Affiliations: Centre for Paediatric Pharmacy Research, The School of
Pharmacy and Institute of Child Health, University of London, London,
UK | Consorzio per Valutazioni Biologiche e Farmacologiche,
Note:  Corresponding author: Adriana Ceci, Consorzio per Valutazioni
Biologiche e Farmacologiche, Via Palestro 26, 27100 Pavia, Italy. Tel.: +39
0382 25075; Fax: +39 0382 536544; E-mail: aceci@ cvbf.net
Abstract: The lack of specific drugs and labelling recommendations for the
paediatric population is a long-standing problem. Physicians frequently prescribe marketed medicines as off-label on
the basis of clinical practice and medical knowledge. Moreover 'unapproved'
drugs are employed in different formulations, routes, combinations to adapt
them to children. TEDDY studied the definitions of off-label and unlicensed use of
medicines in paediatrics as defined by regulatory agencies and by scientific
literature. This study confirmed the need for a common definition for
unlicensed and off-label uses to be incorporated into the European legislation.
On the basis of the results of this investigation, TEDDY conducted a
survey in order to reach a common definition with the intention to favour the
use of a European official regulatory terminology and facilitate
pharmaco-epidemiological research. The definitions will be circulated within the scientific community
and recommended to be adopted by relevant regulatory authorities.