Incidence of unlicensed and off-label prescription in children.
BACKGROUND
Many common drugs have not been licensed for use in children.


METHODS
This study evaluated the incidence of unlicensed and off-label prescriptions at the Department of Pediatrics during a period of six months. A total of 8,559 prescriptions for 4,282 children were processed.


RESULTS
Off-label and unlicensed prescriptions were found in 9.01% and 1.26% of all prescriptions, respectively. Unlicensed prescriptions were significantly more common in boys (1.5%) than in girls (1.0%) (p = 0.037). There was no significant difference between off-label prescriptions in boys (9.0%) and in girls (9.1%) (p = 0.89). The prescription of unlicensed drugs was significantly more frequent in school age children (p < 0.0001). The most commonly prescribed unlicensed drugs were angiotensin-converting enzyme inhibitors; among off-label drugs, antihistamines and bronchodilators.


CONCLUSIONS
This study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.
Petra
P
Langerová
Jiří
J
Vrtal
Department of Pharmacology, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Hněvotínská 3, 77515 Olomouc, Czech Republic. urbanek@fnol.cz.
Karel
K
Urbánek
D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems; D002648:Child; D002675:Child, Preschool; D018153:Czech Republic / Q000453:epidemiology; D004348:Drug Labeling; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D004366:Nonprescription Drugs / Q000009:adverse effects* / Q000600:supply & distribution; D056687:Off-Label Use / Q000706:statistics & numerical data*; D010045:Outpatients / Q000706:statistics & numerical data*; D010818:Practice Patterns, Physicians'; D012189:Retrospective Studies; D013997:Time Factors
D004366:Nonprescription Drugs