A Cross-sectional Observational Study on Audit of Biotherapeutics Used in Pediatric Patients in a Tertiary Care Hospital

Background: Biotherapeutics are a class of therapeutic products derived from biological sources and used in the treatment of different diseases and disorders. Data on biotherapeutic utilization in different diseases is inadequate in the pediatric population. Methods: This observational, cross-sectional study was conducted for a year to audit the use of biotherapeutics in Pediatric patients (1-12 yrs) at a tertiary care hospital. The data on biotherapeutics was collected in Case Report Forms (CRFs) validated by peers and subject experts. The adverse reaction of biotherapeutics was recorded in the Suspected Adverse Drug Reaction Form (version 1.4). The price of biotherapeutics was calculated as the average price of a standard manufacturer available at the hospital. Results: A total of 141 patients were recruited and it was found that intravenous immunoglobulin (IVIG) (35.46%), 20% human albumin (25.53%), recombinant human growth hormone (17.02%), filgrastim (7.80%), rituximab (6.38%), Tocilizumab (1.41%), factor VIII (2.12%), diphtheria antitoxin (0.70%), erythropoietin (0.70%), infliximab (0.70%), factor VIIa (0.07%), insulin and insulin with glargine (0.07%) and streptokinase (0.07%) were used in treatment of various diseases and disorders. About one-third of patients (35%) received biotherapeutics as a 1st line of treatment, and 90% experienced no adverse effects. Regardless of biotherapeutic use, we observed headache, fever, respiratory distress, and ankle swelling as adverse effects. The annual biotherapeutics budget was INR 6,786,137, with intravenous immunoglobulin (IVIG) accounting for the main expenditures at INR 5,720,000. Conclusion: In developing countries, technological advancements and increased availability of biotherapeutics and the use of biosimilars may reduce costs in the future. This study will also help in the formulation of budgets for tertiary care hospitals.