NEWS FOCUS:THE ANNOUNCEMENT last week that a review of cough and cold medicines for children is currently under way in Europe may come as no surprise to many parents who have doubts about the usefulness of many of these medicines. However, when the UK Medicines and Healthcare Products Regulatory Agency warned parents that certain cough and cold remedies should not be used on children under six, we suddenly want to hear more.
Quick to allay parents’ fears here, the Irish Medicines Board said it was satisfied with the current restrictions on cough and cold remedies for children in Ireland yet it urged parents to “read the patient information leaflet carefully and consult with their GP or pharmacist as appropriate before administering any medicine to a child”.
This advice to be careful about using medicines with children highlights yet again the whole issue of the safety and effectiveness of paediatric medicines and, in fact, the European review of cough and cold medicines is part of a much wider look at the safety and effectiveness of medicines for children across Europe.
Currently, up to 50 per cent of medicines used to treat sick children in hospital have never been tested on children. This figure rises to 90 per cent of medicines used on babies in neonatal intensive care units. Approximately 10 per cent of medicines prescribed by GPs have not been tested on children.
Studies have shown that the use of so called “off-label” drugs for children can result in errors in dosage and/or unexpected side effects. This unlicensed use of medicines has developed in the absence of clinical trials on children.
“Many important medicines we use to treat children with cancer haven’t been licensed for use in children,” explains Aengus O’Marcaigh, paediatric haematologist at the National Paediatric Haemology and Oncology Centre at Our Lady’s Hospital for Sick Children, Crumlin. “The clinical trials have not been done in children but their use has developed through clinical experience. It would be negligent of us not to use them,” he explains.
The newly established European Medicines Agency (EMEA) was set up following an EU regulation passed in January 2007 whose aim is “to ensure that medicines for use in children are of high quality, ethically researched and authorised properly”.
The regulation obliges drug companies to have a “paediatric investigation plan” for any new drugs that might be used for children in the future. The EMEA has also set out a priority list of off-patent medicines used in children which will now be subjected to clinical trials in children.
Dr Joan Gilvarry, director of human medicines at the Irish Medicines Board, views the work of the EMEA as a hugely important step to improve the safety of medicines for children.
“Children are not mini adults. They treat medicines differently as their bodies are not as developed in many ways and to be sure of getting the right dosage of medicine for children of different ages, we need research in children,” she says.
“Up to now, paediatricians and doctors have had to guess the dosage used for children, but now the requirement for research on new medicines used in children will mean we will have much more high quality information before we license a new drug,” she explains. Approximately 120 clinical trials are approved in Ireland each year, 5 per cent (six clinical trials) of which involve children.
Prof James McElnay, Pro-Vice Chancellor for research and post-graduates in Queen’s University, Belfast, has been watching the development of European regulation in paediatric medicines with interest.
“The EU regulation is driven by both a safety and a rights perspective which sees that children should have the same rights as adults to clinical trials,” he says.
Researchers at Queen’s University and the Royal Belfast Hospital for Sick Children are currently involved in clinical trials on children for drugs used in pain management, bowel and heart conditions.
McElnay carried out a survey earlier this year which found that 86 per cent of people claimed that they had never heard of the unlicensed use of medicines in children.
“We were somewhat surprised that parents knew so little about the use of unlicensed medicines in children which means that there is very little discussion between prescribers and patients,” says McElnay, who hopes more parents will give their permission for their children to participate in clinical trials.
“Parental consent is variable at present. Some parents feel that their child is undergoing enough trauma by being in hospital, while others are very happy for their child to participate,” says McElnay. He adds that in other countries such as Australia, parents of sick children in hospital often ask can their children be involved in a drugs trial because they know that they will be observed more closely.
Oncology is one specialist area where doctors are very keen for more clinical trials in children. Dr O’Marcaigh explains how most children with leukaemia currently participate in trials of established licensed drugs used in new combinations.
“These Phase III trials are ongoing but we’d be keen to participate in multi-centre trials of new drugs. I fully support the new requirements for drug companies to carry out clinical trials on children for medicines that will be used in children’s hospitals,” he says.
Meanwhile, Dr Mel Bates, spokesman for the Irish College of General Practitioners, is keen to reassure parents that the majority of medicines given to children by GPs are licensed for use in children. “It’s important that parents understand that the majority of medicines used off-label are used by paediatricians in hospitals and intensive care units and not in general practice,” he says.