• 1
    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: 70318.
  • 2
    Ekins-Daukes S, Helms PJ, Simpson CR, Taylor MW, McLay JS. Off-label prescribing to children in primary care: retrospective observation study. Eur J Clin Pharmacol 2004; 60: 34953.
  • 3
    Ekins-Daukes S, Helms PJ, Taylor MW, McLay JS. Off-label prescribing to children: attitudes and experience of general practitioners. Br J Clin Pharmacol 2005; 60: 1459.
  • 4
    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: 498501.
  • 5
    Choonara I, Conroy S. Unlicensed and off-label drug use in children. Implications for safety. Drug Saf 2002; 25: 15.
  • 6
    Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, de Hoog M, van der Anker J. Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 2000; 320: 7982.
  • 7
    Lindell-Osuagwu L, Korhonen M, Saano S, Helin-Tanninen M, Naaranlahti T, Kokkis 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: 27787.
  • 8
    Winterfeld U, Le Heuzey MF, Acquaviva E, Mouren MC, Brion F, Bourdon O. Off-label use of psychotropic medications in pediatric wards: a prospective study [In French]. Arch Pediatr 2009; 16: 125260.
  • 9
    Winterfeld U, Le Heuzey MF, Acquaviva E, Mouren MC, Brion F, Bourdon O. Psychotropic medication use in the child and adolescent psychiatry wards of a French hospital. Pharm World Sci 2008; 30: 60004.
  • 10
    Morales-Carpi C, Estan L, Rubio E, Lurbe E, Morales-Olivas FJ. Drug utilization and off-label drug use among Spanish emergency room paediatric patients. Eur J Clin Pharmacol 2010; 66: 31520.
  • 11
    Gill A, Leach H, Hughes J, Barker C, Nunn AJ, Choonara I. Adverse drug reactions in a paediatric intensive care unit. Acta Paediatr 1995; 84: 43841.
  • 12
    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: 9658.
  • 13
    Clarkson A, Ingleby E, Choonara I, Bryan P, Artlett P. A novel scheme for the reporting of adverse drug reactions. Arch Dis Child 2001; 84: 3379.
  • 14
    Horen B, Montastruc J, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002; 54: 66570.
  • 15
    Impicciatore P, Mohn A, Chiarelli F, Pandolfini C, Bonati M. Adverse drug reactions to off-label drugs on a paediatric ward: an Italian prospective pilot study. Paed Perinat Drug Ther 2002; 5: 1924.
  • 16
    Ufer M, Kimland E, Bergman U. Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Saf 2004; 13: 14752.
  • 17
    Neubert A, Dormann H, Weiss J, Egger T, Criegee-Rieck M, Rascher W, Brune K, Hinz B. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf 2004; 27: 105967.
  • 18
    Schirm E, Tobi H, van Puijenbroek E, Monster-Simons M, Jong L. Reported adverse drug reactions and their determinants in Dutch children outside the hospital. Pharm Drug Saf 2004; 13: 15965.
  • 19
    Clarkson A, Conroy S, Burroughs K, Choonara I. Surveillance for adverse drug reactions in children: a paediatric regional monitoring centre. Paed Perinatal Drug Ther 2004; 6: 203.
  • 20
    US Food and Drug Administration. Process for Handling Referrals to FDA under 21 CFR 50.54 Additional Safeguards for Children in Clinical Investigations12/22/2006. Available at (last accessed 30 August 2010).
  • 21
    The European Parliament and Council. 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. Available at (last accessed 30 August 2010).
  • 22
    WHO. Promoting Safety of Medicines for Children. Geneva: WHO Library Press, 2007.
  • 23
    Aagaard L, Hansen EH. Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, SSRIs and NSAIDs. BMC Clin Pharmacol 2009; 9: 4.
  • 24
    Aagaard L, Christensen A, Hansen EH. Information about adverse drug reactions reported in children: a qualitative review of studies. Br J Clin Pharmacol 2010; 70: 48191.
  • 25
    Aagaard L, Stenver DI, Hansen EH. Structures and processes in spontaneous reporting systems: a comparative study of Australia and Denmark. Pharm World Sci 2008; 30: 56370.
  • 26
    MSSO. MedDRA. Available at[Password required] (last accessed 30 August 2010).
  • 27
    EudraLex. Volume 9 Pharmacovigilance: medicinal products for human use and veterinary products. Available at (last accessed 30 August 2010).
  • 28
    WHO Collaboration Centre for Drug Statistics Methodology. Complete ATC index 2007. Available at (last accessed 30 August 2010).
  • 29
    Dessi A, Salemi C, Fanos V, Cuzzolin L. Drug treatments in a neonatal setting: focus on the off-label use in the first month of life. Pharm World Sci 2010; 32: 1204.
  • 30
    Aagaard L, Weber CB, Hansen EH. Adverse drug reactions reported for children in Denmark from 1998 to 2007. Drug Saf 2010; 33: 32739.
  • 31
    Mukattash T, Millership J, Collier P, McElnay J. Public awareness and views on unlicensed use of medicines in children. Br J Clin Pharmacol 2008; 66: 83845.