I wish to refer to Geoff Stark's message on the issue of expiry date
of pharmaceuticals.
It is certain that the practice of assigning a fixed number of months
of shelf life to pharmaceuticals is based on economical, legal
(liability) and practical considerations rather than on the actual
demonstration that use is dangerous after such number of months. Thus,
it is known and not surprising that certain drugs that have reached
the expiry date written on their box could still be usable with the
same benefit/risk ratio as those that have not reached expiry date.
The practical problem is to find who, how and when can identify them.
Permitting expired drugs to be used just because some of them may still
be usable may open the door to too many inappropriate operations with
no practical advantage at all since it is not easy to see who will take
the burden and the responsibility to revalidate all expiry dates and
relabel the boxes to distinguish them from those not revalidated.
From Geoff Stark's experience one can draw only the following
conclusion: in a place which is fully under your control, if you have
time and resources to undertake testing and revalidating of specific
expired items that are already there, and you have the authority to do
so, you may wish to release the responsibility of the manufacturer,
replace it with yours, and set new expiry dates for the tested items.
Then you should also make clear to those who are going to use them that
these are 'revalidated drugs'.
I believe that many NGOs have been using expired drugs for many years
without documenting adverse consequences (I do not know whether someone
was looking for them). But I do not believe that this should be taken
into account when preparing general guidelines like those on drug
donations.
Valerio Reggi
Operational Drug Registration/DMP
WHO, Geneva
Email: reggiv@who.ch
PS- Don't be mislead by the above affiliation. These are just personal
views, I have had no role in the development of WHO guidelines on drug
donations.
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