Off-label Prescription in Paediatric Dermatology: A Retrospective Observational Study in a Tertiary Hospital

Abstract

Off-label prescription in paediatric patients is common, where some studies indicate that dermatological conditions are more prone to off-label treatment. This is the first study to analyse the prevalence of off-label prescription in paediatric dermatology consultation. This retrospective observational study was performed using the medical records of paediatric patients who were evaluated in a paediatric dermatological consultation in Pontevedra University Hospital, Pontevedra, Spain. Of the 468 patients reviewed, 186 prescriptions were issued and 51.10% were off-label prescription drugs. The dermatological conditions for which off-label prescription was most common were atopic dermatitis (29.0%), followed by warts (12.9%) and infantile haemangiomas (11.8%). With respect to drugs, topical tacrolimus (23.7%) was the most frequently prescribed off-label drug. The main reason for prescribing an off-label drug was for a disease not included on the label (62.4%), followed by issuing it at a lower age than authorized (55.9%). There was a significant association between a higher percentage of off-label prescription and younger age (p < 0.001), and the treatment of vitiligo, infantile haemangiomas and warts (p < 0.001). Likewise, the off-label prescription was significantly more common in the case of topical terbinafine, timolol, desloratadine and topical salicylic acid (p < 0.001). To conclude, off-label prescription is predominant in paediatric dermatology, as observed in 51.1% of our patients.