Adverse drug reaction monitoring of antidepressants in the psychiatry out patient department at a tertiary care teaching hospital in India: A cross-sectional observational study

Abstract

Background: Antidepressant drugs, though of great benefit in a range of psychiatric disorders, are associated with a wide range of potential adverse effects. There is growing concern among the healthcare personnel to assess these adverse drug reactions (ADRs) of newer psychotropic drugs, which have an impact on long-term compliance and achieving successful treatment. The present study was thus designed to monitor and analyze the pattern of occurrence of ADRs to antidepressant medications in Outpatient Department (OPD) of a tertiary-care hospital. Materials and Methods: A cross-sectional observational clinical study was carried out in the OPD of Psychiatry in Medical College, Kolkata. A total of 190 patients who received antidepressants were studied. 5-8 consecutive previously diagnosed depression patients attending follow-up per day, were screened for suspected ADRs, 2 days (one male OPD and one female OPD) in a week, over 6 months (October 2013 to March 2014). Adverse event history, medication history and other relevant details were captured in a format as adopted in the Pharmacovigilance Programme of India (PvPI). Causality of ADR was assessed by Naranjo's ADR probability scale. The severity of each reported ADR was assessed using Hartwig and Siegel Scale. All the statistical analysis was done by using SPSS-version 20 (SPSS Inc). Results: A total of 190 patients were screened for the study of which males and females represented 43.68% and 56.31% of the cases respectively. The age-group presenting with maximum depressive problems was found to be 30-39 years. A total of 481 ADRs were noted of which dry mouth was the commonest, closely followed by nausea and tremor. Out of 130 ADRs assessed for causality, 89.23% of the ADR cases, were found to be 'probable', while 10.77% were found to be 'possible'. According to Hartwig and Siegel's Scale 83.99% of the cases were found to be mild, 14.97% moderate and 1.04% severe. Conclusion: The study enables to obtain information on the incidence and pattern of adverse drug reactions associated with antidepressants in the local population thereby reducing its occurrence and protecting the user population from avoidable harm.