Prabha Dwivedi, Obinna Onwujekwe, Elizabeth Louise Allan, David Schellenberg, Harparkash Kaur, Isabel Swamidoss, Siân E. Clarke, Ogochukwu Ibe, Zoe Hall, Michael D. Green, Facundo M. Fernández, María J. Culzoni, Mohamed El Sherbiny, Ibrahim Mamadu, Shunmay Yeung, and Albert W. W. Van Wyk
Background Artemisinin-based combination therapies are recommended by the World Health Organisation (WHO) as first-line treatment for Plasmodium falciparum malaria, yet medication must be of good quality for efficacious treatment. A recent meta-analysis reported 35% (796/ 2,296) of antimalarial drug samples from 21 Sub-Saharan African countries, purchased from outlets predominantly using convenience sampling, failed chemical content analysis. We used three sampling strategies to purchase artemisinin-containing antimalarials (ACAs) in Enugu metropolis, Nigeria, and compared the resulting quality estimates. Methods ACAs were purchased using three sampling approaches - convenience, mystery clients and overt, within a defined area and sampling frame in Enugu metropolis. The active pharmaceutical ingredients were assessed using high-performance liquid chromatography and confirmed by mass spectrometry at three independent laboratories. Results were expressed as percentage of APIs stated on the packaging and used to categorise each sample as acceptable quality, substandard, degraded, or falsified. Results Content analysis of 3024 samples purchased from 421 outlets using convenience (n=200), mystery (n=1,919) and overt (n=905) approaches, showed overall 90.8% ACAs to be of acceptable quality, 6.8% substandard, 1.3% degraded and 1.2% falsified. Convenience sampling yielded a significantly higher prevalence of poor quality ACAs, but was not evident by the mystery and overt sampling strategies both of which yielded results that were comparable between each other. Artesunate (n=135; 4 falsified) and dihydroartemisinin (n=14) monotherapy tablets, not recommended by WHO, were also identified. Conclusion Randomised sampling identified fewer falsified ACAs than previously reported by convenience approaches. Our findings emphasise the need for specific consideration to be given to sampling frame and sampling approach if representative information on drug quality is to be obtained.This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication. Fil: Kaur, Harparkash. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Allan, Elizabeth Louise. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Mamadu, Ibrahim. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Hall, Zoe. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Ibe, Ogochukwu. University of Nigeria; Nigeria Fil: El Sherbiny, Mohamed. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Van Wyk, Albert. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Yeung, Shunmay. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Swamidoss, Isabel. US Centers for Disease Control and Prevention; Estados Unidos Fil: Green, Michael D.. US Centers for Disease Control and Prevention; Estados Unidos Fil: Dwivedi, Prabha. US Centers for Disease Control and Prevention; Estados Unidos Fil: Culzoni, Maria Julia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentina. Universidad Nacional del Litoral. Facultad de Bioquímica y Ciencias Biológicas; Argentina Fil: Calrke, Sian. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Schellenberg, David. London School of Hygiene & Tropical Medicine; Reino Unido Fil: Fernández, Facundo M.. Georgia Institute of Techology; Estados Unidos Fil: Onwujekwe, Obina. University of Nigeria; Nigeria