Abstract
Good-quality antimalarials are crucial for the effective treatment and control of malaria. A total of 7,740 individual and packaged tablets, ampoules, and syrups were obtained from 60 randomly selected public (N = 35) and private outlets (N = 25) in Afghanistan. Of these, 134 samples were screened using the Global Pharma Health Fund (GPHF) MiniLab® in Kabul with 33/126 (26%) samples failing the MiniLab® disintegration test. The quality of a subsample (N = 37) of cholorquine, quinine, and sulfadoxine/pyrimethamine tablets was assessed by in vitro dissolution testing following U.S. Pharmacopeia (USP) monographs at a bioanalytical laboratory in London, United Kingdom. Overall, 12/32 (32%) samples of sulfadoxine/pyrimethamine and quinine were found not to comply with the USP tolerance limits. Substandard antimalarials were available in Afghanistan demonstrating that continuous monitoring of drug quality is warranted. However, in Afghanistan as in many low-income countries, capacity to determine and monitor drug quality using methods such as dissolution testing needs to be established to empower national authorities to take appropriate action in setting up legislation and regulation.
Highlights
Poor-quality drugs† in malaria-endemic countries are a threat to effective disease control and there has been an increase in reports of their detection in developing countries.[1,2]Drug quality reports are lacking for 63 (60.3%) of 104 malariaendemic countries including Afghanistan
A total of six private sector outlets in three provinces were found to stock halofantrine whereas amodiaquine was obtained in four private sector outlets in Nangahar and Ghanzi provinces, even though neither of these drugs is listed in the national guidelines
None of the antimalarials analyzed in this study contained low active pharmaceutical ingredient (API)
Summary
Poor-quality drugs† in malaria-endemic countries are a threat to effective disease control and there has been an increase in reports of their detection in developing countries.[1,2]Drug quality reports are lacking for 63 (60.3%) of 104 malariaendemic countries including Afghanistan. Poor-quality drugs† in malaria-endemic countries are a threat to effective disease control and there has been an increase in reports of their detection in developing countries.[1,2]. The population of Afghanistan was 29,790,000, in 2011, with an estimated 60% at risk of malaria.[6,7] Malaria is endemic throughout Afghanistan, at altitudes below 2,000 m, especially in the populous rice-growing regions in the eastern and north-eastern part of the country.[8] According to World Health Organization (WHO) estimates, there were 1,934 (per 100,000) cases of malaria in Afghanistan in 2011.9 Plasmodium vivax infection is predominant, accounting for 80–90% of malaria cases annually with the remainder caused by P. falciparum species.[10] Chloroquine remains the most effective antimalarial drug treatment of P. vivax and artemisinin combination therapy (ACT) is recommended for treating uncomplicated P. falciparum and mixed infections.[11]
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