Unlicensed and off-label drug use in children

Journal of Postgraduate Medicine

Volumn 51, Issue 4, 2005, Pages 249-252

  Bavdekar, S B ^a   Gogtay, N J ^a  

^a KEM HOSPITAL   (India)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG EFFICACY; DRUG FORMULATION; DRUG LABELING; EDITORIAL; HEALTH PRACTITIONER; HUMAN; LICENSING; MEDICAL LITERATURE; MEDICAL PRACTICE; MEDICINE; OFF LABEL DRUG USE; PEDIATRICS; PHYSICIAN; QUALITY CONTROL; RISK ASSESSMENT; SAFETY;

CHILD; DRUG APPROVAL; DRUG INDUSTRY; DRUG LABELING; HUMANS; PHARMACEUTICAL PREPARATIONS; PHYSICIAN'S PRACTICE PATTERNS; UNITED STATES;

EID: 30444435503     PISSN: 00223859     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Editorial

References (34)

1. Cuzzolin L, Zaccaron A, Fanos V. Unlicensed and off-label uses of drugs in paediatrics:a review of literature. Fundamental and Clinical pharmacology 2003;17:125-31.
2. 't Jong GW, Vulto AG, de Hoog M, Schimmel KJM, Tibboel D, van den Anker JN. A survey of the use of off-label and unlicensed drugs in Dutch Children's Hospital. Pediatrics 2001;108:1089-93.
3. 't Jong GW, Eland A, Strukenboom MCJM, van den Anker JN, Stricker BHC. Unlicensed and off-label prescription of drugs to children:population based cohort study. BMJ 2002;324:1313-4.
4. Dick A, Keady S, Mohamed R Brayley S, Thomson M, Lloyd BW, et al. Use of unlicensed and off-label medications in pediatric gastroenterology with a review of the commonly used formularies in the UK. Aliment Phrmacol Ther 2003;17:571-5.
5. Carvalho PRA, Carvalho CG, Alievi PT, Martinbiancho J, Trotta EA. Prescription of drugs not appropriate for children in a pediatric intensive care unit. Journal de Pediatria 2003;79:397-402.
6. Pandolfini C, Impicciatore P, Provasi D, Rocchi F, Campi R, Bonati M, Italian Paediatric Off-label Collaborative Group. Off-label use of drugs in Italy:a prospective, observational and multicenter study. Acta Paediatr 2002;91:339-47
7. Chalumeau M, Treluyer JM, Salanave B, Assathiany R, Cheron G, Crocheton N, et al. Off-label and unlicensed drug use among French office based pediatricians. Arch Dis child 2000;83:502-5.
8. McIntyre J, Conroy S, Avery A, Corns H. Choonara I. Unlicensed and off-label prescribing of drugs in general practice. Arch Dis Child 2000;83:498-501.
9. Bucheler R, Schwab M, Morike K, Kalchthaler B, Mohr H, Schroderer P, et al. Off-label prescribing to children in primary care in Germany:retrospective cohort study. BMJ 2002;324:1311-2.
10. Schirm E, Tobi H, de Jong-van den Berg LTW. Unlicensed and off-label drug use by children in the community:cross sectional study. BMJ 2002;324:1312-3.
11. Conroy S, Choonara I, Impicciatore P, Mohn A, Arnell H, Rane A, et al. Survey of unlicensed and off-label drug use in paediatric wards in European countries. BMJ 2000;320:79-82.
12. Turner S, Gill A, Nunn T, Hewitt B, Choonara I. Use of 'off-label' and unlicensed drugs in paediatric intensive care unit. Lancet 1996;347:549-50.
13. Turner S, Longworth A, Nunn AJ, Choonara I. Unlicensed and off-label drug use in pediatric wards prospective study. BMJ 1998;316:343-5.
14. Coroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch Dis Child:Fetal Neonat Ed 1999;80:F142-5.
15. Wilton LV, Pearce G, Mann RD. The use of newly marketed drugs in children and adolescents prescribed in general practice. Pharmacoepidemiol Drug Safety 1999;8:537-45.
16. 't Jong GW, Vulto AG, De Hoog M, Schimmel KJM, Tibboel D, van den Anker JN. Unapproved and off-label use of drugs in a children's hospital. N Engl J Med 2000;343:1125.
17. American Academy of Pediatrics Committee on Drugs. Unapproved uses of approved drugs:The Physician, the package insert, and the Food and Drug Administration:Subject Review. Pediatrics 1996;98:143-5.
18. Gavrilov V, Lifshitz M, Levy J, Gorodischer R. Unlicensed and off-label medication use in a general pediatrics ambulatory hospital unit in Israel. Isr Med Assoc J 2000;2:595-7.
19. Craig JS, Henderson CR, Magee FA. The extent of unlicensed and off-label drug use in the pediatric ward of a district general hospital in Northern Ireland. Ir Med J 2001;94:237-40.
20. O'Donnel CPF, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian Neonatal Intensive Care Unit. Pediatrics 2002;110:e52 (http://pediatrics.aappublications.org;last accessed on 23 Sep 2005).
21. Schirm E, Tobi H, de Jong-van den Berg LTW. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics 2003;111:291-5
22. Neubert A, Dormann H, Weiss J, Egger T, Criegee-Rieck M, Rascher W, et al. The impact of unlicensed and off-label drug use on adverse drug reactions in paediatric patients. Drug Safety 2004;27:1059-67.
23. Turner S, Nunn, AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on pediatrics wards:a prospective study. Acta Peadiatr 1999;88:965-8.
24. Conroy S. Unlicensed and Off-label Drug Use. Issues and recommendations. Pediatr Drugs 2002;4:353-9.
25. Blumer JL. Off-label uses of drugs in children. Pediatrics 1999;104:598-602.
26. Horen B, Montastruc J-L, Lapeyre-Mestre M. Adverse drug reactions and off-label use in paediatric outpatients. Br J Clin Pharmacol 2002;54:665-70.
27. Hill P. Off license and off label prescribing in children:litigation fears for physicians. Arch Dis Child 2005;90:17-8.
28. Boos J. Off label use-label off use? Ann Oncol 2003;14:1-5.
29. Chesney RW, Christensen ML. Changing requirements for evaluation of pharmacologic agents. Pediatrics 2004;113:1128-32.
30. Steinbrook R. Testing medications in children. New Engl J Med 2002;347:1462-70.
31. Bavdekar SB. Protecting children participating in Research trials:Review Boards should take up Pro-active Role. Indian Pediatrics [in press]
32. Wong I Sweis D, Cope J, Florence A. Paediatric Medicines Research in the UK. How to move forward? Drug Safety 2003;26:529-37.
33. Committee on Drug, American Academy of Pediatrics. Uses of drugs not described in the Package Insert (Off-Label Uses). Pediatrics 2002;110:181-3.
34. Beggs SA, Cranswick NE, Reed MD. Improving drug use for children in the developing world. Arch Dis Child 2005;90:1091-3.