Dr Beate Aurich | Identifying, Understanding and Managing Treatment-Related Risks of Medicines Prescribed to Children

Further information about the general principles of paediatric pharmacovigilance has been published in the article “C4C: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A C4C expert group white paper”. This white paper describes some of the points to consider with regards to the detection, analysis and proactive management of treatment-related risks in paediatric studies and paediatric clinical practice.

Importantly, treatment-related risks in children are often different compared to adults. They can also vary between different paediatric age groups, for example, between babies and adolescents. These differences can be due to factors such as age-related changes in the body’s metabolism, comorbidities and comedications. A further challenge is a higher risk of medication errors because formulations are frequently not adapted to children’s needs.

Unfortunately, many medicines prescribed to children have very limited child-specific information on treatment-related risks.

The product information on the label is used for risk management. However, it is often difficult to understand, even for adults, and is often not adapted to the needs of children. Informing children, parents and doctors about any important safety updates, especially for medicines taken regularly, is a challenge.

Paediatric pharmacovigilance and risk management require a multidisciplinary effort. The inclusion of children and their families should be standard practice for paediatric pharmacovigilance and risk management activities.

The aim of proactive paediatric pharmacovigilance and risk management is to reduce the frequency and severity of adverse drug reactions in children, including fatal reactions. Further research into developmental pharmacology and high-quality child-specific electronic healthcare data will play an important role in reducing the frequency and severity of adverse drug reactions in children.

Developing open access, multilingual information on treatment-related risks in children and evidence-based dosing of medicines will contribute to improved treatment outcomes for children across the globe.