A Retrospective Study on Adverse Drug Reactions of Anticancer Drugs in a Tertiary Care Hospital in Northeast India

Abstract

Introduction: Anticancer drugs account to high susceptibility towards Adverse Drug Reactions (ADRs) due to their narrow therapeutic window and increased toxicity, which makes pharmacovigilance studies essential. Aim: To determine the nature and severity of ADRs in cancer patients based on the reports received from the Department of Radiation Oncology to the Pharmacovigilance centre of a tertiary care hospital. Materials and Methods: A retrospective, descriptive study was conducted in the Regional Institute of Medical Sciences (RIMS), Imphal, Manipur, India on the patients who developed ADRs due to anticancer drugs during the period from January 2018 to December 2020. These ADRs were assessed for causality using World Health Organisation- Uppsala Monitoring Centre (WHO-UMC) criteria. The data was analysed using Statistical Package for the Social Sciences (SPSS) version 21.0 and frequencies and percentages were determined for each variable. Results: A total of 913 ADRs were reported from 334 patients. Total 62.57% females developed ADRs and age group of 51-60 years (31.14%) were affected the most. Bronchogenic carcinoma (20.9%) was found to be the most common cancer and haematological system (31.11%) was mostly affected. Most common ADRs observed were alopecia (16.32%) followed by anorexia and anaemia. Carboplatin (23.21%) followed by Cisplatin, Paclitaxel, Docetaxel were the most common drugs causing different ADRs. On causality assessment, as per WHO-UMC criteria 67.25% ADRs were ‘probable’ and 32.75% were ‘possible’. Severity assessment using modified Hartwig and Siegel scale showed 56.41% ADRs as mild, 41.95% moderate and 1.64% severe reaction. Preventability assessment using Schumock-Thornton scale showed 44.69% ADRs were ‘not preventable’ whereas 41.62% ADRs were ‘definitely preventable’ and 13.69% were ‘probably preventable’. Conclusion: The use of anticancer drugs is associated with various adverse effects. However, early detection of the ADRs may help to modify the doses or the drug regimen to minimise the adverse effects.