A new study has shown there is an urgent need for more children to take part in clinical trials to make sure medicines can be licensed for their safe and effective use.
The study has been carried out by Professor James McElnay, a leading academic at Queen's University Belfast.
Professor of Pharmacy Practice as well as Pro-Vice-Chancellor for Research and Postgraduates at Queen's, Professor McElnay led a study which showed many people in Northern Ireland do not know medicines are being used outside their license to treat children.
The paper has been published in the British Journal of Clinical Pharmacology .
A survey of 1,000 members of the public found that 86 per cent of respondents claimed that they had never heard or read about the unlicensed use of medicines in children.
Unlicensed medicine involves using medicines outside their license in terms of dose, the way in which they are administered or the age of the recipient.
At least one third of children in paediatric medical and surgical wards and up to 90 per cent of children in neonatal intensive care units are prescribed unlicensed medicines, according to previous European studies.
It is generally considered to be the role of the prescriber or the pharmacist to provide information to parents about the unlicensed use of medicines in their children without causing undue confusion or distress. But the study acknowledges that this can lead to a lack of trust which could influence the treatment negatively.
Views about the safety of children's medicine
At the outset of the questionnaire, only 1.8 per cent of those involved felt the use of medicines in children was unsafe but after being told about unlicensed use of medicines the figure increased to over 62 per cent. 90 per cent of participants felt unlicensed medicines would increase the risk of side-effects.
Communication between the doctor and parents
92 per cent of participants felt parents should be informed about the use of unlicensed medicine in their child.
When asked what they would do if their children was prescribed such a medicine, 42 per cent said they would use the medicine but check the child carefully for side-effects, while 40 per cent indicated they would ask the doctor to change the medicine to one which has been fully tested and licensed for use in children. 18 per cent indicated they would simply accept that the doctor knew best.
Clinical trials in children