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Scandal of the Doctors Who Give Children the Wrong Dose

Posted on: Monday, 15 August 2005, 12:00 CDT

IT IS a parent's worst nightmare: the drugs their children are prescribed to treat a minor illness could be killing them.

While most parents place absolute trust in their family doctor, many are unaware of the risks some GPs are exposing youngsters to.

Four in 10 practitioners admit to prescribing medicines to children that have only been approved for use in adults, according to a study by child-health experts.

The research also revealed that many doctors are giving children drugs at doses higher than the recommended safety levels even for adults.

Children suffering from conditions including asthma and epilepsy are among those most likely to be put at risk, usually without their parent's knowledge.

The disturbing findings on the widespread use of 'off-label' drugs on children come as ministers launch a crackdown on GPs who disregard prescription limits.

Doctors will receive an electronic warning on their PC if they try to prescribe unsuitable medicines to youngsters, a practice which could be putting as many as 300 children a year in hospital.

The study of 202 family doctors was carried out by a team at Aberdeen University amid growing concern over off-label prescription and the death in 2001 of a child who was given an adult asthma drug.

Many doctors complain few drugs are tested on children - for reasons of ethics and cost - and so they must use medicines approved only for adults. Some medics feel free to disregard the rules because there are no real sanctions at present for doing so.

The Aberdeen research found that about a quarter of those who prescribed off-label admitted giving higher or lower doses than recommended. Many base doses on the height and weight of child patients.

Dr James McLay, a senior lecturer in child health, also found 22 per cent of doctors had given drugs to children to treat illnesses other than those the medicines were originally intended for.

In all, 26 per cent of children under 16 had been given off- label drugs by their GP, a figure that jumps to 90 per cent of children in hospitals.

McLay says most parents are unaware their children are being given drugs outside of the guidelines set out by the pharmaceutical companies. "When we surveyed Scottish paediatricians most said they did not tell patients they were giving them off-label drugs," he said.

He has found that doctors commonly prescribe powerful drugs for treating asthma and anti-epilepsy drugs to children at higher than recommended doses.

Antihistamines are often given to children at a younger age than they should be while antibiotics are prescribed at lower doses than recommended, a practice that can make the drugs ineffective later in life.

"Manufacturers can only license a drug for the ages they have tested it for, but children younger than those ages can still suffer from that illness," said McLay. "Instead, doctors use an approach based on their experience of the drug in adults, but there is very little evidence on how drugs effect young children. When they are young, children are changing dynamically until they reach the age of 16 and, as a result, their drug metabolism can be significantly different. It makes it hard to predict how a drug will work and the effect it will have.

"There are also concerns that using a drug while a child is growing can actually affect this process. Adults are relatively static in terms of bone growth but in children they are growing at a very fast rate and drugs like steroids, for example, can affect bone development."

He added: "Even prescribing drugs like antibiotics at lower-than- recommended limits could be harmful as it may be contributing to antibiotic resistance by not getting rid of the bacteria completely."

A separate study recently found that 900 Scots children are hospitalised each year because they have suffered adverse reactions to prescription drugs. Research in Europe suggests about 35 per cent are due to off-label prescriptions.

Among the most common drugs given off-label to children by doctors are inhaled steroids, which are used to treat asthma. While hugely effective at cutting the symptoms of asthma, some steroids can cause potentially lethal side-effects in children. In 2001, five- year-old Emma Frame, from Strathaven, Lanarkshire, died after being prescribed a huge dose of the powerful steroid, Flixotide.

Manufacturer GlaxoSmithKline does not recommend giving the drug to children under the age of four. But Emma's GP, Frank Shapiro, decided to prescribe it when she was just 18 months as he believed it would help her get better more quickly.

By the time she was five she was taking five times the maximum recommended dose. She suffered a fatal drop in blood pressure and blood sugar.

Three months later her older brother, Calum, then aged seven, suffered the same symptoms. He needed months of hospital treatment before he could return home.

Emma's devastated parents, Stewart, 42, and Karen, 40, are now demanding the pharmaceutical industry be made more accountable for how drugs are used in children.

Stewart said: "We were aware Emma had been prescribed a drug not licensed for use in children. What we did not know was that the dose she was being given was so high.

"That 40 per cent of doctors prescribe off-label drugs does not surprise me. Doctors are in a difficult position as drugs are not tested on children. The drug companies must not shun that responsibility. They must be made to monitor how their drugs are being used as other children cannot be allowed to die."

Ministers are so concerned about the practice of off-label prescribing they have approved funding for a pilot project aimed at cutting the practice.

Using the GP computer system, doctors will be alerted to the defined limits of a drug every time they try to prescribe off- label.

If the doctor still decides to prescribe the medicine then they will be required to input their justification into the system.

Six GP practices in Scotland will have the system installed in October as part of a GBP 18,347 trial commissioned by the Executive's Chief Scientist's Office. It is hoped this will cause the number of off-label prescriptions in under-16s to drop.

A spokeswoman for the Executive said: "When GPs prescribe off- licence they must consider all the risks and benefits of that decision and the clinical circumstances of the patient.

"There are ethical issues and other difficulties in testing medicines in children.

"In Scotland, we have a pilot study that will seek to reduce the number of off-label prescriptions in the NHS. We will look carefully at the results."

The European Commission is now preparing to debate proposals for a regulation on medicines for paediatric use.

Its research shows more than 50 per cent of the medicines used to treat children in Europe have not been tested and are not authorised for use in children. The new regulation will ensure that all drugs used to treat children have been subject to high quality research and are appropriately authorised for use in children.

The UK government has placed raising awareness of off-label drug use high on its agenda during its presidency of the EU.

Euro MPs are due to debate the new regulation in October. If passed it is likely to come into force in late 2006.

Scottish MEP Catherine Stihler, the deputy leader of the European Parliamentary Labour Party, has been fighting for the regulation to be adopted.

She said: "New rules are long overdue. It is frightening that 50 per cent of medicines given to children across Europe are not being tested or authorised for use in children.

"Every parent wants to have peace of mind that the medicines being used on their son or daughter have been through a testing regime and are safe."

But doctors have given the tighter regulation only a cautious welcome, fearing it may hamper their ability to treat young children.

Lyndon Braddick, of the Royal Pharmaceutical Society Scotland, said: "There is a common misconception that drug licences are legally binding.

"They are not and doctors do not have to stick to them. Off- label prescribing is a worldwide problem and there is increasing concern about it.

"But carrying out clinical trials is extremely difficult due to the ethical problems with testing drugs on children who are unable to consent for themselves."

See epages link for graphic table: Children's Drugs: Side effects.

Source: Scotland on Sunday

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