One third of junior drugs are not tested on children sparking demand for probe
- Official study calls for urgent investigation after ‘high number of drug errors’
- 95 per cent of all hospital medicines for babies affected
PUBLISHED:16:00 EST, 1 September 2012| UPDATED:16:00 EST, 1 September 2012
Children are being prescribed unlicensed medicines that could be causing harm, a report has warned.
The Government study is demanding an urgent investigation into the ‘unacceptable’ fact that almost a third of drugs given to sick children are officially approved for only adult use.
It warns of ‘a high number of drug errors’ in which children may be wrongly prescribed too much of a medicine because the doses are meant for adults.
Historically, pharmaceutical companies have not had an obligation to test medicines on youngsters. The law changed in 2007 and new drugs coming to market must now be tested on children before they can be used on them.
But this still means about 30 per cent of drugs prescribed to under-18s – and up to 95 per cent of drugs given to babies in intensive care – have never been tested on children.
These include common antibiotics, painkillers, asthma inhalers and cancer medicines.
The use of unlicensed drugs is so common that many parents will not even be told that their child is receiving medication ‘off-label’.
Over-the-counter medicines designed for children – such as Calpol and Nurofen for Children – which parents can buy from high street pharmacies are not affected.
The report, commissioned by the Department of Health and written by leading child health experts, warns that unlicensed medicines may be causing side effects that could be going unreported.
It is calling for an investigation by the drugs watchdog, the Medicines and Healthcare products Regulatory Agency, because it is not known how many children may potentially have been harmed – or how much it is costing the NHS.
The report, from the Children and Young People’s Health Outcomes Forum, says: ‘New medicines account for a relatively small percentage of those used by children, and those introduced before [the 2007] legislation largely remain unregulated and, critically, therefore possibly untested formally in children.
‘This contributes to the high number of drug errors and leads to wider implications – including the fact that the National Institute for Health and Clinical Excellence will not give advice on unlicensed medicines and this limits the guidance that they can offer on care for children.’
It goes on to caution: ‘The Forum believes that the situation with regard to the absence of licensing for the majority of children and young people’s medicines in this country is unacceptable.’
Historically, it has been difficult to test medicines on children because regulators have made it hard for drugs companies to get ethical approval to do so.
There has also been no legal responsibility for the pharmaceutical industry to conduct the tests once they have a licence for their drug to be used in adults, which is more commercially beneficial.
In the past, doctors have waited up to ten years after a drug is introduced before giving it to children, to make sure there are no serious side effects. But this has left children’s medicine at a disadvantage.
The medics’ and pharmacists’ bible, the British National Formulary for Children, publishes recommended dosages for licensed and unlicensed medicines based on evidence from doctors and regulators.
Warren Lenney, professor of respiratory child health at Keele University and chair of the paediatric formulary committee at the BNFC, said: ‘The people who say we shouldn’t prescribe unlicensed or off-label medicines don’t know what they’re talking about.
‘By no means are we using dangerous medicines. If a medicine has been on the market for 30 years, no company is going to spend millions of pounds testing it on children.
What has been shown is that using an unlicensed medicine in children does increase the risk of side effects. We don’t know why. It is one possibility that we are really underestimating the number of side effects – but I don’t want to scaremonger.’
The Children and Young People’s Health Outcomes Forum was set up this year to look at how the reorganisation of the NHS could improve the health of children.
Co-chair Professor Ian Lewis, medical director of Alder Hey Children’s NHS Foundation Trust, said: ‘Most of the drugs we use in children’s cancer like leukaemia have not been formally tested in children but have cured many of them.
‘It’s very expensive for pharmaceutical companies to do this additional testing, and the question that must be asked is whether there’s enough incentive for them.’
But Dr Helen Sammons, vice chair of the medicines committee of the Royal College of Paediatrics and Child Health, said: ‘Parents shouldn’t be concerned that children are being treated with unlicensed and off-label medicines.
‘We know what we should be giving children and that it works based on our experience and evidence, but there’s no legal drive to update the licences sometimes.’
A spokesman for the MHRA said: ‘We’re fully aware of the recommendations outlined in the report and are working closely with the Department of Health to best take forward these recommendations.’
A spokesman for the Department of Health said it would have a formal response to the recommendations later this year.