Ensuring An Effective Public Health Emergency Medical Countermeasures Enterprise

Author : National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Health and Medicine Division,Board on Health Sciences Policy,Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise
Publisher : Unknown
Page : 150 pages
File Size : 50,6 Mb
Release : 2022-08-03
Category : Medical
ISBN : 0309271487

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Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise by National Academies of Sciences, Engineering, and Medicine,National Academies Of Sciences Engineeri,Health and Medicine Division,Board on Health Sciences Policy,Committee on Reviewing the Public Health Emergency Medical Countermeasures Enterprise Pdf

The U.S. medical countermeasures (MCMs) enterprise is interconnected, complex, and dynamic. It includes public and private entities that develop and manufacture new and existing MCMs, ensure procurement, storage, and distribution of MCMs, and administer, monitor, and evaluate MCMs. The interagency group known as the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) is the nation's sole coordinating body, responsible for ensuring end-to-end MCM preparedness and response. Ensuring an Effective Public Health Emergency Medical Countermeasures Enterprise provides recommendations from an expert committee for a re-envisioned PHEMCE. Four priority areas of improvement emerged from committee deliberations: (1) articulating PHEMCE's mission and role and explicating the principles guiding PHEMCE's operating principles and processes, (2) revising PHEMCE operations and processes, (3) collaborating more effectively with external public and private partners, and (4) navigating legal and policy issues.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Forum on Medical and Public Health Preparedness for Catastrophic Events
Publisher : National Academies Press
Page : 194 pages
File Size : 54,8 Mb
Release : 2010-07-01
Category : Medical
ISBN : 9780309150248

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The Public Health Emergency Medical Countermeasures Enterprise by Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation,Forum on Medical and Public Health Preparedness for Catastrophic Events Pdf

During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the public's well-being. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)-a partnership among federal, state, and local governments; industry; and academia-is at the forefront of the effort to develop and manufacture these countermeasures. However, despite the PHEMCE's many successes, there are still serious challenges to overcome. Government-funded medical research is not always focused on countermeasures for the most serious potential threats, and it is difficult to engage pharmaceutical and biotechnology companies to develop and manufacture medical countermeasures that have a limited commercial market. At the request of the Secretary of the U.S. Department of Health and Human Services and the Assistant Secretary for Preparedness and Response, the IOM held a workshop February 22-24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures and explored opportunities to improve the process and protect Americans' safety and health.

Author : HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.)
Publisher : Unknown
Page : 44 pages
File Size : 43,8 Mb
Release : 2007
Category : Disaster medicine
ISBN : UOM:39015075641509

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HHS Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats by HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.) Pdf

Author : HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.)
Publisher : Unknown
Page : 32 pages
File Size : 50,5 Mb
Release : 2007
Category : Disaster medicine
ISBN : OCLC:475653180

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HHS Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats by HHS Public Health Emergency Medical Countermeasures Enterprise (U.S.) Pdf

Author : Niel A. Harris
Publisher : Unknown
Page : 147 pages
File Size : 50,6 Mb
Release : 2013
Category : HEALTH & FITNESS
ISBN : 1628088621

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Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan by Niel A. Harris Pdf

Author : United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response
Publisher : Unknown
Page : 12 pages
File Size : 43,8 Mb
Release : 2010
Category : Electronic
ISBN : OCLC:658227595

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The Public Health Emergency Medical Countermeasures Enterprise Review by United States. Department of Health and Human Services. Office of the Assistant Secretary for Preparedness and Response Pdf

The MCM (medical countermeasure) enterprise exists to develop, manufacture, procure, stockpile, and eventually distribute products deemed critical to protecting or treating our population against a variety of naturally occurring or intentionally delivered CBRN threats. However, this MCM enterprise does not exist in a vacuum. It is part of a complex, multi-component system of capabilities necessary to protect our country from a wide range of health threats. This document was prepared in response to the Secretary's request for a review of the MCM development enterprise. HHS recognizes that there are multiple components and organizations essential to the timely development, deployment, and use of MCMs, including critical investment in the Nation's public health system. Indeed, absent the means to detect a health threat or distribute and administer an MCM, investments in the development and manufacturing of MCMs are of limited value. While recognizing these important dependencies, this review is limited to that part of the MCM enterprise that focuses specifically on the processes, policies, and infrastructure required to take a product concept derived from a national requirement through research, early and advanced development, manufacturing, regulatory approval, procurement, and sustained stockpiling. A larger framing of the public health infrastructure needs for national health security is described in the NHSS (National Health Security Strategy).

Author : Niel A. Harris
Publisher : Nova Science Publishers
Page : 0 pages
File Size : 54,8 Mb
Release : 2013
Category : Emergency medical services
ISBN : 1628088613

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Public Health Emergency Medical Countermeasures Enterprise Strategy and Implementation Plan by Niel A. Harris Pdf

The United States continues to face a range of serious threats to its national health security from the deliberate use or accidental release of chemical, biological, radiological, and nuclear (CBRN) agents, as well as from naturally occurring and emerging infectious diseases, including pandemic influenza. This book looks at how the United States has planned and implemented for these threats.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy
Publisher : National Academies Press
Page : 143 pages
File Size : 41,5 Mb
Release : 2016-10-24
Category : Medical
ISBN : 9780309443708

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The Nation's Medical Countermeasure Stockpile by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy Pdf

Large catastrophic events, or rare acute events, may cause situations in which a local jurisdiction's medicines and medical supplies are not sufficient to provide care to the population it serves. In these cases of natural or engineered disasters, such as a terrorist attack, influenza pandemic, or earthquake, state or local authorities can request that the federal government provide assets from the Strategic National Stockpile to augment the state and local jurisdictions' resources. The Centers for Disease Control and Prevention's (CDC's) Strategic National Stockpile (SNS) is the nation's repository of antibiotics, chemical antidotes, antitoxins, vaccines, antiviral drugs, and other medical materiel designed to supplement and resupply state and local public health agencies in the event of an emergency. The materiel is intended to support national health security and is managed by the Office of Public Health Preparedness and Response's (OPHPR's) Division of Strategic National Stockpile (DSNS). The stated mission of the SNS is to prepare and support partners and provide the right resources at the right time to secure the nation's health. The National Academies of Sciences, Engineering, and Medicine organized a two-day public workshop to explore opportunities to improve the efficiency, effectiveness, and sustainable methods used by the CDC's SNS to distribute medical countermeasures and other supplies during disasters and other public health emergencies, especially those which result in disruption of physical infrastructure such as the electrical grid, central roadways, bridges, and tunnels within the impacted community. Participants explored relevant distribution lessons learned from other federal agency stockpiles and the private sector as well as opportunities to develop public-private collaborations in the purchase, warehousing, management, and distribution of medical countermeasures. This report summarizes the presentations and discussions from the workshop.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events
Publisher : National Academies Press
Page : 126 pages
File Size : 54,5 Mb
Release : 2008-11-03
Category : Medical
ISBN : 9780309120968

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Dispensing Medical Countermeasures for Public Health Emergencies by Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events Pdf

On March 3-4, 2008, the Institute of Medicine (IOM) Forum on Medical and Public Health Preparedness for Catastrophic Events hosted a workshop titled "Medical Countermeasures Dispensing." The overall objective was to discuss a range of solutions to rapidly provide medical countermeasures to protect large numbers of people prior to or during a public health emergency, such as a bioterrorist attack or infectious disease outbreak. The United States is currently unprepared to confront the range of threats it is facing, such as an intentional anthrax release, severe acute respiratory syndrome (SARS), or pandemic influenza, and it must plan aggressively to counteract the threat of these and other future public health emergencies. Countermeasure dispensing must harness all types of imaginative partnerships between public and private institutions, working together in ways tailored to meet individual community needs. This workshop summary highlights the presentations and subsequent discussion that occurred at the workshop.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Board on Health Sciences Policy,Committee on Evidence-Based Practices for Public Health Emergency Preparedness and Response
Publisher : National Academies Press
Page : 501 pages
File Size : 47,8 Mb
Release : 2020-11-28
Category : Medical
ISBN : 9780309670388

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Evidence-Based Practice for Public Health Emergency Preparedness and Response by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Population Health and Public Health Practice,Board on Health Sciences Policy,Committee on Evidence-Based Practices for Public Health Emergency Preparedness and Response Pdf

When communities face complex public health emergencies, state local, tribal, and territorial public health agencies must make difficult decisions regarding how to effectively respond. The public health emergency preparedness and response (PHEPR) system, with its multifaceted mission to prevent, protect against, quickly respond to, and recover from public health emergencies, is inherently complex and encompasses policies, organizations, and programs. Since the events of September 11, 2001, the United States has invested billions of dollars and immeasurable amounts of human capital to develop and enhance public health emergency preparedness and infrastructure to respond to a wide range of public health threats, including infectious diseases, natural disasters, and chemical, biological, radiological, and nuclear events. Despite the investments in research and the growing body of empirical literature on a range of preparedness and response capabilities and functions, there has been no national-level, comprehensive review and grading of evidence for public health emergency preparedness and response practices comparable to those utilized in medicine and other public health fields. Evidence-Based Practice for Public Health Emergency Preparedness and Response reviews the state of the evidence on PHEPR practices and the improvements necessary to move the field forward and to strengthen the PHEPR system. This publication evaluates PHEPR evidence to understand the balance of benefits and harms of PHEPR practices, with a focus on four main areas of PHEPR: engagement with and training of community-based partners to improve the outcomes of at-risk populations after public health emergencies; activation of a public health emergency operations center; communication of public health alerts and guidance to technical audiences during a public health emergency; and implementation of quarantine to reduce the spread of contagious illness.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy
Publisher : National Academies Press
Page : 121 pages
File Size : 55,9 Mb
Release : 2018-01-20
Category : Medical
ISBN : 9780309466424

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Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy Pdf

During public health emergencies (PHEs) involving chemical, biological, radiological, or nuclear threats or emerging infectious diseases, medical countermeasures (MCMs) (e.g., drugs, vaccines, devices) may need to be dispensed or administered to affected populations to help mitigate the human health impact of the threat. The optimal MCMs determined for use during an emergency might be U.S. Food and Drug Administration (FDA) approved but used in unapproved ways (e.g., in a new age group or against a new agent); FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any indication. As part of the United States' scientific and research preparedness enterprise, there is an imperative to go "beyond the last mile" of MCM dispensing and administration to build and maintain a national capability to monitor and assess the use of MCMs (e.g., safety, compliance, clinical benefit) after they have been dispensed during PHEs. To further the discussion on this need, the Board on Health Sciences Policy of the National Academies of Sciences, Engineering, and Medicine hosted a 2-day public workshop, Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies. The workshop, sponsored by FDA, was held on June 6â€"7, 2017, in Washington, DC. Workshop participants discussed the roles and efforts of the federal government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability. This publication summarizes the presentations and discussions from the workshop.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Prepositioned Medical Countermeasures for the Public
Publisher : National Academies Press
Page : 358 pages
File Size : 55,8 Mb
Release : 2012-02-26
Category : Medical
ISBN : 9780309218085

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Prepositioning Antibiotics for Anthrax by Institute of Medicine,Board on Health Sciences Policy,Committee on Prepositioned Medical Countermeasures for the Public Pdf

If terrorists released Bacillus anthracis over a large city, hundreds of thousands of people could be at risk of the deadly disease anthrax-caused by the B. anthracis spores-unless they had rapid access to antibiotic medical countermeasures (MCM). Although plans for rapidly delivering MCM to a large number of people following an anthrax attack have been greatly enhanced during the last decade, many public health authorities and policy experts fear that the nation's current systems and plans are insufficient to respond to the most challenging scenarios, such as a very large-scale anthrax attack. The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response commissioned the Institute of Medicine to examine the potential uses, benefits, and disadvantages of strategies for repositioning antibiotics. This involves storing antibiotics close to or in the possession of the people who would need rapid access to them should an attack occur. Prepositioning Antibiotics for Anthrax reviews the scientific evidence on the time window in which antibiotics successfully prevent anthrax and the implications for decision making about prepositioning, describes potential prepositioning strategies, and develops a framework to assist state, local, and tribal public health authorities in determining whether prepositioning strategies would be beneficial for their communities. However, based on an analysis of the likely health benefits, health risks, and relative costs of the different prepositioning strategies, the book also develops findings and recommendations to provide jurisdictions with some practical insights as to the circumstances in which different prepositioning strategies may be beneficial. Finally, the book identifies federal- and national-level actions that would facilitate the evaluation and development of prepositioning strategies. Recognizing that communities across the nation have differing needs and capabilities, the findings presented in this report are intended to assist public health officials in considering the benefits, costs, and trade-offs involved in developing alternative prepositioning strategies appropriate to their particular communities.

Author : National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Global Health,Board on Health Sciences Policy,Forum on Microbial Threats,Forum on Drug Discovery, Development, and Translation,Forum on Medical and Public Health Preparedness for Catastrophic Events
Publisher : National Academies Press
Page : 177 pages
File Size : 46,5 Mb
Release : 2016-03-12
Category : Medical
ISBN : 9780309378611

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Rapid Medical Countermeasure Response to Infectious Diseases by National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Global Health,Board on Health Sciences Policy,Forum on Microbial Threats,Forum on Drug Discovery, Development, and Translation,Forum on Medical and Public Health Preparedness for Catastrophic Events Pdf

Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world's health since these diseases also know no boundaries and will easily cross borders. Sustaining public and private investment in the development of medical countermeasures (MCMs) before an emerging infectious disease becomes a public health emergency in the United States has been extremely challenging. Interest and momentum peak during a crisis and wane between events, and there is little interest in disease threats outside the United States until they impact people stateside. On March 26 and 27, 2015, the Institute of Medicine convened a workshop in Washington, DC to discuss how to achieve rapid and nimble MCM capability for new and emerging threats. Public- and private-sector stakeholders examined recent efforts to prepare for and respond to outbreaks of Ebola Virus Disease, pandemic influenza, and coronaviruses from policy, budget, and operational standpoints. Participants discussed the need for rapid access to MCM to ensure national security and considered strategies and business models that could enhance stakeholder interest and investment in sustainable response capabilities. This report summarizes the presentations and discussions from this workshop.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Page : 150 pages
File Size : 49,8 Mb
Release : 2011-08-27
Category : Medical
ISBN : 9780309214902

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Advancing Regulatory Science for Medical Countermeasure Development by Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events,Forum on Drug Discovery, Development, and Translation Pdf

Whether or not the United States has safe and effective medical countermeasures-such as vaccines, drugs, and diagnostic tools-available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the Institute of Medicine (IOM) held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures. During public health emergencies such as influenza or chemical, biological, radiological/nuclear (CBRN) attacks, safe and effective vaccines, treatments, and other medical countermeasures are essential to protecting national security and the well being of the public. Advancing Regulatory Science for Medical Countermeasure Development examines current medical countermeasures, and investigates the future of research and development in this area. Convened on March 29-30, 2011, this workshop identified regulatory science tools and methods that are available or under development, as well as major gaps in currently available regulatory science tools. Advancing Regulatory Science for Medical Countermeasure Development is a valuable resource for federal agencies including the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), the Department of Defense (DoD), as well as health professionals, and public and private health organizations.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events
Publisher : National Academies Press
Page : 94 pages
File Size : 41,7 Mb
Release : 2011-01-16
Category : Medical
ISBN : 9780309158039

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Medical Countermeasures Dispensing by Institute of Medicine,Board on Health Sciences Policy,Forum on Medical and Public Health Preparedness for Catastrophic Events Pdf

During public health emergencies such as terrorist attacks or influenza outbreaks, the public health system's ability to save lives could depend on dispensing medical countermeasures such as antibiotics, antiviral medications, and vaccines to a large number of people in a short amount of time. The IOM's Forum on Medical and Public Health Preparedness for Catastrophic Events held a workshop on November 18, 2009, to provide an overview of current threats, recent progress made in the public health system for distributing and dispensing countermeasures, and remaining vulnerabilities.