[e-drug] Oseltamivir expiry date (2)

e-drug
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E-DRUG: Oseltamivir expiry date (2)
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Dear colleagues,

From the comments of Professor Harvey, there seems to be a discrepancy as per the expiry date of the same formulation depending in which setting and/or country this drug is available.

Is the term expiry date inappropriate to use? This is because most of these dates have been predicted from initial accelerated stability studies and may not actually mean the product will degrade after the date on the label. In the past I had analyzed some commercially available artemether tablets which were about 8yrs past the expiry and still found up to 94% of the active (unpublished). It should be noted that these tablets were stored in normal ambient conditions.

Should we therefore be adopting the term re-test date instead of expiry date or shelf-life which might (sometimes) be misleading? In this way, the drugs could still be qualified during the re-test and if found within acceptance criteria used again.

Kind regards,

Magnus A. Atemnkeng, PhD
Montreal, Canada
magnusajong@yahoo.com

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E-DRUG: Oseltamivir expiry date (3)
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Hi all

Previous postings have raised the issue of the expiry date
determination for oseltamivir - the EMEA has issued a statement in this
regard; not all links are provided, but the Q&A is included). Another
issue raised has been the restriction to use in children aged 1 year and
older - the MHRA has also ruled on that issue. Both are examples of how
regulatory and public health authorities are having to deal with
uncertainty n the face of a major potential threat.

I've appended two stories from the UK Guardian - copied as "fair use" - that underline how the authorities are dealing with that uncertainty. One of the greatest sources of uncertainty is the timing of this outbreak - the Northern Hemisphere may escape this wave, but the Southern Hemisphere is entering winter, when the chances for human-to-human spread may be increased.

regards

Andy