Evaluation of the Adverse Drug Reactions reported to the Adverse Drug Reaction Monitoring Centre in a Tertiary Care Hospital, Ongole, Prakasam District

Abstract

According to the World Health Organization (WHO), an Adverse Drug Reaction (ADR) is defined as a “noxious and unintended response to a drug that occurs at doses normally used in humans for diagnosis, prophylaxis, treatment, or modification of physiological functions1.” Periodic monitoring of ADRs in hospital settings is crucial to identifying risks associated with drug use and ensuring patient safety and efficacy. Aims of current study were to evaluate and analyze ADRs reported to the AMC, GMC, Ongole, to determine the severity of ADRs using the Modified Hartwig–Siegel Scale, and assessment of the causality of ADRs using the WHO-UMC scale. ADRs reported to the AMC, Government Medical Collage (GMC), Ongole between December 2022 and August 2024 were assessed. Parameters included patient demographics, suspected drugs, organ systems involved, and categorization of ADRs based on causality and severity. The WHO-UMC scale was used for causality assessment, and the Modified Hartwig–Siegel scale for severity classification. A total of 337 ADR cases were analyzed. The most affected group was adult males (n=174). Dermatological reactions were the most frequently reported. Antimicrobials, particularly amoxicillin, were the leading drug class involved. Based on causality assessment, 256 (75%) cases were classified as ‘possible’. Most ADRs (88%) were mild in severity. Antimicrobials were the leading cause of ADRs, emphasizing the need for strict antibiotic stewardship and rational prescribing practices. There is a need for increased awareness and training in pharmacovigilance.