Off label and unlicensed drugs use in paediatric cardiology

European Journal of Clinical Pharmacology

Volumn 61, Issue 10, 2005, Pages 775-779

  Bajcetic, M ^a,c   Jelisavcic, M ^b   Mitrovic, J ^c   Divac, N ^a   Simeunovic, S ^c   Samardzic, R ^a   Gorodischer, R ^d  

^a UNIVERSITY OF BELGRADE   (Serbia)

^b IRITEL Telecomunications and Electronic Co   (Serbia)

^c UNIVERSITY CHILDREN S HOSPITAL   (Serbia)

^d BEN GURION UNIVERSITY OF THE NEGEV   (Israel)

Author keywords

Drugs; Off label prescribing; Paediatric cardiology; Unlicensed prescribing

Indexed keywords

ADOLESCENT; ARTICLE; CARDIOLOGY; CHILD; COMPUTER PROGRAM; DRUG EFFICACY; DRUG FORMULARY; DRUG SAFETY; HUMAN; INFORMATION PROCESSING; LICENSING; MAJOR CLINICAL STUDY; MEDICAL RECORD; NEWBORN; PATIENT; POPULATION RESEARCH; PRESCRIPTION; PRIORITY JOURNAL; PROSPECTIVE STUDY; SUPPORT GROUP; WARD;

EID: 27944456865     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-005-0981-y     Document Type: Article

References (38)

1. Turner S, Longworth A, Nunn AJ, Choonara I (1998) Unlicensed and off label drug use in paediatric wards: prospective study. BMJ 316:F343-F345
2. Conroy S, Choonara I, Impicciatore P, et al. (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 320:79-82
3. Pandolfini C, Impicciatore P, Provasi D et al. (2002) Off label use of drugs in Italy: a prospective, observational and multicentre study. Acta Paediatr 91:339-347
4. Conroy S, Mc Intyre J, Choonara I (1999) Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 80:F142-F145
5. Avenel S, Bomkratz A, Dassieu G, Janaud JC, Danan C (2000) The incidence of prescriptions without marketing product license in a neonatal intensive care unit. Arch Pediatr 7:143-147
6. Gavrilov V, Berkovich M, Ling G et al. (2003) Unapproved prescriptions in two pediatric intensive care units in Israel. Curr Ther Res 64:734-742
7. McIntyre J, Conroy S, Avery A, Corns H, Choonara I (2000) Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 83:F498-F501
8. Chalumeau M, Treluyer JM, Salanave B et al. (2000) Unlicensed and off label drug use among French office based paediatricians. Arch Dis Child 83:F502-F505
9. Lifshitz M, Gavrilov V, Grossman Z et al. (2002) Unapproved prescribing practices in primary pediatric clinics in Israel. Curr Ther Res 64:734-742
10. Daukes-Ekins S, Helms PJ, Simpson CR et al. (2004) Off label prescribing to children in primary care: retrospective observational study. Eur J Clin Pharmacol 60:349-353
11. Conroy S, Choonara I (2002) Unlicensed and off label drug use in children: implications for safety. Drug Saf 25:1-5
12. Turner S, Nunn AJ, Fielding K, Choonara I (1999) Adverse drug reactions to unlicensed and off label drugs on paediatric wards: prospective study. Acta Paediatr 88:965-968
13. Ufer M, Kimland E, Bergman U (2004) Adverse drug reactions and off label prescribing for paediatric outpatients: a one year survey of spontaneous report in Sweden. Pharmacoepidemiol Drug Saf 13:147-152
14. Jonville-Bera AP, Bera F, Autret-Leca E (2005) Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study. Eur J Clin Pharmacol 61:231-236
15. European Agency for the Evaluation of Medical Products. Human Medicines Evaluation Unit. Committee for Proprietary Medicinal Products (1977) Note for guidance on clinical investigation of medical products in children. EMEA, London
16. WHO (1997) Anatomical therapeutic chemical index with defined daily doses (DDDs). WHO Collaborating Centre for Drug Statistical Metodology, Geneva
17. Registar Lekova (2002) Apotekarska ustanova Beograd. 11 izdanje, Belgrade
18. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary (2001) No 41. BMA, RPSGB, London
19. Physicans' desk reference (PDR) (2002) Medical economics, 56th edn. Thomson Healthcare, London
20. Cuzzolin L, Zaccaron A, Fanos V (2003) Unlicensed and off-label uses of drugs in paediatrics: a review of the literature. Fundam Clin Pharmacol 17:125-131
21. O'Donnell CPF, Stone RJ, Morley CJ (2002) Unlicensed and off label drug use in an Australian neonatal intensive care unit. Pediatrics 110:e52
22. 't Jong GW, van der Linden PD, Bakker EM (2002) Unlicensed and off-label drug use in a paediatric ward of a general hospital in the Netherlands. Eur J Clin Pharmacol 58:293-297
23. Efron D, Hiscock H, Sewell JR et al. (2003) Prescribing of psychotropic medications for children by Australian pediatricians and child psychiatrists. Pediatrics 111:372-375
24. 't Jong GW, Eland IA, Sturkenboom MC et al. (2004) Unlicensed and off-label prescription of respiratory drugs to children. Eur Resp 123:310-313
25. Conroy S, Peden V (2001) Unlicensed and off-label drug analgesic use in paediatric pain management. Paediatr Anaesth 11:431-436
26. Conroy S, Newman C, Gudka S (2003) Unlicensed and off-label drug use in acute lymphoblastic leukaemia and other malignancies in children. Ann Oncol 14:42-47
27. Nahata MC (1999) Lack of pediatric drug formulations. Pediatrics 104:607-609
28. Roberts R, Rodriguez W, Murphy D et al. (2003) Pediatric drug labeling. Improving the safety and efficacy of pediatric therapies. JAMA 290:905-911
29. Steinbrook R (2002) Testing medications in children. N Engl J Med 347:1462-1470
30. Sammos HM, Choonara I (2005) Clinical trials of medication in children, 1996-2002. Eur J Clin Pharmacol 61:165-167
31. Medicines for children - The European Paediatric initiative. EMEA 2005 (http://www.emea.eu.int/htms/human/peg/peg-faq.htm)
32. MacLeod SM (1993) Clinical pharmacokinetics: a pediatric overview. In: Radde IC, MacLeod SM (eds) Pediatric pharmacology and terapeutics, 2nd edn. Mosby Year Book, St Louis, pp 157-161
33. Wolfe RR, Boucek M, Schaeffer MS, Wiggins JW Jr (1995) Cardiovascular diseases. In: Hay WW Jr, Groothuis JR, Hayward AR, Levin MJ (eds) Current pediatric diagnosis & treatment, 12th edn. Appleton & Lange, pp 1190-1201
34. Bajcetic M, Mitrovic J, Vukomanovic G et al. (2002) Preliminary report of efficacy and safety of carvedilol in children with dilated cardiomyopathy. J Am Coll Cardiol 39:423
35. Bruns LA, Chrisant MK, Lamour JM et al. (2001) Carvedilol as therapy in pediatric heart failure: an initial multicenter experience. J Pediatr 138:505-511
36. Laer S, Mir TS, Behn F et al. (2002) Carvedilol therapy in pediatric patients with congestive heart failure: a study investigating clinical and pharmacokinetic parameters. Am Heart J 143: F916-F992
37. Choonara I (2004) Unlicensed and off-label drug use in children: implications for safety. Expert Opin Drug Saf 3:81-83
38. Neubert A, Dorman H, Weiss J et al. (2004) The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Saf 27:1059-1067