Abstract

BackgroundEfficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. Healthcare professionals interact with both ACT and malaria patients they treat and hence could observe, first-hand, suspect poor quality artemisinin-based combinations linked to poor malaria treatment outcomes and the factors associated with inappropriate use or treatment failure.MethodsA cross-sectional study of 685 HCP perspectives about the efficacy of ACT between June and July 2018 at selected health facilities in Uganda. Medicine samples were obtained from the seven regions of Uganda and tested for quality using the Germany Pharma Health Fund™ minilabs.ResultsThe average age of the 685 respondents was 30 (SD = 7.4) years. There was an almost equal distribution between male and female respondents (51:49), respectively. Seventy percent (n = 480) were diploma holders and the nurses contributed to half (49%, n = 334) of the study population. Sixty-one percent of the HCPs reported having ever encountered ACT failures while treating uncomplicated malaria. Nineteen percent of HCPs thought that dihydroartemisinin/piperaquine gave the most satisfactory patient treatment outcomes, while 80% HCPs thought that artemether/lumefantrine gave the least satisfactory patient treatment outcomes, possibly due to dosing schedule and pill burden. Healthcare professionals from the Central region (OR = 3.0, CI 0.3–1.0; P = 0.0001), Eastern region (OR = 5.4, CI 2.9–9.8; P = 0.0001) and Northern region (OR = 5.3, CI 2.9–9.9; P = 0.0001) had a higher chance of encountering ACT failure in 4 weeks prior to the survey as compared to those from the western region. Healthcare professionals from private health facilities also had higher chances of encountering ACT failures in past 4 weeks as compared to those from public health facilities (OR = 2.7, CI 1.7–3.9; P = 0.0001). All 192 samples passed the quality screening tests. The random sample of 10% of all samples randomly obtained by the laboratory staff also passed the chemical content analysis and dissolution tests.ConclusionACT medicines are widely available over-the-counter to the public and it is very difficult to report and monitor a decrease in efficacy or treatment failure. The perspectives of HCPs on treatment failure or lack of efficacy may potentially guide optimization efforts of sampling methodologies for the quality survey of ACT medicines.

Highlights

  • Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria

  • Demographic and professional characteristics of healthcare professionals A total of 685 HCPs from the seven regions participated in the study with an average age of 30 (SD = 7.4) years

  • A bioequivalence analysis of these four brands with the highest perceived treatment failure rates is highly recommended to verify this view

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Summary

Introduction

Efficient testing to identify poor quality artemisinin-based combination therapy (ACT) is important to optimize efforts to control and eliminate malaria. The proliferation of substandard and falsified artemisinin-based combinations (SF ACT medicines) is of global concern and has disproportionately affected highly malaria-endemic Southeast Asian and sub-Sahara African (SSA) countries [1,2,3,4]. Studies have warned of a possible global spread of artemisinin-resistant parasites to SSA [7]. The emergence of artemisinin-resistant strains of Plasmodium falciparum in SSA is of increasing concern [8] and likely results from decades of sub-therapeutic monotherapy and substandard artemisinin-derivative consumption [9]. Medicine quality is one of the many threats to appropriate and effective malaria case management and is critical in SSA countries using ACT as first-line therapy for malaria

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