Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands
Titel:
Paediatric status and off-label use of drugs in children in Italy, United Kingdom and the Netherlands
Auteur:
Sturkenboom, M. Felisi, M. Manfredi, C. Neubert, A. Cantarutti, L. Padula, R. Sen, F. Verhamme, K.
Verschenen in:
Pharmaceuticals policy and law
Paginering:
Jaargang 11 (2009) nr. 1-2 pagina's 51-59
Jaar:
2009-03-10
Inhoud:
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.