Effects of manipulations of adult medicine for use in children: Focus on dose accuracy and stability

The lack of drugs that have been developed for children, tested in children and approved for children, results in the situation where children are being treated with drugs that are meant for the adult population. All use of a marketed drug product that is not described in the SmPC is unauthorized, called “off-label” use, and often associated with certain risk.

Illustration: Colorbox.no

A practical consequence of using adult drugs for children is the need to reduce the dose (splitting, dispersing, giving fraction), ease administration by reducing the size (splitting, crushing), ease administration by masking or hiding the bitter taste in food (jam, yoghurt, Nutella etc), all of which is manipulation of the drug product and most likely also unauthorized use.

Published Oct. 13, 2017 3:01 PM - Last modified Oct. 13, 2017 5:09 PM