Defining and Evaluating In-Home Drug Disposal Systems For Opioid Analgesics: Proceedings of a Workshop (2024)
Chapter: Appendix A: Workshop Agenda
Appendix A
Workshop Agenda
DEFINING AND EVALUATING IN-HOME DISPOSAL SYSTEMS FOR OPIOID ANALGESICS
DAY 1: JUNE 26, 2023
| 9:00 a.m. |
Welcome and Opening Remarks |
|
ALASTAIR WOOD, Workshop Co-Chair |
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Professor of Medicine Emeritus |
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Vanderbilt University School of Medicine |
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| 9:05 a.m. |
FDA Authority for In-Home Opioid Disposal |
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MARTA SOKOLOWSKA |
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Deputy Center Director for Substance Use and Behavioral Health |
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Center for Drug Evaluation and Research |
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Food and Drug Administration |
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| 9:15 a.m. |
Fireside Chat: Life Cycle of Prescribed Opioids |
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ROBERT HOFFMAN, Speaker |
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Professor, Department of Emergency Medicine |
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New York University Grossman School of Medicine |
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BETH McGINTY, Workshop Co-Chair, Moderator |
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Chief, Division of Health Policy and Economics |
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Professor, Department of Population Health Sciences |
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Weill Cornell Medicine |
SESSION I — ENVISIONING DISPOSAL SYSTEMS TO REMOVE OPIOIDS FROM THE HOME
Session Objectives:
- Describe the properties or characteristics that an ideal in-home disposal system might possess such that it minimizes barriers to patient use.
- Consider under what circumstances people will use an in-home disposal system, with a focus on conditions that impede use and how those can be overcome.
- Discuss how human-centered design can inform the goals, development, and use of in-home disposal systems.
- Discuss health equity considerations in developing and implementing in-home disposal systems.
| 9:55 a.m. |
Presentation |
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LAURA BIX |
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Assistant Dean for Teaching, Learning and Academic Analytics |
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Michigan State University College of Agriculture & Natural Resources |
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| 10:15 a.m. |
Panel Discussion |
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RUCHI FITZGERALD, Moderator |
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Assistant Professor, Rush University |
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Service Chief of Inpatient Addiction Medicine, PCC Community Wellness Center |
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Panelists |
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Health Care Innovation Perspective |
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ANISH AGARWAL |
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Assistant Professor of Emergency Medicine |
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University of Pennsylvania Perelman School of Medicine |
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Behavioral Science Perspective |
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KATHLEEN EGAN |
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Assistant Professor, Health Education and Promotion |
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East Carolina University College of Health and Human Performance |
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Consumer/Patient Perspective |
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LINDSAY BARAN |
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Senior Research Director |
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Health Care Evaluation Department |
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NORC at the University of Chicago |
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Opioid Stewardship Perspective |
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LYEN HUANG |
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Assistant Professor of Surgery |
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University of Utah Spencer Fox Eccles School of Medicine |
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| 11:15 a.m. |
BREAK (30 mins) |
SESSION II — REGULATORY LANDSCAPE FOR HOUSEHOLD OPIOID DISPOSAL
Session Objectives:
- Examine the current landscape of laws and regulations that apply to in-home drug disposal systems.
- Explore the role of state and local policies on drug disposal and how FDA regulations may interact with those policies, including any unintended consequences.
- Consider the intersection of federal, state, and local waste disposal policies regarding the use of in-home disposal systems for opioid analgesics.
| 11:45 a.m. |
Presentation |
|
HANZ ATIA |
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Associate, Policy and Programs |
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Product Stewardship Institute |
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| 12:05 p.m. |
Panel Discussion |
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LEWIS GROSSMAN, Moderator |
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Professor |
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American University Washington College of Law |
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Panelists |
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EPA Regulatory Perspective |
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KRISTIN FITZGERALD |
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Environmental Protection Specialist |
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Office of Resource Conservation and Recovery |
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Environmental Protection Agency |
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State Drug Disposal Policy Perspective |
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MARY KELLINGTON |
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Safe Medication Return Program Manager |
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Washington State Department of Health |
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FDA Regulatory Perspective |
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PATRICK RAULERSON |
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Senior Regulatory Counsel |
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Center for Drug Evaluation and Research |
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Food and Drug Administration |
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Former Federal Opioid Policy Perspective |
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UTTAM DHILLON |
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Partner |
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Michael Best & Friedrich LLP |
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| 1:05 p.m. |
LUNCH BREAK (55 mins) |
SESSION III — SCIENTIFIC CONSIDERATIONS FOR IN-HOME OPIOID DISPOSAL
Session Objectives:
- Identify ideal characteristics of an in-home disposal system from a mechanistic, safety, and environmental perspective.
- Explore the scientific considerations for in-home drug disposal systems that could be used to remove unused opioid analgesics from the home.
- Discuss what is known/unknown about available and developing methods (e.g., sequestration, adsorption, absorption) by which in-home disposal systems work, assuming the product is used as intended.
- Discuss scientific approaches for assessing and gathering data on the environmental impact of in-home drug disposal systems.
| 2:00 p.m. |
Presentation |
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MARGARET SHIELD |
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Owner and Principal |
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Community Environmental Health Strategies LLC |
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| 2:20 p.m. |
Panel Discussion |
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JESSICA YOUNG, Moderator |
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Chief, Recycling and Generator Branch |
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Environmental Protection Agency |
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Panelists |
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Opioid Chemistry Perspective |
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ANDREW COOP |
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Professor, Pharmaceutical Sciences |
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Associate Dean for Academic Affairs |
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University of Maryland School of Pharmacy |
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Toxicology Perspective |
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KAITLYN BROWN |
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Clinical Managing Director |
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America’s Poison Centers |
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FDA Perspective |
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MARTA SOKOLOWSKA |
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Deputy Center Director for Substance Use and Behavioral Health |
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Center for Drug Evaluation and Research |
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Food and Drug Administration |
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Environmental Chemistry Perspective |
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PAUL BRADLEY |
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Project Lead |
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Drinking-Water and Wastewater Infrastructure Integrated Science Team |
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Ecosystems Mission, Environmental Health Program |
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U.S. Geological Survey |
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| 3:20 p.m. |
BREAK (30 mins) |
SESSION IV — REAL-WORLD USE AND IMPLEMENTATION OF IN-HOME OPIOID DISPOSAL SYSTEMS
Session Objectives:
- Consider what approaches/methodologies are needed to evaluate the safe and correct use of in-home drug disposal systems in real-world settings.
- Explore approaches for engaging consumers on how to use in-home disposal systems safely and as intended.
- Consider best practices to promote safe and effective use of in-home disposal systems, including the roles of clinicians, prescribers, and pharmacists.
- Discuss use studies to lay out tangible examples of unintended consequences.
| 3:50 p.m. |
Presentation |
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CHAD BRUMMETT |
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Bert N. LaDu Professor of Anesthesiology |
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Co-Director, Opioid Research Institute |
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Co-Director, Opioid Prescribing Engagement Network |
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University of Michigan Medical School |
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| 4:10 p.m. |
Panel Discussion |
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MARK BICKET, Moderator |
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Assistant Professor |
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Director, Pain & Opioid Research |
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Department of Anesthesiology |
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Institute for Healthcare Policy and Innovation |
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University of Michigan Medical School |
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Panelists |
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Implementation Perspective |
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ANDREA TSATOKE |
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Injury Prevention Specialist |
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Indian Health Service, Headquarters |
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Program Evaluation Perspective |
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ELEANOR T. LEWIS |
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Deputy Director, Program Evaluation & Resource Center |
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U.S. Department of Veterans Affairs |
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REMS Design and Implementation Perspective |
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JAMES SHAMP |
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Vice President for Data Intelligence & Program Analytics |
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United BioSource LLC |
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Retail Pharmacy Perspective |
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KEVIN NICHOLSON |
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Vice President, Public Policy, Regulatory, and Legal Affairs |
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National Association of Chain Drug Stores |
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Behavioral Science and Communication Perspective |
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TAMAR KRISHNAMURTI |
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Assistant Professor, Medicine and Clinical and Translational Science |
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Department of Medicine Center for Research on Health Care |
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University of Pittsburgh |
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| 5:20 p.m. |
Summary Remarks |
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ALASTAIR WOOD, Workshop Co-Chair |
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| 5:30 p.m. |
DAY 1 ADJOURN |
DAY 2: JUNE 27, 2023
| 8:30 a.m. |
Welcome and Opening Remarks |
|
BETH McGINTY, Workshop Co-Chair |
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| 8:50 a.m. |
Risk Evaluation and Mitigation Strategies: An Overview |
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LYNN MEHLER |
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Practice Area Lead, Pharmaceuticals & Biotechnology |
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Hogan Lovells LLP |
SESSION V — THE ROLE OF IN-HOME OPIOID DISPOSAL
Session Objectives:
- Consider the role of an ideal in-home disposal system in addressing the public health goal of mitigating the risk of non-medical use or overdose associated with opioids.
- Discuss how previous workshop discussions may inform the design, implementation, and evaluation of in-home disposal systems.
- Consider data needs and practical approaches for assessing the use and effectiveness of disposal systems in real-world settings.
| 9:15 a.m. |
Presentation |
|
KATHLEEN EGAN |
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Assistant Professor, Health Education and Promotion |
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East Carolina University College of Health and Human Performance |
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| 9:35 a.m. |
Panel Discussion |
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ROBERT MORONES, Moderator |
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Injury Prevention Specialist |
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Indian Health Service (Phoenix Area) |
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U.S. Department of Health and Human Services |
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Panelists |
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Pediatric Injury Prevention Perspective |
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CHRISTOPHER GAW |
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Pediatric Emergency Medicine Fellow |
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Associate Fellow, Center for Injury Research and Prevention |
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Children’s Hospital of Philadelphia |
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Overdose Prevention Perspective |
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JEFF HORWITZ |
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Chief Executive Officer |
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SAFE Project |
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Harm Reduction Perspective |
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SUSAN SHERMAN |
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Bloomberg Professor of American Health |
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Department of Health, Behavior and Society |
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Johns Hopkins Bloomberg School of Public Health |
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National Institute on Drug Abuse Perspective |
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WILSON COMPTON |
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Deputy Director, National Institute on Drug Abuse |
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National Institutes of Health |
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| 10:45 a.m. |
BREAK (30 mins) |
SYNTHESIS DISCUSSION
Purpose:
- Integrate information gathered throughout the workshop in a discussion on the properties and characteristics of an ideal in-home disposal system, factors impacting implementation, and regulatory considerations for household opioid disposal.
| 11:15 a.m. |
Moderated Panel Discussion |
|
ALASTAIR WOOD, Workshop Co-Chair, Moderator |
|
|
Panelists |
|
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Pharmaceutical Sciences Perspective |
|
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ANDREW COOP |
|
|
Professor, Pharmaceutical Sciences |
|
|
Associate Dean for Academic Affairs |
|
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University of Maryland School of Pharmacy |
|
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Implementation Perspective |
|
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MARK BICKET |
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Assistant Professor |
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Director, Pain & Opioid Research |
|
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Department of Anesthesiology |
|
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Institute for Healthcare Policy and Innovation |
|
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University of Michigan Medical School |
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Overdose Prevention Perspective |
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JEFF HORWITZ |
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Chief Executive Officer |
|
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SAFE Project |
|
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Human-Centered Design Perspective |
|
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LAURA BIX |
|
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Assistant Dean for Teaching, Learning and Academic Analytics |
|
|
Michigan State University College of Agriculture & Natural Resources |
|
|
Food and Drug Administration Perspective |
|
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PATRICK RAULERSON |
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Senior Regulatory Counsel |
|
|
Center for Drug Evaluation and Research |
|
|
Food and Drug Administration |
| 12:15 p.m. |
Panel Discussion with Audience Engagement |
| 12:45 p.m. |
Closing Remarks |
|
BETH McGINTY, Workshop Co-Chair |
|
| 1:00 p.m. |
DAY 2 ADJOURN |
