Many drugs used to treat children in hospital are either not licensed for use on children or are prescribed outside the terms of their product licence. A newly published survey of paediatric wards in five European hospitals found that two-thirds of children admitted there were prescribed drugs that were unlicensed or 'off-label'.
"A small, and diminishing, proportion of the medicine which is prescribed to children has gone through clinical trials on children," said Professor Anders Rane at the department of clinical pharmacology at Karolinska Institutet to Svenska Dagbladet.
"That means that a lot of medicine is prescribed blindly, with no awareness of how it will influence the child."
The new proposal for a regulation, adopted by the European Commission in September, is designed to increase the EU-wide availability of high quality medicines made specifically for children.
About 100 million babies, toddlers, children and adolescents make up the 'paediatric population' of the EU-25, accounting for over 20 per cent of the EU's total population. Yet the European Commission argues that more than half of the medicines used to treat children in the EU have neither been specifically tested, nor authorised for use in children.
The European Network for Drug Investigation in Children looked at prescribing for 624 children admitted to paediatric units over four weeks in the United Kingdom, Sweden, Germany, Italy, and the Netherlands.
They found that 39% of the 2,262 drug prescriptions given to children were 'off-label', with some children, of course, receiving multiple prescriptions. Over two-thirds (67%) of the 624 children studied received unlicensed or off-label drugs.
The new law will force medical companies to begin testing medicines intended for children, on children.
Professor Anders Rane told Svenska Dagbladet that the reason that drugs have not been tested widely on children in the past is partly to do with ethics - but mostly to do with cash.
"The main reason is that there is no economic incentive for the drugs companies to test medicine on children," said Rane.
However, a few months ago a US study showed that teenagers who were prescribed a certain anti-depressant were twice as likely to commit suicide. The Commission has concluded that market forces alone do not sufficiently stimulate the development of medicines that take into account the specific needs of children.
According to SvD, doctors back dealing with the problem by legislative means, comprising obligations, rewards and incentives.
Björn Wettergren, a consultant at the Academic Children's hospital in Uppsala told the paper that the medicine to be made available to children is currently decided by district committees, while doses are a fraction of the adult dose depending on the child's weight.
"That's not good," said Wettergren, "since children have a completely different metabolism and can experience different side effects to adults."
Sources: Svenska Dagbladet, Aftonbladet, Sharon Conroy, et al., "Survey of Unlicensed and Off Label Drug Use in Paediatric Wards in European Countries," British Medical Journal, January 8, 2000 euractiv.com
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