Drug use: Children routinely receive drugs that have not been tested for them as safe, and doctors and hospitals frequently prescribe medication that is authorised for adults but not for use by children.
In a session entitled "Are We Taking the Right Medicines?", the science festival yesterday heard how medicines we take for granted might not be right for us.
The prescribing of adult-approved medicines for infants and young children was a particular problem, according to lecturer in paediatric clinical pharmacy at the University of Nottingham Dr Sharon Conroy.
She cited studies showing a full two-thirds of children in hospital take drugs that are not approved for them, rising to 70 per cent in paediatric intensive-care units. A startling 90 per cent of babies in neonatal intensive-care units receive unapproved drugs, another study found.
The drugs are either not licensed (not tested specifically for children via the drug-approval process) or used "off-label" (outside the terms of the existing licence). Such drugs are used without licence or off-label because of a shortage of suitable medicines licensed for use by children, Dr Conroy added.
"We haven't got appropriate medications for infants," she said, partly because it is not profitable for drug companies to carry out the costly trials needed for authorisation.
Unfortunately, there are no formal follow-ups after use of these drugs to measure effectiveness or side-effects. Information on drug response would be valuable in setting dose levels.
Dr Conroy added: "We haven't evidence that this is having adverse effects on children." She knew of only two relatively small studies looking at the issue. One, from Liverpool, showed adverse effects when using off-label or unlicensed drugs in 6 per cent of the children who used them. Another, from France, showed 3.9 per cent adverse effects.
Drugs of concern given to infants and babies included Salbutamol, an adult asthma drug licensed for use four times a day. "It was one of the most common off-licence drugs in our study," she said. Another was morphine, given for the control of pain which wasn't licensed for children under the age of 12. Drugs often act very differently in children. Dr Conroy cited the antibiotic Chloramphenicol, which works well in adults but is not tolerated by children.
Things are changing, however, with new EU regulations expected to come into force in December 2006, she said. "All of the excuses being put out by the pharmaceutical companies have been overcome."
The new regulations are similar to controls in the US. The drug manufacturers will be required to test medicines for paediatric use before they can be used by children.
Prof Theo Raynor, of the University of Leeds, discussed the misleading instructions provided with many drugs. The current trend is towards empowering the patient with good information, he said, but the leaflets do not provide it.
The wording served to mislead people. Drug companies describe a side-effect as "common" if it occurs in one to 10 per cent of patients taking the drug. However, a survey showed that "common" was interpreted by a majority of people to be one-in-three, Prof Raynor said.
Up to 90 per cent of drugs sold in Britain now include leaflets showing side-effects. "About half of people said they read some of it, and a third said they read all of it. People don't value them, they screw up the box and the print is too small, so there is a bit of work involved in getting people to value them," Prof Raynor said.
New EU regulations now require that companies test their drug leaflets on the public before the drug can be approved.
