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Abstract

Background: Neonatal sepsis remains a critical health Challenge in developing countries, contributing heavily to infant illness and death. Effective management on the judicious use of medications, particularly antibiotics, and strict adherence to antimicrobial stewardship principles are critical for improving outcomes. This study investigates how medications are utilized, identifies adverse drug reactions (ADRs), and evaluates clinical results in neonates diagnosed with sepsis at a tertiary care hospital in Coimbatore, Tamil Nadu.
Methods: Study was prospective and observational review of patients record in the hospital.400 neonates admitted to the NICU. Cases were categorized into early-onset (EOS) and late-onset sepsis (LOS). Prescribing trends were reviewed using WHO indicators, and ADRs were assessed using the WHO-UMC causality scale and the Naranjo algorithm.
Results: Males comprised 53.75% of the study group, with an 85.25% survival rate. EOS was prevalent among preterm and home-born neonates. A total of 1,428 drugs were prescribed, averaging 3.57 medications per neonate. Antibiotics were administered in 60.3–100% of cases, most commonly ampicillin, gentamicin, and cefotaxime. Injectable drugs accounted for 86.97% of prescriptions. Between 71.2–73.33% of drugs were from the Essential Medicines List, and 78–91% were prescribed generically. ADRs were recorded in 2.5% of cases, most categorized as "possible." The most frequently isolated microorganism was Staphylococcus aureus.
Conclusion: Initial antibiotic prescribing was generally appropriate, though the findings point to the necessity for more consistent prescribing practices, better ADR documentation, and stricter adherence to essential medicine guidelines