Appendix B

Public Meeting Agendas

PUBLIC WORKSHOP

Day 1: Monday, February 28, 2011

Washington Plaza Hotel
10 Thomas Circle
Washington, DC

Workshop Goals

1. Identify gaps and challenges in the existing infrastructure and strategies for dispensing antibiotics to protect the public against a terrorist attack using Bacillus anthracis or a similar pathogen.

2. Assess current prepositioning efforts and identify challenges.

3. Discuss appropriate target population groups, advantages, issues, and challenges associated with a range of prepositioning strategies, including workplace caches, hospital caches, caches in schools/universities/ daycares, caches in institutional facilities for older adults, and household stockpiles.

4. Examine ethical, legal, regulatory, and safety issues relevant to the development of prepositioning strategies.

5. Discuss methods, metrics, and available data for evaluating the cost and effectiveness of prepositioning strategies.



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Appendix B Public Meeting Agendas PUBLIC WORKSHOP Day 1: Monday, February 28, 2011 Washington Plaza Hotel 10 Thomas Circle Washington, DC Workshop Goals 1. Identify gaps and challenges in the existing infrastructure and strate- gies for dispensing antibiotics to protect the public against a terrorist attack using Bacillus anthracis or a similar pathogen. 2. Assess current prepositioning efforts and identify challenges. 3. Discuss appropriate target population groups, advantages, issues, and challenges associated with a range of prepositioning strategies, including workplace caches, hospital caches, caches in schools/ universities/daycares, caches in institutional facilities for older adults, and household stockpiles. 4. Examine ethical, legal, regulatory, and safety issues relevant to the development of prepositioning strategies. 5. Discuss methods, metrics, and available data for evaluating the cost and effectiveness of prepositioning strategies. 221

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222 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX 8:00 a.m. Welcome and Introductions RobeRt bass, Committee Chair Executive Director Maryland Institute for Emergency Medical Services Systems tia Powell, Committee Vice-Chair Director Montefiore-Einstein Center for Bioethics SESSION 1: FEDERAL STAKEHOLDER PERSPECTIVES Session Objectives: • Describe relevant federal efforts associated with prepositioning antibiotics for anthrax. — Examine the gaps, challenges, and emerging issues that federal agencies are facing. • Discuss which prepositioning strategies are likely to be successful under which circumstances and for which segments of the popula- tion, and the potential role of these strategies within an overall strategy for dispensing antibiotics. 8:15 a.m. RobeRt bass, Session Chair Executive Director Maryland Institute for Emergency Medical Services Systems elin GuRsky Senior Advisor Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services GReG buRel Director, Division of Strategic National Stockpile Office of Public Health Preparedness and Response Centers for Disease Control and Prevention kathRyn bRinsfield Director, Workforce Health and Medical Support Division Office of Health Affairs Department of Homeland Security

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223 APPENDIX B 9:10 a.m. Discussion with Committee 9:45 a.m. BREAK SESSION 2: STATE AND LOCAL PERSPECTIVES Session Objectives: • Identify gaps, challenges, and emerging issues associated with cur- rent state and local strategies for dispensing antibiotics to the public: What evidence supports the need for further refinement of medical countermeasures dispensing plans? • Describe relevant state and local efforts associated with preposi- tioning antibiotics for anthrax. — Where available, examine data assessing current prepositioning strategies. • Discuss which prepositioning efforts are likely to be successful un- der which circumstances and for which segments of the population, and the potential role of these strategies within an overall strategy for dispensing antibiotics. • Discuss state and local needs associated with developing preposi- tioning strategies. 10:00 a.m. heRminia Palacio, Session Chair Executive Director Harris County Public Health and Environmental Services, Texas susan cooPeR Commissioner Tennessee Department of Health david staRR Director, Countermeasures Response Office of Emergency Preparedness and Response New York City Department of Health and Mental Hygiene andRea mathias Deputy Health Officer Worcester County, Maryland 10:50 a.m. Discussion with Committee

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224 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX SESSION 3: PUBLIC ENGAGEMENT ON PREPOSITIONING Session Objective: Discuss concurrent public engagement project on prepo- sitioning, also sponsored by ASPR, and general considerations for engaging the public on prepositioning strategies. 11:30 a.m. kevin massey, Session Chair Director, Lutheran Disaster Response Evangelical Lutheran Church of America RoGeR beRnieR Member Medical Countermeasure Public Engagement Initiative Steering Committee 11:45 a.m. Discussion with Committee 12:00 p.m. LUNCH Note: The committee met in closed session from 12:00-1:00 p.m. SESSION 4: PREPOSITIONING EFFORTS IN OTHER DOMAINS Session Objective: Examine successes and lessons learned through the implementation of prepositioning strategies in other domains, including prepositioning of atropine in Israel, potassium iodide provided to people living near nuclear facilities, and household antibiotic kits provided to postal workers and their families in Minneapolis-St. Paul. 1:00 p.m. daniel lucey, Session Chair Adjunct Professor of Microbiology and Immunology Georgetown University Medical Center daniel laoR (by teleconference) Director Emergency and Disaster Management Division Ministry of Health, Israel James blando Assistant Professor School of Community and Environmental Health Old Dominion University

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225 APPENDIX B Jayne GRiffith State Bioterrorism Epidemiologist Minnesota Department of Health 1:30 p.m. Discussion with Committee SESSION 5: MODELING ANTHRAX Session Objective: Examine data and models of inhalational anthrax: dose response, incubation period distribution, disease progression and clinical outcomes, and medical consequences of the timing of providing antibiotics. In particular, assess the evidence supporting the commonly used 48-hour goal for dispensing antibiotics to the affected population. 2:00 p.m. tony cox, Session Chair President Cox Associates sid baccam Senior Scientist Innovative Emergency Management (IEM) dean wilkeninG (by teleconference) Senior Research Scientist Center for International Security and Cooperation Stanford University kenneth RaPuano Director of Advanced Systems and Policy Homeland Security Systems Engineering and Development Institute The MITRE Corporation 3:00 p.m. BREAK SESSION 6: LEGAL AND REGULATORY ISSUES Session Objective: Discuss federal and state legal and regulatory issues as- sociated with prepositioning antibiotics using strategies such as workplace caches, hospital caches, and household stockpiles.

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226 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX 3:15 p.m. eRin mullen, Session Chair Assistant Vice President, Rx Response Pharmaceutical Research and Manufacturers of America elizabeth sadove Regulatory Counsel Office of Counterterrorism and Emerging Threats Food and Drug Administration daniel o’bRien General Counsel, Dimensions Healthcare (Formerly) Principal Counsel, Assistant Attorney General Department of Health & Mental Hygiene, Office of the Attorney General, Maryland mitchel Rothholz Chief of Staff American Pharmacists Association 3:45 p.m. Discussion with Committee SESSION 7: SAFETY ISSUES Session Objective: Discuss safety concerns associated with prepositioning strategies, including workplace caches and household stockpiles. This may include both issues such as adverse effects of antibiotics as well as, for ex- ample, concerns related to health literacy. 4:15 p.m. RobeRt hoffman, Panel Chair Director New York City Poison Control Center nadine shehab Senior Service Fellow Division of Healthcare Quality Promotion National Center for Emerging and Infectious Zoonotic Disease Centers for Disease Control and Prevention kent sePkowitz Vice Chairman of Clinical Affairs Director, Hospital Infection Control Memorial Sloan-Kettering Cancer Center

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227 APPENDIX B daniel faGbuyi Medical Director, Disaster Preparedness and Emergency Management Assistant Professor of Pediatrics and Emergency Medicine The George Washington University School of Medicine Children’s National Medical Center 4:45 p.m. Discussion with Committee 5:15 p.m. Closing Remarks RobeRt bass, Committee Chair Executive Director Maryland Institute for Emergency Medical Services Systems tia Powell, Committee Vice-Chair Director Montefiore-Einstein Center for Bioethics 5:30 p.m. ADJOURN DAY 1 Day 2: Tuesday, March 1, 2011 Washington Plaza Hotel 10 Thomas Circle Washington, DC 8:00 a.m. Welcome and Summary of Day 1 RobeRt bass, Committee Chair Executive Director Maryland Institute for Emergency Medical Services Systems tia Powell, Committee Vice-Chair Director Montefiore-Einstein Center for Bioethics

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228 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX SESSION 8: VULNERABLE POPULATIONS AND ETHICAL ISSUES Session Objectives: • Identify the specific needs of vulnerable populations with regard to prepositioning antibiotics (e.g., children, pregnant women, people with disabilities, people with chronic illnesses, older adults). — Discuss mechanisms for prepositioning antibiotics in environ- ments where these populations will most likely be during an event (e.g., school, child care, at home, care facility). • Discuss ethical issues relevant to developing prepositioning strate- gies, including those related to equity and health literacy. 8:15 a.m. tia Powell, Session Chair Director Montefiore-Einstein Center for Bioethics michael andeRson Vice President and Associate Chief Medical Officer University Hospitals and Associate Professor of Pediatric Critical Care Rainbow Babies & Children’s Hospital, Cleveland, Ohio alexis silveR Vice President of Policy and Clinical Affairs Home Care Association of New York State kevin smith Emergency Disaster Services Director Florida Division of The Salvation Army 9:05 a.m. Discussion with Committee 9:45 a.m. BREAK SESSION 9: PRIVATE-SECTOR PERSPECTIVES AND WORKPLACE CACHES Session Objectives: • Review current private-sector efforts to preposition antibiotics within the organization.

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229 APPENDIX B • Discuss development and implementation of workplace caches: — What kind of companies would be appropriate for the strategy? — What are the advantages associated with the strategy? — How could challenges and issues associated with the strategy be addressed? — Would private sector organizations be interested in additional involvement in prepositioning? What barriers would need to be addressed? • Consider lessons learned from private-sector initiatives to stockpile antivirals that may apply to stockpiling antibiotics. 10:00 a.m. bRad bRekke, Panel Chair Vice President of Assets Protection Target Corporation andRew shulman Chief Operating Officer Affiliated Physicians Jocelyn staRGel Business Assurance Principal Southern Company Services, Inc. Penny tuRnbull (by teleconference) Senior Director, Business Continuity Marriott Hotels International, Ltd. 10:30 a.m. Discussion with Committee SESSION 10: HOSPITAL AND COMMUNITY HEALTH CENTER CACHES Session Objectives: • Review current efforts to preposition antibiotics within hospitals, community health centers, or other health care institutions. • Discuss development and implementation of caches within health care institutions: — What kind of health care settings would be appropriate for the strategy? — What are the advantages associated with the strategy? — How could challenges and issues associated with the strategy be addressed?

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230 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX — Would health care institutions be interested in additional in- volvement in prepositioning? What barriers would need to be addressed? • Consider lessons learned from initiatives to stockpile antivirals that may apply to stockpiling antibiotics. 11:00 a.m. JeffRey uPPeRman, Panel Chair Director of Trauma, Children’s Hospital of Los Angeles Associate Professor of Surgery, Keck School of Medicine University of Southern California michael Robbins Strategic National Stockpile Director Chicago Department of Public Health thomas tiGhe President and Chief Executive Officer Disaster Relief International amelia muccio Director of Disaster Planning New Jersey Primary Care Association 11:30 a.m. Discussion with Committee 12:00 p.m. LUNCH Note: The committee met in closed session from 12:00-1:00 p.m. SESSION 11: OTHER PREPOSITIONING STRATEGIES Session Objective: Discuss development and implementation of additional strategies for prepositioning antibiotics. For each strategy, discuss: • Who would be appropriate targets for the strategy (e.g., population groups, geographic factors, threat status)? • What are the advantages associated with the strategy? • How could challenges and issues associated with the strategy be addressed?

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231 APPENDIX B 1:00 p.m. Panel A: Household MedKits andRew Pavia, Session Chair George and Esther Gross Presidential Professor University of Utah School of Medicine Division of Pediatric Infectious Diseases debRa yeskey Director, Regulatory and Quality Affairs Division Biomedical Advanced Research and Development Agency Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services michael Robbins Strategic National Stockpile Director Chicago Department of Public Health elaine vauGhan (by teleconference) Research Professor and Professor Emerita of Psychology and Social Behavior School of Social Ecology University of California, Irvine 1:30 p.m. Discussion with Committee 2:00 p.m. Panel B: Other Prepositioning Strategies RobeRt buRhans, Panel Chair (Retired) Director of Health Emergency Preparedness New York State Department of Health James tuRneR Immediate Past President American College Health Association tim stePhens Public Health Advisor National Sheriff’s Association 2:30 p.m. Discussion with Committee 3:00 p.m. BREAK

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232 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX SESSION 12: MODELS, COST, AND EFFECTIVENESS Session Objectives: Identify currently available economic evidence regarding prepositioning strategies. What potential models exist that may be helpful? Discuss appropriate measures and metrics (e.g., cost, efficacy, effectiveness). 3:15 p.m. Panel A: Modeling Prepositioning Strategies stePhen Pollock, Panel Chair Herrick Emeritus Professor of Manufacturing University of Michigan JeffRey heRRmann Associate Professor Department of Mechanical Engineering and Institute for Systems Research University of Maryland nathaniel huPeRt Director, Preparedness Modeling Unit Centers for Disease Control and Prevention and Associate Professor of Public Health and Medicine Weill Medical College, Cornell University sid baccam Senior Scientist Innovative Emergency Management (IEM) 3:45 p.m. Discussion with Committee 4:15 p.m. Panel B: Evaluating Cost and Effectiveness of Prepositioning Strategies maRGaRet bRandeau, Panel Chair Coleman F. Fung Professor of Engineering Stanford University fadia t. shaya Associate Professor University of Maryland School of Pharmacy

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233 APPENDIX B fRed selck Doctoral Student in Health Economics Department of Health Policy and Management Johns Hopkins Bloomberg School of Public Health nikhil nataRaJan Associate Director Office of Health Emergency Preparedness New York State Department of Health 4:45 p.m. Discussion with Committee 5:15 p.m. Closing Remarks RobeRt bass, Committee Chair tia Powell, Committee Vice-Chair 5:30 p.m. ADJOURN DAY 2 Open Session at Committee Meeting #3 Day 1: Wednesday, April 20, 2011 The Beckman Center, Board Room 100 Academy Drive Irvine, CA 92617 Open Session Goals 1. Examine ethical issues and considerations for at-risk populations relevant for the development of prepositioning strategies such as (1) hospital and pharmacy caches; (2) caches in locations such as workplaces, educational institutions, and care facilities; and (3) household MedKits. 2. Receive updated briefing on ASPR’s public engagement project and discuss how ASPR anticipates using the results of that project in conjunction with the IOM report.

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234 PREPOSITIONING ANTIBIOTICS FOR ANTHRAX 8:00 a.m. Welcome and Introductions RobeRt bass, Committee Chair Executive Director Maryland Institute for Emergency Medical Services Systems tia Powell, Committee Vice-Chair Director Montefiore-Einstein Center for Bioethics SESSION 1: ETHICAL ISSUES AROUND PREPOSITIONING Session Objective: Discuss ethical issues associated with the development of prepositioning strategies, including caches in workplaces, educational institutions, care facilities, and household MedKits. 8:15 a.m. tia Powell, Panel Chair Director Montefiore-Einstein Center for Bioethics dRue baRRett CAPT, U.S. Public Health Service Lead, Public Health Ethics Unit Office of Science Integrity Office of the Associate Director for Science Centers for Disease Control and Prevention nancy kass (by videoconference) Phoebe R. Berman Professor of Bioethics and Public Health Johns Hopkins Bloomberg School of Public Health SESSION 2: PREPOSITIONING FOR AT-RISK POPULATIONS Session Objectives: Discuss how effective the prepositioning strategies un- der consideration would be for reaching at-risk populations. Highlight any equity issues that may arise, and discuss how members of these groups may view the development and implementation of these strategies. Note: This session will focus specifically on populations who, by virtue of socioeconomic status and/or demographic characteristics, may be at sys- temically increased risk for lower access to disaster mitigation response— for example, people with low incomes/limited transportation outcomes, people with no or limited English proficiency, historically underserved ethnic/racial groups, people with disabilities (especially vision impaired,

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235 APPENDIX B hearing impaired, mobility impaired), people who are homeless, and people who are homebound. 9:15 a.m. heRminia Palacio, Panel Chair Executive Director Harris County Public Health and Environmental Services, Texas mandi Janis (by videoconference) Program Director Catholic Charities USA RobeRta caRlin (by videoconference) Executive Director American Association on Health and Disability bob sPeaRs Director of Emergency Services Los Angeles Unified School District 10:15 a.m. BREAK SESSION 3: PUBLIC ENGAGEMENT ON PREPOSITIONING Session Objective: Receive updated briefing on ASPR public engagement project and discuss how ASPR anticipates using the results of that project in conjunction with the recommendations in the IOM report. 10:30 a.m. elin GuRsky Senior Advisor Office of the Assistant Secretary for Preparedness and Response Department of Health and Human Services 11:00 a.m. ADJOURN OPEN SESSION

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