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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...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2021
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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. |
format | Online Article Text |
id | pubmed-8508135 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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