[e-drug] Expired-shelf life medicines (cont)

E-drug: Expired-shelf life medicines (cont)
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Dear Colleagues,

The issue of expired medicines (ie medicines for which the stated
expiry date is past) comes up on a kind of regular cycle on this
network. The point in question is actually very simple. The date
that is stated is the date beyond which we do not have sufficient
confidence of the medicines continued quality. This date is based on
available data from appropriate testing.

Of course medicines do not suddenly change the day after the expiry
date and some will have activity and safety profile similar to the
'in-date' product for some time after the stated expiry date. The
problem is that we do not have sufficient confidence of this because
we do not have the right range of data from the right testing
process, and we do not extrapolate the previous data because we know
that is not valid. So we test the medicine and what does that tell
us. It tells us about the actual tablets (or injection, or other
product) that we test. It does not tell us about the other tablets
in the pack. It also does not tell us about the state of the
medicines tomorrow, or the day after, or the week after, month
after.... In other words we not longer have the confidence to say
that the product is fit for use at a particular time or date.

Now there will, of course, be situations where the choice is between
out of date product and no product. This is the time when the
professional
judgement must be made about whether to use the product and it takes
into account many different factors as well as the state of the
product itself. The important point however is that such a judgement
can only be made on an individual basis, it cannot be made as a
blanket decision remote from the situation, and it can only be made
by the professionals close to the patient in question, who then carry
the responsibility for that judgement.

The conclusion then has to be:
Do not use the medicine you do not have confidence in.
Don't try to instill a false confidence by doing the wrong testing.
Most of all do not expect others to use medicine you don't have a known
confidence in.

regards to all
Tim Dodd
Training Advisor
Ghana National Drug Programme
Email: Cath_and_Tim_Dodd@compuserve.com
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