Evaluation of the Quality of Artemisinin-Based Combination Therapy Products Procured Under the National Malaria Elimination Programme in Rivers State

The National Malaria Elimination Programme procures and distributes artemisinin-based combination therapies to healthcare facilities across Nigeria, with product quality being fundamental to treatment efficacy and the prevention of artemisinin resistance. Rivers State, with its high malaria burden and extensive network of programme-supported facilities, provides an important context for evaluating ACT procurement quality. This study assessed the quality of artemether-lumefantrine and artesunate-amodiaquine products distributed through the NMEP supply chain in Rivers State. Forty product batches were systematically collected from state and LGA stores, health centres, and community health extension worker depots. Quality evaluation encompassed authentication of NAFDAC registration, appearance assessment, quantitative API determination by HPLC, and dissolution testing per USP compendial methods. Cold storage compliance documentation was reviewed for all batches. HPLC analysis showed that 12% of batches contained less than 90% of the declared artemether content, and 8% contained less than 90% declared lumefantrine. Artesunate-amodiaquine batches had lower failure rates at 7.5%. Two batches from one supplier could not be authenticated against NAFDAC records. Temperature excursion documentation was incomplete for 35% of batches. These findings indicate a measurable proportion of substandard ACTs entering the Rivers State NMEP supply chain, with recommendations for enhanced incoming quality testing at all levels of the distribution system. Keywords: artemisinin combination therapy, drug quality, NMEP, Rivers State, HPLC.