Healthcare professionals’ perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda

Abstract

Background: Efficient 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. Methods: A 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. Results: The 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. Conclusion: ACT 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.

Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapies: extent, associated factors, challenges and solutions to reporting

“…The study design and setting have been described elsewhere 6 . Brie y, we conducted a survey from June to July 2018 in purposively selected public and private health facilities in the seven operational regions of NDA.…”

“…A nationally representative sample of public and private health facilities was obtained by taking each NDA region to be a cluster from which we selected a random sample of hospitals, health centres, private for-pro t clinics, private community pharmacies and drug shops. Health facilities were selected from the central (Kampala), eastern (Iganga, Soroti), northern (Arua, Lira) and western (Kabale, Fort Portal) parts of the country [6].…”

“…The private healthcare system is similar to the public healthcare system and includes both for-pro t and not-for-pro t clinics, outpatient health centres, and hospitals. Private community pharmacies and drug shops also exist as standalone entities [6].…”

“…An ACT-failure was de ned as any clinically suspected and/or laboratory con rmed malaria case that did not improve despite having received an ACT, as reported by the HCP [1,6]. Descriptions of ACT-failure were elicited from the interviewed HCPs but will be reported elsewhere.…”

“…There is a widespread belief among healthcare professionals (HCPs) and the public in Uganda that ACTs are losing therapeutic effectiveness [6]. However, recent therapeutic e cacy studies and ACT surveillance reports in SSA show that ACTs are still highly e cacious and are of good pharmacopoeial quality [6,7].…”