A cross sectional study to analyse the ADR reported in a hospital during the past three years

Abstract

Introduction: Cross sectional study is a type of observational study that analyzes data from apopulation, or a representative subset, at a specific point in time-that is, cross sectional data. The causality appraisal is assessment of the probability that the detected adverse event is produced by a specific medication. The most commonly used causality assessment scales are Naranjo Probability Scale and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scales. The study is to analyze the adverse drug reaction reported in a hospital for the past three years. Aim: A cross sectional study to analyze the ADR reported in a hospital during the past three years. Methodology: A cross sectional observational study was conducted at Nirmala medical centre, Muvattupuzha. ADR reported in the past three years in this hospital were analyzed. Drug leading to ADR, department .gender, observed reaction, severity, Naranjo probability scale and WHO UMC causality assessment were done. Classification of drugs according to their drug class, classification of ADR according to the system, based on severity, sex, Naranjo score, WHO UMC criteria were done. The datas were analysed and represented into graphs. Result: A total of 342 ADR reports were analyzed in this study. The key findings of this study include: Skin-related ADRs were the most frequently reported, affecting 27.83% of cases. The majority of reported ADRs were of moderate severity (56.7%).Naranjo probability scale and WHO-UMC causality assessment indicated that most cases were in the probable category, with 63% and 76%, respectively. The general medicine department had the highest number of reported ADRs. Males accounted for the majority of reported ADRs (57.18%).Cardiovascular agents and antibiotics were the drug classes most commonly associated with reported ADRs, at 25.6% and 22.28%, respectively. Among cardiovascular agents, diuretics were found to be the primary culprits, causing 38.66% of reported ADRs. Conclusion: This study highlights the importance of monitoring, assessing, and documenting ADRs in healthcare facilities, as it provides valuable insights into the prevalence, severity, and causality of adverse drug reactions. This information can contribute to improving patient safety and the rational use of medications in clinical practice.