Defining and Evaluating In-Home Drug Disposal Systems For Opioid Analgesics: Proceedings of a Workshop (2024)
Chapter: 1 Introduction
1
Introduction1
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018 (Public Law 115-271) gave the Food and Drug Administration (FDA) authority to require that drug manufacturers provide a safe drug disposal system for certain drugs that pose a serious risk of non-medical use or overdose, if FDA determines that the disposal system could mitigate that risk. The requirement to make in-home disposal systems available to patients would be implemented under a risk evaluation and mitigation strategy (REMS). On June 26–27, 2023, the Forum on Drug Discovery, Development, and Translation of the National Academies of Sciences, Engineering, and Medicine (the National Academies) hosted a public workshop as a venue for stakeholders to examine the development and use of in-home drug disposal systems, with a focus on removing unused opioid analgesics from the home. The National Academies appointed an ad-hoc planning committee to address the statement of task (Box 1-1).
Alastair Wood, professor of medicine emeritus at Vanderbilt University School of Medicine, said the workshop agenda was designed to
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1 This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers. This Proceedings of a Workshop was prepared by the rapporteurs as a factual summary of the presentations and discussions that took place at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
BOX 1-1
Workshop Statement of Task
A planning committee of the National Academies of Sciences, Engineering, and Medicine will organize a public workshop on the development and use of in-home drug disposal systems with a focus on removing unused opioid analgesics from the home. The public workshop will feature invited presentations and discussions to:
- Explore the types of in-home drug disposal options, other than mail-back envelopes, that could be used to remove unused opioid analgesics from the home.
- Examine the current landscape of laws and regulations that apply to in-home opioid disposal systems.
- Discuss scientific, behavioral, health equity, and policy considerations for assessing the safety, use, and effectiveness of in-home opioid disposal systems, including the following questions:
- What is known/unknown about the methods (e.g., sequestration, adsorption, absorption) used in in-home disposal systems for rendering opioids unavailable for non-medical use, assuming the product is used as intended?
- What approaches/methodologies are needed to evaluate the safe and correct use of in-home opioid disposal systems in real-world settings?
- How could person-centered design inform the development and use of in-home opioid disposal systems?
- Consider potential strategies for encouraging and assessing the development and use of in-home opioid disposal systems that support the public health goal of mitigating the risk of non-medical use or overdose associated with opioids.
The planning committee will organize the workshop, develop the agenda, select and invite speakers and discussants, and moderate or identify moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
gather information on topics such as how well in-home disposal systems work to remove opioids from the home; the impact of in-home disposal systems on reducing opioid misuse; barriers and facilitators impacting whether people will actually use a provided in-home disposal system; and the safety of disposal systems themselves, including user safety when used as intended or otherwise, as well as safety risks for those attempting to recover drugs that have been disposed of in a system. The workshop also included discussions of the types of evidence that FDA might need if the REMS for opioid analgesics were to be expanded to include in-home
opioid disposal systems (e.g., evidence of efficacy, safety, practicality, user acceptability, environmental impact).
THE FDA OVERDOSE PREVENTION FRAMEWORK
Marta Sokolowska, deputy center director for substance use and behavioral health at the FDA Center for Drug Evaluation and Research (CDER), provided a brief overview of FDA’s Overdose Prevention framework and the agency’s authority to regulate in-home opioid disposal systems.
Provisional data from the Centers for Disease Control and Prevention (CDC) indicate there were around 110,000 drug overdose deaths in the United States in 2022, the majority of which involved opioids, Sokolowska said. Furthermore, “the 2021 National Survey on Drug Use and Health estimates that 8.7 million people aged 12 and older misused prescription pain relievers in 2021,” she said. A recent study of fatal poisonings in young children identified opioids as the most common cause (Gaw et al., 2023). Despite efforts to promote more appropriate prescribing, a recent systematic review found that 50 to 70 percent of opioid tablets prescribed for postsurgical pain management were not used (Mallama et al., 2022).
The National Drug Control Strategy issued by the White House Office of National Drug Control Policy (ONDCP) in 2022 calls for consistent guidance on the safe disposal of unused prescription drugs. To this end, FDA is collaborating with the United States Postal Service (USPS), the Drug Enforcement Administration (DEA), the Environmental Protection Agency (EPA), CDC, and other governmental agencies on this issue. “It is our shared responsibility to address the significant risk of non-medical use, accidental exposure, overdose, and death associated with unused opioids in patients’ homes,” Sokolowska said.
In alignment with the National Drug Control Strategy and the U.S. Department of Health and Human Services (HHS) Overdose Prevention Strategy, FDA launched its Overdose Prevention Framework in 2022. The framework prioritizes “primary prevention, harm reduction, providing evidence-based treatment for substance use disorders, and supporting safe drug supply,” Sokolowska said, and is “guided by the same four crosscutting principles as the HHS strategy: equity; data and evidence; coordination, collaboration, and integration; and reducing stigma.”
Under the primary prevention priority area, FDA is working to “eliminate unnecessary initial prescription exposure and inappropriate prolonged prescribing” of opioid medications, Sokolowska said. Initiatives have included product label changes that promote safer use and supporting the development of clinical practice guidelines for safer pain management prescribing.
The agency is also focused on identifying approaches for the safe removal of unused opioids from patient homes as a primary prevention strategy using its authority under the 2018 SUPPORT Act. Current options for disposing of unused opioids include collection kiosks and DEA’s National Prescription Drug Take Back Days, which Sokolowska noted require patients to store unused opioids in the home until a local take-back day or until they can travel to a kiosk. There are also in-home disposal options, such as “flushing; mixing opioids with unpalatable substances and disposing them in trash; using commercially available in-home disposal systems and disposing them in trash; and having patients put unused opioids in mail-back envelopes that are transported to a facility for incineration,” she continued.
Sokolowska elaborated on the mail-back option. Following a call for public comment on this issue in April 2022, FDA is modifying the current Opioid Analgesic REMS to require manufacturers of opioids to make prepaid mail-back envelopes available to outpatient dispensers (e.g., retail pharmacies) to provide to patients when dispensing prescribed opioids. Manufacturers must also develop patient education materials on safe disposal of opioids for dispensers to provide to patients.
While moving forward with the prepaid mail-back envelope strategy, FDA is also considering public feedback regarding the need for additional in-home disposal options. For example, Sokolowska said many patients and health care providers reported a preference for in-home disposal systems that can be discarded in household trash because they are “easier to use, less expensive, or less subject to diversion.” Feedback from retail pharmacists indicates that “patients are familiar with using in-home disposal systems and appreciate receiving these with their medications,” she said. There were also concerns raised by those in rural and Tribal communities that limited access to postal services made the use of mail-back envelopes less practical. She added that data in the literature suggest that counseling patients about opioid disposal and making in-home disposal options available promote disposal (Butler et al., 2021).
Under the authority provided by the SUPPORT Act, FDA is considering “where and under what circumstances to require other home disposal systems … be provided to patients dispensed opioid analgesics,” Sokolowska said. She explained that the SUPPORT Act, as passed in 2018, required that these in-home disposal systems render the medications “non-retrievable,” a standard that refers to a controlled substance being rendered unusable for all practical purposes by means of irreversible physical or chemical changes to a substance (21 CFR § 1300.05). The non-retrievable requirement was “explicitly removed” from the SUPPORT Act in the Consolidated Appropriations Act of 2023.
Sokolowska emphasized that the agency has not made a decision on whether to expand the Opioid Analgesic REMS to include in-home disposal systems. FDA is seeking public input on this matter through a call for comments in the Federal Register.2 The agency is eager to hear from patients and health care providers regarding “beliefs and perceptions around in-home disposal products, including those related to ease of use and environmental impact, as well as beliefs and perceptions that can impact willingness to use these products,” she said.
ORGANIZATION OF THE PROCEEDINGS
This Proceedings of a Workshop summarizes the presentations and discussions that took place during the public workshop held on June 26 and 27, 2023. Chapter 2 presents an overview of the life cycle of prescribed opioids, from the prescribing encounter to after the patient has completed or stopped treatment, including the potential for non-medical use, diversion, and misuse along the pathway. Chapter 3 discusses characteristics of usable in-home opioid disposal systems, barriers to their implementation and use, and health equity considerations in the development of in-home disposal systems. Chapter 4 considers the role of an ideal in-home opioid disposal system in mitigating the risk of misuse or overdose of unused prescription opioids. An overview of the legal and practical aspects of REMS is provided in Chapter 5, followed by panelist perspectives on the current laws and regulations relevant to in-home drug disposal systems in Chapter 6. Chapter 7 considers the ideal characteristics of an in-home drug disposal system from mechanistic, safety, and environmental perspectives, and approaches for assessing the environmental impact of such systems. In Chapter 8, panelists discuss issues surrounding the implementation and use of in-home opioid disposal systems in real-world settings, including opportunities and barriers to disposal, and studies of disposal behaviors. The proceedings concludes in Chapter 9 with panelist and participant reflections on recurring themes from across the workshop. Appendix A contains the workshop agenda and Appendix B contains the biographical sketches of the workshop planning committee members, speakers, and panelists.
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2 Comments were accepted through August 28, 2023. See https://www.federalregister.gov/documents/2023/04/04/2023-06650/in-home-disposal-systems-for-opioid-analgesics-request-for-information (accessed November 18, 2023).
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