Introduction: There are ample of psychotropic drugs in the market and their enormous use is seen day by day in psychiatric departments and peripheral institutions. The epidemiological data are limited regarding Adverse drug reaction (ADR) reporting due to these medications and its comparison with intensive monitoring studies in terms of causality, seriousness and preventability.

Objectives: To assess the prevalence and different spectrum of adverse drug reactions and to find out the causal relationship, severity and preventability.

Material and Methods: This is a cross sectional, hospital based study carried out in Dept. of Pharmacology in collaboration with Department of Psychiatry  from 1st July 2014 to 30 th June 2016  in patients attending OPD/IPD in  Dept. of Psychiatry in S.C.B. Medical College and  Hospital, Cuttack, Odisha. Causality, Severity and Preventability of ADR due to medications were assessed. To predict the association of ADRs with different variables like age, gender and prescribed no of medications, assessment was done by binomial logistic regression method.

Results: Out of 289 no of patients reported with suspected ADRs, 168 (58.13%) were male and irrespective of gender maximum ADRs were reported in 20-29 yrs of age group. Total no of suspected ADRs reported were 410. Maximum no (33.56%) of patients were receiving three drugs, followed by 29.41% were on four drugs. Maximum were diagnosed as schizophrenia spectrum of disorders (35.29%) followed by Bipolar affective disorder 37(15.74%). Most common ADR observed was extra pyramidal syndrome (EPS) (20.24%). Frequently encountered drug causing ADRs was Olanzapine (22.43%). Among the ADRs 60.55% were of probable type, 61.09% of mild type in severity and regarding preventability, 87.64% were not preventable. There was no predictable significant association of age, gender and no of medications with suspected ADRs.

Conclusion: Our study shows EPS was the commonest ADR detected and Olanzapine was the commonest drug causing ADRs. Majority of ADRs were assessed as probable, severity was mild  and not preventable.

Keywords: Adverse drug reaction, Psychotropic drugs, Prevalence, Extra pyramidal syndrome, Olanzapine, Schizophrenia.

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Dr Priti Das

Associate Professor, Dept of Pharmacology, SCB Medical College, Cuttack, Pin code: 753007, India

Mobile No:+91-720506777, Email: pritidaspatnaik@gmail.com