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.


CONCLUSIONS
Efforts to improve pediatric labeling are important and need full support. The present results can be used to focus these efforts.
Schirm
Eric
E
Groningen University Institute for Drug Exploration (GUIDE), University of Groningen, Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen, The Netherlands.
Tobi
Hilde
H
de Jong-van den Berg
Lolkje T W
LT
D000293:Adolescent; D002648:Child; D002673:Child, Hospitalized; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D011307:Drug Prescriptions / Q000706:statistics & numerical data; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D005194:Family Practice / Q000639:trends; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007880:Legislation, Drug; D008004:Licensure / Q000639:trends*; D008297:Male; D009426:Netherlands; D004364:Pharmaceutical Preparations / Q000600:supply & distribution; D010593:Pharmaceutical Services; D010818:Practice Patterns, Physicians' / Q000639:trends; D012307:Risk Factors
D004364:Pharmaceutical Preparations