OBJECTIVES : The objective of this study was to describe the spontaneous reporting of the Adverse Drug Reactions (ADRs) among the patients admitted to medicine department of tertiary care hospital.

METHODS : A prospective observational study was conducted over a period of four months at the medicine department of a tertiary care hospital in North India. All the patients of aged > 18 years, admitted to internal Medicine department were followed and analyzed on a daily basis for the occurrence ADRs following the treatment. Naranjo scale was used to determine the causal relationship between the ADR and suspected drug. The nature of ADR and its severity was determined using Hartwig scale.

RESULTS : A total of 4530 patients were screened for the ADRs, out of which 90 ADRs were developed in the 89 patients. The overall incidence of ADRs was found to be 1.96% in the studied population. The most common ADRs encountered during the study period were Type A (Augmented). The least number of ADRs were observed in the age group of 31- 40 years. The greater number of male patients were suffering from a severe type of ADRs as compared to the female. Sixteen ADRs were of muco-cutaneous type of reaction followed by dizziness in 12 cases. The higher number of patients recovering from the ADRs were in the age group 41-60 years. The outcomes of ADRs were not found to be statistically significant with gender and age groups.

CONCLUSIONS : There is a strong need to extend the monitoring and reporting of the ADRs further to ensure the safety of the patients. However, the overall incidence of ADRs appeared to be less in our study, which highlights the need for strengthened reporting system. The results indicate that elder patients are at major risk of developing ADRs.