Substandard Antiviral Medicine Distributed Throughout Sub-Saharan
08 February 2010
by Anai Rhoads
AnaiRhoads.org -- A large-scale study of key anti-malarial medicines in ten Sub-Saharan African countries reveals that the majority of these medicines are of substandard quality.
It is now feared that this may lead to a large number of growth of drug-resistant strains of Plasmodium falciparum, the most virulent form of malaria.
The report was released Monday by the Promoting the Quality of Medicines (PQM) Program, a USAID-funded programme implemented by the U.S. Pharmacopeial Convention (USP).
Madagascar, Senegal and Uganda were among the countries were surveyed for the study. The results are part of the larger Quality of Antimalarials in Sub-Saharan Africa (QAMSA) study, a ten-country collaborative study conducted by the World Health Organization (WHO) and PQM.
Basic tests were performed on 491 of the most common antimalarials. Of these, 197 samples were sent in for full-scale quality control testing. The main focal point was on artemisinin-based combination therapy (ACT) products, which is currently the WHO's recommended first-line treatment for uncomplicated malaria and sulfadoxine-pyrimethamine (SP) products. These are often used for preventative treatment of malaria during pregnancy.
The QAMSA study found that approximately 44 percent of sampled medicines from Senegal, 30 percent of samples from Madagascar, and 26 percent of samples from Uganda, which underwent full quality control laboratory testing - failed to make the grade.
"The results of the study paint a very unfortunate picture of the situation in Sub-Saharan Africa," said Anthony Boni, the Agreement Officer's Technical Representative for the PQM Program, USAID Office of Health, Infectious Diseases, and Nutrition.
"With almost half of medicines in Senegal and more than one out of four medicines in Madagascar and Uganda failing quality testing, clearly much work needs to be done to provide patients with medicines that meet the level of quality they require - and deserve. These countries are committed to protecting the health of their citizens, but the authorities face many challenges in regulating their markets. We look forward to working together with them to reduce the morbidity and mortality caused by malaria, by improving the quality of the medicines used to treat this disease."
Plasmodium falciparum has become resistant to traditional mono-therapy drugs such as chloroquine, and more recently to SP products.
"Although alarming, this study offers extremely valuable information that has already been shared with those countries 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."
Other findings across the three countries revealed that SP products had a probability dissolution failure rate by 35 percent. Meanwhile, ACTs were most likely to fail impurity tests by 29 percent.
In Madagascar, 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.
Fortunately despite overall failure rates, in Uganda's public sector, all ACT and SP samples passed quality tests.
The problem may stem from counterfeit versions of antimalarial medicines, which are said to be problematic throughout Africa, Asia and Latin America.
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