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Building a national capability to monitor and assess medical countermeasure use during a public health emergency : going beyond the last mile: proceedings of a workshop
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| 자료유형 | 단행본 |
|---|---|
| 서명/저자사항 | Building a national capability to monitor and assess medical countermeasure use during a public health emergency : going beyond the last mile: proceedings of a workshop/ Morgan Boname, Theresa Wizemann, and Justin Snair, rapporteurs ; Board on Health and Science Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine. |
| 개인저자 | Boname, Morgan L.,rapporteur. Wizemann, Theresa M.,rapporteur, Snair, Justin,rapporteur, |
| 단체저자명 | National Academies of Sciences, Engineering, and Medicine (U.S.). Board on Health Sciences Policy. |
| 발행사항 | Washington, DC: National Academies Press, [2017]. |
| 형태사항 | 1 online resource (1 PDF file (xiv, 105 pages)): illustrations. |
| 기타형태 저록 | 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 |
| ISBN | 9780309466431 0309466431 |
| 기타표준부호 | 10.17226/24912doi |
| 서지주기 | Includes bibliographical references. |
| 내용주기 | 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. |
| 요약 | 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. |
| 기금정보주기 | 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. |
| 회의명 | Building a National Capability to Monitor and Assess Medical Countermeasure Use in Response to Public Health Emergencies (Workshop) (2017 : Washington, D.C.) |
| 주제명(지명) | United States. United States. --fast |
| 일반주제명 | Disaster medicine --United States --Congresses. Drug monitoring --United States --Congresses. Public health surveillance --United States --Congresses. Medical records --United States --Data processing --Congresses. Biological disasters --United States --Congresses. Patient monitoring --United States --Congresses. Disasters. Emergency Treatment. Communicable Diseases, Emerging --therapy. Terrorism. Off-Label Use. Drug Evaluation --methods. POLITICAL SCIENCE --Public Policy --Social Security. POLITICAL SCIENCE --Public Policy --Social Services & Welfare. Biological disasters. Disaster medicine. Drug monitoring. Medical records --Data processing. Patient monitoring. Public health surveillance. |
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