Children: Introduction

Last updated: Monday, December 10, 2018

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 of medicines 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.

So if you are asked about the choice of drug in a paediatric patient, always consider if there is an appropriate, licensed option first. However, if the medicine required is not licensed for use in children you will need to take extra steps to check the indication, dose and frequency, suitability of formulation, precautions, interactions and monitoring parameters.


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
  • Child – from 2 years up to 12 years
  • Adolescent from 12 years up to 18 years of age

Therefore, 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 (SPCs).