• 1
    Australian Register of Therapeutic Goods. Therapeutic Goods Administration, Department of Health and Ageing, Australian Government. 2010. Available from: [accessed 6 September 2010].
  • 2
    eMIMS. eMIMS Prescribing Information. Sydney: MediMedia Australia Pty Ltd, 2010.
  • 3
    Bicknell ME, Weekes LM. Off-label drug use in an outpatient setting – a pilot study. Aust. J. Hosp. Pharm. 1995; 25: 527529.
  • 4
    Turner S. Unregistered and off-label drug use in paediatric inpatients. Aust. J. Hosp. Pharm. 1999; 29: 265268.
  • 5
    O'Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics 2002; 110: e52.
  • 6
    Tan E, Cranswick NE, Rayner CR, Chapman CB. Dosing information for paediatric patients: are they really ‘therapeutic orphans’? Med. J. Aust. 2003; 179: 195198.
  • 7
    Shirkey H. Therapeutic orphans. J. Pediatr. 1968; 72: 119120.
  • 8
    Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. Br. Med. J. 2000; 320: 7982.
  • 9
    Di Paolo ER, Stoetter H, Cotting J et al. Unlicensed and off-label drug use in a Swiss paediatric university hospital. Swiss Med. Wkly 2006; 136: 218222.
  • 10
    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: 497502.
  • 11
    Santos DB, Clavenna A, Bonati M, Coelho HLL. Off-label and unlicensed drug utilization in hospitalized children in Fortaleza, Brazil. Eur. J. Clin. Pharmacol. 2008; 64: 11111118.
  • 12
    t'Jong GW, van der Linden PD, Bakker EM et al. Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur. J. Clin. Pharmacol. 2002; 58: 293297.
  • 13
    Charney RL, Yan Y, Schootman M, Kennedy RM, Luhmann JD. Oxycodone versus codeine for triage pain in children with suspected forearm fracture: a randomized controlled trial. Pediatr. Emerg. Care 2008; 24: 595600.
  • 14
    Kokki H, Lintula H, Vanamo K, Heiskanen M, Eskelinen M. Oxycodone versus placebo in children with undifferentiated abdominal pain: a randomized, double-blind clinical trial of the effect of analgesia on diagnostic accuracy. Arch. Pediatr. Adolesc. Med. 2005; 159: 320325.
  • 15
    Kemp C, McDowell J. Paediatric Pharmacopoeia 13th Ed.: Pharmacy Department, Royal Children's Hospital Melbourne; 2005.
  • 16
    Rossi S , ed. Australian Medicines Handbook 2011. Adelaide: Australian Medicines Handbook Pty Ltd, 2011.
  • 17
    Pokela ML, Anttila E, Seppala T, Olkkola KT. Marked variation in oxycodone pharmacokinetics in infants. Paediatr. Anaesth. 2005; 15: 560565.
  • 18
    Barclay ML, Begg EJ, Hickling KG. What is the evidence for once-daily aminoglycoside therapy? Clin. Pharmacokinet. 1994; 27: 3248.
  • 19
    National Asthma Council Australia. Asthma Management Handbook 2006. Melbourne: National Asthma Council Australia Ltd, 2006.
  • 20
    Alhashimi D, Al-Hashimi H, Fedorowicz Z. Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents. Cochrane Database Syst. Rev. 2009; (2): CD005506.
  • 21
    Kozer E, Greenberg R, Zimmerman DR, Berkovitch M. Repeated supratherapeutic doses of paracetamol in children – a literature review and suggested clinical approach. Acta Paediatr. 2006; 95: 11651171.
  • 22
    Antibiotic Expert Group. Therapeutic Guidelines: Antibiotic, Version 14. Melbourne: Therapeutic Guidelines Limited, 2010.
  • 23
    Guerra MM, Garcia E, Pilan RR, Rapoport PB, Campanholo CB, Martinelli EO. Antibiotic use in post-adenotonsillectomy morbidity: a randomized prospective study. Braz. J. Otorhinolaryngol. 2008; 74: 337341.
  • 24
    Aagaard L, Hansen EH. Prescribing of medicines in the Danish paediatric population outwith the licensed age group: characteristics of adverse drug reactions. Br. J. Clin. Pharmacol. 2011; 71: 751757.
  • 25
    Neubert A, Dormann H, Weiss J et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf. 2004; 27: 10591067.
  • 26
    Beggs S. Australian report on pediatric medication issues: is any magic happening in the ‘land of Oz’ to save the therapeutic orphan? Paediatr. Drugs 2009; 11: 3840.