ABSTRACT:
Objective: To identify the adverse drug reactions caused by psychotropic drugs and to evaluate the causality, severity, preventability and management of those Adverse Drug Reactions (ADRs). Methods: A prospective observational study was carried out in hospitalised patients with psychiatric disorders. All the in-patients prescribed with psychotropic drugs were enrolled in the study and followed regularly for the identification of ADRs. Identified ADRs were assessed for causality, severity and preventability using various scales. Approaches towards the management of the ADRs and the patient outcomes were analysed. Results: A total of 200 patients were monitored, of which 79 ADRs were identified from 56 patients. The most commonly reported ADRs were tremor (18.98%) followed by drowsiness (17.72%). Olanzapine was found to be associated with more number of ADRs (29.11%) followed by Clozapine (12.65%). Causality assessment using World Health Organisation- Uppsala Monitoring Centre (WHO-UMC) scale showed that most of the ADRs were probable (62.02%) and possible (37.97%). Severity assessment revealed that 54.42% of ADRs were found to be moderately severe. 48.10% of ADRs were definitely preventable and 44.30% were probably preventable. Assessment on the management of ADRs says that most of them were resolved by specific treatment approach to the reaction. Conclusion: The end results of the study created the evidence on the incidence of ADRs in patients prescribed with psychotropic drugs. The study emphasises on monitoring of those drugs that are considered to have high risk in developing ADRs. Thus, it can influence to a chance of preventing or reducing an unwanted reaction.