Survey of off-label prescribing in a university paediatric outpatient in Brazil

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 t...

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Bibliographic Details
Published in:Tropical doctor 2022-04, Vol.52 (2), p.270-275
Main Authors: Monteiro, Francelle A. S. G., Soares, Cristina N., Chaveiro, Letícia G., Cabral, Valeska A., Lima, Paulo M. A.
Format: Article
Language:English
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Summary: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.
ISSN:0049-4755
1758-1133
DOI:10.1177/00494755211068644