[Translated article] Current situation and evolution of the availability of drugs in the pediatric population in Spain.

Autor:	Paradas-Palomo JD; Servicio de Farmacia del Hospital Materno Infantil de Málaga, Málaga, Spain. Electronic address: juand.paradas.sspa@juntadeandalucia.es., Yunquera-Romero L; Servicio de Farmacia del Hospital Materno Infantil de Málaga, Málaga, Spain., Gallego-Fernández C; Servicio de Farmacia del Hospital Materno Infantil de Málaga, Málaga, Spain.
Jazyk:	English; Spanish; Castilian
Zdroj:	Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria [Farm Hosp] 2024 May-Jun; Vol. 48 (3), pp. T122-T128. Date of Electronic Publication: 2024 Apr 16.
DOI:	10.1016/j.farma.2023.10.008
Abstrakt:	Objective: To analyze the characteristics of the new medicines approved in the pediatric population in the last 3 years, both those with studies only in the pediatric population and those that extend their indication in this population group, as well as the current situation in relation to their marketing and financing. Methods: Descriptive observational study of all drugs that include an indication in the pediatric population in Spain (by extension of the indications of drugs already authorized or because they are new drugs that already include an indication in this population group), from January 2019 to March 2022. Results: During the study period, 129 drugs included their indication in the pediatric population. 13.9% of them are not marketed, 46.5% are in a situation of non-financing, under study or without a request for financing, and 4.6% are financed for a specific pediatric subpopulation. 52.7% are original drugs, 4.7% are generic, 38.8% are biological, 3.8% are biosimilar, and 17.8% are orphan drugs. 57.36% of these medicines obtain the pediatric indication due to extension of the indication and 42.64% obtain it because they are new medicines that already include their studies in the pediatric population. Conclusions: Drugs with authorized indications are increasingly available in the pediatric population and the trend is to extend the indication of authorized drugs to the adult population. However, barriers in terms of financing and marketing need to be expedite and overcome to facilitate access to them. Competing Interests: Conflict of interest None declared. This work has not been presented in any scientific congress or meeting. (Copyright © 2023 Sociedad Española de Farmacia Hospitalaria (S.E.F.H). Publicado por Elsevier España, S.L.U. All rights reserved.)
Databáze:	MEDLINE
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