Rational Pharmacotherapy In Children – Issues Concerning off-Label Drug Use

Abstract

Many medicines used in children are used in an off-label manner. This means they are used either at a greater dose than that recommended in the product licence, for an alternative indication, or in an age group for which the medicine was not originally authorised. The main issue with regards to the use of medicines is not whether they are off-label but whether there is an evidence basis to justify their use in that particular condition. This means, specifically, has the medicine been used in a rational manner or not. Rational prescribing has been recognised as an important issue in low-income and lower middle-income countries. It has not been considered a major issue in high-income countries. This is unfortunate as many medicines are used inappropriately. There is significant variation in the utilisation of antibiotics. Broad-spectrum antibiotics in particular are often used inappropriately. Polypharmacy is often used when this is inappropriate. Other examples of inappropriate drug use include the overutilisation of medicines for infants with gastro-oesophageal reflux. 1. Choonara I. Rational prescribing is important in all settings. Arch Dis Child. 2013;98:720. 2. Puntis JW. Gastro-oesophageal reflux in young babies: who should be treated? Arch Dis Child 2015; 0: 1-5. doi:10.1136/archdischild-2014-306232.