Abstract

A HOSPITAL BASED PROSPECTIVE STUDY ON CLASSIFICATION, CAUSALITY, PREVENTABILITY, SEVERITY OF ADVERSE DRUG REACTIONS AND BARRIERS TO ADVERSE DRUG REACTION REPORTING

A. R. Shabaraya, Abd Al Rahman Ismail* and Sudhamshu K. Tantry

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Abstract

Adverse drug reactions (ADRs) pose a significant threat to patient safety and healthcare systems worldwide. Understanding ADR patterns and the barriers to reporting is essential for improving patient care. This prospective observational study was aimed to evaluate ADRs, their causality, severity, preventability and management, and barriers faced by healthcare professionals in reporting them, over a period of 6 months in a tertiary care hospital in Dakshina Kannada. Data collection included patient demographics, causative drugs, ADR descriptions, assessments of ADRs, and a questionnaire on reporting barriers. Causality, severity, and preventability of ADRs were assessed using established scales. Among 200 collected ADRs, the majority (50.5%) occurred in the geriatric population and were more prevalent in females (52%). Highest percentage of ADRs were reported from General Medicine department (47.5%). Most ADRs were type A (Augmented) reactions (73%). Antibiotics were the most common causative drugs (35%). Constipation was the most prevalent ADR (24%). The Naranjo and WHO-UMC scales indicated probable causality in most cases (73%). The Modified Schumock and Thornton Criteria categorized a significant portion as probably preventable (62%). Severity assessment revealed a predominance of moderate ADRs (68.5%). Barriers to ADR reporting were identified across 8 domains. While healthcare professionals exhibited strong knowledge (96%) and positive social influences in ADR reporting (100%), challenges included reporting skills deficits (10%), concerns about legal consequences (66%), lack of time (76%), constraints (71%), and heavy workloads (80%). Encouragingly, healthcare professionals displayed high motivation (92%) and a commitment to reporting ADRs, indicating the potential for enhanced medication safety practices.

Keywords: Adverse Drug Reactions (ADRs), Causality Assessment, Severity Assessment, Preventability.