Assessment and Monitoring of Adverse Drug Reactions at a Tertiary Care Hospital

Background: Incidences of adverse drug reactions were reported through spontane-ous reporting at an ADR monitoring unit in a tertiary care hospital. Aims: This study was conducted to describe the distribution pattern of adverse drug reaction (ADR). Objective: The objective of this study was to monitor and report the adverse drug reactions (ADRs) occurring in a tertiary care hospital and to evaluate the incidence, causality, severity, and preventability of adverse drug reactions. Methods: A prospective, observational study was conducted at a tertiary care hospital in Punjab for 6 months. All patients admitted to the hospital above 18 years of age were included in the study. Results: A total of 103 ADRs were observed over the study period of 6 months. The majority of them were females (60), comprising of 58.25%. The therapeutic class of drug associated with most of the ADRs was antibiotics 18 (17.5%). Maximum number of ADRs occurred in the gen-eral medicine ward with frequency of 27 (26.2%) and were of type b 58 (56.3%). Causality was assessed using the Naranjo scale, and most of the ADRs came out to be probable 64 (62.1%) in nature. Severity was assessed using Hartwig’s severity assessment scale, and most of the cases, 66 (64.1%), were moderate in intensity. ADR preventability was assessed using the Schumock and Thornton preventability scale, and it was observed that most of the cases, 82 (79.6%), were not preventable. Conclusion: This study seeks to strengthen the ADR database through analysis of spontaneous reporting patterns of ADRs from various clinical departments of a tertiary care teaching hospital, thereby increasing awareness and improving the reporting culture among health care practition-ers. It can be concluded that continuous medication monitoring and a well-organized and com-mitted pharmacovigilance system led by a clinical pharmacist in a hospital setting would un-doubtedly lower the incidence of adverse drug reactions.