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Drug Quality Bill Brieger | 11 Feb 2010 10:20 am

A Closer Look at Malaria Drug Quality

Yesterday we presented some of the findings from the malaria drug studies conducted by US Pharmacopeia (USP) in Madagascar, Uganda and Senegal.  We conjectured that the problem may be less in the public sector since it is often guided by WHO drug pre-qualification approvals – especially if the drugs are purchased through major donor programs like Global Fund, World Bank or PMI. At times the US Food and Drug Administration may be involved.

proportion-of-substandard-malaria-drugs-by-sector.jpgAfter reviewing the whole report from USP our faith in the public sector is somewhat shaken.  While the chart at the right shows that the informal and private sectors have the greatest proportion of substandard malaria drugs, the public sector is not without problems – 23% of SP products tested 14% of ACTs in the public sector were not up to standard.

An interesting finding is that the problem of substandard drugs rests in inadequate amounts of active ingredients or the presence of impurities in the product – not specifically the issue of counterfeit/fake medications.

Problems in the public sector may arise in the procurement processes. In some cases there are central procurement agencies in the national health ministry. In some countries states/provinces and local governments/districts can do their own tendering and procurement. This opens the door to a variety of medications entering the public sector, not just the few recommended prequalified products.

As mentioned in yesterday’s post, it is often necessary to back to the manufacturer to correct problems.  The USP report had the following observations about common brands that may find their way into public procurement processes:

The results were similar for the ACT products, that is, samples of most of the brands either all passed or all failed the QC test requirements, with only a few exceptions. One example is the Larimal brand, sampled from both Uganda and Senegal. All six Larimal samples tested failed the QC test requirements. Coartem and Duo-Cotecxin brands, on the other hand, were found in all three countries, and all samples of these brands passed the testing requirements. Also, all samples of the Lonart brand sampled from Uganda passed the QC test requirements.

This type of information should inform both donors and national malaria control programs. We look forward to reports from the seven other countries in the study.

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