Adverse drug reactions in hospitalized patients in a tertiary care teaching hospital: analysis of the reported cases

Althab Begum M., Satyajit Mohapatra, R. Jamuna Rani


Background: Adverse Drug Reactions (ADR’s) contributes to the burden of drug-related morbidity and mortality. ADRs are seen frequently in hospitals due to a variety of factors like complexity of diseases, drug interactions, polypharmacy, and possible negligence. The purpose of the study was to identify and assess ADR in various departments of a tertiary care teaching hospital.

Methods: A prospective spontaneous reporting was carried out in a tertiary care teaching hospital during a period of four months from November 2016 to February 2017. All suspected spontaneous ADRs were assessed and the information was collected and analyzed by the pharmacologists for causality assessment using the Naranjo’s causality assessment scale.

Results: A total of 30 ADRs were reported with female preponderance (70%). Majority of ADRs were from General Medicine and Oncology departments. The most affected organ systems were skin (80%) followed by the gastrointestinal system (13.3%). The most frequent drugs causing ADRs were antibiotics (56.3%) in which type B reactions were more compared to type A and followed by anticancer drugs (10%). The severity assessment showed that most of them were mild reactions (76.6%). Causality assessment revealed that 90% of the reactions were probable, 10% were possible and no reactions were unlikely.

Conclusions: The study accomplished that ADRs are widespread and a few of them raised the healthcare expenditure due to increased hospital stay. The reporting of the ADRs to regional Pharmacovigilance centers should be encouraged to ensure drug safety.


Adverse drug reactions, Drug safety, Pharmacovigilance

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