Skip Navigation

This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (14)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Conroy, S.
Right arrow Articles by Gudka, S.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Conroy, S.
Right arrow Articles by Gudka, S.
Related Collections
Right arrow 2003 - Editors Choice
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Annals of Oncology 14:42-47, 2003
© 2003 European Society for Medical Oncology

Original Paper

Unlicensed and off label drug use in acute lymphoblastic leukaemia and other malignancies in children

S. Conroy1,+, C. Newman2 and S. Gudka2

1 Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Uttoxeter Road, Derby; 2 Pharmacy Department, Queen’s Medical Centre University Hospital NHS Trust, Nottingham, UK

Received 13 May 2002; revised 13 August 2002; accepted 11 September 2002

Background:

The need to use unlicensed and off label drugs in children due to the lack of suitable, licensed formulations with appropriate prescribing information creates many problems on an everyday basis for healthcare professionals, carers and children.

Patients and methods:

This prospective study was designed to examine the incidence and nature of unlicensed and off label prescribing, in paediatric oncology patients with acute lymphoblastic leukaemia and other malignancies. Inpatient and outpatient prescriptions were analysed for a 4-week period.

Results:

All patients received at least one unlicensed or off label drug. Fifty-five per cent of prescriptions were licensed, 19% were unlicensed and 26% were licensed drugs used in an off label manner. Unlicensed preparations were used in 40% of prescriptions for cytotoxic agents, due to a lack of commercially available formulations suitable for the paediatric patient. These drugs included mercaptopurine and methotrexate which have been used in the treatment of paediatric leukaemia for many years, their efficacy having been demonstrated by on-going Medical Research Council trials.

Conclusions:

It is disappointing that drugs, which are the mainstay of therapy for paediatric leukaemia and other malignancies, are unavailable in appropriate licensed formulations to facilitate their administration to children. This needs to be urgently addressed.

Key words: chemotherapy, children, leukaemia, off label, unlicensed


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Ann OncolHome page
P. G. Casali and On behalf of the Executive Committee of ESMO
The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO)
Ann. Onc., December 1, 2007; 18(12): 1923 - 1925.
[Full Text] [PDF]

Home page
 Arch Pediatr Adolesc MedHome page
S. S. Shah, M. Hall, D. M. Goodman, P. Feuer, V. Sharma, C. Fargason Jr, D. Hyman, K. Jenkins, M. L. White, F. H. Levy, et al.
Off-label Drug Use in Hospitalized Children
Arch Pediatr Adolesc Med, March 1, 2007; 161(3): 282 - 290.
[Abstract] [Full Text] [PDF]

Home page
 Ann OncolHome page
J. Boos
Off label use--label off use?
Ann. Onc., January 1, 2003; 14(1): 1 - 5.
[Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.