Do Physicians Have a Duty to Discuss Expanded Access to Investigational Drugs with their Patients? A Normative Analysis.

Expanded Access Investigational Treatments Moral Obligations Professional Obligations Shared Decision Making Treatment Options

Journal

The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics
ISSN: 1748-720X
Titre abrégé: J Law Med Ethics
Pays: England
ID NLM: 9315583

Informations de publication

Date de publication:
2023
Historique:
medline: 26 5 2023
pubmed: 25 5 2023
entrez: 25 5 2023
Statut: ppublish

Résumé

Drawing on ethical and legal frameworks in the Netherlands, the United States and France, we examine whether physicians are expected to inform patients about potentially relevant opportunities for expanded access to investigational drugs. While we found no definitive legal obligation, we argue that physicians have a moral obligation to discuss opportunities for expanded access with patients who have run out of treatment options to prevent inequality, to promote autonomy, and to achieve beneficence.

Identifiants

pubmed: 37226748
doi: 10.1017/jme.2023.53
pii: S1073110523000530
pmc: PMC10209970
doi:

Substances chimiques

Drugs, Investigational 0

Types de publication

Journal Article

Langues

eng

Pagination

172-180

Commentaires et corrections

Type : CommentIn

Références

JAMA Intern Med. 2018 Mar 1;178(3):321-322
pubmed: 29356821
Rev Hist Pharm (Paris). 2004;52(341):47-54
pubmed: 15264349
J Allergy Clin Immunol. 2010 Feb;125(2 Suppl 2):S182-94
pubmed: 20042228
Ther Innov Regul Sci. 2017 Jul;51(4):494-500
pubmed: 30227050
Respir Care. 2020 Feb;65(2):233-251
pubmed: 31772069
Value Health Reg Issues. 2014 Sep;4:47-52
pubmed: 29702806
Ther Innov Regul Sci. 2019 Mar;53(2):243-248
pubmed: 29714573
BMJ. 2012 Jan 27;344:e256
pubmed: 22286508
Med Health Care Philos. 2022 Dec;25(4):693-701
pubmed: 35951276
Med Decis Making. 2015 Jan;35(1):114-31
pubmed: 25351843
J Health Econ. 2003 Mar;22(2):151-85
pubmed: 12606142
BMJ. 2019 Jul 10;366:l4340
pubmed: 31292109
Ther Innov Regul Sci. 2016 Nov;50(6):705-709
pubmed: 27917324
Clin Transl Sci. 2015 Oct;8(5):526-32
pubmed: 25588691
Ther Innov Regul Sci. 2017 Mar 1;51(2):177-179
pubmed: 28553565
Br J Clin Pharmacol. 2019 Mar;85(3):501-507
pubmed: 30536603
Patient Educ Couns. 2012 Jan;86(1):9-18
pubmed: 21474265
J Paediatr Child Health. 2012 Jun;48(6):458-65
pubmed: 22050238
Ned Tijdschr Geneeskd. 2021 Feb 25;165:
pubmed: 33651496
Bioethics. 2020 Sep;34(7):703-711
pubmed: 32134519
Drug Discov Today. 2021 Feb;26(2):593-603
pubmed: 33253920
J Clin Oncol. 2015 Nov 20;33(33):3979-80
pubmed: 26282656
Intractable Rare Dis Res. 2016 Nov;5(4):244-254
pubmed: 27904819
BMC Med Ethics. 2019 Nov 9;20(1):80
pubmed: 31706313
J Manag Care Spec Pharm. 2018 Jul;24(7):677-681
pubmed: 29952706
J Med Ethics. 2003 Oct;29(5):269-74
pubmed: 14519835
J Med Internet Res. 2021 Oct 28;23(10):e26890
pubmed: 34709189

Auteurs

Stefan F Vermeulen (SF)

DEPARTMENT OF MEDICAL ETHICS, PHILOSOPHY AND HISTORY OF MEDICINE, ERASMUS MC, UNIVERSITY MEDICAL CENTRE ROTTERDAM, THE NETHERLANDS.
GGZ BREBURG, TILBURG, THE NETHERLANDS.

Marjolijn Hordijk (M)

DEPARTMENT OF MEDICAL ETHICS, PHILOSOPHY AND HISTORY OF MEDICINE, ERASMUS MC, UNIVERSITY MEDICAL CENTRE ROTTERDAM, THE NETHERLANDS.

Ruben J Visser (RJ)

DEPARTMENT OF MEDICAL ETHICS, PHILOSOPHY AND HISTORY OF MEDICINE, ERASMUS MC, UNIVERSITY MEDICAL CENTRE ROTTERDAM, THE NETHERLANDS.

Eline M Bunnik (EM)

DEPARTMENT OF MEDICAL ETHICS, PHILOSOPHY AND HISTORY OF MEDICINE, ERASMUS MC, UNIVERSITY MEDICAL CENTRE ROTTERDAM, THE NETHERLANDS.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH