High prevalence of off-label and unlicensed drug prescribing in a brazilian intensive care unit;A alta prevalência de prescrições de medicamentos off-label e não licenciados em unidade de terapia intensiva pediátrica brasileira

Revista da Associacao Medica Brasileira

Volumn 58, Issue 1, 2012, Pages 82-87

  Ferreira, Lilian de Abreu ^a   Ibiapina, Cássio da Cunha ^b   Machado, Márcia Gomes Penido ^b   Fagundes, Eleonora Druve Tavares ^b  

^a Faculdade de Patos de Minas (FPM)   (Brazil)

^b FEDERAL UNIVERSITY OF MINAS GERAIS   (Brazil)

Author keywords

Drug package inserts; Drug prescribing; Off label drug use; Pediatrics

Indexed keywords

EID: 84858048428     PISSN: 01044230     EISSN: None     Source Type: Journal    
DOI: 10.1590/S0104-42302012000100019     Document Type: Article

References (28)

1. Novak E, Allen PJ. Prescribing medications in pediatrics: concerns regarding FDA approval and pharmacokinetics. Pediatr Nurs. 2007;33(1):64-70.
2. Saavedra I, Quiñones L, Saavedra M, Sasso J, León J, Roco A. Farmacocinética de medicamentos de uso pediátrico, visión actual. Rev Chil Pediatr. 2008;79(3):249-58.
3. Wertheimer A. Off-label prescribing of drugs for children. Curr Drug Saf. 2011;6(1):46-8.
4. Lass J, Käär R, Jõgi K, Varendi H, Metsvaht T, Lutsar I. Drug utilisation pattern and off-label use of medicines in Estonian neonatal units. Eur J Clin Pharmacol. 2011;67(2):1263-71.
5. Pandolfini C, Bonati M. European paediatric research and children's therapeutic needs. A trial review. Acta Paediatr. 2008;97(9):1232-37.
6. Baiardi P, Ceci A, Felisi M, Cantarutti L, Girotto S, Sturkenboom M, Baraldi E. In-label and off-label use of respiratory drugs in the Italian paediatric population. Acta Paediatr. 2010;99(4):544-9.
7. Naubert A, Wong IC, Bonifazi A, Catapano M, Felisi M, Baiardi P et al. Defining Off-Label and unlicensed use of medicines for children: results of a Delphi survey. Pharmacol Res. 2008;58(5-6):316-22.
8. 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; 136:218-22.
9. Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol. 2003;17(1):125-31.
10. Naubert A, Dormann H, Weiss J, Egger T, Criegee-Rieck M, Rascher W et al. The impact of unlicensed and off label drug use on adverse drug reactions in paediatric patients. Drug Saf. 2004;27(13):1059-67.
11. Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006;5(5):703-18.
12. Patel H, Bell D, Molokhia M, Srishanmuganathan J, Patel M, Car J et al. Trends in hospital admissions for adverse drug reactions in England: analysis of national hospital episode statistics 1998-2005. BMC Clin Pharmacol. 2007; 25(1):9.
13. Pandolfini C, Bonati M. A literature review on off-label drug use in children. Eur J Pediatr. 2005;164:552-8.
14. 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.
15. OMS. Organização Mundial de Saúde. Promover la Seguridad de los medicamentos para Niños. 2007. [citado 6 nov 2009]. Disponível em: http://whqlibdoc.who.int/publications/2007/9789241563437_spa.pdf.
16. Shah S, 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;61(3):282-90.
17. Santos DB, Clavenna A, Bonatti M, Coelho HL. Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. Eur J Clin Pharmacol. 2008;64(11):1111-8.
18. Carvalho PR, Carvalho CG, Alievi PT, Martinbiancho J, Trotta EA. Identificação de medicamentos "não apropriados para crianças" em prescrições de unidade de tratamento intensivo pediátrica. J Pediatr. 2003;79(5):397-402.
19. Dell'Aera M, Gasbarro AR, Padovano M, Laforgia N, Capodiferro D, Solarino B et al. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci. 2007;29(4):361-7.
20. 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.
21. Conroy S, McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med. 2005;10(2):115-22.
22. Costa PQ, Rey LC, Coelho HL. Lack of drug preparations for use in children in Brazil. J Pediatr. 2009;85(3):229-35.
23. Meiners, MMMA. Bergsten-mendes, G. Prescrição de medicamentos para crianças hospitalizadas: como avaliar a qualidade?. Rev Assoc Med Bras. 2001; 47(4):332-7.
24. a ed. São Paulo: Publicações Científicas; 2009/2010.
25. Nahata MC, Allen LV Jr. Extemporaneous drug formulations. Clin Ther. 2008; 30(11):2112-9.
26. Kairuz T, Gargiulo D, Bunt C, Garg S. Quality, safety and efficacy in the "off-label" use of medicines. Curr Drug Saf. 2007;2(1):89-95
27. Sociedade Brasileira de Pneumologia e Tisiologia. Diretrizes brasileiras em pneumonia adquirida na comunidade em Pediatria. J Bras Pneumol. 2007; 33(Supl 1):S31-50.
28. Ministério da Saúde. Agência Nacional de Vigilância Sanitária. Bulário. [citado 15 jun 2009] Brasília (DF); 2005. Disponível em: http://www.anvisa.gov.br/medicamentos/bulas/index.htm.