Accessibilità e sicurezza dei farmaci in pediatria

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.