Affiliations: Pharmacoepidemiology Unit, Departments of Medical
Informatics and Epidemiology & Biostatistics, Erasmus University Medical
Center, Rotterdam, The Netherlands | Consorzio per Valutazioni Biologiche e Farmacologiche,
Pavia, Italy | Centre for Paediatric Pharmacy Research, The School of
Pharmacy and Institute of Child Health, University of London, London,
UK | Pedianet, Società Servizi Telematici, Padova,
Italy
Abstract: Purpose. The differences in off-label prescriptions rate on the 5
most prescribed drugs in 14 ATC classes in 2005 were evaluated. Methods. Prescription data on 143 drugs were extracted from
3 primary care research databases. Off-label was defined as the use of a drug
below the Lowest Approved Age derived from the Summary of Products
Characteristics. Results. Only 25% of the drugs show the same Lowest
Approved Age in all three Countries and 52% are currently used off-label in
at least one (38%: UK, 40%: Holland, 46%: Italy). The percentage of
off-label prescriptions varies from 4.7 (UK) and 7.6 (Italy) to 32.4 (The
Netherlands). Conclusions. Off-label prescriptions rate considerably varies
in the three Countries due to the significant differences in the paediatric
status. The Paediatric Regulation provides rules and incentives aimed at
reducing the off-label uses in children. New criteria facilitating the
paediatric status harmonisation should be urgently proposed.
Keywords: TEDDY, off-label, prescription, children
