Utilisation médicamenteuse hors AMM en pédiatrie (au niveau du service de pédiatrie chu de Sétif)

Abstract

It is essential to obtain marketing authorisation before a pharmaceutical speciality can be marketed definitively. The aim of this study is to evaluate drug prescriptions and their use outside the AMM in children hospitalised in the paediatrics department and the neonatology department of the mother and child hospital in Sétif, from 01/12/2023 to 31/04/2024. This department is classified into several specialities: neonatology, day hospital, adult side (over 5 years), oncology, within the framework of a retrospective descriptive study carried out on 709 patients, the study was carried out on prescriptions archived from 01/01/2023 to 31/12/2023. The majority of prescriptions studied (83.77%) were treated with at least one off-label drug, while 68.13% of drugs were prescribed off-label according to categories (age, indication, dose). Work was carried out on the following age groups: (newborns, infants, children, adolescents): Out of 147 newborns, 58.50% received at least one off-label drug, all infants received at least one offlabel drug, out of 124 children, the majority (92.74%) received at least one off-label drug and out of 90 adolescents, 84.44% received at least one off-label drug. The lack of availability of authorised paediatric medicines is highlighted by the use of magistral preparations (0.62%), as there are no galenic forms adapted to the paediatric population, particularly NN.