Adverse Drug Reaction Monitoring in a North Indian Public Teaching Hospital

Abstract

Background: ADRs are a significant cause of morbidity and mortality. Hospital-based monitoring is one of the methods to identify and assess the ADRs. The aim of this study is to monitor the incidence, causality, preventability and severity of ADRs occurring in the wards of a public teaching hospital. Method: A prospective-observational study was conducted in medical wards of a public teaching hospital to assess the Causality, level of severity and preventability of identified ADRs. All the relevant information was collected from patients’ record file in a standard case record form. To find out the incidence of ADRs between different gender and age groups, chi- square was applied. Results: 60 ADRs in 56 patients were detected in 520 patients admitted to the hospital. The most commonly occurring ADRs were constipation, hypokalemia and diarrhea. Most troublesome classes of drugs contributing to adverse drug reactions were antibiotics. All the ADRs were Type ‘A’ reaction (100%). According to Naranjo’s ADR probability scale, 13% ADRs were ‘possible’ and 87% ADRs were ‘probable’. Severity assessment, using Modified Hartwig criteria, showed that 53% ADRs were mild and 47% ADRs were moderate respectively. Preventability of ADRs was assessed using modified Shumock and Thornton method; and, it was found that all the 95% ADRs were not preventable. Conclusion: The results of this study concluded that adverse drug reactions were significant cause of increase burden on health care system, decrease quality of life, and increase hospitalizations. The results would help in the early detection and to ensure safer drug therapy.