Antimalarial Drug Quality in the Most Severely Malarious Parts of Africa – A Six Country Study

Abstract

A range of antimalarial drugs were procured from private pharmacies in urban and peri-urban areas in the major cities of six African countries, situated in the part of that continent and the world that is most highly endemic for malaria. Semi-quantitative thin-layer chromatography (TLC) and dissolution testing were used to measure active pharmaceutical ingredient content against internationally acceptable standards. 35% of all samples tested failed either or both tests, and were substandard. Further, 33% of treatments collected were artemisinin monotherapies, most of which (78%) were manufactured in disobservance of an appeal by the World Health Organisation (WHO) to withdraw these clinically inappropriate medicines from the market. The high persistence of substandard drugs and clinically inappropriate artemisinin monotherapies in the private sector risks patient safety and, through drug resistance, places the future of malaria treatment at risk globally.

Artemether–Lumefantrine Concentrations in Tablets and Powders from Ghana Measured by a New High-Performance Liquid Chromatography Method

“…[15][16][17] A study of artesunate content in tablets sampled from pharmacies in Kumasi, Ghana, in 2008, showed varied contents ranging from 47.9% to 99.9% with only 17.6% passing for content of active ingredients by the European Pharmacopoeia standards. 18 In this study, 20 of 24 (83.3%) samples from the market passed the assay for content; they contained the active ingredients indicated by the manufacturers and in the requisite amounts as indicated by the USP.…”

Indian Generics Producers, Access to Essential Medicines and Local Production in Africa: An Argument with Reference to Tanzania

“…Some Indian companies initially failed to satisfy the inspectors, and some have improved and now have products registered. Problems do persist, as Bate et al (2008) found for example for anti-malarial drugs in private urban and peri-urban retail markets in six African countries including Tanzania. There is active public scrutiny of the issue: newspapers continue to report sales of fake drugs.…”

Health – Seeking Behaviour of Rural Dwellers for the Treatment of Presumptive Malaria in North-Western Nigeria

“…This statistical fi nding is also supported by the large proportion of respondents (55.2%) that mentioned lack of money as the main reason for not treating their last episodes of malaria at the rural health facility ( Table 2). Patronage of private drug vendor shops for treatment of malaria poses a great obstacle to malaria control in the country because the private vendor shops are potential sources of substandard and fake antimalarial drugs which have resulted in several treatment failures (Obinna et al 2009;World Health Organisation 2003;Bate et al 2008). Moreover, the drug vendors know little or nothing about the correct dosage of the drugs.…”