ABSTRACT
Background:Pharmacovigilance in psychiatry units can play vital role in detecting adverse drug reactions (ADRs) and alerting physician to such events, thereby protecting the user population from avoidable harm. Objective: To assess the suspected ADRs profile of psychotropic drugs in psychiatry OPD of a tertiary care hospital and its comparison with available literature data as well as to create awareness among the consultant psychiatrists to these ADRs profile. Materials and Methods: A prospective study was conducted in the psychiatry OPD. Thirty five consecutive patients per day were screened irrespective of their psychiatric diagnosis for suspected ADRs on 3 fixed days in a week from January 2011 to December 2011. CDSCO form was used to record the ADRs. Causality was assessed by WHO causality assessment scale while severity was assessed using Hartwig and Siegel scale. Results: Out of 4410 patients were screened, 383 patients were suspected of having at least one ADR. Thus, 8.68 % of our study population reported ADRs. Of 407 events recorded, 369(90.60%) were “probable” and rest “possible” according to WHO-UMC causality assessment scale. According to Hartwig and Siegel scale, 268 ADRs (65.85%) were “moderate” category. Twenty one different kinds of ADRs were noted. Conclusion: This study enables to obtain information on the incidence and frequency of ADRs in the local population that allows opportunity for education to the physicians to improve the patient’s quality of life.