A Prospective Study on Adverse Drug Reaction- Monitoring, Reporting, Patient Counselling on Safe Medication Practice in A Tertiary Care Hospital

Background: Adverse Drug Reactions (ADRs) remain a critical challenge in clinical therapeutics, significantly impacting global morbidity, mortality, and healthcare costs. In the Indian context, the Pharmacovigilance Programme of India (PvPI) serves as the primary regulatory framework for identifying and mitigating these risks.  Objective: This study aimed to evaluate the incidence, clinical patterns, and severity of suspected ADRs, perform rigorous causality assessments, and implement a structured pharmaceutical counseling framework to enhance medication safety in a tertiary care setting.  Methodology: A prospective, non-interventional observational study was conducted across the Inpatient Departments (IPD) of Orthopedics and General Surgery at Arunai Medical College and Hospital (October 2025–February 2026). Out of 728 screened patient records, suspected ADRs were documented using the CDSCO reporting tool. Causality was validated via the WHO-UMC scale and Naranjo’s Probability Scale, while severity was stratified using the Modified Hartwig and Siegel Scale.  Results: A total of 80 ADRs were identified, representing an incidence rate of 10.98%. Demographic analysis revealed a male predominance (63.75%) and a higher susceptibility within the geriatric and middle-aged cohorts (mean age: 53.6 \pm 21.1 years). Antimicrobials (23.75%) and Analgesics (15%) were identified as the primary pharmacotherapeutic triggers. The most frequent clinical manifestations were gastrointestinal (39.2%), with constipation being the predominant symptom. Severity assessment categorized 56.25% of reactions as "Mild" and 43.75% as "Moderate." Causality analysis classified the majority of cases (66.25%) as "Probable."  Conclusion: The study underscores a notable ADR burden in surgical and orthopedic settings, frequently exacerbated by polypharmacy. These findings advocate for an integrated pharmacovigilance approach—led by clinical pharmacists— emphasizing active surveillance and patient education to pre-emptively manage medication-related risks and optimize therapeutic outcomes.