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Wednesday, February 17, 1999 Published at 20:35 GMT


Child drug doses 'need stricter control'

Doctors sometimes judge children's doses using guidelines for adults

Doctors are calling for stricter controls to ensure children are not given dangerous doses of adult drugs.

From April pharmaceutical companies in the US will be compelled to provide information about the effects of their drugs on children if such use is likely.

Professor Imti Choonara, Derbyshire Children's Hospital: Children's medicines aren't studied as thoroughly as adult medicines
No such controls exist in the UK and there are occasions where doctors have to estimate what is a suitable dose for children without firm evidence to back up their judgement.

There have been cases where children died after being prescribed adult drugs that had unforeseen side-effects in paediatric use.

Questions of responsibility

When a medicine is licensed for use, the manufacturer provides prescribing advice.

This provides details of known side-effects, who should get the drug and appropriate doses.

Adult prescribing guidelines are based on effects to a 70kg grown-up, but doctors cannot simply compensate for differences in weight as children's organs react differently to chemicals.

A company will not always provide advice for paediatric use, even though doctors may want to give it to children. In this event it is not licensed for use in children.

This means that when doctors want to prescribe adult medicines to children, they have to do it "off label", and take responsibility for any harm caused to the patient.

Catalogue of errors

The problems surrounding the issue are reported in New Scientist magazine. It lists instances where children have suffered as a result of taking unsuitable medicines.

The first case was 40 years ago, when an antibiotic called chloramphenicol was prescribed to children in the US.

Dozens of them died of a condition called grey baby syndrome.

The drug had been successfully used in adults to treat blood infections, but children's young livers were unable to process the drug, leading to a fatal build-up of toxins in the blood stream.

During the 80s, a drug called verapamil was used in the treatment of heart conditions in children until it was discovered that such use could lead to heart attacks.

Its use is no longer recommended in children.

Use outside the licence

Other examples exist.

"Another drug is one that is used to treat reflux - acid from the stomach coming up to the throat - called cisapride," said Dr Chaand Nagpaul.

[ image: Not all medicines used by children are licensed for such use]
Not all medicines used by children are licensed for such use
"It was used by a lot of consultants and continues to be used in children outside the manufacturer's licence indications.

"But now we've heard that it has adverse effects on the heart in children, so have been advised not to use it."

Dr Nagpaul is a member of the British Medical Association's prescribing committee.

He explained the dangers of using a drug outside its licence.

"It has not gone through all the hurdles of testing and safety and efficacy and correct dosage issues that have to be demonstrated before the drug can get a licence.

"Doctors use judgement in giving the right treatment at the right dose without having the knowledge that it has actually been evaluated to that degree.

"We need to monitor the use of drugs outside the manufacturer's licence where the licence has not been extended to children," he said.


In 1997, a Commons health committee on the needs of young people expressed astonishment that doctors were prescribing drugs outside their licence, New Scientist says.

Dr Al Aynsley-Green is director of clinical research and development at Great Ormond Street Hospital for Children in London.

"The present lack of resources and capacity of the workforce to improve knowledge and practice of paediatric drugs is nothing short of a national disgrace," he told the magazine.

The Royal College of Paediatrics and Child Health is producing guidelines on prescribing for children.

Called Medicines for Children, it will provide information about how the drugs should be used and detail common complications.

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