Launch of new guidance to make children’s medicines safer and more effective

To address the gap in children’s medicines, the World Health Organization (WHO) and the International Pharmaceutical Federation (FIP) today release 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. 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. 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,” said Dr Régis Vaillancourt, Director of Pharmacy at the Children’s Hospital of Eastern Ontario, Canada, and a contributor to the guidance document.

The document “FIP-WHO technical guidelines: Points to consider in the provision by health care professionals of children-specific preparations that are not available as authorized products” is available here: