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.
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