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Off-Label Medication: From a Simple Concept to Complex Practical Aspects

Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet...

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Autores principales: Rusz, Carmen-Maria, Ősz, Bianca-Eugenia, Jîtcă, George, Miklos, Amalia, Bătrînu, Mădălina-Georgiana, Imre, Silvia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8508135/
https://www.ncbi.nlm.nih.gov/pubmed/34639747
http://dx.doi.org/10.3390/ijerph181910447
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author Rusz, Carmen-Maria
Ősz, Bianca-Eugenia
Jîtcă, George
Miklos, Amalia
Bătrînu, Mădălina-Georgiana
Imre, Silvia
author_facet Rusz, Carmen-Maria
Ősz, Bianca-Eugenia
Jîtcă, George
Miklos, Amalia
Bătrînu, Mădălina-Georgiana
Imre, Silvia
author_sort Rusz, Carmen-Maria
collection PubMed
description Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet clinical needs. Several therapeutic areas require off-label approaches; therefore, this practice is challenging for prescribing physicians. Meanwhile, the regulatory agencies are making efforts in order to ensure a safe practice. The present paper defines the off-label concept, and it describes its regulation, together with several complex aspects associated with clinical practices regarding rare diseases, oncology, pediatrics, psychiatry therapeutic areas, and the safety issues that arise. A systematic research of the literature was performed, using terms, such as “off-label”, ”prevalence”, ”rare diseases”, ”oncology”, ”psychiatry”, ”pediatrics”, and ”drug repurposing”. There are several reasons for which off-label practice remains indispensable in the present; therefore, efforts are made worldwide, by the regulatory agencies and governmental bodies, to raise awareness and to ensure safe practice, while also encouraging further research.
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spelling pubmed-85081352021-10-13 Off-Label Medication: From a Simple Concept to Complex Practical Aspects Rusz, Carmen-Maria Ősz, Bianca-Eugenia Jîtcă, George Miklos, Amalia Bătrînu, Mădălina-Georgiana Imre, Silvia Int J Environ Res Public Health Review Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is still a current issue, triggered especially by unmet clinical needs. Several therapeutic areas require off-label approaches; therefore, this practice is challenging for prescribing physicians. Meanwhile, the regulatory agencies are making efforts in order to ensure a safe practice. The present paper defines the off-label concept, and it describes its regulation, together with several complex aspects associated with clinical practices regarding rare diseases, oncology, pediatrics, psychiatry therapeutic areas, and the safety issues that arise. A systematic research of the literature was performed, using terms, such as “off-label”, ”prevalence”, ”rare diseases”, ”oncology”, ”psychiatry”, ”pediatrics”, and ”drug repurposing”. There are several reasons for which off-label practice remains indispensable in the present; therefore, efforts are made worldwide, by the regulatory agencies and governmental bodies, to raise awareness and to ensure safe practice, while also encouraging further research. MDPI 2021-10-04 /pmc/articles/PMC8508135/ /pubmed/34639747 http://dx.doi.org/10.3390/ijerph181910447 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Rusz, Carmen-Maria
Ősz, Bianca-Eugenia
Jîtcă, George
Miklos, Amalia
Bătrînu, Mădălina-Georgiana
Imre, Silvia
Off-Label Medication: From a Simple Concept to Complex Practical Aspects
title Off-Label Medication: From a Simple Concept to Complex Practical Aspects
title_full Off-Label Medication: From a Simple Concept to Complex Practical Aspects
title_fullStr Off-Label Medication: From a Simple Concept to Complex Practical Aspects
title_full_unstemmed Off-Label Medication: From a Simple Concept to Complex Practical Aspects
title_short Off-Label Medication: From a Simple Concept to Complex Practical Aspects
title_sort off-label medication: from a simple concept to complex practical aspects
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8508135/
https://www.ncbi.nlm.nih.gov/pubmed/34639747
http://dx.doi.org/10.3390/ijerph181910447
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