Economic impact and severity of adverse drug reactions in patients with mental illness: A prospective observational study

Abstract

INTRODUCTION: Psychotropic medications are the mainstay in the management of psychiatric disorders but they are not devoid of side effects. The occurrence of adverse drug reactions (ADRs) in Indian psychiatry populace varies from 5.9% to 45%. The cost associated with the management of ADRs in general settings ranges from Rs. 412.76 to 1080/- per ADR. MATERIALS AND METHODS: A prospective observational study was conducted for a period of 1 year. The ADRs were assessed for causality by the World Health Organization probability scale and severity by modified Hartwig and Siegel scale. The direct costs in the management of ADRs were calculated. RESULTS: A total of 494 ADRs were reported and evaluated from 300 patients. Of the total reported ADRs, 3.44% (n = 17) lead to hospital admissions and 2.83% (n = 14) prolonged the hospital stay. The gastrointestinal system 25.10% (n = 125) and central and peripheral nervous system 20.64% (n = 102) were the most common system organ class affected by ADRs. The drug classes mainly implicated with ADRs were antipsychotics 53.03% (n = 262) and antidepressants 23.88% (n = 118). Majority (24.29%) of the reactions that lead to cost impact was moderate in severity. Total cost incurred for the management of 131 reported ADRs was Rs. 57,891.33/- with an average cost of Rs. 117.18/- per ADR. CONCLUSION: In 131 cost impact ADRs, 114 patients had a cost impact of Rs. 57,891.33/- A directly proportionate relationship was observed between the severity and cost incurred for the management of ADRs. Hence, it is necessary to identify and prevent these reactions as they cause burden to the patients.