UN health agency stresses need to ensure safety of children’s medicines

The lack of thorough and reliable clinical data on the way medicines affect children, particularly side effects, requires strengthened safety monitoring and vigilance of medicinal products, the United Nations World Health Organization (WHO) warned today.

“We need to learn more about the way children’s bodies react to medicines so we can improve global child health,” WHO Assistant Director-General for Health Technology and Pharmaceuticals Howard Zucker said as the Agency released a new report – Promoting Safety of Medicines for Children.

“That’s why it’s extremely important to keep track of potential side effects in child populations. Ultimately, this will save lives and build up a knowledge base for the future,” he added of the study, which is intended for policy-makers, manufacturers, medicines control bodies and researchers.

It gives an overview of the problem and offers solutions on how best to address side effects from medicines in children through improved reporting systems and collaboration between governments, regulatory authorities, research institutions and the pharmaceutical industry, and is part of a broad effort WHO is initiating to expand children’s access to quality-assured, safe and effective medicines.

A large proportion of side effects or adverse reactions to medicines in the adult population are due to irrational use or human error and are therefore preventable. In the case of children, even more factors come into play. The main challenge is the lack of clinical data, resulting in fewer medicines being developed, produced and marketed specifically for children. Often, children are given medicines that have only been tested in adults and are not officially approved for use in child populations.

Non-availability of appropriate paediatric formulations forces health care providers to resort to administering portions of crushed or dissolved tablets or the powder contained inside a capsule without any specific indication of the required dosage. For that reason, according to the report, potentially harmful medication errors may be three times more common in children than in adults.

An appropriate format or structure for a child's medicine is also important. Small children sometimes choke or asphyxiate while trying to swallow big tablets. For instance, earlier this year four children under 36 months died from choking on albendazole tablets during a de-worming campaign in Ethiopia.

In another example, side effects associated with antiretroviral medicines have been reported to occur in up to 30 per cent of HIV-infected children. Most of those side effects could be reversed by modifying the dosage or changing to an alternative medicine.

The study proposes that all countries establish national and regional monitoring systems for the detection of serious adverse reactions and medical errors in children. When such reporting systems exist, it is crucial that manufacturers follow up on adverse reactions to their products once they are on the market.

In addition, regulatory authorities need to make an effort to refine the science of clinical trials in children, create an active post-marketing surveillance programme and develop public databases of up to date information about efficacy and safety in paediatric medicines.

To assist countries, WHO will publish an official List of Essential Medicines for Children, continue to create awareness in countries and in the research community on the urgent need to monitor use of medicines in children, identify research gaps in children’s medicines, and create protocols to monitor adverse effects for child-specific medicine.