ASSESSMENT OF ADVERSE DRUG REACTION IN INPATIENT WARD AT A TERTIARY CARE HOSPITAL- A PROSPECTIVE OBSERVATIONAL STUDY

The main aim of the study is to evaluate causality, severity, preventability, categories of medication concerned in ADR's, organ system affected, underlying cause and management of adverse drug reaction. An observational prospective study was conducted over a period of six months in a tertiary care hospital using spontaneous reporting system for identifying ADRs. CDSCO-ADR reporting form along with Naranjo algorithm for causality assessment was used as data collection tool for this study. In our study during 6months duration 76 patients were identified with ADRs. All the ADRs were classified as per age group which revealed predominance in adults 60.52% over geriatrics 26.30%. ADR's in females were predominant. Antibiotics were associated with maximum of all the ADR's reported 19 (25%). Gastroenterological ADR'S was found to be maximum 21 (30.26%). Classification and assessment of ADR's showed that most of the reactions 50 (65.7%) were of type A followed by type B 15(19.7%). The suspected ADR's were assessed for their causality using the Naranjo's algorithm probability scale. It was observed that the majority of reports were rated as probable 46 (60.52%) followed by possible 29 (38.15%) and definite 1 (1.31%). About 63 (82.89%) ADR's were Definitely Preventable, 11(14.47%) were Probably Preventable, while remaining 2 (2.63%) were Not Preventable. In 52 (68.42%) cases the drug was withdrawn followed by dose altered in 3 (4%) cases and no change in 21 (28%) cases. It was observed that out of 76ADR's reports, 26 cases (34.2%) were mild, 49 cases (64.4%) were moderate and 1 case (1.3%) were severe.The results from this prospective, study shows that ADRs in patients may be a Public health issue, impose a big burden on patients by prolongation of hospital keep, increasing the admission rates, health care charge, morbidity, and mortality thus, reporting of ADRs desires continuous stimulation