Abstract
BackgroundTherapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Yet, little has been done to promote the pharmacovigilance (PV) of ACT ineffectiveness in sub-Saharan Africa, particularly in Uganda. This study aimed to determine the extent and associated factors of the past 6 months reporting of suspected or confirmed ACT therapeutic ineffectiveness by healthcare professionals (HCPs), and difficulties and potential solutions to the PV of ACT therapeutic ineffectiveness.MethodsSurvey of 685 HCPs conducted using a self-administered questionnaire from June to July 2018 in a nationally representative sample of public and private health facilities in Uganda. HCPs disclosed if they had spontaneously reported ACT therapeutic ineffectiveness to appropriate authorities in the previous 6 months. Multivariable logistic regression models were used to identify determinants of past 6-months, HCP-reported ACT therapeutic ineffectiveness.ResultsOne in five (20%, 137/685; 95% CI 17–23%) HCPs reported ACT therapeutic ineffectiveness to an appropriate authority in the previous 6 months. HCPs commonly reported ACT therapeutic ineffectiveness to immediate supervisors (72%, 106/147), mostly verbally only (80%, 109/137); none had ever submitted a written report of ACT therapeutic ineffectiveness to Uganda’s National Pharmacovigilance Centre. Common difficulties of reporting ACT therapeutic ineffectiveness were: unavailability of reporting procedures (31%, 129/421), poor follow-up of treated patients (22%, 93/421) and absence of reporting tools (16%, 68/421). Factors associated with reporting ACT therapeutic ineffectiveness in the past 6 months were: hospital-status (vs other; OR = 2.4, 95% CI 1.41–4.21), HCPs aged under 25 years (OR = 2.2, 95% CI 1.29–3.76), suspicion of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.3, 95% CI 1.29–3.92), receipt of patient-complaint(s) of ACT therapeutic ineffectiveness in the past 4 weeks (OR = 2.9, 95% CI 1.62–5.12) and HCPs from northern (vs central; OR = 0.5, 95% CI 0.28–0.93) and western (vs central; OR = 0.4, 95% CI 0.17–0.77) parts of Uganda.ConclusionOne in five HCPs reported ACT therapeutic ineffectiveness, mostly verbally to supervisors. The existing adverse drug reaction (ADR)-reporting infrastructure could be leveraged to promote the PV of ACT therapeutic ineffectiveness.
Highlights
Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs
Recent emergence and spread of ACT resistance coupled with the occurrence of sub-standard and falsified ACT threatens the therapeutic effectiveness of ACT in sub-Saharan Africa (SSA) [2,3,4,5]
Reporting of ACT therapeutic ineffectiveness in the past 6 months One in five (20%, 137/685; 95% CI 17–23%) healthcare professionals (HCPs) had reported ACT therapeutic ineffectiveness to at least one appropriate authority in the previous 6 months (Table 1); a third (34%, 47/137; 95% CI 26–43%) of whom received feedback
Summary
Therapeutic ineffectiveness of artemisinin-based combination therapy (ACT) increases the risk of malaria-related morbidity and mortality, and raises healthcare costs. Recent therapeutic efficacy studies and ACT surveillance reports in SSA show that ACT is still highly efficacious, with laboratory-confirmed treatment failure rates < 2%, and is of good pharmacopoeial quality [6, 7]. Since 94% of the 405,000 global malariarelated deaths in 2018 were from malaria-endemic settings, it is essential to promote the pharmacovigilance (PV) of ACT therapeutic ineffectiveness in these regions. This study defined suspected or confirmed ACT therapeutic ineffectiveness as any clinically suspected and/or laboratory-confirmed malaria case that did not improve despite having received ACT, as reported by the HCP [1, 6]
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