces an accumulative
effect so maintenance of cold chain is essential to ensure viability at the
point of use. The advice of the American Diabetes Assoc presupposes that
the insulin has been stored in perfect conditions up to the moment it is
taken from the refrigerator, this is not likely to be the case in tropical
countries.
WHO has guidelines on the storage and handling of vaccines and these apply
also to the storage and handling of insulin and other heat labile drugs.
The use of cold chain monitor cards which track the accumulating effect of
high temperatures and Freeze Watch indicators which show if the product has
been exposed to dangerously low temperatures are two devices which assist
in maintaining the correct storage conditions for vaccines.
Anthony Battersby
FBA Health Systems Analysts
[The question still remains what happens after the insulin is dispensed if
it is not kept in a fridge? R Laing Co-Moderator]
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