scholarly journals Authors’ Response to Peer Reviews of “No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19”

JMIRx Med ◽  
10.2196/24485 ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. e24485
Author(s):  
Moshe Rogosnitzky ◽  
Esther Berkowitz ◽  
Alejandro R Jadad
Keyword(s):  
Real World ◽  
Generic Drugs ◽  
Peer Reviews

scholarly journals Authors’ Response to Peer Reviews of “No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19” (Preprint)

2020 ◽  
Author(s):  
Moshe Rogosnitzky ◽  
Esther Berkowitz ◽  
Alejandro R Jadad
Keyword(s):  
Peer Review ◽  
Real World ◽  
Generic Drugs ◽  
Author Response ◽  
Peer Reviews

UNSTRUCTURED Author response to peer review for MS#19583

scholarly journals No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19 (Preprint)

2020 ◽  
Author(s):  
Moshe Rogosnitzky ◽  
Esther Berkowitz ◽  
Alejandro R Jadad
Keyword(s):  
Public Health ◽  
Real World ◽  
Generic Drugs ◽  
Antiplatelet Agent ◽  
Safety Data ◽  
Drug Repurposing ◽  
Extensive Literature ◽  
Off Label ◽  
Drug Candidates ◽  
Track Record

UNSTRUCTURED Real-world drug repurposing—the immediate “off-label” prescribing of drugs to address urgent clinical needs—is an indispensable strategy gaining rapid traction in the current COVID-19 crisis. Although off-label prescribing (ie, for a nonapproved indication) is legal in most countries, it tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, in urgent public health crises, it is often the only realistic source of a meaningful potential solution. To be considered for real-world repurposing, drug candidates should ideally have a track record of safety, affordability, and wide accessibility. Although thousands of such drugs are already available, the absence of a central repository of off-label uses presents a barrier to the immediate identification and selection of the safest, potentially useful interventions. Using the current COVID-19 pandemic as an example, we provide a glimpse at 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 pleiotropically target the underlying pathophysiology that makes COVID-19 so dangerous. Having previously fast-tracked this paper to publication in summary form, we now expand on why cimetidine/famotidine (histamine type-2 receptor antagonists), dipyridamole (antiplatelet agent), fenofibrate/bezafibrate (cholesterol/triglyceride-lowering agents), and sildenafil (phosphodiesterase-5 inhibitor) are worth considering for patients with COVID-19 based on their antiviral, anti-inflammatory, renoprotective, cardioprotective, and anticoagulation properties. These examples also reveal the unlimited opportunity to future-proof public health by proactively mining, synthesizing, and cataloging the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.

scholarly journals Approval rating and opinion of outpatients and general practitioners toward generic drugs: a questionnaire-based real-world study

2017 ◽  
Vol Volume 11 ◽  
pp. 1423-1433 ◽  
Author(s):  
Francesca Mattioli ◽  
Giacomo Siri ◽  
Francesca Castelli ◽  
Matteo Puntoni ◽  
Maria Laura Zuccoli ◽  
...  
Keyword(s):  
General Practitioners ◽  
Real World ◽  
Generic Drugs ◽  
Approval Rating

scholarly journals Delivering Benefits at Speed Through Real-World Repurposing of Off-Patent Drugs: The COVID-19 Pandemic as a Case in Point

10.2196/19199 ◽  
2020 ◽  
Vol 6 (2) ◽  
pp. e19199 ◽  
Author(s):  
Moshe Rogosnitzky ◽  
Esther Berkowitz ◽  
Alejandro R Jadad
Keyword(s):  
Real World ◽  
Generic Drugs ◽  
Health Care Systems ◽  
Safety Data ◽  
Drug Repurposing ◽  
Extensive Literature ◽  
Off Label ◽  
Drug Candidates ◽  
Track Record ◽  
Care Systems

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.

scholarly journals No Time to Waste: Real-World Repurposing of Generic Drugs as a Multifaceted Strategy Against COVID-19

JMIRx Med ◽  
10.2196/19583 ◽  
2020 ◽  
Vol 1 (1) ◽  
pp. e19583 ◽  
Author(s):  
Moshe Rogosnitzky ◽  
Esther Berkowitz ◽  
Alejandro R Jadad
Keyword(s):  
Public Health ◽  
Real World ◽  
Generic Drugs ◽  
Antiplatelet Agent ◽  
Safety Data ◽  
Drug Repurposing ◽  
Extensive Literature ◽  
Off Label ◽  
Drug Candidates ◽  
Track Record

Real-world drug repurposing—the immediate “off-label” prescribing of drugs to address urgent clinical needs—is an indispensable strategy gaining rapid traction in the current COVID-19 crisis. Although off-label prescribing (ie, for a nonapproved indication) is legal in most countries, it tends to shift the burden of liability and cost to physicians and patients, respectively. Nevertheless, in urgent public health crises, it is often the only realistic source of a meaningful potential solution. To be considered for real-world repurposing, drug candidates should ideally have a track record of safety, affordability, and wide accessibility. Although thousands of such drugs are already available, the absence of a central repository of off-label uses presents a barrier to the immediate identification and selection of the safest, potentially useful interventions. Using the current COVID-19 pandemic as an example, we provide a glimpse at 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 pleiotropically target the underlying pathophysiology that makes COVID-19 so dangerous. Having previously fast-tracked this paper to publication in summary form, we now expand on why cimetidine/famotidine (histamine type-2 receptor antagonists), dipyridamole (antiplatelet agent), fenofibrate/bezafibrate (cholesterol/triglyceride-lowering agents), and sildenafil (phosphodiesterase-5 inhibitor) are worth considering for patients with COVID-19 based on their antiviral, anti-inflammatory, renoprotective, cardioprotective, and anticoagulation properties. These examples also reveal the unlimited opportunity to future-proof public health by proactively mining, synthesizing, and cataloging the off-label treatment opportunities of thousands of safe, well-established, and affordable generic drugs.

scholarly journals The Potential to Reduce Patient Co-Payment and the Public Payer Spending in Poland through an Optimised Implementation of the Generic Substitution: The Win-Win Scenario Suggested by the Real-World Big Data Analysis

Pharmaceutics ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 1165
Author(s):  
Przemysław Kardas ◽  
Aneta Lichwierowicz ◽  
Filip Urbański ◽  
Beata Szadkowska-Opasiak ◽  
Ewa Karasiewicz ◽  
...  
Keyword(s):  
Big Data ◽  
Real World ◽  
Generic Substitution ◽  
Positive Impact ◽  
Patient Adherence ◽  
Generic Drugs ◽  
Drug Market ◽  
Economic Consequences ◽  
Medication Costs ◽  
Public Payer

High medication costs are one of the major barriers to patient adherence. Medication affordability might be improved by generic substitution. The aim of this study was to assess the effectiveness of the implementation of generic substitution mechanisms in Poland. This was a retrospective analysis of nationwide real-world big data corresponding to dispensation of metformin preparations in 2019 in Poland. Relevant prescription and dispensation data were compared to assess the prevalence of generic substitution and its economic consequences. Among the 1,135,863 e-prescriptions analysed, a generic substitution was found in only 4.81% of the packs dispensed, based on e-prescriptions issued for metformin under its originator version and 2.73% under generic drugs. It is estimated that if these values were applied to the total Polish drug market, patients could lose the opportunity to lower their co-payment by 15.91% and the national payer to reduce its reimbursement expenditures by 8.31%. Our results point at the suboptimal implementation of generic substitution in Poland. Therefore, relevant actions need to be taken in order to maximise the benefits provided by this mechanism. It could not only lead to the win-win scenario in which both patients and the national payer are secured substantial savings, but it could also have a positive impact on patient adherence.

Sign in / Sign up

Export Citation Format

Share Document