This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow E-mail this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My File Cabinet
Right arrow Download to citation manager
Right arrowRequest Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via CrossRef
Right arrow Citing Articles via Web of Science (17)
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Schirm, E.
Right arrow Articles by de Jong-van den Berg, L. T.W.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Schirm, E.
Right arrow Articles by de Jong-van den Berg, L. T.W.
Related Collections
Right arrow Genetics & Dysmorphology
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us   Add to Digg   Add to Facebook   Add to Reddit   Add to Technorati   Add to Twitter  
What's this?
PEDIATRICS Vol. 111 No. 2 February 2003, pp. 291-295

Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital

Objective. To establish risk factors of unlicensed and off-label drug use by children outside the hospital.

Methods. A cross-sectional study based on 66 222 pharmacy dispensing records for the year 2000 was performed in the northern part of the Netherlands. All prescriptions were divided into the following categories: unlicensed (no product license), off-label (licensed drugs used outside the terms of the product license), and on-label (licensed drugs used according to the product license). For identifying possible problem areas, the proportions of unlicensed and off-label drug use were determined per age group (0–1, 2–5, 6–11, or 12–16 years) and per drug group. For all systemic drugs, a logistic regression was done that models the odds of receiving an unlicensed or off-label prescription as a function of several possible risk factors.

Results. Unlicensed drug use in Dutch children is the highest among 0 to 1-year-olds, and off-label drug use is the highest among 12- to 16-year-olds. Drug groups with highest percentages of unlicensed and off-label drug use were ophthalmologicals/otologicals (80.7% of all prescriptions in this group), blood and blood-forming organs (mainly vitamin K for breastfed newborns; 75.7%), cardiovascular drugs (74.7%), and dermatologicals (73.3%). Prescriptions by specialists (outpatient), prescriptions for new drugs, prescriptions for drugs with a low use in the pediatric population, and prescriptions for infants were risk factors for using a systemic drug unlicensed or off-label.

Conclusion. Efforts to improve pediatric labeling are important and need full support. The present results can be used to focus these efforts.

Eric Schirm, MPharmSc*, Hilde Tobi, PhD* and Lolkje T.W. de Jong-van den Berg, PhD*,{ddagger}

* Groningen University Institute for Drug Exploration (GUIDE), University of Groningen, Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen, the Netherlands
{ddagger} InterAction Working Group, Northern Netherlands, the Netherlands

Key Words: children • pediatrics • drug utilization • unlicensed • off-label • pharmacy dispensing data

Abbreviations: GP, general practitioner • ATC, Anatomic Therapeutic Chemical • FDA, US Food and Drug Administration

Received for publication Apr 1, 2002; Accepted Aug 5, 2002.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Facebook Facebook   Add to Reddit Reddit   Add to Technorati Technorati   Add to Twitter Twitter    What's this?


This article has been cited by other articles:


Home page
 Eur Respir JHome page
A. Bush
Evidence-based medicines for children: important implications for new therapies at all ages
Eur. Respir. J., December 1, 2006; 28(6): 1069 - 1072.
[Full Text] [PDF]

Home page
 PediatricsHome page
R. H. Clark, B. T. Bloom, A. R. Spitzer, and D. R. Gerstmann
Reported medication use in the neonatal intensive care unit: data from a large national data set.
Pediatrics, June 1, 2006; 117(6): 1979 - 1987.
[Abstract] [Full Text] [PDF]

Home page
 Eur Respir JHome page
G.W. 't Jong, I.A. Eland, M.C.J.M. Sturkenboom, J.N. van den Anker, and B.H.C. Stricker
Unlicensed and off-label prescription of respiratory drugs to children
Eur. Respir. J., February 1, 2004; 23(2): 310 - 313.
[Abstract] [Full Text] [PDF]