Quality of Artemisinin Combination Therapies in Sub Saharan Africa and Cambodia, assessed using laboratory analytical techniques

KAUR; ALLAN; HALL; LONG; MALIK; VAN WYK; MAMADU; FADEI; CULZONI ; DWIVEDI; HOSTETLER; SWAMIDOSS; GREEN; FERNANDEZ

Congreso; ASTMH 63rd Annual Meeting; 2014

Artemisinin combination therapies (ACTs) are recommended as first line treatment for malaria by the World Health Organisation (WHO) and officially implemented in 79 of 88 countries. Early reports of ad hoc surveys from SE Asia showed that up to 50% of the artesunate monotherpy sold was falsified. Alarmingly the first case of falsified artesunate (that almost resulted in a fatality) and ACTs were also reported from Africa where the predominant parasite species is the potentially fatal Plasmodium falciparum. Resource poor countries do not have the technical (medicines control laboratories), financial, or human resources required to inspect and police the drug supply. The lack of reliable estimates of poor quality drug prevalence and its causes makes it difficult for national regulatory authorities to determine the need and scale of interventions to assure drug quality. We purchased and carried out qualitative and quantitative content analyses on over 10,500 ACTs from Cambodia, Ghana (Kintampo), Tanzania, Nigeria (Enugu and Ilorin) and Equatorial Guinea (Bioko Island) following varying sample collections methods to provide effective surveillance of ACTs available in a given geographical region. The percentage active pharmaceutical ingredient (% API), determined by laboratory chromatographic analysis, was used to classify the medicines as good quality (85% - 115%), as recommended by the United States Pharmacopeia for the analysis of single tablet samples. Poor quality samples included substandard samples (<85% or >115% of both APIs), degraded samples (improper storage and/or transport) and falsified samples (absence of correct APIs).Most of the samples contained the stated APIs, with the exception of samples from Enugu (1% out of 2865), Ilorin (0.8% out of 1449) and Bioko (7.3% out of 683) which did not contained the stated APIs. Of concern are the monotherapy tablets on sale in countries with falsified ACTs. The results were disseminated to the country-specific ministry of health, as well as the relevant manufacturers and logged on the World Health Organisations Rapid Alert System for the surveillance and monitoring of Substandard/ Spurious/Falsely Labelled/ Falsified Counterfeit, SSFFC, medicinal products.