METHODS
The study was conducted as a single-centre, cross-sectional, observational study in the paediatric oncology day care unit of a tertiary care hospital in India from November 2019 to May 2021. A sample size of 100 patients was targeted based on published literature [4]. Ethical approval was obtained from the Institutional Ethics Committee (IEC) with the IEC number IEC/381/19, and written informed consent and assent were obtained from all participants before enrolling them in the study.
The study included paediatric cancer patients (less than 18 years of age) who were scheduled to receive parenteral chemotherapy drugs. Patients whose chemotherapy details were recorded once were excluded from the study. The details were recorded based on the information obtained from the patient and their medical record. The information recorded included the chemotherapy drug, dose (mg/m2), total calculated dose, formulation details, actual drug consumed (mg), drug wasted (mg), the total cost of the drug (INR), cost of the wasted drug (INR), and measures taken to reduce drug wastage (if any), such as rounding off the dose or sharing of the vial. All this information was recorded on a case record form. The cost of one unit was obtained from the hospital pharmacy, outside pharmacies, or NGOs. If provided by NGOs, the retail price for that brand was noted by the pharmacy, and an expense assessment was
conducted.
Our independent analysis of drug wastage included the following scenarios: 1) Calculation of the unused dose by subtracting the prescribed dose from the total amount of drug in the vial in mg; 2) Estimation of the total cost of the drug in INR and the cost of the wasted drug; 3) Determination of the frequency of sharing vial or rounding off dose if applicable.
We also estimated whether the prescribed doses for different chemotherapy drugs matched the vial size availability at our hospital pharmacy and outside pharmacies as per CIMS 2022.
Statistical analysis : All collected data was entered into Microsoft Excel 2016. Continuous variables were expressed as mean ± standard deviation (SD), and categorical variables were expressed as percentages and frequency. The percentage of drug wastage was determined at a 95% confidence interval.
RESULTS
Our analysis included 100 patients who received 140 parenteral chemotherapy drug administrations of 22 different drugs. The mean (±SD) age of patients was 6.67 (±3.63) years, with a male predominance of 67 (67%) compared to females, who were 33 (33%).
Hematological malignancies were observed in 89% of our study population (n=100) compared to solid tumors, which were observed in 11% (Table 1 ).