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Off-label drug prescribing in a Portuguese Paediatric Emergency Unit

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Abstract

Background Many drugs are prescribed outside the terms of the marketing authorization (“off-label”). Several studies have shown that this is a common practice in various European healthcare settings. Objective This study aimed to quantify and characterize off-label drug prescribing in children admitted to a Portuguese Paediatric Unit (PEU). Setting This study was conducted in the Paediatric Unit of the university teaching hospital of Cova da Beira Hospital Centre (CHCB), Covilhã, located in the Eastern Central Region of Portugal. Method A descriptive study was conducted, including a sample of 700 children, randomly selected from those admitted between January to October 2010. Drug prescription was assessed by retrospective review of clinical files. Main outcome measure Off-label prescribing was defined as the utilization of a drug at an indication, age, dosage, frequency or route of administration different from those recommended in the Summary of Product Characteristics (SPC). For purposes of this study only the medicines prescribed to be used after discharge from the hospital were studied. Results 364 boys and 336 girls, aged from 4 days to 18 years, were included in this study. Of the 724 medicines prescribed, 32.2 % were off-label. At least one drug was used off-label in 28.1 % of the studied population, corresponding to 46.1 % of the 427 children that received prescriptions. “Alteration in dosage” was the commonest reason for off-label prescribing (28.2 %). The off-label prescriptions comprised mainly drugs acting on the “Respiratory System” and “Anti-infectious agents for systemic use”. Amoxicillin/clavulanic acid, paracetamol, amoxicillin, ibuprofen and salbutamol were the five active principles most frequently prescribed off-label. Conclusion The prevalence of off-label drug prescribing in the Portuguese PEU of CHCB is high, the use in a dose or for an age group not approved in the SPC being the most common reasons for off-label prescription.

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References

  1. Di Paolo ER, Stoetter H, Cotting J, Frey P, Gehri M, Beck-Popovic M, et al. Unlicensed and off-label drug use in a Swiss paediatric university hospital. Swiss Med Wkly. 2006;136(13–14):218–22.

    PubMed  Google Scholar 

  2. Muhlbauer B, Janhsen K, Pichler J, Schoettler P. Off-label use of prescription drugs in childhood and adolescence: an analysis of prescription patterns in Germany. Dtsch Arztebl Int. 2009;106(3):25–31.

    PubMed  Google Scholar 

  3. Yaffe SJ, Aranda JV. Neonatal and pediatric pharmacology: therapeutic principles in practice. 4th ed. Philadelphia: WB Saunders; 2010. ISBN: 9780781795388.

  4. Duarte D. Medicamentos para Crianças A realidade actual na União Europeia. Revista Lusófona de Ciências e Tecnologia da Saúde. 2006;3(1):9–18.

    Google Scholar 

  5. Venitz J, Sittner We. Appropriate dose selection—how to optimize clinical drug development. Vol. 59. Springer; 2007. p. 111–134.

  6. Meadows M. Drug research and children. FDA Consum. 2003;37(1):12–7.

    Google Scholar 

  7. Winterfeld U, Le Heuzey MF, Acquaviva E, Mouren MC, Brion F, Bourdon O. Utilisation hors autorisation de mise sur le marché (AMM) des psychotropes en pédiatrie: une étude prospective. Arch Pediatr. 2009;16(9):1252–60.

    Article  PubMed  CAS  Google Scholar 

  8. Strolin Benedetti M, Baltes EL. Drug metabolism and disposition in children. Fundam Clin Pharmacol. 2003;17(3):281–99.

    Article  PubMed  CAS  Google Scholar 

  9. Kimland E, Bergman U, Lindemalm S, Bottiger Y. Drug related problems and off-label drug treatment in children as seen at a drug information centre. Eur J Pediatr. 2007;166(6):527–32.

    Article  PubMed  Google Scholar 

  10. Novak E, Allen PJ. Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics. Pediatr Nurs. 2007;33(1):64–70.

    PubMed  Google Scholar 

  11. Johnson TN. The problems in scaling adult drug doses to children. Arch Dis Child. 2008;93(3):207–11.

    Article  PubMed  CAS  Google Scholar 

  12. ICH Guidance E11: “Note for Guidance on Clinical Investigation of Medicinal Products in the Paediatric Population” (CPMP/ICH/2711/99) [on-line]. Available from: http://www.ema.europa.eu/pdfs/human/ich/271199en.pdf. Accessed July 2012.

  13. Amending Regulation EC No 1902/2006 on Medicinal Products for Paediatric Use [on-line]. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1902/reg_2006_1902_en.pdf. Accessed July 2012.

  14. Autret-Leca E, Bensouda-Grimaldi L, Le Guellec C, Jonville-Béra AP. L’enfant et les médicaments: application à la prescription en pédiatrie. Archives de Pédiatrie. 2005;13:181–5.

    Article  PubMed  Google Scholar 

  15. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164(9):552–8.

    Article  PubMed  Google Scholar 

  16. Gazarian M, Kelly M, McPhee JR, Graudins LV, Ward RL, Campbell TJ. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust. 2006;185(10):544–8.

    PubMed  Google Scholar 

  17. McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child. 2000;83(6):498–501.

    Article  PubMed  CAS  Google Scholar 

  18. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr. 1999;88(9):965–8.

    Article  PubMed  CAS  Google Scholar 

  19. Jonville-Bera AP, Bera F, Autret-Leca E. Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study. Eur J Clin Pharmacol. 2005;61(3):231–6.

    Article  PubMed  CAS  Google Scholar 

  20. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ. 2000;320(7227):79–82.

    Article  PubMed  CAS  Google Scholar 

  21. Shah SS, Hall M, Goodman DM, Feuer P, Sharma V, Fargason C Jr, et al. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007;161(3):282–90.

    Article  PubMed  Google Scholar 

  22. Lindell-Osuagwu L, Korhonen MJ, Saano S, Helin-Tanninen M, Naaranlahti T, Kokki H. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther. 2009;34(3):277–87.

    Article  PubMed  CAS  Google Scholar 

  23. Morales-Carpi C, Estan L, Rubio E, Lurbe E, Morales-Oliva FJ. Drug utilization and off-label drug use among Spanish emergency room paediatric patients. Eur J Clin Pharmacol. 2010;66:315–20.

    Article  PubMed  CAS  Google Scholar 

  24. Instituto Nacional de Estatística [on-line]. Available from: http://www.ine.pt. Accessed July 2012.

  25. International Statistical Classification of Diseases and Related Health Problems—ICD-10 [on-line]. Available from: http://apps.who.int/classifications/apps/icd/icd10online/. Accessed July 2012.

  26. Anatomical Therapeutic Chemical Code—ATC [on-line]. Available from: http://www.whocc.no/atc_ddd_index/. Accessed July 2012.

  27. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol. 2002;54(6):665–70.

    Article  PubMed  Google Scholar 

  28. Jain SS, Bavdekar SB, Gogtay NJ, Sadawarte PA. Off-label drug use in children. Indian J Pediatr. 2008;75(11):1133–6.

    Article  PubMed  Google Scholar 

  29. Bajcetic M, Jelisavcic M, Mitrovic J, Divac N, Simeunovic S, Samardzic R, et al. Off label and unlicensed drugs use in paediatric cardiology. Eur J Clin Pharmacol. 2005;61(10):775–9.

    Article  PubMed  CAS  Google Scholar 

  30. ‘t Jong GW, Eland IA, Sturkenboom MC, van den Arker JN, Strickerf BH. Unlicensed and off-label prescription of respiratory drugs to children. Eur Respir J. 2004;23(2):310–3.

    Article  PubMed  Google Scholar 

  31. Hsien L, Breddemann A, Frobel AK, Heusch A, Schmidt KG, Laer S. Off-label drug use among hospitalised children: identifying areas with the highest need for research. Pharm World Sci. 2008;30(5):497–502.

    Article  PubMed  Google Scholar 

  32. Report on the survey of all paediatric uses of medicinal products in Europe [on-line]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/01/WC500101006.pdf. Accessed July 2012.

  33. ‘t Jong G, Eland IA, Strickerf BH, van den Anker JN. Information for paediatric use of medicines in a product information compendium. Paediatr Perinatal Drug Ther. 2001;4(4):148–51.

    Google Scholar 

  34. Smith AR, Barbato A, Beydon N, Bisgaard H, de Boeck K, Brand P, et al. Respiratory medicines for children: current evidence, unlicensed use and research priorities. Eur Respir J. 2010;35:247–65.

    Article  Google Scholar 

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The authors did not receive any financial support for the research, authorship, and/or publication of this article.

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Authors and Affiliations

  1. Faculty of Health Sciences, University of Beira Interior, Av. Infante D.Henrique, 6200-506, Covilhã, Portugal

    Marina Ribeiro, Arminda Jorge & Ana Filipa Macedo

  2. Paediatric Emergency Unit of Cova da Beira Hospital Centre, Av. Infante D. Henrique, 6200-506, Covilhã, Portugal

    Arminda Jorge

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  1. Marina Ribeiro
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Correspondence to Marina Ribeiro.

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Ribeiro, M., Jorge, A. & Macedo, A.F. Off-label drug prescribing in a Portuguese Paediatric Emergency Unit. Int J Clin Pharm 35, 30–36 (2013). https://doi.org/10.1007/s11096-012-9699-y

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