Adverse drug reaction monitoring in psychiatry out-patient

Adverse drug reactions (ADRs) to psychotropic agents are common and can lead to non compliance or even discontinuation of therapy. There is paucity of such data in the Indian context. We deemed it worthwhile to assess the suspected ADR profile of psychotropic drugs in a tertiary care hospital in Chennai. A longitudinal observational study was conducted in the out-patient department (OPD) of the concerned psychiatry unit. Patients were screened for suspected ADRs irrespective of their psychiatric diagnosis for over a period of 12 months. Adverse event history, medication history and other relevant details were captured in a format adopted in the National Pharmacovigilance programme. Causality was assessed by criteria of Naranjo’s algorithm. We screened 100 patients, of whom 45 were suspected of having at least one ADR, 55 had insufficient evidence about causality and were excluded from further analysis. Of 45 events recorded, 43 were “probable” and 2 were “possible”. None was labeled “certain” as rechallenge was not performed. Eleven different kinds of ADRs were noted. Among the incriminated drugs, antipsychotics represented the majority. This study offers a representative profile of ADRs to be expected in psychiatry out-patients in an Indian public hospital.