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

2020 ◽  
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

UNSTRUCTURED 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 (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 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 Incidence and Prevalence of Cancer in Colombia: The Methodology Used Matters

2018 ◽  
pp. 1-7 ◽  
Author(s):  
Omaira Valencia ◽  
Gilberto Lopes ◽  
Patricia Sánchez ◽  
Lizbeth Acuña ◽  
Daniel Uribe ◽  
...  
Keyword(s):  
Health Care ◽  
Real World ◽  
Health Care Systems ◽  
National Health System ◽  
Cancer Registries ◽  
Real World Data ◽  
Control Programs ◽  
Number Of Patients ◽  
Care Systems ◽  
Prevalence Of Cancer

Purpose Incidence and prevalence are important factors in policy making and planning in health care systems. The aim of this study was to compare two different estimates of the incidence and prevalence of cancer in Colombia—real-world data from the health care system and estimates from cancer registries. Materials and Methods Data from all providers were aggregated by the High-Cost Diseases Office (Cuenta de Alto Costo [CAC]). The real-world, age-standardized observed incidence (OI) and observed prevalence (OP) rates were calculated using the number of patients with a diagnosis of cancer who were cared for in the national health system between 2014 and 2015. The registry estimated incidence (EI) and estimated prevalence (EP) were extracted from GLOBOCAN population fact sheets for 2012, which use data from four Colombian city-based registries and extrapolate survival using the average for Asian countries, together with registries from Uganda and Zimbabwe. Results A total of 130,441 patients were analyzed. The OI of cancer in Colombia was 69.2 and the OP was 479 (per 100,000 people) in early 2015, whereas the EI was 175.2 and the 5-year EP was 501.2 (per 100,000 people), showing a higher estimate from GLOBOCAN data for 2012 than was observed in early 2015 by the CAC. Some differences were higher in specific cancers. Conclusion Because of differences in methodology, the EI and the EP are not comparable to the OI and the OP. Policymakers need robust and current information to prioritize disease prevention and control programs. In Colombia, the OI and the OP—calculated by the CAC with data from the whole country—offer an opportunity for a more precise real-world estimation of patients with cancer in Colombia.

scholarly journals Real-World Budget Impact of Listing a Biosimilar of Rituximab

2020 ◽  
Vol 73 (1) ◽  
Author(s):  
Arnaud Boidart ◽  
Martin Darveau ◽  
Nicole Déry ◽  
Marie-Claude Racine
Keyword(s):  
Real World ◽  
Impact Analysis ◽  
Budget Impact ◽  
Health Care Systems ◽  
Hospital Setting ◽  
Cost Savings ◽  
University Teaching ◽  
Canadian Market ◽  
Care Systems ◽  
Health Canada

ABSTRACTBackground: The approval of new biosimilars by national health agencies is expected to generate significant cost savings for health care systems. This is particularly the case with the biosimilar of rituximab approved for the Canadian market in 2019. However, several uncertainties remain regarding utilization of this agent.Objectives: To determine the proportion of total annual drug expenses for each indication for rituximab in the hospital setting and to determine potential savings related to introduction of a biosimilar.Methods: A budget impact analysis was performed through 3 real-world scenarios, based on data obtained from a large university teaching hospital for a 12-month period.Results: This study involved data for 420 patients. Annual expenses for rituximab for all indications represented 7.7% of total annual drug spending for the hospital, of which 5.0% was related specifically toindications approved by Health Canada. More than 6% of the annual drug expenses was attributable to the use of rituximab for oncologic indications, including 1.8% for uses not approved by Health Canada.Overall, each 10% reduction in the price of a biosimilar of rituximab (relative to the reference rituximab) would result in annual savings of about 0.8% of total drug expenses in the hospital if a biosimilar was used for all real-world indications, whether approved by Health Canada or not.Conclusions: The introduction of a biosimilar of rituximab to the Canadian market would generate significant savings. To properly assess the potential savings that this agent could generate in the limited budget environment of a hospital, it seems important to consider all of the indications for which it could be used.RÉSUMÉContexte : On s’attend à ce que l’approbation de medicaments biosimilaires par les agences de santé nationales génèrent des économies importantes pour les systèmes de soins de santé. C’est particulièrement lecas pour le biosimilaire du rituximab approuvé pour le marché canadien en 2019. Cependant, plusieurs incertitudes demeurent quant à son utilisation.Objectifs :Déterminer la proportion des dépenses pour chaque indication du rituximab par rapport à la dépense totale annuelle en medicaments dans un contexte hospitalier et déterminer les économies potentielles liées à l’introduction d’un biosimilaire.Méthode : Une analyse d’impact budgétaire a été réalisée à partir de trois scénarios basés sur des données obtenues dans un grand centre hospitalier universitaire sur une période de 12 mois.Résultats : Cette étude a examiné les données de 420 patients. Les dépenses annuelles relatives au rituximab, toutes indications confondues, représentaient 7,7 % des dépenses annuelles totales de l’hôpital. De cellesci, 5 % étaient liées en particulier aux indications approuvées par Santé Canada. Plus de 6 % des dépenses annuelles en médicaments étaient imputables à l’utilisation du rituximab à des fins oncologiques, y compris 1,8 % pour des utilisations que Santé Canada n’a pas approuvées. De manière générale, chaque réduction de 10 % du prix d’un produit biosimilaire du rituximab (parent du rituximab référence) entraînerait des économies annuelles d’environ 0,8 % du total des dépenses en médicaments dans cet hôpital si les produits biosimilaires étaient utilisés pour toutes les indications, qu’elles soient approuvées ou non par Santé Canada.Conclusions : L’introduction d’un biosimilaire du rituximab sur le marché canadien engendrerait des économies importantes. L’évaluation adéquate des économies générées par un biosimilaire pour un hôpital ayant un budget limité nécessite la prise en compte de toutes les indications pour lesquelles il pourrait être utilisé.

scholarly journals Infectious Disease Management: Lessons from Cuba

2006 ◽  
Vol 17 (4) ◽  
pp. 217-220 ◽  
Author(s):  
Noni E Macdonald ◽  
Beth Halperin ◽  
Enrique Beldarrain Chaple ◽  
Jeff Scott ◽  
John M Kirk
Keyword(s):  
Infectious Disease ◽  
Health Care Systems ◽  
Disease Outbreaks ◽  
Local Health ◽  
Infectious Disease Outbreaks ◽  
The North ◽  
Hospital Outbreak ◽  
Track Record ◽  
Local Health Care ◽  
Care Systems

Over the past decade in Canada, infectious disease outbreaks have repeatedly been in the public spotlight. TheEscherichia colioutbreak in Walkerton, Ontario (1), the severe acute respiratory syndrome outbreak in Toronto, Ontario (2) and theClostridium difficilehospital outbreak in Montreal, Quebec (3), have cost lives, grabbed headlines and stressed local health care systems. Each outbreak raised questions about our ability to prevent outbreaks, detect outbreaks early, and respond efficiently and effectively to infectious disease crises; these outbreaks also highlighted gaps in Canada's preparedness for managing major infectious disease problems when multiple jurisdictions are involved (4). Canada's poor track record of tuberculosis control in the north (5) raises the concern that this problem is not limited to crisis situations, but rather has deeper implications for the management of infectious diseases in Canada.

Animal Venom Peptides as a Treasure Trove for New Therapeutics Against Neurodegenerative Disorders

2019 ◽  
Vol 26 (25) ◽  
pp. 4749-4774 ◽  
Author(s):  
Xinwang Yang ◽  
Ying Wang ◽  
Chunyun Wu ◽  
Eng-Ang Ling
Keyword(s):  
Neurodegenerative Diseases ◽  
Health Care Systems ◽  
Drug Candidates ◽  
Physiological Processes ◽  
Rich Diversity ◽  
Novel Drugs ◽  
Care Systems ◽  
Potent Drug ◽  
Therapeutic Tools ◽  
Cerebral Ischemic

Background:Neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, and cerebral ischemic stroke, impose enormous socio-economic burdens on both patients and health-care systems. However, drugs targeting these diseases remain unsatisfactory, and hence there is an urgent need for the development of novel and potent drug candidates.Methods:Animal toxins exhibit rich diversity in both proteins and peptides, which play vital roles in biomedical drug development. As a molecular tool, animal toxin peptides have not only helped clarify many critical physiological processes but also led to the discovery of novel drugs and clinical therapeutics.Results:Recently, toxin peptides identified from venomous animals, e.g. exenatide, ziconotide, Hi1a, and PcTx1 from spider venom, have been shown to block specific ion channels, alleviate inflammation, decrease protein aggregates, regulate glutamate and neurotransmitter levels, and increase neuroprotective factors.Conclusion:Thus, components of venom hold considerable capacity as drug candidates for the alleviation or reduction of neurodegeneration. This review highlights studies evaluating different animal toxins, especially peptides, as promising therapeutic tools for the treatment of different neurodegenerative diseases and disorders.

scholarly journals Molecular Insights in Atrial Fibrillation Pathogenesis and Therapeutics: A Narrative Review

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1584
Author(s):  
Konstantinos A. Papathanasiou ◽  
Sotiria G. Giotaki ◽  
Dimitrios A. Vrachatis ◽  
Gerasimos Siasos ◽  
Vaia Lambadiari ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Health Care Systems ◽  
Drug Repurposing ◽  
Calcium Handling ◽  
Treatment Modalities ◽  
Success Rates ◽  
Mortality And Morbidity ◽  
Therapeutic Modalities ◽  
Molecular Alterations ◽  
Care Systems

The prevalence of atrial fibrillation (AF) is bound to increase globally in the following years, affecting the quality of life of millions of people, increasing mortality and morbidity, and beleaguering health care systems. Increasingly effective therapeutic options against AF are the constantly evolving electroanatomic substrate mapping systems of the left atrium (LA) and ablation catheter technologies. Yet, a prerequisite for better long-term success rates is the understanding of AF pathogenesis and maintenance. LA electrical and anatomical remodeling remains in the epicenter of current research for novel diagnostic and treatment modalities. On a molecular level, electrical remodeling lies on impaired calcium handling, enhanced inwardly rectifying potassium currents, and gap junction perturbations. In addition, a wide array of profibrotic stimuli activates fibroblast to an increased extracellular matrix turnover via various intermediaries. Concomitant dysregulation of the autonomic nervous system and the humoral function of increased epicardial adipose tissue (EAT) are established mediators in the pathophysiology of AF. Local atrial lymphomononuclear cells infiltrate and increased inflammasome activity accelerate and perpetuate arrhythmia substrate. Finally, impaired intracellular protein metabolism, excessive oxidative stress, and mitochondrial dysfunction deplete atrial cardiomyocyte ATP and promote arrhythmogenesis. These overlapping cellular and molecular alterations hinder us from distinguishing the cause from the effect in AF pathogenesis. Yet, a plethora of therapeutic modalities target these molecular perturbations and hold promise in combating the AF burden. Namely, atrial selective ion channel inhibitors, AF gene therapy, anti-fibrotic agents, AF drug repurposing, immunomodulators, and indirect cardiac neuromodulation are discussed here.

160: Cost-Effectiveness of Medical Management Strategies of Nephrolithiasis in Different Health Care Systems

2004 ◽  
Vol 171 (4S) ◽  
pp. 42-43 ◽  
Author(s):  
Yair Latan ◽  
David M. Wilhelm ◽  
David A. Duchene ◽  
Margaret S. Pearle
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Medical Management ◽  
Health Care Systems ◽  
Management Strategies ◽  
Care Systems
Sign in / Sign up

Export Citation Format

Share Document