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Abstract
BackgroundMany common drugs have not been licensed for use in children.MethodsThis 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.ResultsOff-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.ConclusionsThis study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies.
Highlights
Unlicensed drugs were prescribed in 1.26%; offlabel drugs were prescribed in 9.01% of all prescriptions
There was no significant difference between off-label prescription in boys (9.0%, 95% CI 8.08–9.85) and in girls (9.1%, 95% CI 8.22–9.88) (p = 0.89)
This study shows that the incidence of unlicensed and off-label drug prescriptions in our patients is not as high as in other studies
Summary
The information available to pediatricians may not always be as detailed or as robust as when prescribing a medicine that is licensed for an approved indication. This has led to concerns that children can receive drugs at dosages that either lack efficacy or exhibit safety problems. The latter in particular has received a great deal of attention [2,3]. Many common drugs have not been licensed for use in children
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