Assessing the quality and use of antibiotics and associated clinical outcomes in southern Malawi
| dc.contributor.author | Chiumia, Francis | |
| dc.date.accessioned | 2022-01-21T12:17:42Z | |
| dc.date.available | 2022-01-21T12:17:42Z | |
| dc.date.issued | 2021-12-10 | |
| dc.description.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. | en_US |
| dc.description.sponsorship | European and Developing Countries Clinical Trials Partnership (EDCTP) | en_US |
| dc.identifier.uri | http://rscarchive.kuhes.ac.mw/handle/20.500.12988/873 | |
| dc.publisher | Kamuzu University of Health Sciences | en_US |
| dc.relation.ispartofseries | Ethics Approval;P.10/21/3447 | |
| dc.subject | Antibiotic use and associated outcome | en_US |
| dc.title | Assessing the quality and use of antibiotics and associated clinical outcomes in southern Malawi | en_US |
| dc.type | Plan or blueprint | en_US |