The lack of thorough and reliable clinical data on the way medicines affect children requires strengthened safety monitoring and vigilance of medicinal products.
The lack of thorough and reliable clinical data on the way medicines affect children requires strengthened safety monitoring and vigilance of medicinal products. This is the fundamental message of Promoting safety of medicines for children, released recently by the World Health Organisation (WHO).
The publication gives an overview of the problem and offers solutions on how best to address side effects from medicines in children; namely, through improved reporting systems and collaboration between governments, regulatory authorities, research institutions and the pharmaceutical industry.
The publication is part of a broad effort WHO is initiating to expand children's access to quality-assured, safe and effective medicines. "We need to learn more about the way children's bodies react to medicines so we can improve global child health," said Dr Howard Zucker, WHO assistant director-general for health technology and pharmaceuticals. That's why it's extremely important to keep track of potential side effects in child populations."
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.
This results 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 (this is known as "off-label use").
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.
New medicines on the market may provide indications for children, but still lack evidence of long-term benefit and risk. Side effects associated with antiretroviral medicines, for example, have been reported to occur in up to 30% of HIV-infected children on antiretroviral therapy. Most of those side effects could be reversed by modifying the dosage or changing to an alternative medicine.
The report estimates that less than 10% of all serious adverse reactions to medicines are reported globally. In part, this is due to the fact that many developing countries have not yet established medicine safety monitoring and reporting systems; and when they have these are usually under-resourced. Because children, particularly very young ones, are less able to describe symptoms and their non-verbal communication is often misunderstood or ignored, even serious adverse reactions in children often go unreported.