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A retrospective study of adverse drug reactions reported in a tertiary care hospital

Anu Krishna R, Murgesh J V, Vishwanath M, Rakesh Kumar P K.


Background: Adverse drug reactions (ADRs) are defined as noxious changes due to a drug, which can occur at doses normally used in humans that require treatment or dose reduction, and also indicate that caution should be exercised with future use of the same drug. Periodic monitoring of ADRs in hospitals can motivate health-care professionals to realize their role and responsibility in the detection, management, and reporting of suspected ADRs and also make them learn how to make sure patients stay safe and healthy. The current study is expected to raise awareness among health-care professionals on the importance of ADR reporting.

Aims and Objectives: The objective of the study was to analyze the incidence and pattern of ADRs with assessing the severity and causality of ADRs reported in the hospital.

Materials and Methods: All ADR cases which were reported to the pharmacovigilance unit between January 2022 and December 2022 have been evaluated. A total of 220 ADR cases were reported during the study. The demography of patients, causative drugs, reactions, causality assessment, and severity have been analyzed. Causality assessment using the Naranjo scale and severity analysis using the modified Hartwig and Siegel Scale have been done.

Results: A total of 220 ADR cases have been evaluated. The main age group affected in our study was 31–45 years with male preponderance. Maximum cases were reported from the dermatology department. The most commonly affected organ was the skin. Antibiotics like cephalosporins caused most of the ADRs. After causality assessment, the maximum cases were probable type (60%), and severity assessment revealed that most of the cases were moderate in severity (64%).

Conclusion: ADRs are one of the growing causes of morbidity and mortality worldwide. Underreporting of ADRs may result in a loss of clinical information that could prevent significant harm to patients. The need of the hour is to encourage health-care professionals to report any suspected ADR and also keep accurate records to analyze, process, and draw conclusions from data to ensure patient safety.

Key words: Adverse Drug Reaction; Pharmacovigilance; Tertiary Care Center; Causality

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