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    Antibiotic medicine-related problems: pharmaceutical quality, availability, adherence to treatment guidelines and associated adverse drug reactions in Southern Malawi
    (Kamuzu University of Health Sciences, 2024-11-16) Chiumia, Francis Kachidza
    Globally, there are concerns of increasing incidence of antimicrobial resistance (AMR). However, there is limited literature on antibiotic medicine-related problems that may exacerbate the risk of AMR. The aim of this research was to assess the pharmaceutical quality, availability and use of antibiotic medicines and the associated adverse drug reactions in Southern Malawi. We tested the quality of 293 medicine samples from Zomba, Machinga and Nsanje districts and retrospectively reviewed 304 patient files to evaluate the clinical outcomes. Data on medicine availability was collected from stock cards. The prevalence of substandard medicines among antibiotics was 25.4% and were associated with local manufacturing and plastic primary packaging, p<0.01. Over six months, the antibiotic stock outs were 12.5%, 64.3% and 85.7% for Zomba, Machinga and Nsanje respectively. Adherence to treatment guidelines was lower for antibiotics that were stocked out than those that were not stocked out, p< 0.002. About 75% of prescribed antibiotics were from the watch class. The ADR prevalence was 24% of which 27% were serious events. The ADR occurrence was associated with age, polypharmacy and length of hospital stay, p<0.005. Patients who received antibiotics with optimal content of the active pharmaceutical ingredient (API) had higher rates of both ADR occurrence and patient recovery as compared to the patients who received antibiotics with lower than the required API content. However, the differences were not statistically significant. In summary, the study revealed that high prevalence of SF antibiotic medicines, overuse of watch antibiotics, poor adherence to standard treatment guidelines and occurrence of ADRs are serious problems affecting antibiotic therapy. These problems need to be tackled as part of antimicrobial stewardship and pharmacovigilance strategies in Malawi.