The use of unlicensed and off-label medicines in the neonate

Seminars in Fetal and Neonatal Medicine

Volumn 10, Issue 2, 2005, Pages 115-122

  Conroy, Sharon ^a   McIntyre, John ^a  

^a DERBYSHIRE CHILDREN S HOSPITAL   (United Kingdom)

Author keywords

Adverse drug reaction; Clinical trials; Drug; Formulation; License; Medication error; Medicine; Medicine trials; Neonate; Off label; Unauthorised; Unlicensed

Indexed keywords

ACETYLSALICYLIC ACID; AMINOGLYCOSIDE ANTIBIOTIC AGENT; CAFFEINE; DIAMORPHINE; FUROSEMIDE; GENTAMICIN; INDOMETACIN; INSULIN; MIDAZOLAM; MORPHINE; PENICILLIN G; POVIDONE IODINE; SODIUM CHLORIDE; THEOPHYLLINE; TOBRAMYCIN;

CLINICAL TRIAL; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG LABELING; DRUG OVERDOSE; DRUG STABILITY; HEALTH CARE QUALITY; HEALTH SURVEY; HUMAN; HUMAN RIGHTS; INCIDENCE; MEDICAL INFORMATION; MEDICAL PRACTICE; MEDICATION ERROR; MEDICOLEGAL ASPECT; NEWBORN CARE; NEWBORN INTENSIVE CARE; PREMATURITY; PRIMARY MEDICAL CARE; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; SAFETY; TOXICITY; TREATMENT CONTRAINDICATION;

EID: 13444287761     PISSN: 1744165X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.siny.2004.11.003     Document Type: Review

References (40)

1. P. Impicciatore, and I. Choonara Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use Br J Clin Pharmacol 48 1999 15 18
2. A. Ceci, M. Felisi, M. Catapano Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products Eur J Clin Pharmacol 58 2002 495 500
3. G.W. t'Jong, I.A. Eland, B.H.C. Stricker, and J.N. van den Anker Information for paediatric use of medicines in a product information compendium Paediatr Perinatal Drug Ther 4 2001 148 151
4. G. Mudur Indian Medical Association wants off-label prescribing Br Med J 328 2004 974
5. D.C. Sharma Indian experts protest against off-label drug use Lancet 363 2004 1372
6. Committee on Drugs Unapproved uses of approved drugs: the physician, the package insert, and the FDA Pediatrics 62 1978 262 264
7. Committee on Drugs Unapproved uses of approved drugs: the physician, the package insert, and the Food and Drug Administration: subject review Pediatrics 98 1996 143 145
8. C. Bendall The prescription and supply of drugs in children from a legal viewpoint Paediatr Perinatal Drug Ther 3 1999 49 54
9. Royal College of Paediatrics and Child Health and the Neonatal and Paediatric Pharmacists Group Medicines for Children 2nd ed. 2003 RCPCH Publications Limited on behalf of the RCPCH and the Neonatal and Paediatric Pharmacists Group London
10. Joint RCPCH/NPPG Standing Committee on Medicines The Use of Unlicensed Medicines or Licensed Medicines for Unlicensed Applications in Paediatric Practice. Policy Statement 2000 Feb Royal College of Paediatrics and Child Health London
11. D. Hull Birth of a formulary Arch Dis Child 81 1999 197 201
12. I. Choonara, T. Nunn, and D. Hull Editorial: medicines for children J Pharm Med 5 1995 95 96
13. F. Brion, A.J. Nunn, and A. Rieutord Extemporaneous (magistral) preparation of oral medicines for children in European hospitals Acta Paediatr 92 2003 486 490
14. S. Turner Unlicensed and off-label drug use in Australia Paediatr Perinatal Drug Ther 4 2000 24 27
15. S. Conroy Optimal dosing schedules with gentamicin are needed for premature neonates Br Med J 317 1998 204 205
16. S. Conroy The use of gentamicin in the neonate [Abstract] JPPT 8 2003 60 61
17. S. Conroy, J. McIntyre, and I. Choonara Unlicensed and off label drug use in neonates Arch Dis Child Fetal Neonatal Ed 80 1999 F142 F145
18. S. Turner, A.J. Nunn, K. Fielding, and I. Choonara Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study Acta Paediatr 88 1999 965 968
19. S. Avenel, A. Bomkratz, G. Dassieu, J.C. Janaud, and C. Danan Incidence of prescriptions without product licence in a neonatal intensive care unit [French] Arch Pediatr 7 2000 143 147
20. J. Barr, G. Brenner-Zada, E. Heiman Unlicensed and off-label medication use in a neonatal intensive care unit: a prospective study Am J Perinatol 19 2002 67 72
21. G.W. 't Jong, A.G. Vulto, M. de Hoog, K.J.M. Schimmel, D. Tibboel, and J.N. van den Anker Unapproved and off-label use of drugs in a children's hospital N Engl J Med 343 2000 1125
22. G.W. 't Jong, A.G. Vulto, M. de Hoog, K.J.M. Schimmel, D. Tibboel, and J.N. van den Anker A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital Pediatrics 108 2001 1089 1093
23. C.P.F. O'Donnell, R.J. Stone, and C.J. Morley Unlicensed and off-label drug use in an Australian neonatal intensive care unit Pediatrics 110 2002 e52 e55
24. M. Chalumeau, J.M. Treluyer, B. Salanave Off label and unlicensed drug use among French office based paediatricians Arch Dis Child 83 2000 502 505
25. G.W. 't Jong, I.A. Eland, M.C.J.M. Sturkenboom, J.N. van den Anker, and B.H.C. Stricker Determinants for drug prescribing to children below the minimum licensed age Eur J Clin Pharmacol 58 2003 701 705
26. G. Rylance The therapeutic underprivileged Dev Med Child Neurol 21 1979 399 400
27. H. Shirkey Therapeutic Orphans J Pediatrics 72 1968 119 120
28. K. Chappell, and C. Newman Potential tenfold drug overdoses on a Neonatal Unit Arch Dis Child 6 2004 20 23
29. Davies C. Junior doctor is cleared in baby overdose death 1999. http://www.portal.telegraph.co.uk/htmlContent.jhtml?html=/archive/1999/04/21/ ndoc21.html (accessed 19/10/2003).
30. A.M. Gill, H.J. Leach, J. Hughes, C. Barker, A.J. Nunn, and I. Choonara Adverse drug reactions in a paediatric intensive care unit Acta Paediatr 84 1995 438 441
31. A. Clarkson, E. Ingleby, I. Choonara, P. Bryan, and P. Arlett A novel scheme for the reporting of adverse drug reactions Arch Dis Child 84 2001 337 339
32. Clarkson A, Conroy S, Burroughs K, Choonara I. Surveillance for adverse drug reactions in children: a Paediatric Regional Monitoring Centre. Paediatr Perinatal Drug Ther; 2004 (in press).
33. P. Impicciatore, A. Mohn, F. Chiarelli, C. Pandolfini, and M. Bonati Adverse drug reactions to off-label drugs on a paediatric ward: an Italian prospective pilot study Paediatr Perinatal Drug Ther 5 2002 19 24
34. B. Horen, J.-L. Montastruc, and M. Lapeyre-Mestre Adverse drug reactions and off-label drug use in paediatric outpatients Br J Clin Pharmacol 54 2002 665 670
35. Department of Health and Human Services, US Food and Drug Administration. The Pediatric Exclusivity Provision; January 2001: Status Report to Congress.
36. Food and Drug Administration. Available online: http://www.fda.gov/ opacom/laws/pharmkids/contents.html (accessed 22.4.04).
37. G.L. Kearns The pediatric pharmacology research unit network: proof of concept Paediatr Perinatal Drug Ther 3 1999 9 14
38. Licensing Medicines for Children. Joint report of the British Paediatric Association and the Association of the British Pharmaceutical Industry. London 1996.
39. Health Committee. The specific health needs of children and young people. House of Commons Health Committee Second report, vol. 1 Session 1996-7 London, 1997.
40. S. Conroy A positive step forwards for paediatric medicine Hospital Pharmacy Europe 4 2002 78 79