Abstract

ASSESSMENT OF PHARMACOVIGILANCE - INDIVIDUAL CASE SAFETY REPORTS AT TERTIARY CARE HOSPITAL

*Dr. N. Shanthi, S. Muthukumar, Dr. P. Hema, Dr. M. Nandhini Priya, Dr. Kalavathi Prabahar

ABSTRACT

According to WHO an Adverse drug reactions (ADRs) was defined as any Noxious, Unintended effect of drug occurring at normal doses in humans for Prophylaxis, diagnosis and therapy of disease. ADR is one among the leading cause of Mortality and hospitalisation. The objectives of the study are to identify the seriousness of ADRs by analysing the ADR reporting forms to determine the causality assessment Scale. A prospective, observational Multicentre study was carried out in Coimbatore Medical College and Hospital, Coimbatore. Including both In-patients and out patients departments for a period of 17 months. All the data’s were analysed by using Instate Excel sheet. Out of 760 reports, 57% were male and adult patients were more prone to ADR in 50%. Most of the ADRs found in Oncology department with majority of suspected drug was Cisplatin 45%. AMC (Adverse Drug reaction Monitoring Centre) is the centre which reports more ADRs. Hence, the present study indicates that, the Physicians are encouraged in reporting more number of ADRs and educated for rational drug use and Patient safety.

Keywords: Pharmacovigilance, Hospitalisation, Suspected drug, Patient safety. Causality assessment.