RPS Conference 2010, Abstracts 2010 - Royal Pharmaceutical Society

Other published studies have reported between 0.2 to 42% of unlicensed and 18 to 60% of offlabel
use of medicines in hospitalised children. [1,2]
Table 1: Unlicensed and off-label medicine use in hospitalised children in N. Ireland and
Singapore
Parameters N. Ireland Singapore
Unlicensed medicines (UL) 10.4% 1.3%
Off-label medicines (OL) 32.6% 20.6%
Patients receiving at least one UL or 78.7% 41.3%
OL
Primary reason for UL use Use of ‘specials’ Extemporaneous preparation
Most commonly prescribed UL Codeine> omeprazole>
spironolactone
Phenobarbital> rifampicin>
Ursodeoxycholic acid
Primary reason for OL use Outside licensed dose range Outside licensed dose range
Most commonly prescribed OL Paracetamol> ibuprofen>
salbutamol
Salbutamol> trimebutine
maleate> epinephrine
Conclusions
The study highlights widespread use of unlicensed/off-label medicines, particularly in N. Ireland.
Although further work is required in reviewing the license status and use characteristics of
individual medicines in the two countries, the study draws the attention to the need for further
co-ordinated research to improve the availability of licensed medicines (especially in suitable
paediatric formulations) for children internationally.
References
1. Cuzzolin L et al. Off-label and unlicensed prescribing for newborns and children in different settings: a
review of the literature and a consideration about drug safety. Exp Op Drug Saf 2006; 5: 703–718.
2. Lindell-Osuagwu L et al. Off-label and unlicensed drug prescribing in three paediatric wards in Finland
and review of the international literature. J Clin Pharm Ther 2009; 34: 277–287.