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One-Third of Antimalarial Medicines Sampled in Three African Nations Found to Be Substandard in Large-Scale USP-WHO Study
Date:2/8/2010

ntries in the hope that local regulatory bodies will focus their attention on products, brands and geographical locations where substandard medicines were found to pose the biggest threats," said Patrick Lukulay, Ph.D., Director of the PQM Program at USP. "The results show some significant differences in terms of where the problems lie. These findings can be used immediately by officials to target their efforts -- an especially useful approach when resources are scarce, as they are in these countries."

The main purpose of the study was to update and expand the knowledge base about the prevalence of substandard antimalarials in Sub-Saharan Africa, which are believed to contribute to antimicrobial resistance of Plasmodium 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 app
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SOURCE U.S. Pharmacopeial Convention
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