Off-Label Prescribing in Pediatric Inpatients With Pneumonia in a Children's Hospitaal

  • Hesty Utami Ramadaniati Universitas Pancasila
  • Heni Safarini Department of Pharmacy, Harapan Kita Mother’ and Children’s Hospital
  • Aishah A Regine Universitas Pancasila

Abstract

Off-label is a term used in which a  drug prescribed outside the official information of the marketing authorization.  Off-label prescribing may occur as the result of several factors including  lack of clinical trials data involving pediatrics and suitable formulations for medicines commonly prescribed to this fragile population. Objective: This study aimed to estimate the nature and prevalence of off-label prescribing in pediatric inpatients with pneumonia. Material and Methods: a retrospective study was conducted in a study hospital using medical records from pediatric inpatients with pneumonia during the period of January-December 2015. Patient and prescribing data were collected, and drugs were classified as on-label or off-label based on the Indonesia National Drug Information (IONI) and British National Formulary for Children (BNFC). Thereafter, off-label drugs were categorized with a hierarchical system of age, indication, route of administration and dosage. Results: There were 1141 drugs with 77 different types of drug were administered to 207 patient during the study period. The data uncovered that 405 (35,5%) of the drug prescriptions were used off-label based on IONI, and 319 (28%) of the drug were used off-label based on BNFC. Based on IONI and BNFC, most off-label drugs were from anti infection drugs. Conclusion: The prevalence of off-label use in pediatric inpatients with pneumonia is not high. The off-label prescribing may not be necessarily  be considered irrational, yet this fact reveals that the use of drugs does not comply with the drug label. Clinical trials for pediatric drugs are essential to provide  complete product information for pediatric use.

References

1. Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off label drug use in paediatric wards: prospective study. British Medical Journal. 1998;316:343-5.

2. The American Academy of Pediatrics. Policy statement: off-label use of drugs in children. Pediatrics. 2014;133:563-7.

3. Sinha Y, Cranswick NE. How to use medicines in children: principles of paediatric clinical pharmacology. Journal of Paediatric and Childhood Health. 2007;43:107-11.

4. Rudan I, Boschi-Pinto C, Biloglav Z. Epidemiology and etiology of childhood pneumonia. Bulletion of World Health Organization. 2008;86:408.

5. Harris M, Clark J, Coote N. British Thoracic Society guidelines for the management of community acquired pneumonia in children: update 2011. Thorax. 2011;66:ii1.

6. European Medicines Agency. ICH Topic E11 Clinical Investigation of Medicinal Products in the Paediatric Population2001. Available from: http://www.ema.europa.edu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002926.pdf.

7. Badan Pengawasan Obat dan Makanan. Informatorium Obat Nasional Indonesia. Jakarta: Badan Pengawasan Obat dan Makanan; 2015.

8. The Paediatric Formulary Committee. British National Formulary for Childre. London: Pharmaceutical Press; 2011.

9. Hsien L, Breddemann A, Frobel AK, Heusch A, Schmidt K. Off-label drug use among hospitalised children: identifying areas with the highest need for research. Pharmacy and World Science. 2008;30(5):497-502.

10. Margolis P, Gadomski A. The rational clinical examination: dose this infant have pneumonia?
. Journal of American Medical Association. 1998;279:308-13.

11. Paolo ER, Stoetter H, Cotting J, Frey P, Gehri M, Beck-Popovic M. Unlicensed and off-label drug use in a Swiss paediatric university hospital. Swiss Medical Weekly. 2006;136(13):218-22.

12. Lee J, Redzuan A, Shah NM. Unlicensed and off-label use of medicines in children admitted to the intensive care units of a hospital in Malaysia. International JOurnal of Clinical Pharmacy. 2013;35(6):1025-9.

13. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A. Survey of unlicensed and off-label drug use in paediatric wards in European countries. British Medical Journal. 2000;320(7227):79-82.

14. Avenel S, Bomkratz A, Dassieu G, Janaud JC, Danan C. Incidence des prescriptions hors autorisation de mise sur le marche en reanimation neonatale. Archives de Pediatrie. 2000;7(2):143-7.

15. Barr J, Brenner-Zada G, Heiman E, Pareth G, Bulkowstein M, Greenberg R. Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study. American Journal of Perinatology. 2002;19(2):67-72.

16. Hattingh L. Guidelines for off-label medicine use. Australian Pharmacist. 2014:70-1.

17. Kimland E, Odlind V. Off-label drug use in pediatric patients. Clinical Pharmacology and Therapeutics. 2012;91(5):796-801.

18. European Medicines Agency. Medicines for children2006. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000068.jsp&mid=WC0b01ac0580025b8b.

19. The United States Congress. Pediatric Research Equity Act 2003; (S.650). Available from: http://govtrack.us/congress/bills/108/s650.
Published
2018-04-27
How to Cite
RAMADANIATI, Hesty Utami; SAFARINI, Heni; REGINE, Aishah A. Off-Label Prescribing in Pediatric Inpatients With Pneumonia in a Children's Hospitaal. JURNAL ILMU KEFARMASIAN INDONESIA, [S.l.], v. 16, n. 1, p. 25-29, apr. 2018. ISSN 2614-6495. Available at: <http://jifi.farmasi.univpancasila.ac.id/index.php/jifi/article/view/433>. Date accessed: 26 sep. 2022. doi: https://doi.org/10.35814/jifi.v16i1.433.
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Articles