| Description |
1 online resource (1 PDF file (xiv, 105 pages)) : illustrations |
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text file |
| Bibliography |
Includes bibliographical references. |
| Summary |
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 6-7, 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. |
| Funding |
This project was supported by a contract between the National Academy of Sciences and the U.S. Department of Health and Human Services' U.S. Food and Drug Administration (Contract No. 1R13FD005495-01). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. |
| Contents |
Introduction and overview -- Setting the stage : defining terminologies and sharing stakeholder perspectives -- Data needs, data sources, and collection methodologies for stakeholder decision making -- Considerations for conducting rapid clinical research on MCMs during a PHE -- Inspiring collective action : perspectives from federal stakeholders and reflections from individual workshop participants. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Disaster medicine -- United States -- Congresses.
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Disaster medicine. |
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United States. |
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Drug monitoring -- United States -- Congresses.
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Drug monitoring. |
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Public health surveillance -- United States -- Congresses.
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Public health surveillance. |
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Medical records -- United States -- Data processing -- Congresses.
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Medical records. |
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Biological disasters -- United States -- Congresses.
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Biological disasters. |
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Patient monitoring -- United States -- Congresses.
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Patient monitoring. |
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United States. |
| Genre/Form |
Electronic books.
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Conference papers and proceedings.
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Conference papers and proceedings.
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Congress.
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Technical reports.
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Technical reports.
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| Added Author |
Wizemann, Theresa M., rapporteur.
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Snair, Justin, rapporteur.
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National Academies of Sciences, Engineering, and Medicine (U.S.). Board on Health Sciences Policy.
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Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies (Workshop) (2017 : Washington, D.C.)
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| Other Form: |
Print version: Boname, Morgan L. Building a national capability to monitor and assess medical countermeasure use during a public health emergency. Washington, D.C. : National Academies Press, 2017 9780309466424 (OCoLC)1017603925 |
| ISBN |
9780309466431 |
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0309466431 |
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9780309466424 |
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0309466423 |
| Standard No. |
10.17226/24912 |
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