Children: Introduction

Last updated: Monday, May 16, 2022

NB: See learning outcomes for this tutorial mapped to competencies, a PDF of the whole text, and a one-page summary

☞ Why this subject matters...

Questions about medicines in children can present more of a challenge than questions about adult therapy because of the general lack of evidence in this age group. As a pharmacist you will encounter a range of questions but some of the most common include establishing safe, but effective, doses and finding suitable formulations. This tutorial is not a comprehensive overview of drug use in children, more a summary of these frequent problems and suggestions on how to resolve them.

Licensing of medicines

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The evidence base for the use of many medicines in children is often limited. Historically, many company-sponsored drug trials have not recruited children because of ethical concerns and lack of financial return. It follows that the range of medicines that are licensed for use in children is restricted and many receive unlicensed or off-label medicines.

The Human Medicines Regulations 2012 enables such use, but if you are asked about the choice of drug in a paediatric patient, always consider if there is a clinically appropriate, licensed drug first. If you can't use a licensed medicine, you should take extra steps to ensure that the use of the medicine is justified in terms of evidence, necessity, and safety. A lack of published information may sometimes make it harder to check other parameters like dose and frequency, suitability of formulation, precautions, interactions, and monitoring parameters. 

The Neonatal and Paediatric Pharmacists Group (NPPG) and the Royal College of Paediatrics and Child Health (RCPCH) have produced a position statement on the use of unlicensed medicines or licensed medicines for unlicensed indications in paediatric practice.

Practical tips

When advising on the use of unlicensed/off-label medicines in children it is important to protect the patient, yourself, and other healthcare professionals. These steps will help you do this:

  • Try to gather as much evidence as is available, preferably from higher quality sources (although this is often challenging). Be thorough.

  • Always discuss with your peers (especially when you feel rushed to give a quick answer, the intervention is critical to the patient’s immediate health, or when on-call).

  • Satisfy yourself that your advice follows that of a respectable, responsible body of professional opinion or if not, that your advice can be justified from the data you have collected and the information provided by the prescriber. It is good practice to document your reasoning carefully explaining why you gave this advice (and why other options were not suitable).

  • Make it explicit to the prescriber that the use of the medicine is unlicensed (more accurately we should say that it is outside the terms of a ‘marketing authorisation’), and highlight any limitations in the advice/ information you provide.

Children's ages

Several classification systems have been developed to define the age ranges in childhood. A  commonly used method is as follows:

  • Preterm neonate - born at <37 weeks gestation
  • Neonate – first 28 days of life (or first 4 weeks of life)
  • Infant – from 1 month up to 24 months of age
  • Child – from 2 years up to 12 years of age
  • Adolescent - from 12 years up to 18 years of age

For the purpose of medicine administration, children over the age of 12 years are often considered as adults. This is not always appropriate as many 12-year-olds are not adult height and weight, and have not reached puberty.

Unfortunately, manufacturers of medicines and regulatory authorities have yet to standardise the age groups referred to in Summaries of Product Characteristics (SmPCs).