Defining and Evaluating
In-Home Drug Disposal
Systems for Opioid
Analgesics
_____
Theresa Wizemann, Kyle Cavagnini,
and Carolyn Shore, Rapporteurs
Forum on Drug Discovery,
Development, and Translation
Board on Health Sciences Policy
Health and Medicine Division
Proceedings of a Workshop
NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by Amgen Inc.; Association of American Medical Colleges; AstraZeneca; Biogen; Burroughs Wellcome Fund (Award No. 1023129); Critical Path Institute; Eli Lilly and Company; FasterCures, Milken Institute; Food and Drug Administration (Grant No. 1R13FD007302-01); Foundation for the National Institutes of Health; Friends of Cancer Research; Johnson & Johnson; Medable, Inc.; Merck & Co., Inc. (Award No. MRLCPO-23-166623); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Science Policy; New England Journal of Medicine; and Sanofi (Contract No. 77646387). 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.
International Standard Book Number-13: 978-0-309-71434-1
International Standard Book Number-10: 0-309-71434-6
Digital Object Identifier: https://doi.org/10.17226/27436
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2024. Defining and evaluating in-home drug disposal systems for opioid analgesics: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/27436.
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PLANNING COMMITTEE ON DEFINING AND EVALUATING IN-HOME DRUG DISPOSAL SYSTEMS FOR OPIOID ANALGESICS1
ELIZABETH MCGINTY (Co-Chair), Chief, Division of Health Policy and Economics, and Professor, Department of Population Health Sciences, Weill Cornell Medicine
ALASTAIR J. J. WOOD (Co-Chair), Professor of Medicine Emeritus, Vanderbilt University School of Medicine
MARK C. BICKET, Assistant Professor, Director, Pain & Opioid Research, Department of Anesthesiology, Institute for Healthcare Policy and Innovation, University of Michigan Medical School
IRENE Z. CHAN, Deputy Director, Office of Medication Error Prevention and Risk Management, Center for Drug Evaluation and Research, Food and Drug Administration
RUCHI M. FITZGERALD, Assistant Professor, Rush University; Service Chief of Inpatient Addiction Medicine, PCC Community Wellness Center
LEWIS GROSSMAN, Ann Loeb Bronfman Professor of Law, American University Washington College of Law
STEPHEN W. HOAG, Professor of Pharmaceutical Sciences, University of Maryland Baltimore School of Pharmacy
ROBERT MORONES, Injury Prevention Specialist, Indian Health Service (Phoenix Area), U.S. Department of Health and Human Services
THOMAS PRISINZANO, Professor and Chair, Pharmaceutical Sciences Department, University of Kentucky College of Pharmacy
JESSICA YOUNG, Chief, Recycling and Generator Branch, Environmental Protection Agency
PATRICIA J. ZETTLER, Associate Professor, The Ohio State University Moritz College of Law
Staff
CAROLYN SHORE, Director, Forum on Drug Discovery, Development, and Translation
KYLE CAVAGNINI, Associate Program Officer
MAYA THIRKILL, Associate Program Officer (until May 2023)
NOAH ONTJES, Research Associate
___________________
1The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
MELVIN JOPPY, Senior Program Assistant
CLARE STROUD, Senior Director, Board on Health Sciences Policy
Consultant
THERESA WIZEMANN, Science Writer
FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION1
GREGORY SIMON (Co-Chair), Kaiser Permanente Washington Health Research Institute and University of Washington
ANN TAYLOR (Co-Chair), Retired
BARBARA E. BIERER, Harvard Medical School; Brigham and Women’s Hospital
LINDA BRADY, National Institute of Mental Health, NIH
JOHN BUSE, University of North Carolina at Chapel Hill School of Medicine
LUTHER T. CLARK, Merck & Co., Inc.
BARRY S. COLLER, The Rockefeller University
TAMMY R.L. COLLINS, Burroughs Wellcome Fund
THOMAS CURRAN, Children’s Mercy, Kansas City
RICHARD DAVEY, National Institute of Allergy and Infectious Diseases, NIH
KATHERINE DAWSON, Biogen
JAMES H. DOROSHOW, National Cancer Institute, NIH
JEFFREY M. DRAZEN, New England Journal of Medicine
STEVEN K. GALSON, Retired
CARLOS O. GARNER, Eli Lilly and Company
SALLY L. HODDER, West Virginia University
TESHEIA JOHNSON, Yale School of Medicine
LYRIC JORGENSON, Office of Science Policy, NIH
ESTHER KROFAH, FasterCures, Milken Institute
LISA M. LaVANGE, University of North Carolina
ARAN MAREE, Johnson & Johnson
CRISTIAN MASSACESI, AstraZeneca
ROSS MCKINNEY, JR., Association of American Medical Colleges
JOSEPH P. MENETSKI, Foundation for the National Institutes of Health
ANAEZE C. OFFODILE II, University of Texas MD Anderson Cancer Center
SALLY OKUN, Clinical Trials Transformation Initiative
ARTI RAI, Duke University School of Law
KLAUS ROMERO, Critical Path Institute
JONI RUTTER, National Center for Advancing Translational Sciences, NIH
___________________
1The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
SUSAN SCHAEFFER, The Patients’ Academy for Research Advocacy
ANANTHA SHEKHAR, University of Pittsburgh School of Medicine
ELLEN V. SIGAL, Friends of Cancer Research
MARK TAISEY, Amgen Inc.
AMIR TAMIZ, National Institute of Neurological Disorders and Stroke, NIH
PAMELA TENAERTS, Medable, Inc.
MAJID VAKILYNEJAD, Takeda
JONATHAN WATANABE, University of California, Irvine, School of Pharmacy and Pharmaceutical Sciences
ALASTAIR WOOD, Vanderbilt University School of Medicine
CRIS WOOLSTON, Sanofi
JOSEPH C. WU, Stanford University School of Medicine
Forum Staff
CAROLYN SHORE, Forum Director
KYLE CAVAGNINI, Associate Program Officer
BRITTANY HSIAO, Associate Program Officer (as of September 2023)
MAYA THIRKILL, Associate Program Officer (until April 2023)
NOAH ONTJES, Research Associate
MELVIN JOPPY, Senior Program Assistant
CLARE STROUD, Senior Director, Board on Health Sciences Policy
Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
MARK BICKET, University of Michigan Medical School
STEPHANIE Y. CRAWFORD, University of Illinois Chicago
ANDREA TSATOKE, Indian Health Service
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by ELI Y. ADASHI, Brown University. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
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Acknowledgments
Support from the sponsors of the Forum on Drug Discovery, Development, and Translation is crucial to support this and other work of the National Academies of Sciences, Engineering, and Medicine (the National Academies).
The National Academies’ staff wish to express their gratitude to the speakers whose presentations helped inform workshop discussions on defining and evaluating in-home drug disposal systems and their use; to the members of the planning committee for their work in developing the workshop agenda and shaping the discussions; and to additional National Academies’ staff, without whom this workshop and the accounting thereof would not have been possible: Christie Bell, Samantha Chao, Robert Day, Alexandra Molina, Rebekah Hanover Pettit, Marguerite Romatelli, Lauren Shern, and Taryn Young.
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Contents
The FDA Overdose Prevention Framework
Organization of the Proceedings
2 LIFE CYCLE OF PRESCRIBED OPIOIDS
3 ENVISIONING DISPOSAL SYSTEMS TO REMOVE OPIOIDS FROM THE HOME
Design and Its Relation to Human Behavior
Designing Usable In-Home Opioid Disposal Systems
4 THE ROLE OF IN-HOME OPIOID DISPOSAL
Facilitating In-Home Disposal of Opioid Analgesics
Considering the Roles of In-Home Disposal
Overlapping Statutory Authorities for Controlled Substances
6 REGULATORY LANDSCAPE FOR HOUSEHOLD OPIOID DISPOSAL
Perspectives on Regulatory Authority
7 SCIENTIFIC CONSIDERATIONS FOR IN-HOME OPIOID DISPOSAL
Assessing Utility and Performance
8 REAL-WORLD IMPLEMENTATION AND USE OF IN-HOME OPIOID DISPOSAL SYSTEMS
Opportunities and Barriers for the Disposal of Unused Opioids
9 REFLECTIONS ON THE DESIGN AND IMPLEMENTATION OF IN-HOME OPIOID DISPOSAL SYSTEMS
B BIOGRAPHICAL SKETCHES OF THE WORKSHOP PLANNING COMMITTEE MEMBERS, SPEAKERS, AND PANELISTS
Boxes and Figures
BOXES
1-1 Workshop Statement of Task
FIGURES
2-1 How misused prescription pain relievers are obtained
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Acronyms and Abbreviations
| CDC | Centers for Disease Control and Prevention |
| CDER | Center for Drug Evaluation and Research (FDA) |
| DEA | Drug Enforcement Administration |
| EHR | electronic health record |
| EPA | Environmental Protection Agency |
| EPR | extended producer responsibility |
| ETASU | elements to assure safe use |
| FDA | Food and Drug Administration |
| HHS | U.S. Department of Health and Human Services |
| HUB | Healthcare, Universal Design, and Biomechanics |
| ICD | International Classification of Diseases |
| IHS | Indian Health Service |
| NACDS | National Association of Chain Drug Stores |
| NIDA | National Institute on Drug Abuse (National Institutes of Health) |
| NPI | national provider identifier |
| ONDCP | White House Office of National Drug Control Policy |
| OPEN | Opioid Prescribing Engagement Network |
| OTC | over the counter |
| PSI | Product Stewardship Institute |
| RCRA | Resource Conservation and Recovery Act |
| RCT | randomized controlled trial |
| REMS | risk evaluation and mitigation strategy |
| SAFE | Stop the Addiction Fatality Epidemic |
| SUPPORT Act | Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 |
| USPS | United States Postal Service |
| VA | U.S. Department of Veterans Affairs |
