Prevalence of Adverse Drug Reactions among Pediatric Patients on Antiretroviral Therapy in Selected Hospitals in Eastern Ethiopia: 8-Year Retrospective Cross-Sectional Study

Abstract

Background: Antiretroviral-related adverse drug reactions (ADRs) are one of the leading causes of drug changes, poor adherence, and treatment failure. Therefore, this study was designed to assess the magnitude of ADR and associated factors among pediatric patients on antiretroviral therapy (ART). Methods: A retrospective cross-sectional study was conducted by reviewing the medical records of pediatric patients on ART at Hiwot Fana Specialized University Hospital and Jugal Hospital ART clinics. The collected data were coded, entered, and analyzed using SPSS, IBM version 16. The associations of selected categorical variables were done using binary logistic and multivariate logistic regression. Results: Of 186 medical records of pediatric patients on ART, 153 (82.25%) were reviewed. From the total medical records assessed, ADRs were observed in 23 (15.03%) of pediatric patients on ART, of which the most commonly encountered ADRs were anemia (34.8%) and followed by rash (17.4%). Most of ADRs were ranked as grade 3 (39.13%) and followed by grade 2 (30.4%) based on the degree of their severity. The likelihood of developing ADR was significantly associated with the regimen AZT/3TC/NVP (adjusted odds ratio: 6.420; 95% confidence interval: 1.056-39.018) relative to pediatric patients on D4T/3TC/NVP regimen. Conclusion: This study indicated that few pediatric patients on ART experienced ADRs. Most of the observed ADRs were ranked as grade 2 and 3 in terms of their severity. Drug out of stock and ADRs were the 2 most common reasons for antiretroviral (ARV) drug regimen change that could affect patient’s treatment outcome and limited future option.