James Meikle, health correspondent 

Drug firms pressed to make child-friendly doses

Ministers yesterday began exerting pressure on drug companies to produce more child-friendly medicines.
  
  


Ministers yesterday began exerting pressure on drug companies to produce more child-friendly medicines, arguing that many young people from babies to teenagers were being given unsuitable treatments.

Manufacturers will be given limited incentives to develop drugs, including waiving fees to regulatory watchdogs and free expert advice, but the companies are likely to want more financial return, including the extension of patents.

Most medicines have only been tested for safe and effective use in adults, leaving doctors and other prescribers to modify dosages based on children's age and weight. There is increasing concern that children respond differently from adults.

The government wants to improve information to parents and children, and is trying to persuade companies to develop alternative formulations, such as liquid medicines instead of tablets.

It is also helping to fund a British national formulary specifically for children's medication, to match the standard doctors' prescribing handbook for adult medicines.

EU rules are being drawn up to combat the problem but they are unlikely to be introduced for at least another two years and the British government wants to force the pace.

In the US, companies are given financial breaks if they undertake clinical trials on products used in the treatment of children while they are still patent-protected.

The Department of Health here has asked manufacturers to produce evidence from those trials to help produce better treatment and information for British children too, although makers of only about half the 40 products the government is most interested in have responded. Key areas include asthma drugs, anti-depressants and painkillers.

Until recently there has been a widespread reluctance to conduct drug trials on children, on ethical and cost grounds. Parents have been uneasy about the idea, while companies have doubted the commercial value in targeting the children's drug market, although the success of some treatment trials for childhood cancers and other potentially fatal conditions is helping to change the climate.

The health minister, Lord Warner, said there was a "curious absence" of information about adverse reactions by children to adult drugs, but the question was not only over safety.

"There is a bit of 'by guess and by God' as doctors modify adult dosage. They may overreact, go the other way and produce a dosage so weak it is useless." He added:

"I want the new strategy to give a strong message to pharmaceutical companies to focus on the needs of children."

David Haslam, the chairman of the Royal College of General Practioners, said: "The great majority of drugs prescribed for children by GPs do not pose a problem. But increased consideration of child dosages by drug companies will certainly be helpful when dealing with rarer and more complex medicines."

 

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