E-DRUG: donated drugs (3)
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While I understand and have always propounded a single standard for drug
quality in developed and developing countries, Dr Perlmutter's problem is a
real one, which cannot be dismissed lightly. As someone who was responsible
for pharmaceutical development in industry, I know that many drugs are still
quite useable after the expiration date. That is because Medicines Agencies
will give a maximum of 5 years dating on medicines, since variations in
storage conditions cannot be guaranteed. Thus the expiration date is not a
fixed and immutable determinant of the value of a medicine. The problem is
that unless thorough retesting of the outdated medicine is performed, one
cannot know if it is still usable. Most developing countries have enough of
a problem just obtaining enough medicines without adding the burden of
retesting, which is expensive and time-consuming. In developed countries,
which have the time and money to retest, it is not done because it is
considered that there may be changes that cannot be picked up by QC testing
after five years and it is not worth the effort.
When there is a choice between using a one year outdated antibiotic that has
been reasonably stored to save a life rather than discarding it and letting
the patient die, I think the ethical decision is obvious. The problem that
Dr Perlmutter raises, however, is not solved by this last comment.
Jerome Reinstein PhD
Co-facilitator
Medicines Labelling Group
JeromeReinstein@compuserve.com
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