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Drug Quality Bill Brieger | 12 Feb 2009 07:16 am

Can we guarantee malaria drug safety?

Since November 2008, Nigeria has experienced another round of child deaths due to fake and adulterated drugs for children. Four months later after 84 deaths “Nigerian drug regulators have announced they have arrested 12 people in connection with the poisoning of 111 babies with a tainted medicine” according to the BBC.

BBC explained the problem with the commercial teething mixture: “The paracetamol-based syrup, used for treating sore gums, was found to have been contaminated with diethylene glycol, used as an engine coolant. It caused the babies’ kidneys to fail.”

The Blog “Nigeria Health Watch” pointed out back on December 12th that, “We had the “normal” responses from the concerned parties in our beloved country as we have come to expect…. “  In short, there was lack of preventive detection for the tainted mixture, but a lot of vocal indignation by authorities in the press after children started to die.

abasept03-007b.jpgWhile there have not been reports of deaths from malaria drugs, Onwujekwe and colleagues report on a disturbing situation with quality of drugs in southeastern Nigeria. After collecting and testing products from 225 public and private providers (including medicine shops) in six sites, both rural and urban, they found first and foremost that only around 10% stocked the nationally recommended first line malaria treatment, artemisinin-based combination therapy (ACTs).

Fortunately none of the medicines had passed their expiry dates. Chloroquine (CQ) and sulphadoxine-pyrimethamine (SP) were still being stocked and dispensed although the former has been found to have seriously reduced efficacy and the latter is supposed to be reserved for intermittent preventive treatment (IPT) in antenatal clinics. Around 40% of CQ and SP failed quality testing. The monotherapy artemisinin drugs and the ACTs performed better with only one failure.

While these poor quality malaria drugs will not kill children directly as in the case of the adulterated teething mixture, they contribute to child mortality.  If children can’t get the recommended medicines for malaria and those they get have little or no active ingredient, they may still be receiving a death sentence.

National malaria control efforts involving the Global Fund and DfID are recognizing and responding to the need to involve all sectors in providing appropriate malaria medicines to Nigerian children.  While the drugs provided through such programs are likely of high quality, these donors would also help the country by providing technical assistance and capacity in pharmaceutical surveillance and vigilance so that the total malaria drug supply is safe.

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