Original Articles: 2013 Vol: 5 Issue: 8
Adverse drug reactions in psychiatry outpatients: Clinical spectrum, causality and avoidability
Abstract
The present study was done to study the clinical spectrum of Adverse Drug Reactions (ADRs) and determine their causality and avoidability in patients attending Psychiatry Out patient Department. A prospective observational study over a period of one year (from June 15, 2011 to June 15, 2012) was carried out in the Department of Psychiatry, Victoria hospital. ADRs in patients attending Psychiatry OPD were recorded, irrespective of the diagnosis, using Central Drugs Standard Control Organization (CDSCO) suspected adverse drug reaction reporting form and causality assessed using WHO-UPC causality assessment criteria. ADRs with certain, probable or possible causal relation was considered for analysis. Avoidability was assessed using Granada schema for determining whether drug related harm can be avoided. Data was analyzed using descriptive statistics. A total of 329 patients were screened for ADRs, out of which 67 ADRs were reported. Of 67 events recorded, 61(91.04%) were probable and 6(8.96%) were possible. 21 different types of ADRs were noted, most common being tremors (19.40%), extrapyramidal symptoms (14.93%), insomnia (10.45%) and weight gain (7.46%). Majority of ADRs were noted for antipsychotics (38.88%) followed by antidepressants (35.82%) and antiepileptics (13.42%) with olanzapine (16.41%), chlorpromazine (10.45%) and amitriptyline (8.96%) causing most ADRs. Rare events like clozapine induced delirium, olanzapine induced oculogyric crisis and risperidone induced perioral tremor were noted in our study. A wide spectrum of ADRs including some less frequently reported events were noted in this study. Results are comparable to similar studies conducted in India and abroad.