Monitoring of adverse drug reactions in psychiatry outpatient department of a tertiary care hospital in Central India

Abstract

Background: Adverse drug reactions (ADRs) are prevalent in patients taking psychotropic medications and can occur even at the normal doses used in the management of acute and maintenance phases of psychiatric disorders. Pharmacovigilance have cardinal role in alerting the healthcare providers from the possible ADRs and thus protecting the patients who are using psychotropic medications. To Monitor and estimate the incidence and nature of ADRs in psychiatry OPD of tertiary care hospital in central India and assess the causality, preventability and severity of documented ADRs.Methods: A prospective observational study was conducted in psychiatry out-patient department (OPD). Patients diagnosed with any psychiatric disorder and receiving psychotropic medications was included in the study. The recorded data were filled in the ADR form obtained from pharmacovigilance program of India (PvPI). Causality assessment was done using Naranjo scale and severity was assessed using Hartwig scale and preventability assessment using modified Schumock and Thornton’s scale.Results: The incidence rate of ADR was found to be 15.8%. A total of 61 ADRs were documented. Weight gain 14 (18.1%) followed by nausea 11 (14.2%) was the most commonly reported ADR. Atypical antipsychotics were the most common class of psychotropic drugs implicated in ADRs. Clonazepam 21 (27.2%) followed by amitriptyline 20 (25.9%) were associated with a maximum number of ADRs. Majority of the suspected ADRs were probable in nature (40.9%) followed by possible type (31%).Conclusions: Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and definitely preventable type.