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 | |
Professor of Medicine Emeritus | |
Vanderbilt University School of Medicine | |
| 9:05 a.m. | FDA Authority for In-Home Opioid Disposal |
MARTA SOKOLOWSKA | |
Deputy Center Director for Substance Use and Behavioral Health | |
Center for Drug Evaluation and Research | |
Food and Drug Administration | |
| 9:15 a.m. | Fireside Chat: Life Cycle of Prescribed Opioids |
ROBERT HOFFMAN, Speaker | |
Professor, Department of Emergency Medicine | |
New York University Grossman School of Medicine |
BETH McGINTY, Workshop Co-Chair, Moderator | |
Chief, Division of Health Policy and Economics | |
Professor, Department of Population Health Sciences | |
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 |
LAURA BIX | |
Assistant Dean for Teaching, Learning and Academic Analytics | |
Michigan State University College of Agriculture & Natural Resources | |
| 10:15 a.m. | Panel Discussion |
RUCHI FITZGERALD, Moderator | |
Assistant Professor, Rush University | |
Service Chief of Inpatient Addiction Medicine, PCC Community Wellness Center | |
Panelists | |
Health Care Innovation Perspective | |
ANISH AGARWAL | |
Assistant Professor of Emergency Medicine | |
University of Pennsylvania Perelman School of Medicine |
Behavioral Science Perspective | |
KATHLEEN EGAN | |
Assistant Professor, Health Education and Promotion | |
East Carolina University College of Health and Human Performance | |
Consumer/Patient Perspective | |
LINDSAY BARAN | |
Senior Research Director | |
Health Care Evaluation Department | |
NORC at the University of Chicago | |
Opioid Stewardship Perspective | |
LYEN HUANG | |
Assistant Professor of Surgery | |
University of Utah Spencer Fox Eccles School of Medicine | |
| 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 | |
Associate, Policy and Programs | |
Product Stewardship Institute | |
| 12:05 p.m. | Panel Discussion |
LEWIS GROSSMAN, Moderator | |
Professor | |
American University Washington College of Law |
Panelists | |
EPA Regulatory Perspective | |
KRISTIN FITZGERALD | |
Environmental Protection Specialist | |
Office of Resource Conservation and Recovery | |
Environmental Protection Agency | |
State Drug Disposal Policy Perspective | |
MARY KELLINGTON | |
Safe Medication Return Program Manager | |
Washington State Department of Health | |
FDA Regulatory Perspective | |
PATRICK RAULERSON | |
Senior Regulatory Counsel | |
Center for Drug Evaluation and Research | |
Food and Drug Administration | |
Former Federal Opioid Policy Perspective | |
UTTAM DHILLON | |
Partner | |
Michael Best & Friedrich LLP | |
| 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 |
MARGARET SHIELD | |
Owner and Principal | |
Community Environmental Health Strategies LLC | |
| 2:20 p.m. | Panel Discussion |
JESSICA YOUNG, Moderator | |
Chief, Recycling and Generator Branch | |
Environmental Protection Agency | |
Panelists | |
Opioid Chemistry Perspective | |
ANDREW COOP | |
Professor, Pharmaceutical Sciences | |
Associate Dean for Academic Affairs | |
University of Maryland School of Pharmacy | |
Toxicology Perspective | |
KAITLYN BROWN | |
Clinical Managing Director | |
America’s Poison Centers | |
FDA Perspective | |
MARTA SOKOLOWSKA | |
Deputy Center Director for Substance Use and Behavioral Health | |
Center for Drug Evaluation and Research | |
Food and Drug Administration | |
Environmental Chemistry Perspective | |
PAUL BRADLEY | |
Project Lead | |
Drinking-Water and Wastewater Infrastructure Integrated Science Team | |
Ecosystems Mission, Environmental Health Program | |
U.S. Geological Survey | |
| 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 |
CHAD BRUMMETT | |
Bert N. LaDu Professor of Anesthesiology | |
Co-Director, Opioid Research Institute | |
Co-Director, Opioid Prescribing Engagement Network | |
University of Michigan Medical School | |
| 4:10 p.m. | Panel Discussion |
MARK BICKET, Moderator | |
Assistant Professor | |
Director, Pain & Opioid Research | |
Department of Anesthesiology | |
Institute for Healthcare Policy and Innovation | |
University of Michigan Medical School | |
Panelists | |
Implementation Perspective | |
ANDREA TSATOKE | |
Injury Prevention Specialist | |
Indian Health Service, Headquarters | |
Program Evaluation Perspective | |
ELEANOR T. LEWIS | |
Deputy Director, Program Evaluation & Resource Center | |
U.S. Department of Veterans Affairs |
REMS Design and Implementation Perspective | |
JAMES SHAMP | |
Vice President for Data Intelligence & Program Analytics | |
United BioSource LLC | |
Retail Pharmacy Perspective | |
KEVIN NICHOLSON | |
Vice President, Public Policy, Regulatory, and Legal Affairs | |
National Association of Chain Drug Stores | |
Behavioral Science and Communication Perspective | |
TAMAR KRISHNAMURTI | |
Assistant Professor, Medicine and Clinical and Translational Science | |
Department of Medicine Center for Research on Health Care | |
University of Pittsburgh | |
| 5:20 p.m. | Summary Remarks |
ALASTAIR WOOD, Workshop Co-Chair | |
| 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 | |
| 8:50 a.m. | Risk Evaluation and Mitigation Strategies: An Overview |
LYNN MEHLER | |
Practice Area Lead, Pharmaceuticals & Biotechnology | |
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 | |
Assistant Professor, Health Education and Promotion | |
East Carolina University College of Health and Human Performance | |
| 9:35 a.m. | Panel Discussion |
ROBERT MORONES, Moderator | |
Injury Prevention Specialist | |
Indian Health Service (Phoenix Area) | |
U.S. Department of Health and Human Services | |
Panelists | |
Pediatric Injury Prevention Perspective | |
CHRISTOPHER GAW | |
Pediatric Emergency Medicine Fellow | |
Associate Fellow, Center for Injury Research and Prevention | |
Children’s Hospital of Philadelphia | |
Overdose Prevention Perspective | |
JEFF HORWITZ | |
Chief Executive Officer | |
SAFE Project | |
Harm Reduction Perspective | |
SUSAN SHERMAN | |
Bloomberg Professor of American Health | |
Department of Health, Behavior and Society | |
Johns Hopkins Bloomberg School of Public Health | |
National Institute on Drug Abuse Perspective | |
WILSON COMPTON | |
Deputy Director, National Institute on Drug Abuse | |
National Institutes of Health | |
| 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 | |
Pharmaceutical Sciences Perspective | |
ANDREW COOP | |
Professor, Pharmaceutical Sciences | |
Associate Dean for Academic Affairs | |
University of Maryland School of Pharmacy | |
Implementation Perspective | |
MARK BICKET | |
Assistant Professor | |
Director, Pain & Opioid Research | |
Department of Anesthesiology | |
Institute for Healthcare Policy and Innovation | |
University of Michigan Medical School | |
Overdose Prevention Perspective | |
JEFF HORWITZ | |
Chief Executive Officer | |
SAFE Project | |
Human-Centered Design Perspective | |
LAURA BIX | |
Assistant Dean for Teaching, Learning and Academic Analytics | |
Michigan State University College of Agriculture & Natural Resources | |
Food and Drug Administration Perspective | |
PATRICK RAULERSON | |
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 |
