<LPBBIHBPMJNIMFNDEDNOMEIBCGAA.scott.hillstrom@analyticorp.co.nz>
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E-drug: Re: Wall Street Journal on expired drug (donations)
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The Wall Street Journal article points out that drugs may remain effective
long past the expiration date.
The fact that drugs are effective beyond the expiration date is well know.
Indeed, it is necessarily true. No drug is fully effective on one date and
entirely ineffective the next day. If that were so, we could all agree to
use that date only and always as the expiration date. But it is because
this is *not* true that we debate the significance of expiration dates on
donated drugs. Expiration dates must be set to assure that when a drug
*is*
used it *is* effective. Thus, the drug will necessarily become
*ineffective* at a later date. Evidently, some drug companies choose dates
that give consumers enough time to use the drug but also encourages them to
discard effective drugs and buy more. Why drug companies do what they do
sheds no light on the issues we deal with.
None of this sheds any light on the problem of donated drugs that are past
expiration when administered to a patient. Drugs past expiration may yet
be
effective but they are not *assured* to be effective. And there is no
other
way to know when they actually become ineffective. The fact that
expiration
dates are routinely set earlier than they might have been does not mean
that
any particular drug that is beyond expiration is effective--and that is the
problem. WE need to know that the particular drugs donated are effective
when used.
Only two conclusions seem reasonable from the article.
1. Drugs are effective when used before expiration, and
2. We don't know when they become ineffective after expiration.
Neither of these is news. Knowing what the WSJ has said does not shed any
light on the problem we are dealing with. And it would be dishonest to use
this 'news' in support of relaxation of the Guidelines until a better
method
of determining when drugs become ineffective is established and generally
available.
But perhaps the WSJ article opens the way to new thinking about how to
resolve the ambiguity--that is, when drugs become ineffective--better than
we can do it now. For example, if the US military can recertify drugs
extending expiration, then why can't we do the same? I would be interested
to know what the problems would be in undertaking such an effort.
Scott Hillstrom
President, Cry for the World Foundation
e-mail: scott.hillstrom@analyticorp.co.nz
[I think it is worrying that companies put expiry dates according to when
they want the product to have 'left' the market, not according to what is
actually expected shelflife. I might have mentioned it before that I have
been worried for many years that even WHO and UNICEF (as far as I know)
only demand 3 years shelflife on solid dosage forms to be delivered by
tender. That's one reason we find so many drugs with short remaining
shelflife or expired. The manufacturing companies must be very pleased with
such high turnover! Ideally, of course drugs should have a turnover of less
than 2-3 years, but in real life it is not like that. And the drugs are not
necessarily newly manufactured when they are delivered from the
manufacturer. Also in other countries has the armed forces undertaken
stability studies to extend shelflife, but such studies are normally not
published. However, if we are going to recommend use after stated expiry
date, the manufacturer must guarantee/confirm the extension. Then all
packages will have to be relabelled! It is not enough that a document
follows the consignment - the user will be a health worker in a remote
place. I know from my practice in hospital pharmacy that we sometimes did
that for drugs, most often expensive, which we had to keep for emergencies
or drugs which might be difficult to replace due to e.g. supply problems.
KM, moderator]
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