How Should Resources From National Stockpiles Be Managed?

The Strategic National Stockpile (SNS) is a national system maintained by the US federal government to deliver medical supplies during emergencies. In the past, the SNS has been used to mitigate public health consequences of tragedies, such as Hurricane Katrina and Ebola outbreaks. However, challenges in maintaining and utilizing the SNS for patient safety are prevalent. This article canvasses ways in which the SNS is accessed and suggests needed changes in the wake of the COVID-19 pandemic.

Use of Ebola Vaccines - Worldwide, 2021-2023.

Ebola virus disease (Ebola) is a rare but severe illness in humans, with an average case fatality rate of approximately 50%. Two licensed vaccines are currently available against Orthoebolavirus zairense, the virus that causes Ebola: the 1-dose rVSVΔG-ZEBOV-GP (ERVEBO [Merck]) and the 2-dose regimen of Ad26.ZEBOV and MVA-BN-Filo (Zabdeno/Mvabea [Johnson & Johnson]). The Strategic Advisory Group of Experts on Immunization recommends the use of 1-dose ERVEBO during Ebola outbreaks, and in 2021, a global stockpile of ERVEBO was established to ensure equitable, timely, and targeted access to vaccine doses for future Ebola outbreaks. This report describes the use of Ebola vaccines and the role of the stockpile developed and managed by the International Coordinating Group (ICG) on Vaccine Provision during 2021-2023. A total of 145,690 doses have been shipped from the ICG stockpile since 2021. However, because outbreaks since 2021 have been limited and rapidly contained, most doses (139,120; 95%) shipped from the ICG stockpile have been repurposed for preventive vaccination of high-risk groups, compared with 6,570 (5%) used for outbreak response. Repurposing doses for preventive vaccination could be prioritized in the absence of Ebola outbreaks to prevent transmission and maximize the cost-efficiency and benefits of the stockpile.

Predictors of Food and Water Stockpiling During the COVID-19 Pandemic Among Latinos and Non-Latino Black People.

OBJECTIVE: The study examined factors associated with food and water stockpiling (FWS) during the COVID-19 pandemic. METHODS: A secondary analysis of online survey data collected in two waves: April 2020 (wave 1) and June/July 2020 (wave 2), was conducted through REDCap web application. A total of 2,271 Non-Latino Black and Latino adults (mean age: 36.8 years (SD = 16.0); 64.3% female) living in Illinois were recruited. Participants self-reported if they stockpiled food and/or water (FWS) seven days prior to survey completion because of the pandemic. Logistic regression was used to determine if each variable was associated with the odds of reporting FWS. RESULTS: Nearly a quarter (23.3%) of participants reported FWS. The adjusted model revealed that odds of FWS increase as the number of household members increased (OR: 1.21; 95% CI: 1.05-1.41). Odds of FWS were lower among participants who were not self-quarantining compared to those self-quarantining all the time (OR: 0.32; 95% CI: 0.17 - 0.62). Furthermore, individuals with lower levels of concern about COVID-19 had lower odds of FWS than those extremely concerned. CONCLUSIONS: Household size, self-quarantine status, and concern about COVID-19 were significantly associated with FWS. These findings highlight the need to address the concerns of marginalized individuals to promote healthy behaviors.

The Role of Public Health Emergency Management in Biodefense: A COVID-19 Case Study.

INTRODUCTION: The emergence of the COVID-19 pandemic has had significant impact on human lives as well as economic and social stability. The United States has a complicated history with biosecurity as policy making, biodefense activities, and government transparency have historically been in contention. The terror attacks of September 11, 2001 uncovered various weaknesses in the national public health infrastructure that have persisted into the current pandemic. METHODS: This study explores the biodefense and public health preparedness landscape for trends in federal support and capacity building. It also investigates the applicability of public health emergency management principles to the biodefense structure. A mixed method was utilized in this study to investigate the qualitative and quantitative factors of the research inquiry. Braun and Clarke's six phase framework for thematic analysis will assist with defining the important information from a review of the literature. The concurrent triangulation design permits that use of qualitative and quantitative data to more accurately define and analyze the relationship among the variables of interest. RESULTS: The results included the identification of 8 common themes of failure during the COVID-19 response: (1) accountable leadership, (2) statutory authorities and policies, (3) inter-agency coordination, (4) coherent data system for situational awareness, (5) strategic national stockpile and supply chain, (6) testing and surveillance, (7) health care system surge capacity and resilience, and (8) federal funds and the role of public health emergency management in the evolving landscape of biothreats, both intentional and natural. DISCUSSION: To counter the increasing biothreats, the United States must invest in revamping the biodefense infrastructure to mimic and support public health emergency preparedness initiatives which will increase our resilience to various biothreats.

Create a COVID-19 commission.

We need a definitive public reference for the history of events.

Avaliação da qualidade na gestão de estoque em laboratório clínico no município de Fortaleza, Ceará / Quality assessment in stock management in a clinical laboratory in Fortaleza Municipality, Ceará

Objetivo: Este trabalho visa discutir sobre a correta gestão de insumos em um laboratório de análises clínicas. Nesse tipo de atividade, o Sistema de Gestão da Qualidade embasa uma série de processos visando garantir a fidedignidade dos resultados, pautados em processos bem estabelecidos. A gestão de insumos e estoque é uma atividade integrada entre os diversos setores existentes na empresa, fundamental para a garantia da qualidade do exame. Dessa forma, falhas na política de qualidade podem desencadear prejuízos materiais, institucionais e humanos. Métodos: Para tanto, realizou-se análise em um laboratório clínico privado de Fortaleza, Ceará, de modo observacional, prospectivo e descritivo, desenvolvido como estudo de caso. Resultados: Verificou-se que, apesar de sistemas de gestão de estoque serem adotados, não há treinamento efetivo e documentação detalhada que norteie todos os processos do setor. Conclusão: A ausência de processos bem definidos de gestão de estoque pode ser interferente importante na correta liberação dos laudos de exames, gerando prejuízos importantes à organização e ao cliente.

Objective: This paper aims to discuss the correct management of inputs in a clinical analysis laboratory. In this type of activity, the Quality Management System is based on a series of processes aimed at guaranteeing the reliability of results, based on well-established processes. The management of inputs and stock is an integrated activity among the various sectors existing in the company, essential for ensuring the quality of the exam. Thus, failures in quality policy can trigger material, institutional and human losses. Methods: For this purpose, an analysis was carried out in a private clinical laboratory in Fortaleza, Ceará, in an observational, prospective and descriptive manner, developed as a case study. Results: It was found that, although inventory management systems are adopted, there is no effective training and detailed documentation to guide all processes in the sector. Conclusion: The absence of well-defined inventory management processes can be an important interferer in the correct release of examination reports, generating significant losses to the organization and the customer.

Vaccine nationalism and the dynamics and control of SARS-CoV-2.

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.

Healthcare risk management during the SARS-CoV-2 virus pandemic in the European Union: The guaranteed access to medicines.

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.

The US Strategic National Stockpile Ventilators in Coronavirus Disease 2019: A Comparison of Functionality and Analysis Regarding the Emergency Purchase of 200,000 Devices.

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.

The Strategic National Stockpile: identification, support, and acquisition of medical countermeasures for CBRN incidents.

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.

USA stockpiling of remdesivir: How should the world respond?

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.

The experiences of using polio outbreak simulation exercises to strengthen national outbreaks preparedness and response plans in sub-Saharan Africa.

INTRODUCTION: globally, by 2020 the paralytic poliomyelitis disease burden decreased to over 99% of the reported cases in 1988 when resolution 41.8 was endorsed by the World Health Assembly (WHA) for global polio eradication. It is clearly understood that, if there is Wild Poliovirus (WPV) and circulating Vaccines Derived Poliovirus (cVDPV) in the world, no country is safe from polio outbreaks. All countries remain at high risk of re-importation depending on the level of the containment of the types vaccine withdrawn, the laboratory poliovirus isolates, and the population immunity induced by the vaccination program. In this regard, countries to have polio outbreak preparedness and response plans, and conducting the polio outbreak simulation exercises for these plans remain important. METHODS: we conducted a cross-section qualitative study to review to 8 countries conducted polio outbreak simulation exercises in the East and Southern Africa from 2016 to 2018. The findings were categorized into 5 outbreak response thematic areas analyzed qualitatively and summarized them on their strengths and weaknesses. RESULTS: we found out that, most countries have the overall technical capacities and expertise to deal with outbreaks to a certain extent. Nevertheless, we noted that the national polio outbreak preparedness and response plans were not comprehensive enough to provide proper guidance in responding to outbreaks. The guidelines were inadequately aligned with the WHO POSOPs, and IHR 2005. Additionally, most participants who participated in the simulation exercises were less familiar with their preparedness and response plans, the WHO POSOPs, and therefore reported to be sensitized. CONCLUSION: we also realized that, in all countries where the polio simulation exercise conducted, their national polio outbreak preparedness and response plan was revised to be improved in line with the WHO POSOPs and IHR 2005. we, therefore, recommend the polio outbreak simulation exercises to be done in every country with an interval of 3-5 years.

A Commons for a Supply Chain in the Post-COVID-19 Era: The Case for a Reformed Strategic National Stockpile.

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.