Abstract
Introduction
Chemotherapy remains a cornerstone of cancer treatment, but a narrow therapeutic index and toxic effects on normal tissues frequently constrain its clinical utility. Pharmacovigilance of these drugs is limited due to significant underreporting, which poses a substantial risk to patient safety. We aimed to assess the frequency, types, severity, and management of ADRs in chemotherapy patients.
Methods
A 12-month cross-sectional study was conducted in a tertiary-care hospital, including 327 chemotherapy patients. The data was collected in a suspected ADR reporting form by the Central Drugs Standard Control Organisation (CDSCO) and reported to the ADR Monitoring Centre and Vigiflow at the National Coordinating Centre (NCC). The suspected drugs were evaluated for causality using the Modified Naranjo scale, and ADR severity was assessed with the Hartwig et al. severity scale.
Results
Out of 327 patients, 230 developed ADR (70%). A total of 372 ADRs were reported, which indicated 1.6 events per patient. ADRs primarily occurred in the 40–60-year age group (57.0%), with a predominance among females (64.8%). Common ADRs included thrombocytopenia (11.2%), neutropenia (9.9%), and diarrhoea (7.7%). Ovarian (17.3%) and breast cancer patients (15.6%) had the highest ADR incidence. Platinum-based agents and antimetabolites were the common culprit drugs. Causality assessment showed 36.1% of ADRs as ‘possible’ and 61.7% as ‘probable.’ The severity of ADRs was categorised as ‘mild’ (49.13%), ‘moderate’ (46.08%), and ‘severe’ (4.79%).
Conclusion
The study emphasises the critical need for vigilant surveillance to minimise the impact of these complications on treatment outcomes. Future studies could stratify data by cancer stage.
Keywords
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