Adverse drug reaction monitoring study in hospitalized patients: support for pharmacovigilance at a tertiary care hospital

Abstract

Background: Adverse drug reaction (ADR) reporting is an integral component of pharmacovigilance. However, under-reporting of ADR is commonly observed. The present study has been planned with aim to assess the pattern of reported ADRs in terms of its frequency, causality and severity so as to reinforce pharmacovigilance activities.Methods: This prospective observational study was conducted with the aim to evaluate suspected ADRs in hospitalized patients in departments of Medicine, Surgery and Orthopaedics of a tertiary care hospital in North India for a period of 6 months. The ADRs were assessed in terms of the demographic parameters, organ system affected, drugs implicated, type of ADRs by Rawlin’s and Thompson classification, causality using WHO-UMC scale and severity of ADR by Modified Hartwig’s and Siegel scale.Results: A total of 111 ADRs were reported during the study period. There was male preponderance (54.96%) with majority of ADRs in age group of 18-60 years (79.28%). Gastrointestinal system was most commonly affected (36.36%). The most common drug implicated in causing ADRs was Ceftriaxone (11.71%). Majority of ADRs were Type A reactions (86.49%). Causality assessment using WHO-UMC scale depicted that 74.77% of ADRs were possible. Severity analysis showed that 82.88% of ADRs were mild as per Modified Hartwig’s and Siegel scale.Conclusions: ADR reporting should be encouraged among health-care professionals, para-medical staff and patients in general so that the ultimate goal of pharmacovigilance can be fulfilled.