Licensing and labelling of drugs in a paediatric oncology ward

British Journal of Clinical Pharmacology

Volumn 72, Issue 3, 2011, Pages 474-481

  van den Berg, Henk ^a,b   Tak, Nanda ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b MEDICINES EVALUATION BOARD   (Netherlands)

Author keywords

Children; Drug licensing; Drug off label use; Oncology; Pharmacotherapy

Indexed keywords

ALCOHOL; ALLOPURINOL; AMSACRINE; ASPARAGINASE; BLEOMYCIN; CARBOPLATIN; CLADRIBINE; CYCLOPHOSPHAMIDE; CYTARABINE; DACARBAZINE; DACTINOMYCIN; DEXAMETHASONE; DOMPERIDONE; DOXORUBICIN; ENOXAPARIN; ETOPOSIDE; GEMCITABINE; HEPARIN; IFOSFAMIDE; IRINOTECAN; MERCAPTOPURINE; METHOTREXATE; NAVELBINE; OXALIPLATIN; PREDNISOLONE; RITUXIMAB; TOPOTECAN; UNINDEXED DRUG; VANCOMYCIN; VINBLASTINE;

ADOLESCENT; ARTICLE; CANCER PATIENT; CHILD; CLINICAL ARTICLE; HOSPITAL PHARMACY; HUMAN; LICENSING; LOW DRUG DOSE; NETHERLANDS; OFF LABEL DRUG USE; PEDIATRIC WARD; PRESCRIPTION; PRIORITY JOURNAL;

ADOLESCENT; AGE FACTORS; ANTINEOPLASTIC AGENTS; CHILD; CHILD, PRESCHOOL; DRUG APPROVAL; DRUG LABELING; DRUG PRESCRIPTIONS; HOSPITALS; HUMANS; INFANT; LEGISLATION, DRUG; MEDICAL ONCOLOGY; NETHERLANDS; OFF-LABEL USE; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; PHYSICIAN'S PRACTICE PATTERNS;

EID: 79961139523     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2011.03977.x     Document Type: Article

References (32)

1. Bua J, L'Erario I, Barbi E, Marchetti F. When off-label is a good practice: the example of paracetamol and salbutamol. Arch Dis Child 2008; 93: 546-7.
2. Schirm E, Tobi H, de Jong-van den Berg LT. Unlicensed and off label drug use by children in the community: cross sectional study. BMJ 2002; 324: 1312-3.
3. Chalumeau M, Treluyer JM, Salanave B etal. Off label and unlicensed drug use among French office based paediatricians. Arch Dis Child 2000; 83: 502-5.
4. 't Jong GW, Vulto AG, de HM, Schimmel KJ, Tibboel D, van den Anker JN. A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital. Pediatrics 2001; 108: 1089-93.
5. Conroy S, Newman C, Gudka S. Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children. Ann Oncol 2003; 14: 42-7.
6. Woods WG, O'Leary M, Nesbit ME. Life-threatening neuropathy and hepatotoxicity in infants during induction therapy for acute lymphoblastic leukemia. J Pediatr 1981; 98: 642-5.
7. Allen JC. The effects of cancer therapy on the nervous system. J Pediatr 1978; 93: 903-9.
8. Reaman G, Zeltzer P, Bleyer WA, De Lorenzo P, Hann I, De Rossi G, Felice M, Hovi L, LeBlanc T, Szczepanski T, Ferster A, Janka G, Rubnitz J, Silverman L, Stary, Campbell M, Li CK, Mann G, Suppiah R, Biondi A, Vora A, Valsecchi MG. Acute lymphoblastic leukemia in infants less than one year of age: a cumulative experience of the Children's Cancer Study Group. J Clin Oncol 1985; 3: 1513-21.
9. Jones B, Breslow NE, Takashima J. Toxic deaths in the Second National Wilms' Tumor Study. J Clin Oncol 1984; 2: 1028-33.
10. Reaman GH. Special considerations for the infant with cancer. In: Pediatric Oncology, eds Pizzo PA, Poplack DG. Philadelphia, PA: J.B.Lippincott, 1989; 263-74.
11. Murry DJ, Crom WR, Reddick WE, Bhargava R, Evans WE. Liver volume as a determinant of drug clearance in children and adolescents. Drug Metab Dispos 1995; 23: 1110-6.
12. Pieters R, Schrappe M, De Lorenzo P, Hann I, De Rossi G, Felice M, Hovi L, LeBlanc T, Szczepanski T, Ferster A, Janka G, Rubnitz J, Silverman L, Stary, Campbell M, Li CK, Mann G, Suppiah R, Biondi A, Vora A, Valsecchi MG. A treatment protocol for infants younger than 1 year with acute lymphoblastic leukaemia (Interfant-99): an observational study and a multicentre randomised trial. Lancet 2007; 370: 240-50.
13. van der Linden MH, Valsecchi MG, De Lorenzo P, Moricke A, Janka G, LeBlanc TM, Felice M, Biondi A, Campbell M, Hann I, Rubnitz JE, Stary J, Szczepanski T, Vora A, Ferster A, Hovi L, Silverman LB, Pieters R. Outcome of congenital acute lymphoblastic leukemia treated on the Interfant-99 protocol. Blood 2009; 114: 3764-8.
14. Hempel G, Relling MV, de Rossi G, Stary J, De Lorenzo P, Valsecchi MG, Barisone E, Boos J, Pieters R. Pharmacokinetics of daunorubicin and daunorubicinol in infants with leukemia treated in the Interfant 99 protocol. Pediatr Blood Cancer 2010; 54: 355-60.
15. Adamson PC. It's not easy being small. Pediatr Blood Cancer 2010; 54: 341-3.
16. Food and Drug Administration HHS. International Conference on Harmonisation; guidance on E11 clinical investigation of medicinal products in the pediatric population; availability. Notice. Federal Register 2000; 78493-4.
17. Poole SG, Dooley MJ. Off-label prescribing in oncology. Support Care Cancer 2004; 12: 302-5.
18. Leveque D, Michallat AC, Schaller C, Ranc M. [Off label drug use in adult patients treated by anticancer chemotherapy]. Bull Cancer 2005; 92: 498-500.
19. Milne CP, Bruss JB. The economics of pediatric formulation development for off-patent drugs. Clin Ther 2008; 30: 2133-45.
20. Grieve J, Tordoff J, Reith D, Norris P. Effect of the paediatric exclusivity provision on children's access to medicines. Br J Clin Pharmacol 2005; 59: 730-5.
21. Lilleyman JS, Lennard L. Non-compliance with oral chemotherapy in childhood leukaemia. BMJ 1996; 313: 1219-20.
22. Brion F, Nunn AJ, Rieutord A. Extemporaneous (magistral) preparation of oral medicines for children in European hospitals. Acta Paediatr 2003; 92: 486-90.
23. Piro CC, Crossno CL, Collier A, Ho R, Koyama T, Frangoul H. Initial vancomycin dosing in pediatric oncology and stem cell transplant patients. J Pediatr Hematol Oncol 2009; 31: 3-7.
24. Muhlbauer B, Janhsen K, Schoettler P. Off-label use of prescription drugs in childhood and adolescents. Dtsch Arztebl 2009; 106: 25-31.
25. Kumar P, Walker JK, Hurt KM, Bennett KM, Grosshans N, Fotis MA. Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications. J Pediatr 2008; 152: 412-5.
26. Schirm E, Tobi H, de Jong-van den Berg LT. Risk factors for unlicensed and off-label drug use in children outside the hospital. Pediatrics 2003; 111: 291-5.
27. O'Donnell CP, Stone RJ, Morley CJ. Unlicensed and off-label drug use in an Australian neonatal intensive care unit. Pediatrics 2002; 110: e52.
28. Bavdekar SB, Gogtay NJ. Unlicensed and off-label drug use in children. J Postgrad Med 2005; 51: 249-52.
29. Sturkenboom MC, Verhamme KM, Nicolosi A, Murray ML, Neubert A, Caudri D, Picelli G, Sen EF, Giaquinto C, Cantarutti L, Balardi P, Felisi MG, Ceci A, Wong IC Teddy European Network of Excellence. Drug use in children: cohort study in three European countries. BMJ 2008; 337: a2245.
30. Groninger E, Proost JH, de Graaf SS. Pharmacokinetic studies in children with cancer. Crit Rev Oncol Hematol 2004; 52: 173-97.
31. Bramwell VH, Burgers M, Sneath R, Souhami R, Van Oosterom AT, Voute PA, Rouesse J, Spooner D, Craft AW, Somers R. A comparison of two short intensive adjuvant chemotherapy regimens in operable osteosarcoma of limbs in children and young adults: the first study of the European Osteosarcoma Intergroup. J Clin Oncol 1992; 10: 1579-91.
32. LeGuyader N, Pouliquen A-L, Benoit G, Leverger G. Medicaments hors autorisation de mise sur le marche en hematologie-oncologie pediatrique. Arch Pediatr 2006; 13: 1267-1268.