To study the pattern of adverse drug reactions among patients hospitalized in the medical wards of a tertiary care hospital

Background: ADRs have a major impact on public health, quality of life. ADRs are a recognized hazard of drug therapy. Although some ADRs are minor and resolve without squeal, others can cause permanent disability or death. Despite the methodological rigor of clinical trials, it is generally not possible to identify all safety issues associated with drugs during the pre-marketing research phase. The only way to find out such occurrences is to be on active-look out for adverse events over a long time horizon in large population and in different host conditions. The information may be useful in identifying and minimizing preventable ADRs, while generally enhancing the knowledge of the prescribers to deal with them more efficiently.Methods: This retro-prospective study was conducted in a tertiary care hospital for one year. Data of those patients who experienced ADRs was recorded in detail from internal Medicine ward. An assessment of causality was done. Data was evaluated to determine the class of drugs and the organ systems frequently associated with ADR within the settings of the institute.Results: The total incidence of ADRs was 7.59% in hospitalized patients with male predominance. Most common system involved was GIT followed by CNS and CVS. Antibiotics were most common culprits for ADRs followed by NSAIDS and hypoglycemic agents. In causality assessment probable ADRs were much more than possible ADRs. Severity of reaction in most of the patients was moderate. Majority of ADRs were Type A and maximum were probably preventable.Conclusions: There is need to explore the reasons for this relatively low incidence rate of ADR’s in the Indian population. Under­reporting is one of the major factors with a lack of proper pharmacovigilance system which is still in budding state in India