Friday, February 12, 2010

Substandard Medicines

"A high percentage of medicines circulating on national markets", in ten Sub-Saharan African countries, "are of substandard quality and thus may contribute to the growth of drug-resistant strains of Plasmodium falciparum, the most virulent form of malaria." First results of the "large-scale study of key antimalarial medicines" were released for Madagascar, Senegal, and Uganda by the Promoting the Quality of Medicines (PQM) Program, a USAID-funded program.

"Within Madagascar, Senegal and Uganda, the study" focused "on artemisinin-based combination therapy (ACT) products, currently the WHO's recommended form of first-line treatment for uncomplicated malaria, and sulfadoxine-pyrimethamine (SP) products, often used for preventative treatment of malaria during pregnancy." Researchers collected samples from "public and regulated private sectors" and from "informal markets, as many patients obtain their medicines from these sources."

"Substandard and counterfeit versions of antimalarial medicines are highly problematic throughout Africa, Asia and Latin America because of the direct threat they pose to the lives of individual patients as well as their contribution to the development of drug-resistant strains of these diseases." The "study found that approximately 44 percent of sampled medicines from Senegal, 30 percent of samples from Madagascar, and 26 percent of samples from Uganda that underwent full quality control laboratory testing failed such testing and were thus substandard."

"Substandard" medicines are classified as "those that do not meet the quality specifications set for them, primarily because they do not contain the correct amount of the active ingredient(s), do not dissolve properly in the body or include unacceptable levels of potentially harmful impurities." According to the released results, "[n]o 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."

Substandard medicines were not limited to informal markets, and their point of sale varied by country. "In Madagascar, for instance, poor quality medicines appear to be widespread across regions and not limited to any particular type of distributor [public, private, or informal]. 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 purpose of this study was reveal "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" treatments "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."

US Pharmacopeia (2010, February 10). One-third of antimalarial medicines sampled in three African nations found to be substandard.

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