New laws introduced mean that any new medicine that will be used by children needs to demonstrate that it is acceptable to children. This sounds straightforward and sensible but can actually be complex.
Acceptable is a tricky word to define – typically for our purposes it is defined as, “an overall ability of the patient and caregiver (defined as ‘user’) to use a medicinal product as intended (or authorised)” . This means that is should be used as directed.
However, acceptable means just about OK so that children will take their medicines with the minimum fuss. Most tests that are used measure how much someone likes a product – this is different to acceptable. Many methods that have been used with children have been adapted from the food industry where the purpose of the test was to see which product children preferred out of two options. It is important with medicines that we measure acceptability and not liking – a child that likes a medicine can become problematic as we don’t want medicines to be seen as treats.
We are conducting a large trial that uses three separate tools to measure acceptability of medicines to see which, if any, is useful. We are using patient reported tools to hear exactly what children and young people think as well as researcher observations. Often a child will report that they dislike a medicine yet take it without complaint – this is a classic example of an acceptable medicine and the complexity of what we are doing!
We have currently measured the acceptability in over 300 patients and hope to undertake the analysis soon – watch this space!
For a video on why we are doing this study see this link: Video on working with children to develop age-appropriate medicines