Healthy Skepticism Library item: 10631
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
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 Feb; 111:(2):291-5
http://pediatrics.aappublications.org/cgi/content/full/111/2/291
Abstract:
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.
Keywords:
Adolescent
Child
Child, Hospitalized*
Child, Preschool
Cross-Sectional Studies
Drug Approval/legislation & jurisprudence*
Drug Labeling/legislation & jurisprudence*
Drug and Narcotic Control/legislation & jurisprudence
Family Practice/trends
Female
Humans
Infant
Infant, Newborn
Legislation, Drug*
Licensure/trends*
Male
Netherlands
Pharmaceutical Preparations/supply & distribution
Pharmaceutical Services
Physician's Practice Patterns/trends
Prescriptions, Drug/statistics & numerical data
Risk Factors
