Paediatric Pharmacology Flashcards
1
Q
what does an off-label medicine mean?
A
- medicines licensed for human use but not for use in children below a certain age such as 16 or 18 years or via a certain route or for a certain disease.
2
Q
what is an unlicensed medicine?
A
- medicines which have no license for human use in this country.
- this includes licensed medicines which are reformulated for easy use in children.
3
Q
what are the reasons for off-label prescribing?
A
- formulation administered via a route not intended
- medicines used for an indication not intended
- medicines used at a different dose to that recommended
- children below stated recommended age limit
- medicines without a license: including those made especially for the child or being used in clinical trials.
4
Q
what is the objective of the Paediatric Regulation (2007)?
A
- to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years.
