Utilisation médicamenteuse hors amm en pédiatrie dans la wilaya de Sétif

Abstract

The use of a medicinal product that is not subject to a marketing authorisation is a widespread practice, particularly in pediatrics. Failure to comply with the data contained in the in the summary of product characteristics (indications, dosage, route of administration, age/weight, etc.) means that the medicinal product is no longer authorised for use. A study was carried out with two models, in order to evaluate the off-label medical prescription in pediatrics in the wilaya of Sétif, involving 214 cases hospitalised at the CHU Sétif pediatrics department, as well as two questionnaires relating to a sample of 90 doctors and pharmacists (45 doctors, 45 pharmacists). The results obtained are: -At the pediatrics department level: 71% of patients had at least one drug off-label, 46% of prescriptions were off-label, 40% of prescriptions off-label were due to an age different from that specified in the RCP. -47% of doctors prescribe rugs outside of marketing authorisation, and 67% of pharmacists receive them. Prescribing off-label drugs can be made on a doctor's prescription: 47% of doctors prescribe medicines outside the MA due to the lack of therapeutic alternatives, or by self-medication: 33% of pharmacists dispense medicines outside the MA because doctors are used to prescribing them. Prescriptions off-label are difficult to detect: 93% of doctors do not mention "not covered by MA" on the prescription and 96% of pharmacists cannot find it. In some cases, off-label prescribing is dangerous, particularly in pediatrics, however, it is an element of highquality patient care where there is no therapeutic alternative, so a regulatory framework for this practice needs to be put in place to ensure that it is used in the right way.