WHO launches campaign to make drugs safer for children

An initiative from the World Health Organization has been launched to make drugs as simply and safely available to children as they are to adults.

Speaking last week at the launch in London, WHO’s assistant director general, Howard Zucker, said that “there is a gap between the availability of children’s medicines and the actual need. That gap is global and must be addressed.”

The problem is not new. “It’s a reality we’ve lived with for many years,” Dr Zucker admitted. Most drugs are developed for and tested in adults. Less than a third come in a form appropriate for children.

As a result, many children are treated using drugs that are effectively unlicensed. Medical staff may be obliged to estimate the appropriate fraction of an adult dose, and then crush tablets or extract part of the contents of a capsule.

One study by WHO has shown that drug errors are three times as common in children as in adults (JAMA 2001;285:2114-2120). Unicef claims that of the 10 million under 5s who will have died by the end of this year, specific products for children could have saved two thirds.

Hans Hogerzeil, WHO’s director of drugs policy and standards, listed areas in which more effort is needed, in which drugs do exist or were of unknown safety and efficacy. Examples include agents for dealing with tuberculosis; HIV; and several neglected conditions, such schistosomiasis and filariasis.

Development is needed in areas in which adult drugs need to be adapted to make them suitable and safe for children. Illnesses in this category include malaria, neonatal infections that could be treated by antibiotics, and tuberculosis.

Finally, said Dr Hogerzeil, improved access is the priority where drugs exist but are prevented from reaching the children who needed them because of cost or poor distribution systems. In this category he placed drugs for pain, oral rehydration salts, drugs for asthma, and specific antibiotics for pneumonia.

Although the problem of paediatric drugs was most pressing in poor countries, it was not confined to them, the audience at the launch heard. More than half of all children in rich countries had taken drugs that were unlicensed or prescribed off-label.

The “make medicines child size” campaign will seek the cooperation of governments, researchers, medical staff who care for children, and the drug industry to tackle the problem.

Harvey Bale, director the International Federation of Pharmaceutical Manufacturers Associations, listed some of the hurdles that had to be negotiated in developing and testing drugs for children. They include the difficulty of obtaining informed consent; the rapid changes that occur in children as they grow; and children’s relative inability to describe how the product was affecting them.

Despite these difficulties, said Mr Bale, the industry was committed to developing more drugs for children. His association intends to keep the matter high on its agenda.

Although he did not deny the gravity of the problem, Mr Bale also reminded his audience that many more studies of paediatric drugs were under way than at a decade ago.

WHO itself has already taken action, including compiling a paediatric version of its long established list of essential drugs. This list comprises some 200 items, but many are still marked with a symbol to show that more information is needed.

The problem of drugs for children is not one that needs large amounts of basic research, according to Stuart MacLeod, of the International Alliance for Medicines for Children: “The problem lies in the gap between what we know and what we do.”