Assessing the quality and use of antibiotics and associated clinical outcomes in southern Malawi
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Date
2021-12-10
Authors
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Publisher
Kamuzu University of Health Sciences
Abstract
Type of study
This study will be a quantitative cohort study which will use both prospective and
retrospective approaches.
Problem
Inappropriate medication and use of poor-quality antibiotic medicines have the potential to
cause poor outcomes such as occurrence of adverse drug reactions, treatment failure and
antimicrobial resistance. Substandard and falsified medicines is a global problem which
disproportionally affects LMICs such as Malawi but its clinical impact has been poorly
assessed and documented. Moreover, it has been known that high disease incidence is
associated with a high prevalence of substandard and falsified (SF) medicines, suggesting
that the risk of SF antibiotics is high in Malawi as antibiotics are one of the most prescribed
class of medicines in low-middle income countries (LMICs). In addition, the appropriateness
of the use antibiotics and clinical outcomes is still not investigated.
Objectives
The goal or purpose of this study is to assess the quality and use of antibiotic medicines and
the associated clinical outcomes in southern Malawi. The specific objectives are to:
1. To assess the availability of antibiotics in public and private health sectors
2. To determine the prevalence of substandard and falsified antibiotics in public and
private health sectors
3. To assess the storage factors that affect quality of antibiotics
4. To evaluate appropriateness of the use of antibiotics
Methodology
We will focus on a list of 15 selected antibiotics (sample size of 553) that are prescribed to
treat common infections according to the Malawi standard treatment guidelines and the
essential medicine list and recruit a sample size of 398 in-patients who are exposed to these
antibiotics.
Firstly, we will collect data from stock cards on the availability of our selected antibiotics in
government, CHAM and private sector using a form. We will also collect data from clinical
records such as patient files to assess the appropriateness of the use of these antibiotic
medicines according to local and international guidelines. A global trigger tool will be used
to detect any occurrence of adverse drug events or failure of treatment and the patient
outcomes will be assessed for each patient. Medicine quality analysis will be done for the
batches of the antibiotic medicines administered to the study participants. This will involve
inspection of visual defects, labelling and registration status of the medicine, followed up by
dissolution tests and chemical analysis for the presence and quantity of the active ingredients
according to official pharmacopeial specifications. The analytical assays will apply different
techniques such as thin layer chromatography, high performance liquid chromatography and ultra-violet visible spectrophotometry and titration. Furthermore, storage conditions will be longitudinally recorded for these antibiotic conditions to determine the effect of storage on the quality of the antibiotic formulations.
Data will be entered in Microsoft excel and analyzed in SPSS or STATA. We will use
descriptive statistics to describe the baseline characteristics of our variables and apply
analytical statistics to determine associations among quality of antibiotic medicines, factors
that influence the quality of medicines, appropriateness of antibiotic use and the patient
outcomes. These results will be presented in appropriate tables, graphs and charts.
Expected finding and their dissemination
By the end of this study, we expect to describe the prevalence of SF antibiotic medicines and
establish the pattern for the use of antibiotics and characteristics of associated outcomes such
as any adverse drug reactions including failure of treatment. The study will be done in a
period of three years and the results will finally be disseminated to College of Medicine
Research and Ethics Committee (COMREC), local and international stakeholders in the
medical or pharmaceutical field and the academia through conference presentations and
scientific publications in peer reviewed journals.
Description
Keywords
Antibiotic use and associated outcome