Queen's study highlights need for more licensed medicines for children
A new study at Queen's University, Belfast has revealed 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.
A new study at Queen's University, Belfast has revealed 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 led by Professor James McElnay, professor of Pharmacy Practice as well as Pro-Vice-Chancellor for Research and Postgraduates at Queen's, showed that many people in Northern Ireland do not know medicines are being used outside their licence to treat children.
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.
The results of the study of 1,000 members of the public in Northern Ireland have been published in the British Journal of Clinical Pharmacology.
In this, 86% of respondents said they had never heard or read about the unlicensed use of medicines in children, while 92% felt parents should be informed about their use in their child.
When asked what they would do if their children were prescribed such a medicine, 42% said they would use the medicine but check the child carefully for side effects, while 40% indicated they would ask the doctor to change the medicine to one which has been fully tested and licensed for use in children. Nearly 20% indicated they would simply accept that the doctor knew best.
Many of those interviewed said they would be reluctant to involve a child in clinical trials, which are necessary for medicines to gain a licence. Only about 4% said they would enter their own child into a trial if the child were in good health, while 42% said they would agree if the child had a life-threatening condition and the medicine being tested was being used for that condition.
Professor McElnay said there is a lack of medicines available for children that have undergone the strict testing procedures used for adult medicines, which puts children at a disadvantage.
"There is a need for more clinical trials in children so that more licensed medicines are available," he said.
"Parents in some other countries get upset if their children are not included in clinical trials while in hospital, whereas in Northern Ireland there is sometimes a reluctance within parents to include their children in such trials."
Professor McElnay is now leading a further programme of research to explore some of these issues in greater depth.
