The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia

OBJECTIVE: To review the sequence of events that led to the Therapeutic Goods Administration (TGA) approval of esketamine in Australia, and to explore the potential ethical and clinical consequences of it. CONCLUSIONS: Trust in the TGA is of paramount importance to Australian psychiatrists. The appr...

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Detalles Bibliográficos
Autor principal: Lugg, William
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2023
Materias:
Psychotropic Medication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10088336/
https://www.ncbi.nlm.nih.gov/pubmed/36802863
http://dx.doi.org/10.1177/10398562231156475
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author Lugg, William
author_facet Lugg, William
author_sort Lugg, William
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description OBJECTIVE: To review the sequence of events that led to the Therapeutic Goods Administration (TGA) approval of esketamine in Australia, and to explore the potential ethical and clinical consequences of it. CONCLUSIONS: Trust in the TGA is of paramount importance to Australian psychiatrists. The approval of esketamine raises serious questions about the processes, independence and authority of the TGA, and therefore the confidence Australian psychiatrists can have in the ‘quality, safety and efficacy’ of the drugs they offer their patients.
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spelling pubmed-100883362023-04-12 The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia Lugg, William Australas Psychiatry Psychotropic Medication OBJECTIVE: To review the sequence of events that led to the Therapeutic Goods Administration (TGA) approval of esketamine in Australia, and to explore the potential ethical and clinical consequences of it. CONCLUSIONS: Trust in the TGA is of paramount importance to Australian psychiatrists. The approval of esketamine raises serious questions about the processes, independence and authority of the TGA, and therefore the confidence Australian psychiatrists can have in the ‘quality, safety and efficacy’ of the drugs they offer their patients. SAGE Publications 2023-02-20 2023-04 /pmc/articles/PMC10088336/ /pubmed/36802863 http://dx.doi.org/10.1177/10398562231156475 Text en © The Royal Australian and New Zealand College of Psychiatrists 2023 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Psychotropic Medication
Lugg, William
The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia
title The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia
title_full The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia
title_fullStr The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia
title_full_unstemmed The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia
title_short The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia
title_sort parable of the therapeutic goods administration approval of esketamine (spravato) in australia
topic Psychotropic Medication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10088336/
https://www.ncbi.nlm.nih.gov/pubmed/36802863
http://dx.doi.org/10.1177/10398562231156475
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