Feb. 4, 2009 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
Many of those interviewed said they would be reluctant to involve a child in clinical trials which are necessary for medicines to gain a license. Only about four per cent said they would enter their own child into a trial if the child was in good health, while 42 per cent 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: “The situation regarding unlicensed use of medicines in children has received relatively little media attention and intuitively one would consider that children would be afforded more protection than adults regarding evidence based medicine.
“There is a lack of medicines available for children which have undergone the strict testing procedures which take place for adult medicines.
“This puts children at a disadvantage when compared to adults. There is a need for more clinical trials in children so that more licensed medicines are available.
“The relative lack of licensed medicines for use in children has been described as a breach of their basic human rights.
“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.
“Further research needs to be carried out to explore some of these issues in more depth and I am leading a programme of research between the School of Pharmacy at Queen’s and neonatologists, paediatricians and pharmacists in the Belfast Health and Social Care Trust.”
Other academics involved include Tareq Mukattash, Dr Jeff Millership, Dr Paul Collier, all from the School of Pharmacy.
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