Adverse Drug Reactions (ADR) in the inPatients of Medicine Department of a Rural Tertiary Care Teaching Hospital and Influence of Pharmacovigilance in Reporting ADR

OBJECTIVES: (i) To find the incidence and study various aspects of Adverse Drug Reactions (ADR) in the inpatients of medicine department of Shree Krishna Hospital, a rural tertiary care teaching hospital. (ii) To test the impact of pharmacovigilance in reporting ADR. MATERIAL & METHODS: A prospective study involving 600 patients admitted to the medical wards and TB & Chest diseases ward over a period of six months and a retrospective analysis of 600 case files for the corresponding period of the previous year were carried out to find the incidence rate of ADR, study various aspects of ADR like causality assessment, drugs frequently causing ADR etc. Suitably structured and pre-tested format was used for compiling the data. RESULTS: In the prospective study, 18 of the 600 patients (3%) developed ADR. A significant number (77.78%) of patients developed ADR between the 3(rd) and 10(th) days of administering the drug/s. As the number of drugs increased, the incidence of ADR also increased. Majority of ADR (72.22%) occurred due to chemotherapeutic agents. 66.67% of ADR involved the gastrointestinal tract. None of the ADR was fatal. Sex of the patients did not influence the incidence rate of ADR. On the other hand, in the retrospective analysis, only ADR were reported in just 6 out of 600 patients (1%). CONCLUSION: The incidence rate of ADR is found to be much lower (3%) than the reported rate (10%-20%). Pharmacovigilance certainly contributes to picking up ADR.