Study of prescription patterns and adverse drug reaction monitoring in patients of oral cavity malignancies attending radiotherapy department in a tertiary care teaching institute

To study prescriptions of patients having oral cavity malignancy on antineoplastic drugs and study adverse drug reaction occurred.

an observational study was carried out in radiotherapy out-patient department in tertiary care teaching institute, Nagpur after approval from Institutional Ethics Committee for 2 months period. In this prospective study, diagnosed cases of oral cavity malignancies were included. Epidemiological data and details of prescribed drugs were recorded. Collected data was analyzed for prescription pattern of antineoplastic drugs and reported adverse drug reactions.

Out of 34 enrolled patients, majority were male (73.05%) with mean age 48 ± 13.29. Carcinoma of buccal mucosa (35.2%) was most common. Chemotherapy drugs commonly used were Cisplatin (79.4%), 5-fluorouracil (47%), Paclitaxel (41.1%), Carboplatin (20.5%), Docetaxel (20.5%). Monotherapy (Cisplatin) developed 4.6% ADRs, two drug therapy (Cisplatin+Paclitaxel, Cisplatin+5-fluorouracil, Carboplatin+Paclitaxel) developed 79% ADRs and three drug therapy (Cisplatin+Paclitaxel+5-fluorouracil, Cisplatin+Docetaxel+5-fluorouracil) developed 16.2% ADRs.

A total of 43 adverse reactions were reported during this study. Reactions observed were nausea (18.6%), vomiting (18.6%), anorexia (16.2%), alopecia (13.9%), diarrhea (2.3%), constipation (4.6%), weakness (18.6%), insomnia (2.3%), hemoptysis (2.3%) and black nails (2.3%). In Naranjo causality assessment, 62.7% of ADRs were probable and 37.2% were possible. In Hartwig and Siegel scale analysis, most reactions (76.7%) were of “mild” severity, 20.9% of reactions were of “moderate” severity, while 2.3% of reactions were of “severe” severity. Modified Schumock and Thornton criteria indicated that 44% of ADRs as “definitely preventable” and 55.8% of ADRs as “not preventable”.

Study concludes that antineoplastic drugs, Cisplatin, Carboplatin, Docetaxel, Paclitaxel and 5-fluorouracil were commonly prescribed. Higher incidence of ADRs was observed with two drug therapy as compared to single drug regimen.