Information in summaries of product characteristics about use in children is limited and needs standardisation: a systematic analysis in Switzerland

• Published in: Archives of disease in childhood Vol. 109; no. 7; pp. 586 - 591
• Main Authors: Tilen, Romy, Berger, Christoph, Allemann, Samuel, Meyer zu Schwabedissen, Henriette
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Royal College of Paediatrics and Child Health 01.07.2024; BMJ Publishing Group LTD
• Subjects: Adolescent; Adolescents; Age; Child; Child, Preschool; Children; Children & youth; Classification; Contraindications; Data Analysis; Drug Approval; Drug dosages; Drug therapy; Drugs; Hospitals; Humans; Infant; Infant, Newborn; Marketing; Natural Language Processing; Off-Label Use - statistics & numerical data; Paediatrics; Pediatrics; Pharmaceutical industry; Pharmacology; Prescription drugs; Switzerland; Teenagers; Therapeutics; Young Children; Switzerland; Pharmacology; Paediatrics; Therapeutics
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/archdischild-2023-325611

BackgroundA considerable proportion of drugs administered to children are not authorised for this purpose, and consequently off-label use is common in paediatric care. Our aims were to quantify systematically the number of drugs authorised in Switzerland for use in children based on their current summary of product characteristics (SmPC) and to assess the quality of this information.MethodsWe used natural language processing to screen all Swiss SmPCs, available in German language in the open-source drug database, for information about use in children. Based on the SmPCs of the most frequently used drugs in Swiss children’s hospitals, 10 search terms were defined to retrieve this information.ResultsOf the analysed 4214 drugs corresponding to 1553 active substances, 2322 (55.1%) drugs were authorised for use in children. In only 639 (15.2%) SmPCs, information about authorisation for children was found in the section ‘Therapeutic indications’. 320 (13.8%) SmPCs of drugs authorised for use in children contained only verbal age indications such as ‘children’ and ‘adolescents’ without a clear definition of the age or an age range.ConclusionsMost Swiss SmPCs contain information about children, but only a minority refer to an official indication. Even if some SmPCs clearly indicate that use in children is authorised, a clear statement of the age at which the drug may be administered is missing. Standardisation of information about use in children in SmPCs is needed.