Klin Farmakol Farm. 2012;26(4):161-165

Unlicensed and off-label drug use in children

Petra Langerová¹, Jiří Vrtal¹, Jana Fürstová²

¹ Ústav farmakologie LF UP a FN Olomouc

² Katedra matematické analýzy a aplikací matematiky, Přírodovědecká fakulta Univerzity Palackého v Olomouci

Many common drugs have not been registered for use in children or their prescription for children is limited to a certain age. Therefore, they

are sometimes prescribed as unlicensed (drugs unregistered for children) or off-label (prescribed for children younger than those for whom the

drug is registered). In this study, we evaluated the incidence of this type of prescription for medicinal products prescribed by the Department

of Pediatrics, University Hospital Olomouc in a period of 3 months. A total of 4,174 prescriptions for 2,100 children were evaluated. Unlicensed

or off-label drugs were found in 8.62 % of prescriptions. Unlicensed prescriptions were significantly more common in boys than in girls. The

prescription of unlicensed drugs was significantly more frequent in school age children than in any other age group. The most commonly

prescribed unlicensed drugs were ACE inhibitors; among off-label drugs, antihistamines and bronchodilators were most frequently prescribed.

Keywords: off-label, unlicensed, drugs, children, pediatrics, prescriptions, hospital

Published: December 1, 2012  Show citation