Drug, Healthcare and Patient Safety (Jul 2024)
Adverse Drug Reactions Related with Antibiotic Medicines in Malawi: A Retrospective Analysis of Prevalence and Associated Factors
Abstract
Francis Kachidza Chiumia,1 Frider Chimimba,1 Happy Magwaza Nyirongo,1 Elizabeth Lusungu Kampira,2 Adamson Sinjani Muula,3 Felix Khuluza1 1Department of Pharmacy, School of Life Sciences and Allied Health Professions, Kamuzu University of Health Sciences, Blantyre, Malawi; 2Department of Medical Laboratory Sciences, School of Life Sciences and Allied Health Professions, Kamuzu University of Health Sciences, Blantyre, Malawi; 3Department of Community and Environmental Health, School of Global and Public Health, Kamuzu University of Health Sciences, Blantyre, MalawiCorrespondence: Felix Khuluza, Email [email protected]: We aimed to assess the occurrence and characteristics of antibiotic-associated adverse drug reactions (ADRs) in Malawi.Methods: We retrospectively reviewed 304 patient records from medical wards in three hospitals in Southern Malawi. A global trigger tool was applied for the detection of suspected ADRs, and we used the Naranjo scale, the World Health Organization classification and the Schumock and Thornton scale for causality, seriousness and preventability assessment respectively. ADRs were also further characterized according to anatomical systems. Statistical analysis was done in STATA 14.1. The Chi-square test was used to determine the association between categorical variables and logistic regression analysis was used to measure the strength of the association between various independent variables and the occurrence of ADRs.Results: Suspected ADRs were detected in 24% (73/304) of patients, of which 1.4% were definite, 15.1% were probable and 83.6% were possible ADRs. Most of the sADRs were gastrointestinal events (42.5%), followed by: musculoskeletal (26.3%); cardiovascular (16.3%); central nervous system (13.8%; and urinary events (1.3%). About 27% of the sADRs were serious events such as convulsions. The geriatric age group (≥ 65 years) was more likely to experience sADRs as compared to the younger age group, with an adjusted odds ratio (aOR) of 4.53, 95% CI (2.21– 9.28), P 3days was associated with a higher risk of sADRs with aOR of 5.11, 95% CI (2.47– 10.55), p < 0.001 than those who stayed ≤ 3 days in the hospital.Conclusion: We found a higher prevalence of serious sADRs associated with antibiotic medicines than reported elsewhere. This may, among others, contribute to high patient mortality, poor treatment adherence, antibiotic resistance and increased cost of care.Plain Language Summary: What is already known and why we did the study?Most health care workers and patients are less likely to voluntarily report suspected adverse drug reactions in low- and middle-income countries such as Malawi.Studies have revealed a high usage of antibiotic medicines in Malawi, but there is limited data on the associated adverse drug reactions.What did we do?We assessed the occurrence and characteristics of ADRs associated with antibiotics.What are the new findings?We found a higher prevalence (24%) of adverse drug reactions associated with antibiotic therapy than reported elsewhere using the global trigger tool.About 27.4% of the events were serious ADRs such as convulsions, arrhythmia and hypotension.We observed a higher rate of convulsions which could be a potential safety signal.What do the new findings imply?The high prevalence of serious ADRs leads to complicated treatment strategies and contribute to patient mortality, poor treatment adherence and antibiotic resistance.ADR risk factors need to be considered when prescribing and monitoring patients on antibiotic therapy.Keywords: adverse drug reactions, antibiotic medicines, pharmacovigilance, global trigger tool, Malawi
