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Many medicines prescribed for children are not licensed for use in this age group. Many common medicines have not been tested properly or at all in children; frequently medicines are administered to this age group based on how they work in adults and the doses used are often a best guess. This means that children are at a high risk of suffering serious and unexpected side effects, known as adverse drug reactions, from many medicines prescribed by doctors or available at the chemist.
Liverpool has an impressive heritage in drug safety sciences: the PMRU has led on an extensive research programme into adverse drug reactions (ADRs) in children. The requirement for validated tools to characterise ADRs in children has grown as clinical trials of new and existing drugs have been driven by the EU and FDA regulations for paediatric medicines.
[LINK TO DRUG SAFETY STUDIES TABLE]
[LINK TO DRUG SAFETY PUBLICATIONS]
Medicines optimisation aims to help patients to make the most out of their medicines and ensure value for money from medicines. The Royal Pharmaceutical Society outlines four principles of medicines optimisation, which are, to understand the patient’s experience of medicines, the use of evidence-based medicines, ensuring medicines use is as safe as possible and making medicines optimisation part of routine practice.
[LINK TO MEDICINES OPTIMISATION STUDIES TABLE]
[LINK TO MEDICINES OPTIMISATION PUBLICATIONS]
Many medicines are only available in dosage forms which are suitable for use in adults. For instance, small children are typically unable to swallow large tablets or capsules. When developing and prescribing medicines for children it is important to consider how suitable the product (or formulation) is for them. One important factor is the acceptability of the medicine to the child who needs to take it. Acceptability includes how straightforward it is to prepare the dose, how easy it is to take and how it tastes.
Due to the lack of licensed ‘authorised’ medicines available for children, medicines often need to be manipulated (e.g. tablets are split or crushed; capsules are opened and their contents sprinkled onto food or into a drink). This is called ‘off-label’ use as the medicine is being used outside the terms of its marketing authorisation. Other considerations in paediatrics include selection of the most appropriate strength of a medicine available and the suitability of its excipients. A careful risk-benefit assessment is needed when age-appropriate formulations (AaFs) are unavailable to ensure safe, effective and appropriate medicines can be successfully administered to children, in an acceptable manner.
The PMRU team is working with the pharmaceutical industry to help co-design AaFs for children, which are ‘age-appropriate’ and designed with the needs of children in mind.
[LINK TO FORMULATIONS STUDIES TABLE]
[LINK TO FORMULATIONS PUBLICATIONS]
Alder Hey Children's Charity