E-drug: The use of expired e-drugs (cont)
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Thank you, Naomi Adams, for raising this issue which is a continuous
problem not only in Tanzania. I have three comments:
1. We have to keep the rule: no use of drugs beyond expiry date unless
there is an urgent need and no alternative, as indicated already in Wilbert
Bannenberg's comment.
But most likely we are wasting a lot of valuable drugs due to the present
system of "standardised" expiry dates of generally either 3 or 5 years,
which appears rather arbitrary. There are even examples where the same
active substance in the same dosage form carries a shelf-life of either 3
or 5 years, depending on the manufacturer. Obviously drug formulation and
excipients can play a role. Yet such a big difference does not appear to
have any scientific justification.
The only example of re-testing from my own experience: a sample from a
large donation of Penicillin V was found to comply almost fully with the
required standards about 3 years after expiry and storage under moderately
tropical conditions. The test was done in the laboratory of a German
manufacturer.
2. Tanzania: my own observation in rural Tanzania is that expired drugs
come through donations from outside. But more recently they also originate
from "internal" donations. The national drug supply system, following a
re-organisation effort which started in 1993, is now fairly well stocked
with essential drugs, but the main customers, i.e. the government health
system, does not have enough funds to buy them. The World Bank supported
"Capitalization Program for Government Hospital Pharmacies" project aims at
solving this problem. For various, unforeseeable reasons the start of the
programme is very much delayed. Result: drugs were piling up and in recent
months the national drug supply system donated drugs, a few months before
expiry, to both government and NGO health facilities in quantities which
could not possibly be used before the expiry date (more details available).
3. The long-term solution is indeed the improvement of the drug supply
system to avoid as much as possible expiry of drugs. But the example of
Tanzania shows the range of factors which can play a role. I would very
much support the idea of research into the question of expiry dates, not so
much in the sense of re-testing, but to start with by getting a clearer
idea of the criteria used in determining individual expiry dates. Any
supporters of this idea?
Best regards,
Christel Albert
pharmacist
Heimbacher Str. 12
50937 K�ln, Germany
Tel./Fax: +49/221/417128
e-mail: c.albert@netcologne.de
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