Assessment of Adverse Drug Reactions to Antibiotics: A Hospital Survey

Pharmacovigilance has evolved significantly with advancements in data analytics, enhancing drug safety evaluation and the monitoring of adverse drug reactions (ADRs). Historically, ADR reporting was minimal, but legal requirements now mandate this practice in many regions. Pharmacovigilance plays a crucial role in medical interventions, focusing on patient safety by assessing the risk-benefit profile of medicines. The World Health Organization (WHO) defines it as activities related to detecting, assessing, and preventing adverse drug effects. The first formal pharmacovigilance organization was established in 1938 following fatalities due to sulfanilamide elixir. In 1968, WHO launched the Programme for International Drug Monitoring to centralize global ADR data. Continuous monitoring is essential to maximize drug benefits while minimizing risks. In India, pharmaceutical companies are investing in research and development, necessitating robust pharmacovigilance standards. Antibiotics, critical in treating bacterial infections, face challenges due to rising antimicrobial resistance (AMR), complicating treatment of common diseases. Misuse of antibiotics exacerbates this issue, making infections harder to treat. Antibiotics like amoxicillin, ciprofloxacin, and azithromycin are commonly used but associated with significant ADRs, especially in children. Understanding the causality and severity of these reactions is vital for safer pediatric use. This review emphasizes the importance of pharmacovigilance in mitigating risks associated with antibiotic therapy, ensuring drugs are used effectively while minimizing potential adverse effects. The integration of pharmacovigilance in drug development and clinical practice is crucial for optimizing patient safety and therapeutic outcomes.