Ours is a cross-sectional, descriptive, retrospective study evaluating the extent of off-label prescribing for patients attending a university paediatric outpatient department in Goiás, Brazil. 391 patients were treated in the outpatient, and 668 medicines were prescribed. Of these, 70.4% followed the terms of the marketing authorization; 0.3% were unlicenced, and 11% were off-label. Dose was the main factor in off-label prescribing. Infants (0-2 years) received 37.8% of the off-label prescriptions. Vitamins and drugs for the treatment of respiratory diseases were the most prevalent culprits. Of the total prescriptions, 23 different drugs were defined as off-label. Salbutamol was the most prescribed (41.9%). Owing to practical and legal difficulties in carrying out clinical trials, medicines are inadequately studied in children; cooperation between industry, regulatory authorities, and healthcare professionals is required to improve treatment safety. Our results may help guide clinical researcher on off-label prescripting in future trials.
Keywords: drugs; off-label; paediatrics; pharmacoepidemiology; prescribing policies.