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

                             Details van artikel 7 van 13 gevonden artikelen
 
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