Challenges to the validity of using medicine labels to categorize clinical behavior: An empirical and normative critique of “off-label” prescribing

Author:

Ghinea Narcyz12,Kerridge Ian23,Little Miles2,Lipworth Wendy2

Affiliation:

1. St Vincent's Clinical School; University of New South Wales; Darlinghurst NSW 2010 Australia

2. Centre for Values, Ethics and the Law in Medicine; University of Sydney; NSW 2006 Australia

3. Haematology Department; Royal North Shore Hospital; Sydney NSW 2065 Australia

Funder

National Health and Medical Research Council

Publisher

Wiley

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference43 articles.

1. Australian ClinicalTrials Phases of clinical trials www.australianclinicaltrials.gov.au/what-clinical-trial/phases-clinical-trials

2. Henning PJ F.D.A's ‘off-label’ drugs policy leads to free-speech fight The New York Times August 10, 2015

3. Off-label prescribing among office-based physicians;Radley;Arch Intern Med,2006

4. Off-label use of misoprostol for labor induction: a nation-wide survey in Switzerland;Krause;Eur J Obstet Gynecol Reprod Biol,2011

5. “Off-label” indications for oncology drug use and drug compendia: history and current status;Soares;J Oncol Pract,2005

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