GPs 'give children unproven doses'

Drugs are often not tested on children

GPs are prescribing a significant number of drugs to children in doses that have not been officially approved for use, according to research.

Researchers found that the practice of prescribing drugs to children that are outside the terms of the product licence or not specified on the label (off-label) is widespread among GPs.

There is evidence to suggest that adverse drug reactions among children in hospital are higher for off label and unlicensed drugs.

Children deserve the same rights and benefits as adults

Dr John McIntyre, University of Nottingham

The research team examined the prescribing records for 1997 for one suburban general practice in the Midlands.

Children up to the age of 12 represented one-fifth of this practice's list.

Around two-thirds of them were given at least one prescription during the year.

The practice records showed there were almost 3,500 prescriptions for almost 1,200 children involving 160 different drugs.

Some 84% of the drugs had been prescribed for licensed medicines within the terms of the product licence.

Less than half of one per cent were for unlicensed medicines, but one in 10 were for off label licensed medicines.

Almost all of these involved using dosages that were not recommended on the label.

By far the most frequently prescribed off label drugs were antibiotics.

Other off-label drugs included anti-asthmatic medications, creams, and antihistamines.

GPs not to blame

The authors stress that GPs are not to blame for the current situation.

Instead, say the authors, they are victims of inadequate product licence information which recommends, for example, that the same dose of a commonly prescribed antibiotic should be given to a new-born and a 10-year-old.

Licensing, say the authors, is unable to keep abreast of current practice and there is no system to monitor and co-ordinate the information.

There is also little incentive for the pharmaceutical industry to carry out research on drugs that are already licensed, and funding for research into the way medicines are used in children is not considered a high priority.

However, they go on to say: "It is essential that the regulatory framework ensures medicines in children are safe, effective, and of high quality."

Lead researcher Dr John McIntyre, from the University of Nottingham, said research had found that adverse reactions to drugs among children occurred in 6% of unlicensed or off-label medicines, compared with 3.9% of licensed prescriptions.

He stressed that these figures could not be directly extrapolated to drugs prescribed by GPs.

However, he told BBC News Online: "The current position is unacceptable.

"The licensing framework is there to ensure patients receive safe, effective, high quality drugs - children deserve the same rights and benefits as adults."

Drug company response

Clinicians who deal with children are not blind guessing about drugs

Richard Ley, Association of the British Pharmaceutical Industry

Richard Ley, a spokesman for the Association of the British Pharmaceutical Industry, said that more could be done to improve testing of drugs on children, and said his organisation was negotiating to get international agreement on a more satisfactory system.

However, he told BBC News Online: "The situation is not as bad as the headline would suggest.

"Clinicians who deal with children are not blind guessing about drugs, they have a huge body of knowledge and shared experience of these medications and they know what they are doing."

Mr Ley said it was difficult to carry out trials of drugs on children because few volunteers could be found.

"If you ask a parent if they want their child to take a medication that has not previously been tested on children, they say no.

"Anyone who is a parent understands that reaction, but clearly it makes it difficult to find volunteers to take part in trials."

The research is published in the journal Archives of Disease in Childhood.