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Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use
Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to estimate the prevalence of psychotropic use in...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10312111/ https://www.ncbi.nlm.nih.gov/pubmed/37397481 http://dx.doi.org/10.3389/fphar.2023.1157135 |
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author | Pesiou, Stella Barcelo, Rafel Fradera, Marc Torres, Ferran Pontes, Caridad |
author_facet | Pesiou, Stella Barcelo, Rafel Fradera, Marc Torres, Ferran Pontes, Caridad |
author_sort | Pesiou, Stella |
collection | PubMed |
description | Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to estimate the prevalence of psychotropic use in pediatric subjects of Catalonia (Spain). Anonymised data on dispensation of psychotropics to pediatric patients, demography and other related data were obtained by the local healthcare management for the period 2008–2017. Estimation of off-label use was done through description of drug dispensations with no authorised use related to age range. The prevalence of psychotropics was 40.8–64.2 per 1,000 pediatric inhabitants. Hydroxyzine-only represented two-thirds of dispensations, and when removed, the prevalence dropped to 26.4–32.2 per 1,000 pediatric inhabitants. Adolescents and boys were more likely to receive a psychotropic. Psychostimulants had the highest exposure rate, mainly due to methylphenidate. Off-label use was observed in 12% of subjects, corresponding to 4.6% of all dispensed psychotropics with boys being more exposed. The proportion of off-label use vs. labelled use was higher in younger populations. Aripiprazole had the highest off-label frequency. Our data support the frequent reality of off-label use in pediatrics, despite the potential underestimation related to the selected off-label definition. There is an urgent need to systematically ascertain effectiveness and any potential adverse events in the off-label pediatric setting, and to generate valuable information for risk-benefit assessment in these populations where extrapolation from adults is not reliable. |
format | Online Article Text |
id | pubmed-10312111 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-103121112023-07-01 Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use Pesiou, Stella Barcelo, Rafel Fradera, Marc Torres, Ferran Pontes, Caridad Front Pharmacol Pharmacology Psychotropics are increasingly used in pediatrics, often as off-label medicines. The guarantees of safety and efficacy are not always granted in clinical practice compared to adult authorised indications. A retrospective observational study was done to estimate the prevalence of psychotropic use in pediatric subjects of Catalonia (Spain). Anonymised data on dispensation of psychotropics to pediatric patients, demography and other related data were obtained by the local healthcare management for the period 2008–2017. Estimation of off-label use was done through description of drug dispensations with no authorised use related to age range. The prevalence of psychotropics was 40.8–64.2 per 1,000 pediatric inhabitants. Hydroxyzine-only represented two-thirds of dispensations, and when removed, the prevalence dropped to 26.4–32.2 per 1,000 pediatric inhabitants. Adolescents and boys were more likely to receive a psychotropic. Psychostimulants had the highest exposure rate, mainly due to methylphenidate. Off-label use was observed in 12% of subjects, corresponding to 4.6% of all dispensed psychotropics with boys being more exposed. The proportion of off-label use vs. labelled use was higher in younger populations. Aripiprazole had the highest off-label frequency. Our data support the frequent reality of off-label use in pediatrics, despite the potential underestimation related to the selected off-label definition. There is an urgent need to systematically ascertain effectiveness and any potential adverse events in the off-label pediatric setting, and to generate valuable information for risk-benefit assessment in these populations where extrapolation from adults is not reliable. Frontiers Media S.A. 2023-06-16 /pmc/articles/PMC10312111/ /pubmed/37397481 http://dx.doi.org/10.3389/fphar.2023.1157135 Text en Copyright © 2023 Pesiou, Barcelo, Fradera, Torres and Pontes. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Pesiou, Stella Barcelo, Rafel Fradera, Marc Torres, Ferran Pontes, Caridad Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
title | Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
title_full | Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
title_fullStr | Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
title_full_unstemmed | Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
title_short | Utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
title_sort | utilisation of drugs for the treatment of psychiatric diseases in the pediatric population: focus on off-label use |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10312111/ https://www.ncbi.nlm.nih.gov/pubmed/37397481 http://dx.doi.org/10.3389/fphar.2023.1157135 |
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