Antibiotic medicine-related problems: pharmaceutical quality, availability, adherence to treatment guidelines and associated adverse drug reactions in Southern Malawi
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Date
2024-11-16
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Kamuzu University of Health Sciences
Abstract
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.