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.