A–Z of prescribing for children

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) grants licences that confirm the specific medical condition a drug should be used for, alongside the recommended dosage. This has been the case since the 1960s following the thalidomide tragedy (Collier, 1999), with the introduction of the Medicines Act in 1968. However, the term ‘therapeutic orphan’ has since been introduced to describe children taking medicines that are not recommended for them, due to insufficient evidence from clinical trials (Choonara and Conroy, 2002).

Due to this, many children may receive unlicensed or off-label drug prescriptions – sometimes up to 70% of children in intensive care units (Choonara and Conroy, 2002), although some studies suggest it can be as high as 95% (Meng et al, 2022).

Off-label prescribing (Schrier et al, 2020) is prescribing a drug that has a licence in the UK, but given outside the recommended age range or the indication that it has been approved for. For example, dinoprostone, which is licensed to prepare a woman's cervix during labour, is also used in paediatric cardiac patients to maintain a patent ductus arteriosus (Choonara and Conroy, 2002), and this would be a different indication. An alternative route could refer to adrenaline for injection being administered via a nebuliser to treat croup (Choonara and Conroy, 2002).