<abstract xml:lang="en" xmlns="http://www.w3.org/1999/xhtml"><p>This review deals with the use of medicinal products in children. Many medicinal products administered routinely to paediatric patients have been either not licensed for use in children (unlicensed use) or have been prescribed outside the terms of their product license (off-label prescribing). A lot of surveys have been conducted in the context of identifying the extent of off-label used drugs in children documenting high rates (45-60 %) of such use. Recognising and meeting challenges as development of suitable formulations for very young children and realization of clinical trials involving children present important steps in the enhancement of the present situation. To improve the health of children in Europe, the Regulation (EC) No 1901/2006 addressing the pharmaceutical industry, research teams and member states proposing important incentives and obligations was assigned. Paediatric Investigation Plan and Paediatric Use Marketing Authorisation present the key measures of the EU regulation on medicinal products for paediatric patients.</p></abstract>

This review deals with the use of medicinal products in children. Many medicinal products administered routinely to paediatric patients have been either not licensed for use in children (unlicensed use) or have been prescribed outside the terms of their product license (off-label prescribing). A lot of surveys have been conducted in the context of identifying the extent of off-label used drugs in children documenting high rates (45-60 %) of such use. Recognising and meeting challenges as development of suitable formulations for very young children and realization of clinical trials involving children present important steps in the enhancement of the present situation. To improve the health of children in Europe, the Regulation (EC) No 1901/2006 addressing the pharmaceutical industry, research teams and member states proposing important incentives and obligations was assigned. Paediatric Investigation Plan and Paediatric Use Marketing Authorisation present the key measures of the EU regulation on medicinal products for paediatric patients.

Better medicines for children: challenges and unmet needs

Faculty of Pharmacy, Department of Pharmacology and Toxicology, Comenius University in Bratislava

Hospital pharmacy, University Children's hospital, Bratislava

European Pharmaceutical Journal

{"article-title":"Better medicines for children: challenges and unmet needs"}

This review deals with the use of medicinal products in children. Many medicinal products administered routinely to paediatric patients have been either not...

Better medicines for children: challenges and unmet needs

Publicado en línea: 19 jun 2012

Páginas: 21 - 37

DOI: https://doi.org/10.2478/v10219-012-0007-7

Palabras clave
Children, Off-label drug use, Paediatric Regulation

This content is open access.

Better medicines for children: challenges and unmet needs

Publicado en línea: 19 jun 2012

Páginas: 21 - 37

DOI: https://doi.org/10.2478/v10219-012-0007-7

Palabras claveChildren, Off-label drug use, Paediatric Regulation

This content is open access.

Palabras clave
Children, Off-label drug use, Paediatric Regulation