E-DRUG: The quality and stability of essential drugs
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Excerpt from a paper in this week's BMJ. Full article can be accessed
via the internet from the BMJ website: http://www.bmj.com
BMJ 1998;317:512-513 ( 22 August )
The quality and stability of essential drugs in rural Zimbabwe:
controlled longitudinal study
Hanif Nazerali, pharmacist, Hans V Hogerzeil, medical officer.
In 1988 an alarming WHO report of substandard ergometrine injection
in three developing countries led to field studies on the stability
of essential drugs during international transport to the tropics and
to specific stability studies on oxytocic drugs. We performed a
controlled longitudinal study to measure the quality of essential
drugs within rural Zimbabwe and to determine whether any failure was
due to poor initial quality or to instability of the drugs during
inland distribution and storage.
Comment
Serious instability occurred only with ergometrine injection. This
result is in line with two earlier longitudinal studies during
transport to and within tropical countries, in which only ergometrine
injection, methylergometrine injection, and retinol capsules showed
a loss of active ingredient; 12 other essential drugs were stable.
As all three studies focused on essential drugs suspected of being
unstable we conclude that, even under the most adverse tropical
conditions, clinically relevant instability of essential drugs is
rare. Poor initial quality (as with ampicillin, retinol, and
ergometrine in our study) poses a much more serious problem as it
could, in principle, occur with any drug.
The practical implication of this conclusion is that careful selection
of suppliers and quality control at the entry point of the distribution
chain are essential to ensure drug quality. Even in tropical climates
subsequent quality checks at the district level are not necessary.
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