Evaluation of the quality of artemisinin-based antimalarial medicines distributed in ghana and togo.

Dorcas Osei-Safo,Messanvi Gbeassor,Daniel Yeboah Konadu,Jerry Joe Ebow Kingsley Harrison,Amegnona Agbonon,Mamadou Edoh,Ivan Addae-Mensah,Andrew Gordon

doi:10.1155/2014/806416

Abstract

This study, conducted as part of our overall goal of regular pharmacovigilance of antimalarial medicines, reports on the quality of 132 artemisinin-based antimalarial medicines distributed in Ghana and Togo. Three methods were employed in the quality evaluation—basic (colorimetric) tests for establishing the identity of the requisite active pharmaceutical ingredients (APIs), semi-quantitative TLC assay for the identification and estimation of API content, and HPLC assay for a more accurate quantification of API content. From the basic tests, only one sample totally lacked API. The HPLC assay, however, showed that 83.7% of the ACTs and 57.9% of the artemisinin-based monotherapies failed to comply with international pharmacopoeia requirements due to insufficient API content. In most of the ACTs, the artemisinin component was usually the insufficient API. Generally, there was a good correlation between the HPLC and SQ-TLC assays. The overall failure rates for both locally manufactured (77.3%) and imported medicines (77.5%) were comparable. Similarly the unregistered medicines recorded a slightly higher overall failure rate (84.7%) than registered medicines (70.8%). Only two instances of possible cross-border exchange of medicines were observed and there was little difference between the medicine quality of collections from border towns and those from inland parts of both countries.

Highlights

Artemisinin-based combination therapies (ACTs) which are currently the World Health Organization (WHO) recommended first-line treatment for uncomplicated malaria in endemic areas are under serious threat of resistance due to several reasons
The presence of insufficient active pharmaceutical ingredient was identified as the main cause of the poor quality
The study has revealed that the registration status of antimalarial medicines on the Ghanaian market has not improved since the 2011 publication of the WHO QAMSA report on the quality of antimalarials in selected African countries including Ghana

Summary

Introduction

Artemisinin-based combination therapies (ACTs) which are currently the World Health Organization (WHO) recommended first-line treatment for uncomplicated malaria in endemic areas are under serious threat of resistance due to several reasons. The relatively high cost of these antimalarials has made their manufacture a lucrative venture for pharmaceutical industries; a situation that has led to the proliferation of diverse brands on the market. This has led some unscrupulous people to indulge in the manufacture of substandard and falsified brands [1,2,3,4,5,6,7,8,9,10,11,12,13,14]. Ghana and Togo have already adopted artemether/lumefantrine and artesunate/amodiaquine as their first-line treatment for Plasmodium falciparum malaria but according to the World Malaria Report 2013 these countries still present high endemicity with 100 percent of their populations living in high transmission areas [15]. P. falciparum resistance has been confirmed in several parts of South East Asia, where the problem of counterfeit medicines is well-organised [1,2,3, 6, 7]

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Conclusion