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| 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. |
| Uitgever: |
IOS Press |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 7 van 13 gevonden artikelen
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