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One-third of antimalarial medicines sampled in 3 African nations found to be substandard
Date:2/9/2010

modium falciparum. Already, Plasmodium falciparum has become resistant to traditional monotherapy drugs such as chloroquine, and more recently to SP products. The sustainability of treatment success depends to a large extent on preventing Plasmodium falciparum's exposure to incomplete doses of these medicines to minimize the possibility of the emergence of drug resistance.

Beyond the overall failure rates, other noteworthy findings across the three countries were that SP products were most likely to fail dissolution tests (35 percent), while ACTs were most likely to fail impurity tests (29 percent). No samples in the full study completely lacked the active ingredient(s). The results also showed that, as a general rule, when a brand passed or failed in one country, it would also pass or fail in other countries. This indicates that the problem of quality is created at the source, rather than during passage through the distribution chain.

Despite some similarities, results by country varied in a number of areas, including at which points of sale the substandard medicines were found. In Madagascar, for instance, poor quality medicines appear to be widespread across regions and not limited to any particular type of distributor. In Uganda, samples fared much better in the public sector than in the country's private sector. Despite overall failure rates, this was one of the bright spots the study revealed; in Uganda's public sector, all ACT and SP samples passed quality tests.

The report is believed to be unique in terms of the large numbers of samples collected as well as the two-step testing approach employed in the study, which included initial screening on site using Global Pharma Health Fund portable Minilabsreg; and full-scale quality control confirmatory testing of roughly 40 percent of the total samples at USP's headquarters in the US.


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Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

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