E-DRUG: The use of expired e-drugs (cont)
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SUBTITLE: DOCUMENTING EXTENDED STABILITY?
THE INDUSTRY IS AGAINST IT
Stocking of drugs for long periods will have to conflict with the
standard expiry dates. Short expiry dates have an obvious
commercial advantage from the manufacturer's point of view by
increasing wastage and increasing turnover. It also gives a
competitive edge to newly manufactured products directly from the
manufacturer (and sold at list price) compared to products that
have been in stock for a while and which may be purchased at a
lower or minimal price, for example because the text on the
packages have been changed. So there will be consensus for going
for the more expensive products with a longer official shelf
life. This means that the really low-priced drugs are likely to
go to waste because of the expiry date.
RESEARCH PROJECT
In my opinion it would be a wise and profitable project to enter
into systematic research on stability of different forms of
essential drugs under ideal and less ideal conditions. In this I
fully agree with Christel Albert. It should have been done a long
time ago. I think the relevant NGOs should launch an initiative
in that direction. There is little reason to expect help from the
WHO, with the present atmosphere of constructive and cozy
collaboration with the industry. ("100 million people may
eventually benefit" - when the need is 4000 million).
I do not think there is a need to establish a fully equipped
laboratory. One could purchase (or "borrow") analysis of drugs
stored under different conditions in labs with spare capacity.
This would probably not be easy to do officially: The industry is
likely to be opposed to it, and I guess few dedicated drug
quality control labs will risk their reputation or good standing
with the industry for doing this anti-commercial service to the
Essential Drugs Community. Some governmental labs might do it
officially, but I'm not sure. I am surprised and impressed that
Christel Albert managed to make a German manufacturer's
laboratory do it, but I suppose and fear that the results are
inofficial and untraceable from an official point of view. I
suppose there are also some toxicology labs that could do it if
challenged, even though they are equipped for measuring the drugs
in low concentrations. Labs that analyse drugs seized by the
police may also be a possibility if they are asked the right
questions. Anyone out there with friends in a lab that does drug
analyses by IR or chromatography? How about establishing this
function as part of the laboratory training of pharmacy students?
Perhaps the E-drug community should establish a group to develop
a simple unofficial pharmacopeia with SIMPLE methods to test for
content of active substance and breakdown products?
IT HAS BEEN DONE BEFORE
But it has already been done for some drugs. The E-drug community
could try to make a quite unlikely and politically entirely
incorrect ally: The military system. I find it highly likely that
the military systems of the affluent world still keep drugs in
long-term storage because the emergency drugs must be ready at
all times. The turnover is likely to be low. I take it almost for
granted that such stability studies have already been done,
particularly with essential drugs. I have heard rumours from
quite well informed sources that some products had been shown to
be stable for 30 years, and not only potassium iodide.
So how about asking the US Ministry of Defense? Or the German?
Not to mention the British and the French, which have extensive
experience in colonial warfare? In this particular matter an
entirely bad tradition could perhaps be turned into something
good?
PS. Some time ago I launched the idea of putting on the Web the
basic information about some off-patent essential drugs. I did
some and put it on my Web page, but was unable to carry it very
far because of time and other constraints. Anybody willing to
help?
Gaut Gadeholt, MD, PhD
Clinical pharmacologist
Dept of Clinical Chemistry, Rikshospitalet (The National
Hospital),
N-0027 Oslo, Norway
Tel +47 22 86 70 80 (direct), +47 22 86 70 10 (switchboard), +47
22 86 70 29 (fax)
E-mail gaut(dot)gadeholt(at)labmed(dot)uio(dot)no, private
gaut(at)online(dot)no
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