The World Health Organization and the International Pharmaceutical Federation have released new guidelines for health care professionals prescribing or supplying medicines for children when no authorised product exists.
The guidelines are available to all countries and professionals on the two organisations’ web sites.
Paediatricians and health professionals all over the world have long struggled with the lack of authorised and commercially available child-specific medicines, the two organisations say.
They are often forced to use adult medicines when treating children, for example by crushing tablets or making products from scratch. This approach poses significant risks, increasing the potential for inaccurate dosing and impacting on the quality, safety and efficacy of the medicine.
The new guidance provides advice based on the available evidence, best practices and sound scientific and therapeutic principles.
For instance, if a prescribed medicine is not available in an age-appropriate formulation, using a commercially available medicine with a similar therapeutic action, which is available in a more suitable form, may be considered. Examples are provided.
“Children are more susceptible to medication errors and at greater risk of negative consequences from them,” says Dr Régis Vaillancourt, Director of Pharmacy at the Children’s Hospital of Eastern Ontario, Canada, and a contributor to the guidance document.
“Right now in hospitals we still have to compound products for children every day, many times a day, and this guidance — the first international consensus-based approach dealing with this subject — is much needed.”
“We need to ensure these guidelines are made available to all countries, particularly in poorly-resourced ones, where the burden of disease and children’s need for treatments are more acute,” said Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, WHO.
“While we wait for the research industry to catch up on children’s medicines, this is the best alternative we have at present.”
“Better access to safe and effective medicines for children is an important part of reducing child mortality; a United Nations Sustainable Development Goal target. This guidance, the result of more than five years of work, will improve children’s access to treatment,” says Gugu Mahlangu, chairperson of the expert committee to the guidance and Director General of the Medicines Control Authority of Zimbabwe.