Pharmacovigilance study of anticancer drugs in a tertiary care rural hospital in central India

Abstract

The present study has been undertaken to evaluate the pattern of adverse drug reactions (ADRs) of intravenous anticancer (i.v.) drugs with their causality and severity in a tertiary health care set up. The study was an observational cross-sectional survey over a period of 18 months. The indoor patients who were diagnosed to have cancer and receiving i.v. anticancer drugs were included in the study. The details of the patients and ADRs were recorded at the time of visit or within one-month of occurrence of ADRs using case record form and ADR reporting form. A total of 374 patients on cancer chemotherapy were included in the study and ADR was seen in 293(78.34%) patients. Out of total 812 number of ADRs, most ADRs (51.60%) were G.I. system related, followed by skin and appendages related ADRs (23.88%). The association of females in developing haematological ADRs is statistically significant (p<0.05). Most common (19.80%) cause of ADRs was the use of combination of Cisplatin, Paclitaxel and 5 Fluorouracil. Most (90.02%) of the ADRs were categorized as 'possible' and the remaining (9.98%) as 'probable/likely'. The maximum number of the ADRs were classified as 'mild'(87.68%) followed by moderate (11.45%) and severe (0.86%). The mild reactions were more common as compare to moderate & severe category in G.I & haematology related ADRs (p<0.05).