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2.
Science ; 373(6562): eabj7364, 2021 Sep 24.
Article in English | MEDLINE | ID: covidwho-1361961

ABSTRACT

Vaccines provide powerful tools to mitigate the enormous public health and economic costs that the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic continues to exert globally, yet vaccine distribution remains unequal among countries. To examine the potential epidemiological and evolutionary impacts of "vaccine nationalism," we extend previous models to include simple scenarios of stockpiling between two regions. In general, when vaccines are widely available and the immunity they confer is robust, sharing doses minimizes total cases across regions. A number of subtleties arise when the populations and transmission rates in each region differ, depending on evolutionary assumptions and vaccine availability. When the waning of natural immunity contributes most to evolutionary potential, sustained transmission in low-access regions results in an increased potential for antigenic evolution, which may result in the emergence of novel variants that affect epidemiological characteristics globally. Overall, our results stress the importance of rapid, equitable vaccine distribution for global control of the pandemic.


Subject(s)
COVID-19 Vaccines/supply & distribution , COVID-19/prevention & control , Global Health , COVID-19/epidemiology , COVID-19/immunology , COVID-19/transmission , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/immunology , Emigration and Immigration , Evolution, Molecular , Humans , Immune Evasion , Models, Theoretical , SARS-CoV-2/genetics , SARS-CoV-2/immunology , Strategic Stockpile , Vaccination Coverage
6.
Int J Risk Saf Med ; 32(2): 77-86, 2021.
Article in English | MEDLINE | ID: covidwho-1081481

ABSTRACT

BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.


Subject(s)
Antiviral Agents/supply & distribution , COVID-19 , Delivery of Health Care/trends , Health Services Accessibility , Risk Management , Strategic Stockpile/organization & administration , COVID-19/drug therapy , COVID-19/epidemiology , European Union , Health Services Accessibility/organization & administration , Health Services Accessibility/standards , Health Services Accessibility/statistics & numerical data , Humans , Quality Improvement/organization & administration , Quality Indicators, Health Care/organization & administration , Quality Indicators, Health Care/standards , Risk Management/methods , Risk Management/standards , SARS-CoV-2
8.
Chest ; 159(2): 634-652, 2021 02.
Article in English | MEDLINE | ID: covidwho-973941

ABSTRACT

BACKGROUND: Early in the coronavirus disease 2019 (COVID-19) pandemic, there was serious concern that the United States would encounter a shortfall of mechanical ventilators. In response, the US government, using the Defense Production Act, ordered the development of 200,000 ventilators from 11 different manufacturers. These ventilators have different capabilities, and whether all are able to support COVID-19 patients is not evident. RESEARCH QUESTION: Evaluate ventilator requirements for affected COVID-19 patients, assess the clinical performance of current US Strategic National Stockpile (SNS) ventilators employed during the pandemic, and finally, compare ordered ventilators' functionality based on COVID-19 patient needs. STUDY DESIGN AND METHODS: Current published literature, publicly available documents, and lay press articles were reviewed by a diverse team of disaster experts. Data were assembled into tabular format, which formed the basis for analysis and future recommendations. RESULTS: COVID-19 patients often develop severe hypoxemic acute respiratory failure and adult respiratory defense syndrome (ARDS), requiring high levels of ventilator support. Current SNS ventilators were unable to fully support all COVID-19 patients, and only approximately half of newly ordered ventilators have the capacity to support the most severely affected patients; ventilators with less capacity for providing high-level support are still of significant value in caring for many patients. INTERPRETATION: Current SNS ventilators and those on order are capable of supporting most but not all COVID-19 patients. Technologic, logistic, and educational challenges encountered from current SNS ventilators are summarized, with potential next-generation SNS ventilator updates offered.


Subject(s)
COVID-19/therapy , Respiration, Artificial/methods , Respiratory Distress Syndrome/therapy , Respiratory Insufficiency/therapy , Strategic Stockpile , Ventilators, Mechanical/statistics & numerical data , Humans , Intensive Care Units , Respiration, Artificial/instrumentation , SARS-CoV-2 , United States , Ventilators, Mechanical/standards , Ventilators, Mechanical/supply & distribution
9.
J Comp Eff Res ; 9(18): 1243-1246, 2020 12.
Article in English | MEDLINE | ID: covidwho-958161

ABSTRACT

The race to find an effective treatment for coronavirus disease 2019 (COVID-19) is still on, with only two treatment options currently authorized for emergency use and/or recommended for patients hospitalized with severe respiratory symptoms: low-dose dexamethasone and remdesivir. The USA decision to stockpile the latter has resulted in widespread condemnation and in similar action being taken by some other countries. In this commentary we discuss whether stockpiling remdesivir is justified in light of the currently available evidence.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19/drug therapy , International Cooperation , Internationality , Strategic Stockpile/methods , Adenosine Monophosphate/therapeutic use , Alanine/therapeutic use , Humans , SARS-CoV-2 , United States
11.
Toxicol Mech Methods ; 31(4): 308-321, 2021 May.
Article in English | MEDLINE | ID: covidwho-933794

ABSTRACT

The Strategic National Stockpile (SNS) serves as a repository of materiel, including medical countermeasures (MCMs), that would be used to support the national health security response to a chemical, biological, radiological, or nuclear (CBRN) incident, either natural or terrorism-related. To support and advance the SNS, the National Institutes of Health (NIH) manages targeted investigatory research portfolios, such as Countermeasures Against Chemical Terrorism (CounterACT) for chemical agents, that coordinate projects covering basic research, drug discovery, and preclinical studies. Project BioShield, managed by the Biomedical Advanced Research and Development Agency (BARDA), guides and supports academia and industry with potential MCMs through the Food & Drug Administration's approval process and ultimately supports the acquisition of successful products into the SNS. Public health emergencies such as the COVID-19 pandemic and the ever-increasing number of MCMs in the SNS present logistical and financial challenges to its maintenance. While MCMs for biological agents have been readily adopted, those for chemical agents have required sustained investments. This paper reviews the methods by which MCMs are identified and supported for inclusion in the SNS, the current status of MCMs for CBRN threats, and challenges with SNS maintenance as well as identifies persistent obstacles for MCM development and acquisition, particularly for ones focused on chemical weapons.


Subject(s)
Biohazard Release , Chemical Hazard Release , Medical Countermeasures , Radioactive Hazard Release , Strategic Stockpile , Drug Approval , Humans , Off-Label Use , Terrorism
12.
Milbank Q ; 98(4): 1058-1090, 2020 12.
Article in English | MEDLINE | ID: covidwho-900863

ABSTRACT

Policy Points Reflecting on current response deficiencies, we offer a model for a national contingency supply chain cell (NCSCC) construct to manage the medical materials supply chain in support of emergencies, such as COVID-19. We develop the following: a framework for governance and response to enable a globally independent supply chain; a flexible structure to accommodate the requirements of state and county health systems for receiving and distributing materials; and a national material "control tower" to improve transparency and real-time access to material status and location. CONTEXT: Much of the discussion about the failure of the COVID-19 supply chain has centered on personal protective equipment (PPE) and the degree of vulnerability of care. Prior research on supply chain risks have focused on mitigating the risk of disruptions of specific purchased materials within a bounded region or on the shifting status of cross-border export restrictions. But COVID-19 has impacted every purchase category, region, and border. This paper is responsive to the National Academies of Sciences, Engineering and Medicine recommendation to study and monitor disasters and to provide governments with course of action to satisfy legislative mandates. METHODS: Our analysis draws on our observations of the responses to COVID-19 in regard to acquisition and contracting problem-solving, our review of field discussions and interactions with experts, a critique of existing proposals for managing the strategic national stockpile in the United States a mapping of the responses to national contingency planning phases, and the identification of gaps in current national healthcare response policy frameworks and proposals. FINDINGS: Current proposals call for augmenting a system that has failed to deliver the needed response to COVID-19. These proposals do not address the key attributes for pandemic plan renewal: flexibility, traceability and transparency, persistence and responsiveness, global independence, and equitable access. We offer a commons-based framework for achieving the opportunities and risks which are responsive to a constellation of intelligence assets working in and across focal targets of global supply chain risk. CONCLUSIONS: The United States needs a "commons-based strategy" that is not simply a stockpile repository but instead is a network of repositories, fluid inventories, and analytic monitoring governed by the experts. We need a coordinated effort, a "commons" that will direct both conventional and new suppliers to meet demands and to eliminate hoarding and other behaviors.


Subject(s)
COVID-19 , Disaster Planning/standards , Government Programs/standards , Health Policy , Personal Protective Equipment/supply & distribution , Personal Protective Equipment/standards , Strategic Stockpile/standards , Humans , SARS-CoV-2 , United States
14.
Am J Kidney Dis ; 76(5): 696-709.e1, 2020 11.
Article in English | MEDLINE | ID: covidwho-676627

ABSTRACT

RATIONALE & OBJECTIVE: During the coronavirus disease 2019 (COVID-19) pandemic, New York encountered shortages in continuous kidney replacement therapy (CKRT) capacity for critically ill patients with acute kidney injury stage 3 requiring dialysis. To inform planning for current and future crises, we estimated CKRT demand and capacity during the initial wave of the US COVID-19 pandemic. STUDY DESIGN: We developed mathematical models to project nationwide and statewide CKRT demand and capacity. Data sources included the Institute for Health Metrics and Evaluation model, the Harvard Global Health Institute model, and published literature. SETTING & POPULATION: US patients hospitalized during the initial wave of the COVID-19 pandemic (February 6, 2020, to August 4, 2020). INTERVENTION: CKRT. OUTCOMES: CKRT demand and capacity at peak resource use; number of states projected to encounter CKRT shortages. MODEL, PERSPECTIVE, & TIMEFRAME: Health sector perspective with a 6-month time horizon. RESULTS: Under base-case model assumptions, there was a nationwide CKRT capacity of 7,032 machines, an estimated shortage of 1,088 (95% uncertainty interval, 910-1,568) machines, and shortages in 6 states at peak resource use. In sensitivity analyses, varying assumptions around: (1) the number of pre-COVID-19 surplus CKRT machines available and (2) the incidence of acute kidney injury stage 3 requiring dialysis requiring CKRT among hospitalized patients with COVID-19 resulted in projected shortages in 3 to 8 states (933-1,282 machines) and 4 to 8 states (945-1,723 machines), respectively. In the best- and worst-case scenarios, there were shortages in 3 and 26 states (614 and 4,540 machines). LIMITATIONS: Parameter estimates are influenced by assumptions made in the absence of published data for CKRT capacity and by the Institute for Health Metrics and Evaluation model's limitations. CONCLUSIONS: Several US states are projected to encounter CKRT shortages during the COVID-19 pandemic. These findings, although based on limited data for CKRT demand and capacity, suggest there being value during health care crises such as the COVID-19 pandemic in establishing an inpatient kidney replacement therapy national registry and maintaining a national stockpile of CKRT equipment.


Subject(s)
Acute Kidney Injury , Civil Defense , Continuous Renal Replacement Therapy/methods , Coronavirus Infections , Critical Illness , Health Services Needs and Demand/organization & administration , Intensive Care Units/supply & distribution , Pandemics , Pneumonia, Viral , Strategic Stockpile/methods , Acute Kidney Injury/etiology , Acute Kidney Injury/therapy , Betacoronavirus , COVID-19 , Civil Defense/methods , Civil Defense/organization & administration , Coronavirus Infections/complications , Coronavirus Infections/epidemiology , Coronavirus Infections/therapy , Critical Illness/epidemiology , Critical Illness/therapy , Humans , Models, Theoretical , Pneumonia, Viral/complications , Pneumonia, Viral/epidemiology , Pneumonia, Viral/therapy , Procedures and Techniques Utilization/statistics & numerical data , Risk Assessment/methods , SARS-CoV-2 , United States/epidemiology
18.
Am J Emerg Med ; 38(10): 2130-2133, 2020 Oct.
Article in English | MEDLINE | ID: covidwho-654523

ABSTRACT

In March 2020, the American College of Emergency Physicians (ACEP) published a national strategic plan for COVID-19, which provides general guidelines yet leaves logistical details for institutions to determine. Key capabilities from this plan provided a crucial foundation for a 16-day Emergency Department (ED) surge planning process at one pediatric institution. This paper describes critical milestones and lessons learned during this brief period, including derivation of criteria for ED surge activation, a full-scale surge drill, and the resultant ED surge protocol. The framework of real-time evaluation was used throughout the planning process and involved constant and iterative synthesis of real-time feedback from multidisciplinary stakeholders for responsive decision-making. Ultimately, the objective of this paper is to provide timely and readily actionable information to other institutions seeking guidance to apply the ACEP strategic plan for COVID-19.


Subject(s)
COVID-19 , Emergency Service, Hospital/organization & administration , Strategic Planning , Surge Capacity/organization & administration , Humans , Pandemics , Strategic Stockpile
20.
Health Aff (Millwood) ; 39(8): 1426-1430, 2020 08.
Article in English | MEDLINE | ID: covidwho-594930

ABSTRACT

Confronted with the coronavirus disease 2019 (COVID-19) pandemic, New York City Health + Hospitals, the city's public health care system, rapidly expanded capacity across its eleven acute care hospitals and three new field hospitals. To meet the unprecedented demand for patient care, NYC Health + Hospitals redeployed staff to the areas of greatest need and redesigned recruiting, onboarding, and training processes. The hospital system engaged private staffing agencies, partnered with the Department of Defense, and recruited volunteers throughout the country. A centralized onboarding team created a single-source portal for medical care providers requiring credentialing and established new staff positions to increase efficiency. Using new educational tools focused on COVID-19 content, the hospital system trained twenty thousand staff members, including nearly nine thousand nurses, within a two-month period. Creation of multidisciplinary teams, frequent enterprisewide communication, willingness to shift direction in response to changing needs, and innovative use of technology were the key factors that enabled the hospital system to meet its goals.


Subject(s)
Communicable Disease Control/organization & administration , Coronavirus Infections/epidemiology , Hospitals, Public/supply & distribution , Medical Staff, Hospital/organization & administration , Pneumonia, Viral/epidemiology , Workforce/statistics & numerical data , COVID-19 , Coronavirus Infections/prevention & control , Disease Outbreaks/statistics & numerical data , Female , Humans , Interdisciplinary Communication , Male , New York City , Organizational Innovation , Outcome Assessment, Health Care , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Strategic Stockpile/organization & administration
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