Adverse Drug Reaction Monitoring in a Tertiary Care Psychiatry Setting: A Comparative Study between Inpatients and Outpatients.

ABSTRACT

BACKGROUND: Psychotropic medications are the mainstay of treatment in psychiatric disorders and are associated with ADRs which affect the compliance and treatment course. Previous studies have looked at the frequency, profile of ADRs and their management aspects. However, the systematic comparison between IP and OP was lacking even though there is a prescription pattern difference. Hence this study was aimed to compare the proportion, pattern, severity and resolution of ADRs once detected. METHODS: This is a hospital based, prospective follow up study done in the psychiatry ward and outpatient setting for a period of 6 months. A total of 491 patients (200 IP, 291 OP) who received psychotropics were monitored in the study. UKU side effect rating scale was used to detect ADRs, WHO - UMC scale for causality, Modified Hartwig and Siegel Scale to assess severity of ADR and CDSCO suspected ADR form for reporting it. RESULTS: Out of 491 patients who were recruited for the study, 83 patients developed ADRs (34 IP, 49 OP, P = 0.963). The mean number of ADRs per patient was found to be higher in IP (IP-2.17±1.14, OP-1.65±1.12, P-0.01). Severe ADRs were observed to be higher IP (IP-67.64%, OP-38.7%, P-0.014) which was statistically significant. There is no statistically significant difference in distribution of ADRs across all age groups (P-0.475). CONCLUSION: The study results emphasises the need for active pharmacovigilance so that ADRs are detected and managed at the earliest, hence reducing the morbidity and improving compliance. There is also need for systematic long term, multicentric study to further examine and correlatethe observations of our study.