Monitoring adverse drug reaction of psychopharmacological agents: a pharmacovigilance study in tertiary care centre

Abstract

Objective: The main purpose of this study was to adverse drug reaction monitoring of psychopharmacological agents. Materials and method: The study was cross sectional and was carried out in Departments of Psychiatry in Chhatrapati Shivaji Subharti Hospital and Pharmacology Department, Subharti Medical College, Meerut the duration of this study was approx 6 months (24 weeks). Institutional ethics committee approval was obtained before the start of the study. Results: A total of 110 patients enrolled in the study, and it occurs 148 adverse events. Among which the male patients were 65 (59%). and female were 45(31%). The most common age group whereas 44.5% were from a higher age group. 40 % patients were in the age group from 36 years up to 55 years. In this study most common adverse effect is found in metabolic syndrome such as these were weight gain 15.45%, change in blood glucose 18.18% and change in cholesterol 9.09%. Antipsychotics were given to 35. % patients, antidepressants to 24.5 %, sedatives and hypnotics were given to 20.9 %, anti epileptic to 10.9%, anti maniac drugs to 5.5% and other drugs 3.0% patients. More patients suffering of 25.45% from anti depressant. This study severity of adverse effects. 70(63.6%) had mild adverse effects where as 40(36.4%) had moderate adverse effects and none had severe adverse effects.38% were definitely preventable, 35% were probably preventable, and 27% were not preventable as per clinical evaluations and application of scale Conclusion: the study results strongly suggests the need for professional healthcare team to focus on assessing and reporting suspect adverse effect to increase the quality of monitoring and managing ADRs. Pharmacovigilance improvement the recognition of ADRs and helps the medical health care professional to have safe practice.

Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders

“…Patients with mental illnesses need long-term treatment with psychotropic drugs which can predispose them to a variety of ADRs (Kumar & Khosla et al, 2018). According to World Health Organization, adverse drug reaction is defined as "any response to a drug which is noxious and unintended and which occurs at a dose normally used in man for prophylaxis, diagnosis or treatment of the diseases for the modification of the physiological function".…”