Abstract

BackgroundChange of first-line treatment of uncomplicated malaria to artemisinin-combination therapy (ACT) is widespread in Africa. To expand knowledge of safety profiles of ACT, pharmacovigilance activities are included in the implementation process of therapy changes. Ghana implemented first-line therapy of artesunate-amodiaquine in 2005. Drug utilization data is an important component of determining drug safety, and this paper describes how anti-malarials were prescribed within a prospective pharmacovigilance study in Ghana following anti-malarial treatment policy change.MethodsPatients with diagnosis of uncomplicated malaria were recruited from pharmacies of health facilities throughout Accra in a cohort-event monitoring study. The main drug utilization outcomes were the relation of patient age, gender, type of facility attended, mode of diagnosis and concomitant treatments to the anti-malarial regimen prescribed. Logistic regression was used to predict prescription of nationally recommended first-line therapy and concomitant prescription of antibiotics.ResultsThe cohort comprised 2,831 patients. Curative regimens containing an artemisinin derivative were given to 90.8% (n = 2,574) of patients, although 33% (n = 936) of patients received an artemisinin-based monotherapy. Predictors of first-line therapy were laboratory-confirmed diagnosis, age >5 years, and attending a government facility. Analgesics and antibiotics were the most commonly prescribed concomitant medications, with a median of two co-prescriptions per patient (range 1–9). Patients above 12 years were significantly less likely to have antibiotics co-prescribed than patients under five years; those prescribed non-artemisinin monotherapies were more likely to receive antibiotics. A dihydroartemisinin-amodiaquine combination was the most used therapy for children under five years of age (29.0%, n = 177).ConclusionThis study shows that though first-line therapy recommendations may change, clinical practice may still be affected by factors other than the decision or ability to diagnose malaria. Age, diagnostic confirmation and suspected concurrent conditions lead to benefit:risk assessments for individual patients by clinicians as to which anti-malarial treatment to prescribe. This has implications for adherence to policy changes aiming to implement effective use of ACT. These results should inform education of health professionals and rational drug use policies to reduce poly-pharmacy, and also suggest a potential positive impact of increased access to testing for malaria both within health facilities and in homes.

Highlights

  • Change of first-line treatment of uncomplicated malaria to artemisinin-combination therapy (ACT) is widespread in Africa

  • Kwa-Zulu Natal was the first health ministry to switch to an ACT in 2001 [3], and ACT have been adopted in 28 African countries, with an additional 13 in the process of implementation [4]

  • The objective of this paper is to describe the mode of diagnosis and pattern of drug management in outpatients diagnosed with suspected uncomplicated malaria in health facilities in Accra, Ghana who were recruited into a prospective pharmacovigilance study

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Summary

Introduction

Change of first-line treatment of uncomplicated malaria to artemisinin-combination therapy (ACT) is widespread in Africa. Artemisinin combination therapy (ACT) is becoming first-line treatment for uncomplicated Plasmodium falciparum malaria episodes throughout Africa. Reports of adverse events with ART-AQ received by the National Centre for Pharmacovigilance at the University of Ghana Medical School (UGMS) and increasing negative media coverage on the safety of ART-AQ led to withdrawal of specified brands of ART-AQ in December 2005 [6] This was accompanied by a fall in the number of reports though there had been 131 reports of adverse events (AEs) to ART-AQ to the UGMS by October 2007 [7]

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