Adverse drug reactions monitoring of psychotropic drugs: A tertiary care centre study Singh Hemendra1, Yacob Mariya2, Sabu Letty2, K Mamatha2,* 1Assistant Professor, Department of Psychiatry, MS Ramaiah Medical College and Hospitals, Bangalore, Karnataka, India 2Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore, Karnataka, India *Correspondence: Mamatha K, Department of Pharmacy Practice, Faculty of Pharmacy, MS Ramaiah University of Applied Sciences, Bangalore-560054, Karnataka, India. mamathampharm@gmail.com
Online published on 30 June, 2017. Abstract Background Background: Many new psychotropic drugs/agents have been developed and found to be effective in the treatment of psychiatric disorders. However, these drugs also exhibit adverse drug reactions (ADRs) which may affect compliance in psychiatric patients. Hence the present study was aimed at monitoring and assessing ADRs caused by psychotropic drugs. Methods A hospital based prospective observational study was carried out in the psychiatry outpatient department of a tertiary care teaching hospital for the duration of six months. Two hundred and two patients were included in the study and ADRs were documented using a predesigned data collection form. The causality assessment was carried out as per the criteria of both the World Health Organization- Uppsala Monitoring Centre (WHO-UMC) and Naranjo scale. Severity and predictability assessment of ADRs were also performed. Results A total of 106 ADRs were observed during the study period with majority of them occurring in 25–35 years of age group (40.56%). Weight gain (18.86%) followed by sedation (16.03%) and insomnia (11.32%) were found to be the commonest ADRs. Risperidone (19.8%) and escitalopram (12.3%) were the drugs responsible for majority of the ADRs. Causality assessment showed that most of ADRs were possible and probable. 94.33% of ADRs were found to be mild and 89% of them were predictable. Conclusion A wide range of ADRs affecting central nervous and metabolic systems were reported with psychotropic drugs. The study findings necessitate the need for an active pharmacovigilance programme for the safe and effective use of psychotropics. Top Keywords Psychiatric Disorders, Compliance, Causality, Risperidone, Pharmacovigilance. Top |