Assessment of prevalence and quality of artemisinin based antimalarials sold in the Kumasi Metropolis

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Date
2011
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Abstract
The study was undertaken to assess the prevalence and quality of artemisinin based antimalarials sold in the Kumasi Metropolis of Ghana. The prevalence of antimalarials was assessed through a survey of 40 pharmacies (P) and 60 licenced chemical seller’s shops (LCSS). One hundred (100) questionnaires consisting of 24 open ended and close ended questions were answered by respondents in P and LCSS in the Kumasi Metropolis through face-to-face interviews. The quality of various types of artemisinin based antimalarials, namely artesunate-amodiaquine tablets, artesunate (monotherapy) tablets, artemether-lumefantrine tablets and artemether injection purchased from various P and LCSS in the Kumasi Metropolis was evaluated. The uniformity of mass, disintegration time, hardness and percentage content of the tablets were determined using established methods. The authenticity of artesunate (monotherapy and combipack) was determined by colorimetric and thin layer chromatographic (TLC) methods while ultraviolet spectroscopy (UV) was employed in determining the percentage content of artesunate and amodiaquine tablets. The authenticity of artemether-lumefantrine tablets was determined by colorimetry while the content of artemether (including the injection) and lumefantrine was assessed by UV spectroscopy and non-aqueous titration, respectively. Eighteen of the pharmacies surveyed were accredited by the NHIS as service providers while none of the LCSS was accredited. The Artemisinin based combination therapy (ACT) drugs were widely available in the Kumasi Metropolis with all the facilities visited (100 %) having in stock artemether-lumefantrine tablets while 93 % had artesunate-amodiaquine tablets. The bestselling ACTs were artemether-lumefantrine (24 % P; 36 % LCSS) and artesunate-amodiaquine (4 % P; 6 % LCSS). ACTs were generally more expensive than other antimalarials with artemether-lumefantrine being the most expensive ACT. Most pharmacists had knowledge of the WHO antimalarial policy while shop attendants and assistants had little or no knowledge of the policy. The cost of treatment of malaria ranged from GH¢5-GH¢7. Most of the respondents (94 %) had never suspected that antimalarials purchased for sale in their facilities could be counterfeit. Apart from artesunate tablet AT2 which failed the uniformity of mass test, all the artesunate and amodiaquine tablets passed both the uniformity of mass and disintegration tests. Artesunate tablets AT3 and AT4 and amodiaquine tablets AM4 and AM6 failed the tablet hardness test while the rest passed the test. Colorimetric and TLC tests on the artesunate tablets showed all the samples contained artesunate. The artesunate and amodiaquine tablets were either overdose or underdose and therefore substandard. All artemether-lumefantrine tablets passed the uniformity of mass, disintegration and tablet hardness tests. Colorimetric tests showed the presence of artemether and lumefantrine in all the artemether-lumefantrine tablets and artemether in the artemether injection. Artemether-lumefantrine tablet AL2 passed the content uniformity test whilst 5 others failed the test (overdose or underdose). Artemether injection was underdose and hence of substandard quality.Whilst none of the samples analysed was counterfeit, all the antimalarial brands (except artemether-lumefantrine tablet AL2) did not contain the stipulated amount of the active pharmaceutical ingredient(s) and were therefore of substandard quality. There is therefore the need for a continuous evaluation of the quality of artemisinin based antimalarials on the Ghanaian market to safeguard the health of the population.
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A Thesis submitted to the Department of Pharmaceutics,Kwame Nkrumah University of Science and Technology, in partial fulfillment of the requirements for the degree of Master of Philosophy (Pharmaceutics)
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