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Accessibilità e sicurezza dei farmaci in pediatria

Alessandro Buzzoni, Alessandro D'Arpino, PierMichele Paolillo, Simonetta Picone

DOI: https://doi.org/10.7175/pmeal.v7i2.672

Abstract

[Accessibilty and safety of drugs in pediatrics]

Many of pediatric drugs have not been tested and evaluate in children. The risks associated with the off-label use of drugs without pediatric indications include adverse effects, inefficacy, and improper formulation. Furthermore the use of magistral or officinal formulations to treat the pediatric population may be of poor quality. The objectives of EU Regulation 1901/2006 on medicinal products for pediatric are to improve the health of children by facilitating the development and availability of medicines for children, ensuring that medicines for use in children are of high quality, ethically researched and authorised appropriately, and improving the availability of information on the use of medicines for children.  Peyona (caffeine citrate) is authorised for the treatment of primary apnea of premature newborns and it’s a good example of drug tested and evaluate in children.

Parole chiave

Pediatric drugs; Marketing authorization; EU regulation

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Riferimenti bibliografici

  • Regolamento (CE) n. 1901/2006 del Parlamento Europeo e del Consiglio del 12 dicembre 2006 relativo ai medicinali per uso pediatrico e che modifica il regolamento (CEE) n. 1768/92, la direttiva 2001/20/CE, la direttiva 2001/83/CE e il regolamento (CE) n. 726/2004. Pubblicato in Gazzetta ufficiale dell’Unione europea del 27 dicembre 2006
  • Decreto Legislativo 24 aprile 2006, n. 219 “Attuazione della direttiva 2001/83/CE (e successive direttive di modifica) relativa ad un codice comunitario concernente i medicinali per uso umano, nonche’ della direttiva 2003/94/CE” pubblicato nella Gazzetta Ufficiale n. 142 del 21 giugno 2006 – Supplemento Ordinario n. 153
  • Loyd V. Allen Jr. Guidelines for Compounding Practices. In The Art, Science, and Technology of Pharmaceutical Compounding, 4th edition. Washington, DC: American Pharmacists Association, 2012
  • Erenberg A, Leff RD, Haack DG et al. Caffeine citrate for the treatment of apnea of prematurity: a double–bind, placebo controlled study. Pharmacotherapy 2000; 20: 644-52
  • Schmidt B, Roberts RS, Davis P, al. Caffeine therapy for apnea of prematurity. N Engl J Med 2006; 354: 2112-21
  • Schmidt B, Roberts RS, Davis P, et al. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med 2007; 357: 1893-1902
  • Schmidt B, Anderson PJ, Doyle LW et al. Survival without disability to age 5 years after neonatal caffeine therapy for apnea of prematurity. Jama 2012; 307: 275-82

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