ANALYSIS AND REPORTING OF ADVERSE DRUG REACTIONS AT A TERTIARY CARE TEACHING HOSPITAL IN MEWAT REGION OF NORTHERN INDIA

Introduction: Adverse drug reactions (ADRs) poses an unforeseeable menace associated with all the prescribed medicines. Thus, ADRs are monitored and assessed on a large scale in our country by the Pharmacovigilance Programme of India through adverse drug reaction monitoring centres (AMCs). Objectives: This study was done to assess the pattern of ADRs reported in a tertiary care teaching hospital in Haryana by applying various aspects of ADR monitoring such as clinical presentation, causality, and severity assessment in various Inpatient departments at SHKM GMC. Material and Methods: A Prospective, Observational study was conducted in all the inpatient clinical departments of SHKM Govt. Medical College, Haryana for a duration of 12 months. ADRs were recorded in pre-designed proforma along with ADR reporting form “Version 1.3”. Processing & analysis of data was done using SPSS version 20. Results: A total of 189 ADRs among 120 patients were reported during the study period. Females were affected more than males. Maximum ADRs were reported in the age group of 19-60 years. ENT department had maximum number of ADRs. Antibacterials implicated for major number of ADRs. GI tract was the most affected organ system. Of the total ADRs, 50.9% were probable. Regarding the severity, 3% ADRs were severe, while 60% were mild. On applying preventability scale, 90% of ADRs were not preventable. Conclusion: By keeping a careful and timely watch majority of ADRs can be prevented by early intervention. This will be a step towards improving patient safety.