{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T12:44:27Z","timestamp":1791031467901,"version":"4.1.0"},"reference-count":22,"publisher":"American Academy of Pediatrics (AAP)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2003,2,1]]},"abstract":"<jats:p>Objective. To establish risk factors of unlicensed and off-label drug use by children outside the hospital.<\/jats:p>\n               <jats:p>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\u20131, 2\u20135, 6\u201311, or 12\u201316 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.<\/jats:p>\n               <jats:p>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.<\/jats:p>\n               <jats:p>Conclusion. Efforts to improve pediatric labeling are important and need full support. The present results can be used to focus these efforts.<\/jats:p>","DOI":"10.1542\/peds.111.2.291","type":"journal-article","created":{"date-parts":[[2004,8,14]],"date-time":"2004-08-14T00:43:47Z","timestamp":1092444227000},"page":"291-295","source":"Crossref","is-referenced-by-count":79,"title":["Risk Factors for Unlicensed and Off-Label Drug Use in Children Outside the Hospital"],"prefix":"10.1542","volume":"111","author":[{"given":"Eric","family":"Schirm","sequence":"first","affiliation":[{"name":"Groningen University Institute for Drug Exploration (GUIDE), University of Groningen, Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilde","family":"Tobi","sequence":"additional","affiliation":[{"name":"Groningen University Institute for Drug Exploration (GUIDE), University of Groningen, Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lolkje T.W.","family":"de Jong-van den Berg","sequence":"additional","affiliation":[{"name":"Groningen University Institute for Drug Exploration (GUIDE), University of Groningen, Department of Social Pharmacy, Pharmacotherapy and Pharmacoepidemiology, Groningen, the Netherlands"},{"name":"InterAction Working Group, Northern Netherlands, the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[2003,2,1]]},"reference":[{"key":"2021121010082392800_R1","doi-asserted-by":"crossref","unstructured":"Wilson JT. 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