Off-label prescribing to children in primary care: retrospective observational study

Objectives. To investigate the extent and pattern of off-label prescribing to children in primary care throughout Scotland.

Design. Assessment of prescribing to 167,865 children aged 0-16 years during the period November 1999 to October 2000 using data from 161 general practices using the national Scottish primary care computer system General Practice Administration System for Scotland.

Setting. One hundred and sixty one general practices in Scotland.

Results. During the study period, at least one off-label prescription was issued to 17,715 (26.1%) children aged 0-16 years. Off-label prescribing due to lower than the recommended dose was the most common form of off-label prescribing (40-50%), with antibiotics and antihistamines making up the majority. Off-label prescribing due to higher than the recommended dose was also common (35% of all off-label prescribing), with antiasthmatics, topical corticosteroids and laxatives making up the majority. Off-label prescribing with respect to age was less common (6-16%) affecting mainly young children (less than 2 years old) and adolescents. Off-label prescribing with respect to formulation was the least common cause accounting for 5-10% of off-label prescribing.

Conclusions. This is the largest and most detailed study to date of paediatric off-label prescribing in primary care within the UK. Such off-label prescribing likely occurs as the result of several factors including a failure to update licensing information with currently accepted practice and confusion or unawareness of the licensing recommendations, further compounded by a lack of clinical trials data and suitable formulations for medicines commonly prescribed to young children and adolescents.