Original Article

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

Abstract

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.

Kinch MS. An Overview of FDA-approved Biologics Medicines. Drug Discov Today. 2015; 20(4):393-98.

Steinberg FM, Raso J. Biotech Pharmaceuticals and Biotherapy: An Overview. J Pharm Pharm Sci. 1998; 1(2):48-59.

Shi S. Biologics: An Update and Challenge of Their Pharmacokinetics. Curr Drug Metab. 2014;15(3):271-290.

Lau SJ, Huang Y, Hsieh J, Wang S, Liu Q, Slattum PW, et al. Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications from 2010 Through 2019. JAMA Netw Open. 2022;5(10):e2236149.

Muralidhara BK, Wong M. Critical Considerations in the Formulation Development of Parenteral Biologic Drugs. Drug Discov Today. 2020; 25(3):574-581.

Batta A, Kalra BS, Khirasaria R. Trends in FDA Drug Approvals Over the Last 2 Decades: An Observational Study. J Family Med Prim Care. 2020;9(1):105-114.

Kute N, Mankar S, Bhawar S. Biosimilar and its Current Perspective–A Review. Res J Pharmacol Pharmacodyn. 2022;14(2):84-88.

Pawar KN, Gore RT, Palekar SR. A Review on Approval Process and Regulation of Medical Devices as per US FDA and CDSCO. Int J Drug Regul Aff. 2023;11(1):61-70.

Clark H, Coll-Seck AM, Banerjee A, Peterson S, Dalglish SL, Ameratunga S, et al. A Future for the World's Children? A WHO–UNICEF–Lancet Commission. Lancet. 2020; 395(10224):605-658.

Chhabra M. Biological Therapeutic Modalities. In: Hasija Y, editor. Translational biotechnology: Academic Press; 2021. p. 137-164.

Newman DJ, Cragg GM. Natural Products as Sources of new Drugs Over the Nearly four Decades from 01/1981 to 09/2019. J Nat Prod. 2020; 83(3):770-803.

Hartung HP, Mouthon L, Ahmed R, Jordan S, Laupland K, Jolles S. Clinical Applications of Intravenous Immunoglobulins (IVIg)–beyond Immunodeficiencies and Neurology. Clin Exp Immunol. 2009; 158:23-33.

Stangel M, Pul R. Basic Principles of Intravenous Immunoglobulin (IVIg) Treatment. J Neurol. 2006; 253:v18-v24.

Zhang J, Zhang R, Wang Y, Li H, Han Q, Wu Y, et al. The Level of Serum Albumin is Associated with Renal Prognosis in Patients with Diabetic Nephropathy. J. Diabetes Res. 2019; 2019(1):7825804.

Mendez CM, McClain CJ, Marsano LS. Albumin Therapy in Clinical Practice. Nutr Clin Pract. 2005; 20(3):314-320.

Gisondi P, Gubinelli E, Cocuroccia B, Girolomoni G. Targeting Tumor Necrosis Factor-α in the Therapy of Psoriasis. Curr Drug Targets Inflamm Allergy. 2004; 3(2):175-183.

Boye J, Elter T, Engert A. An Overview of the Current Clinical Use of the Anti-CD20 Monoclonal Antibody Rituximab. Ann Oncol. 2003; 14(4):520-535.

Ifeanyi OE. A Review on Erythropoietin. Int J Adv Res Biol Sci. 2015; 2(4):35-47.

Sun HY, Phan K, Paller AS, Sebaratnam DF. Biologics for Pediatric Psoriasis: A Systematic Review and Meta‐analysis. Pediatr Dermatol. 2022; 39(1):42-48.

Roth K, Darwish C, Keller MD, Hammer B, Ahmed‐Winston S, Escalante E, et al. Implementation of a Tier System for IVIG Indications to Address IVIG Shortage at a Tertiary Care Pediatric Medical Center. Pediatr Blood & Cancer. 2024; 71(4):e30871.

Files
IssueVol 13, No 1 (Winter 2025) QRcode
SectionOriginal Article(s)
Keywords
Biotherapeutics Pediatric Patients Tertiary Care Hospital Budget

Rights and permissions
Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
1.
Banerjee S, Nandy M, Sarkar S, Mondal R, Sanyamath A, Halsana M, Adak A, Gangopadhyay T. A Cross-sectional Observational Study on Audit of Biotherapeutics Used in Pediatric Patients in a Tertiary Care Hospital. J Pharm Care. 2025;13(1):49-57.