When it comes to dose selection in children it has long been recognised that they are not small adults. They are not a homogenous group. For instance, there is rapidly changing size and weight. In children 3 years old and younger differences exist in the maturity of metabolising enzymes and renal function, along with variation in body structure. All these aspects can affect the disposition of an administered drug and thereby the dose required for efficacy.
Nevertheless, despite this knowledge, medicines safety in children is still of concern as indicated by a recent review in the Pharmaceutical Journal1. Data were based on a voluntary reporting system for patient safety incidents; the National Reporting and Learning System. In the year 2019 -2020, around 5% of the reported incidents occurred in children. Issues around dose were the most common cause in this group. Contributing factors included failure to account for the development stage of the child; off-label or un-licensed prescribing and, the lack of availability of appropriate formulations for children.
What can the pharmaceutical industry do to help clinicians when prescribing to children? Given that dose seems to be at the root cause of the medicine safety incidents noted in children, it is beholden upon pharma to supply prescribers with robust dosing information for this population. To do this requires an understanding of how developmental changes affect the pharmacokinetics and associated pharmacodynamics of a drug and, ultimately how any changes found impact on the dose that needs to be given. Such work needs to be completed across the age range of the target paediatric population.
–1 Connelly D, Pike H Medicines Safety in Children. Pharmaceutical Journal. 2021, 306: 96-97