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

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 observatio...

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Detalles Bibliográficos
Autores: Couselo Rodríguez, Carmen, Batalla Cebey, Ana, Martínez Fernández, Sandra, Dávila Pousa, María del Carmen, Soto García, Diego, Vilanova Trillo, Lucia, Florez Menendez, Maria Angeles
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Servizo Galego de Saúde (SERGAS)
Repositorio:RUNA. Repositorio da Consellería de Sanidade e Sergas
OAI Identifier:oai:runa.sergas.gal:20.500.11940/21803
Acceso en línea:https://portalcientifico.sergas.gal//documentos/65911d9aae63c86e421b97dc
http://hdl.handle.net/20.500.11940/21803
Access Level:acceso abierto
Palabra clave:Child
Humans
Dermatology
Hemangioma
Off-Label Use
Prescriptions
Tertiary Care Centers
Warts
AS Pontevedra
CHUP
AS Santiago
CHUS
Descripción
Sumario: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.