Assessment and analysis of adverse drug reactions in outpatient department of mental hospital of a tertiary care teaching institute of central India

To monitor and analyze the adverse drug reactions (ADRs) in outpatient department of mental hospital of a tertiary care teaching institute of central India. To assess the causality between drug and adverse reaction using WHO-UMC scale.

A total of 209 adverse drug reactions were recorded in ICSR form obtained from CDSCO website in a period of 6 month from December 2016 to May 2017 in outpatient-department of mental hospital. Causality was assessed according to WHO-UMC causality scale.

Among 209 ADRs recorded 2 ADRs were excluded from further analysis because these were belonging to unlikely category of WHO-UMC causality scale. In this analysis 48.32% ADRs were certain, 32.05% ADRs were probable and 18.66% ADRs were possible. In this analysis 57% cases of ADRs were belonging to male while 43% cases were belonging to female. The maximum ADRs were reported in 21–30 years of age group (35.2%) followed by 31–40 years of age group (27%). The antipsychotics were responsible for maximum ADRs (71.02%), antidepressants were causing 12.07% of ADRs, antiepileptic were causing 14.5% of ADRs, ant manic drugs (lithium) were responsible for 2.4% cases of ADRs. CNS is most commonly affected system (44.92%), followed by metabolic side effects (37.68%). Olanzapine was the most common offending drug and weight gain was the commonest adverse drug reaction.