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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

By Jo Macfarlane

PUBLISHED:16:00 EST, 1  September 2012| UPDATED:16:00 EST, 1 September 2012

Untested: A third of medicines for children are not tested on minors
Untested: A third of medicines for children are not  tested on minors

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.

Open wide: Junior medicines face new questions after the Government study
Open wide: Junior medicines face new questions after the  Government study

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.

Safe: Over-the-counter medicines such as Calpol are not affected
Safe: Over-the-counter medicines such as Calpol are not  affected

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.

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