The extent of unlicensed and off-label drug use in the paediatric ward of a district general hospital in Northern Ireland.

Children receive many drugs which are either unlicensed or used outside the licensing terms (off-label prescribing). Children are thereby at greater risk of side-effects. We sought to determine non-licensed drug usage in a non-specialised paediatric unit because previous studies had examined only specialised centres. Drug charts were examined prospectively over two months. Items were compared with product licenses and determined as licensed, unlicensed or off-label usage. Seventy four charts (237 prescriptions) were examined in which 183 (77.2%) drug courses were licensed. The commonest drugs were antipyretics and antibiotics. In 32 children, 8 items (3.4%) were unlicensed and 46 items (19.4%) were off-label prescriptions. The unlicensed prescriptions were mostly anti-emetics and pro-motility drugs. The three commonest off-label prescriptions were bronchodilators, antibiotics and laxatives. Non-licensed drug usage is common in non-specialised wards and therefore probably all levels of paediatric healthcare provision. Governments must re-examine paediatric drug licensing.