Rivista di formazione e aggiornamento professionale del pediatra e del medico di base, fondata nel 1982. In collaborazione con l'Associazione Culturale Pediatri.
Login Abbonamenti Pubblicazioni Carrello Registrazione Perché registrarsi? Contatti

Farmacoriflessioni

PDF

La prima lista dei farmaci cardiovascolari autorizzati per un uso pediatrico

THE FIRST LIST OF CARDIOVASCULAR DRUGS AUTHORIZED IN PAEDIATRICS

Working Group Pediatrico dell’AIFA

Marzo 2010 - pagg. 172 -176

Abstract
29 off label drugs that are necessary and irreplaceable to treat cardiovascular pathologies in children are legitimized by the paediatric working group of the Italian Medicines Agency (AIFA). Thus, their use is authorized and they can be supplied by the National Health Service. Such drugs belong to the following classes: antiarrthymics, calcium antagonists, hypocholesterolemics, hypotensives, peripheral vessel dilators, ACE-inhibitors, beta-blockers, diuretics and sympathicomimetics. RCTs exist for 20 of these drugs; however, for the remaining 9 consensus articles or guidelines that envisage their utilization for said pathologies in children have been produced.
Bibliografia

• Anonimo. Regolamento Europeo dei farmaci pediatrici. Bif 2005;XII:201-2.
• BNF for Children. London: BMJ Publishing Group, 2009.
• Bajcetic M, Jelisavcic M, Mitrovic J, et al. Off label and unlicensed drugs use in paediatric cardiology. Eur J Clin Pharmacol 2005; 61:775-9.
• Bazzano AT, Mangione-Smith R, Schonlau M, Suttorp MJ, Brook RH. Off label prescribing to children in the United States outpatient setting. Acta Pediatr 2009;9:81-8.
• Ceci A, Felisi M, Baiardi P, et al. Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years. Eur J Clin Pharmacol 2006;62:947-52.
• Choonara I. Regulation of drugs for children in Europe. BMJ 2007;335:1221-2.
• Conroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. European Network for Drug Investigation in Children. BMJ 2000;320:79-82.
• Marchetti F, Bua J, Ventura A, et al. The awareness among paediatricians of off label prescribing in children: a survey of Italian hospitals. Eur J Clin Pharmacol 2007;63:81-5.
• Marchetti F. Lo sciopero delle medicine per i bambini. Medico e Bambino 2007;26:483- 4.
• Ministero della Salute. Guida all’uso dei farmaci per i bambini. Roma: Istituto Poligrafico e Zecca dello Stato, 2003.
• Neubert A, Wong IC, Bonifazi A, et al. Defining off label and unlicensed use of medicines for children: results of a Delphi survey. Pharmacol Res 2008;58:316-22.
• Pandolfini C, Bonati M. A literature review on off label drug use in children. Eur J Pediatr 2005;164:552-8.
• Pasquali SK, Hall M, Slonim AD, et al. Off-label use of cardiovascular medications in children hospitalized with congenital and acquired heart disease. Circ Cardiovasc Qual Outcomes 2008;1:74-83.
• Regulation (EC), No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use and, as amended, Regulation (EC), No 1902/2006, Official Journal of the European Union, 27 Dec 2006.
• Sturkenboom MC, Verhamme KM, Nicolosi A, et al.; TEDDY European Network of Excellence. Drug use in children: cohort study in three European countries. BMJ 2008;337: a2245.

Corrispondenza: f.rocchi@aifa.gov.it