Prevalence of substandard quality artemether-lumefantrine antimalarial agents in Uganda

Abstract Background: Substandard antimalarial agents are a key challenge to effective malaria control and elimination efforts especially in sub-Saharan Africa. The quality of antimalarial agents in most low-and-middle income countries (LMICs) is affected by several factors including inadequate regulation and limited resources. In this study, we assessed the pharmacopeial quality of Artemether-Lumefantrine (AL) in low and high malaria transmission settings in Uganda. Methods: This was a cross-sectional study conducted among randomly selected drug outlets (pharmacies/drug shops). The AL antimalarial agents available in drug outlets were purchased using overt method. The samples were screened for quality using visual inspection, weight uniformity and content assay tests. The assay test was done using Liquid chromatography-mass spectrometry (LC-MS) following International and Unites States Pharmacopoeia (USP) method. The samples were considered substandard if the Active Pharmaceutical Ingredient (API) content was outside 90-110% range of the label claim. Data was analysed using descriptive statistics and presented as means with standard deviations, frequencies, and proportions. Correlation between medicine quality and independent variables was determined using fisher’s exact test of independence at 95% level of significance.Results: A total of 74 AL antimalarial samples were purchased from high (49/74; 66.2%) and low (25/74; 33.8%) malaria transmission settings. The most common batch of AL was LONART, 32.4% (24/74), with 33.8% (25/74) having a ‘Green leaf logo’. Overall, prevalence of substandard quality artemether-lumefantrine was 18.9% (14/74; 95%CI: 11.4-29.7). Substandard quality AL was significantly associated with setting (p=0.002). A total of 10 samples (13.5%) failed artemether content assay while, 4 samples (5.4%, 4/74) had substandard lumefantrine content. One sample from a high malaria transmission setting failed both Artemether and Lumefantrine assay test. Of the samples that failed artemether assay test, majority, 90% had low (<90%) artemether content. Conclusion: Substandard quality AL, the recommended first-line antimalarial agent in treatment of uncomplicated malaria is common especially in high malaria transmission settings. There is need for regular surveillance and monitoring of the quality of artemisinin based antimalarial agents across the country.