E-drug: Re: Wall Street Journal on expired drug (cont'd)
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Dear Colleagues,
In some guise or other the debate on expired medicines comes round at
fairly regular intervals. Perhaps we should look back and create a
synopsis of all the comments (not volunteering!) which could be available
every time the debate comes up.
What I'm not hearing in the debate is the nature of the expiry date, and
the fact that it is not a guarantee of fitness for use. No-one can predict
the future and neither can we today predict that a medicine will be fit for
use five years (say) hence. What we can, and indeed, do is to run a series
of tests and experiments which we have validated to give us a 'confidence'
that the medicine will be fit for use within the time we specify - assuming
that appropriate, stated storage conditions, etc have been met.
If some time later, and maybe after the current expiry date has been
exceeded, we examine the medicine to see if it is still patent, find out
that it is, and then pronounce an extended life to that medicine, we are
failing in our duty of care to the patient.
Remember we can either test the product or we can use the product, we
cannot do both to the individual vial or ampoule we are going to give to
the patient. Therefore we can never know for certain that the particular
vial or ampoule we are about to use is fit for use. Yes, there are colour
changes, looking for cracks, etc, etc, but the certainty can never be
there. Again, what we have is a 'confidence' that the medicine is fit for
use. We can even define that confidence with limits, but it is not a
certainty.
The point here is that the lack of certainty means that the processes by
which we arrive at expiry dates or the decisions to extend them had better
be good, accurate and meaningful. So that within the lifespan (original or
extended) of the product, based on sound, validated testing procedures, the
users can have the confidence that the product is fit for use. Anything
short of that is unacceptable.
Tim Dodd
Training Advisor
Ghana National Drugs Programme
Email: Cath_and_Tim_Dodd@compuserve.com
PS I note with dismay a slight personal nature to some contributions.
Lets' keep the personal stuff out and stick to debating the issues.
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