Off label prescribing in children

doi:10.1136/bmj.324.7349.1290

BMJ 2002;324:1290-1291 ( 1 June )

Editorials

Off label prescribing in children

A view from the United States

Primary care pp 1311, 1312, 1313

The first 150 words of the full text of this article appear below.

Three papers in this issue, one from Germany and two from the Netherlands, highlight the problem of off label prescribingin children. ¹ ² At first reading these manuscripts were aconfusing "tower of Babel" for a reader from the United States,but the problem being discussed is all too familiar. In the UnitedStates the Food and Drug Administration has responsibility forthe licensing process for all drugs. The term "approved" is usedfor a drug that has been deemed to have safety and efficacy fora particular disease process. Until recently, the drug need onlyto have been studied in the adult male population. Yet once adrug is approved it may be prescribed by a physician for any populationor disease state desired. The term "off label" has been appliedto describe the use of these drugs in either populations or diseasestates not listed as indicated in the . . . [Full text of this article]

CiteULike

Complore

Connotea

Del.icio.us Add to Digg

Digg

StumbleUpon Add to Technorati

Technorati What's this?

Relevant Articles

Off label prescribing in children: S Guiton, David M Reith, and Valerie L Isitt
BMJ 2002 325: 338. [Extract] [Full Text]

Off label prescribing to children in primary care in Germany: retrospective cohort study: Reinhild Bücheler, Matthias Schwab, Klaus Mörike, Bernhard Kalchthaler, Hartmut Mohr, Helmut Schröder, Peter Schwoerer, and Christoph H Gleiter
BMJ 2002 324: 1311-1312. [Extract] [Full Text] [PDF]

Unlicensed and off label drug use by children in the community: cross sectional study: Eric Schirm, Hilde Tobi, and Lolkje T W de Jong-van den Berg
BMJ 2002 324: 1312-1313. [Extract] [Full Text] [PDF]

Unlicensed and off label prescription of drugs to children: population based cohort study: Geert W `t Jong, Ingo A Eland, Miriam C J M Sturkenboom, John N van den Anker, and Bruno H Ch Stricker
BMJ 2002 324: 1313-1314. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

Curtis, L. H., Masselink, L. E., Ostbye, T., Hutchison, S., Dans, P. E., Wright, A., Krishnan, R. R., Schulman, K. A. (2005). Prevalence of Atypical Antipsychotic Drug Use Among Commercially Insured Youths in the United States. Arch Pediatr Adolesc Med 159: 362-366 [Abstract] [Full text]
Schirm, E., Tobi, H., de Jong-van den Berg, L. T.W. (2003). Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital. Pediatrics 111: 291-295 [Abstract] [Full text]
O'Donnell, C. P. F., Stone, R. J., Morley, C. J. (2002). Unlicensed and Off-Label Drug Use in an Australian Neonatal Intensive Care Unit. Pediatrics 110: e52-52 [Abstract] [Full text]
Guiton, S, Reith, D. M, Isitt, V. L (2002). Off label prescribing in children. BMJ 325: 338-338 [Full text]

Rapid Responses:

Read all Rapid Responses

A cynical view from down-under: David M Reith
bmj.com, 7 Jun 2002 [Full text]
Medicines for Children: Valerie L Isitt
bmj.com, 7 Jun 2002 [Full text]
Off-label prescribing to children in primary care: Maurizio Bonati, et al.
bmj.com, 22 Jun 2002 [Full text]
Re: Off-label prescribing to children in primary care: David G Bartle, et al.
bmj.com, 25 Jun 2002 [Full text]
A view from Europe: Francis P. Crawley, et al.
bmj.com, 4 Jul 2002 [Full text]
Off-label and unlicensed drug use: a view-point from Australia: Elaine Tan, et al.
bmj.com, 15 Jul 2002 [Full text]
Where do our interests lie?: Dimah Sweis, et al.
bmj.com, 17 Jul 2002 [Full text]
Standardised terminology is useful: Gerben ter Riet, et al.
bmj.com, 16 Aug 2002 [Full text]