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Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point.
JMIR Public Health Surveill. 2020 05 13; 6(2):e19199.JP

Abstract

Real-world drug repurposing-the immediate "off-label" prescribing of drugs to address urgent clinical needs-is a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.

Authors+Show Affiliations

MedInsight Research Institute, Rehovot, Israel.MedInsight Research Institute, Rehovot, Israel.Program in Impactful Giving, Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. Department of Anesthesiology and Pain Medicine, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32374264

Citation

Rogosnitzky, Moshe, et al. "Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: the COVID-19 Pandemic as a Case in Point." JMIR Public Health and Surveillance, vol. 6, no. 2, 2020, pp. e19199.
Rogosnitzky M, Berkowitz E, Jadad AR. Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point. JMIR Public Health Surveill. 2020;6(2):e19199.
Rogosnitzky, M., Berkowitz, E., & Jadad, A. R. (2020). Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point. JMIR Public Health and Surveillance, 6(2), e19199. https://doi.org/10.2196/19199
Rogosnitzky M, Berkowitz E, Jadad AR. Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: the COVID-19 Pandemic as a Case in Point. JMIR Public Health Surveill. 2020 05 13;6(2):e19199. PubMed PMID: 32374264.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point. AU - Rogosnitzky,Moshe, AU - Berkowitz,Esther, AU - Jadad,Alejandro R, Y1 - 2020/05/13/ PY - 2020/04/07/received PY - 2020/05/05/accepted PY - 2020/04/29/revised PY - 2020/5/7/pubmed PY - 2020/5/27/medline PY - 2020/5/7/entrez KW - COVID-19 KW - crisis KW - drug costs KW - drug repositioning KW - drugs, generic KW - off-label use KW - pandemic KW - public health KW - severe acute respiratory syndrome coronavirus 2 SP - e19199 EP - e19199 JF - JMIR public health and surveillance JO - JMIR Public Health Surveill VL - 6 IS - 2 N2 - Real-world drug repurposing-the immediate "off-label" prescribing of drugs to address urgent clinical needs-is a widely overlooked opportunity. Off-label prescribing (ie, for a nonapproved indication) is legal in most countries and tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, health crises may mean that real-world repurposing is the only realistic source for solutions. Optimal real-world repurposing requires a track record of safety, affordability, and access for drug candidates. Although thousands of such drugs are already available, there is no central repository of off-label uses to facilitate immediate identification and selection of potentially useful interventions during public health crises. Using the current coronavirus disease (COVID-19) pandemic as an example, we provide a glimpse of the extensive literature that supports the rationale behind six generic drugs, in four classes, all of which are affordable, supported by decades of safety data, and targeted toward the underlying pathophysiology that makes COVID-19 so deadly. This paper briefly summarizes why cimetidine or famotidine, dipyridamole, fenofibrate or bezafibrate, and sildenafil citrate are worth considering for patients with COVID-19. Clinical trials to assess efficacy are already underway for famotidine, dipyridamole, and sildenafil, and further trials of all these agents will be important in due course. These examples also reveal the unlimited opportunity to future-proof our health care systems by proactively mining, synthesizing, cataloging, and evaluating the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs. SN - 2369-2960 UR - https://www.unboundmedicine.com/medline/citation/32374264/Delivering_Benefits_at_Speed_Through_Real-World_Repurposing_of_Off-Patent_Drugs:_The_COVID-19_Pandemic_as_a_Case_in_Point L2 - https://publichealth.jmir.org/2020/2/e19199/ DB - PRIME DP - Unbound Medicine ER -