Off-label drug use among hospitalized children: identifying extent and nature

Bush A. Evidence-based medicines for children: important implications for new therapies at all ages. Eur Respir J. 2006;28:1069-1072.10.1183/09031936.0011630617138673Search in Google Scholar

Conroy S, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini CH, Raffaelli MP, Rocchi F, Bonati M, Jong G, Hoog M, Van Den Anker J. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ. 2000;320:79-81.10.1136/bmj.320.7227.792725110625257Search in Google Scholar

Conroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch Dis Fetal Neonatal Ed. 1999;80:F142-F145.10.1136/fn.80.2.F142172089610325794Search in Google Scholar

Dell'Aera M, Gasborro AR, Padovano M, Laforgia N, Capodiffiero D, Solarino B, Quaranta R, Dell'Erba AS. Unlicensed and off-label use of medicines at a neonatology clinic in Italy. Pharm World Sci. 2007;29:361-367.10.1007/s11096-006-9081-z17351821Search in Google Scholar

Hsien L, Breddemann A, Frobel AK, Heusch A, Schmidt KG, Laer S. Off-label drug use among hospitalized children: identifying areas with highest need for research. Pharm World Sci. 2008;30:497-502.10.1007/s11096-008-9193-818219585Search in Google Scholar

Khdour MR, Hallak HO, Alaysa KSA, Aishahed QN, Hawwa AF, McElnay JC. Extent and nature of unlicensed and off-label medicine use in hospitalized children in Palestine. Int J Clin Pharm. 2011;33:650-655.10.1007/s11096-011-9520-321567279Search in Google Scholar

Lindell-Ouagwu L, Koronen MJ, Saano S, Hellin-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;34:277-287.10.1111/j.1365-2710.2008.01005.x19650250Search in Google Scholar

Medicines for children, European Medicines Agency. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general_content_000302.jsp&mid=WC0b01ac058002d4eaSearch in Google Scholar

Pandolfini C, Impicciatore P, Provasi D, Rocchi F, Campi R, Bonati M, The Italian Paediatric off-label collaborative group. Off-label use of drugs in Italy: a prospective, observational and multicentre study. Acta Paediatr. 2002;91:339-347.10.1111/j.1651-2227.2002.tb01726.xSearch in Google Scholar

Pandolfini Ch, Bonati M. A literature review on off-label drug use in children. Eur J Paediatr. 2005;164:552-558.10.1007/s00431-005-1698-815912383Search in Google Scholar

Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004. Official Journal of the European Union 49. Available at: http://eurlex.europa.eu/Search in Google Scholar

Report on survey of all paediatric uses of medicinal products in Europe. EMA/794083/2009, 2011:1-37.Search in Google Scholar

T Jong GW, Vulto AG, De Hoog M, Schimmel KJM, Tibboel D, Van Den Anker J. A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital. Paediatrics. 2001;108:1089-1093.10.1542/peds.108.5.108911694685Search in Google Scholar