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¹ See https://www.525foundation.org (accessed November 18, 2023).

Indiana region (19 thus far), which Brummett said have collected more than 50,000 pounds of drugs in about 6 years.

A 2017 systematic review found that 60 to 90 percent of the patients in the included studies reported having unused opioids after surgery (Bicket et al., 2017). He acknowledged that there have been efforts to reduce acute care prescribing in recent years while still ensuring the patient’s pain is sufficiently managed. Brummett added that prescribing of opioids to children continues, particularly in association with dental procedures, and opioids that are misused by children ages 12 and older are frequently those that were prescribed for their own care. He suggested that a future National Academies workshop might consider how to reduce opioid prescribing to children, particularly by dentists.

When his group held its first opioid take-back drive in 2016 in Ann Arbor, Michigan, Brummett said it was done as a service to the community and a way to raise awareness of the risks of unused opioids. However, the events also unexpectedly provided data as residents were asked if they would share how they obtained the opioid they were disposing. The most common reason the opioids had been prescribed was for acute care such as surgery, dentistry, or emergency medicine, he said. Less than 20 percent were prescribed the opioid for chronic pain (23 percent could not recall). Since then, OPEN has launched a take-back toolkit (discussed below) and more than 100 sites in 46 counties across the state have participated in a take-back event, netting 28,000 pounds of unused medications. Brummett shared that the oldest drug collected was from 1975, and medications from the 1970s, 1980s, and 1990s are not uncommon.

Studies of Disposal Behaviors

Brummett described an RCT he conducted on the effect of providing an activated charcoal bag for in-home opioid disposal following outpatient surgery. About 25 percent of patients who received usual care and about 30 percent of those who were given an educational information sheet about disposal self-reported having disposed of unused opioids, compared with about 60 percent of those who were given an activated charcoal in-home disposal bag (Brummett et al., 2019).² Similar results were found by other RCTs testing postsurgical provision of in-home disposal systems. In a study of pediatric patients, Lawrence and colleagues (2019) found that about 72 percent of parents provided with an in-home disposal bag self-reported disposing of unused opioid versus about 56 percent in the control group. Agarwal and colleagues (2022) found that

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² Patients were given a Deterra Drug Deactivation System. Brummett said he has no financial interest in the Deterra system.

60 percent of patients given in-home disposal bags self-reported having disposed of unused drug versus about 43 percent of those in the control group. However, a study by Bicket and colleagues (2021) found that only 14 percent of participants given an in-home disposal bag reported using it, versus 10 percent of those in the control group. Brummett said a meta-analysis of the RCTs is planned.

Brummett and colleagues are working to understand why people do or do not dispose of unused opioids. In a survey by the National Poll on Healthy Aging, 86 percent of respondents ages 50 to 80 said they saved leftover opioids for later use. Nine percent said they disposed of them in the trash or by flushing, and 13 percent brought them to a take-back location (Harbaugh et al., 2020). Brummett said that early on, “about 80 percent of the safe disposal sites in the state of Michigan were [at] law enforcement [facilities].” Anecdotally, people have reported not wanting to take unused medications to a police station, and some have gone but left without leaving their medications, saying they felt like a criminal, Brummett said.

Studies have also assessed the impact of financial incentives on disposal behavior. In one qualitative study, responses indicated that convenience had a greater influence than financial incentives on willingness to dispose (Draper et al., 2022). Brummett summarized that “making it easy … less than 5 minutes to do it, was more important than giving people $50.”

The qualitative study by Draper and colleagues and another by Huang and colleagues looked at facilitators and barriers of disposal, and Brummett summarized themes from the findings (Draper et al., 2022; Huang et al., 2023). Facilitators identified included “convenience; financial incentives; safety of family members; moral beliefs; risk of addiction; risk of theft; [and] risk of environmental harms.” Barriers identified included “lack of awareness; less convenient method or process; smaller financial incentive; anticipation of future pain; perception of opioid scarcity; desire to misuse opioids; low perceived risk; [and] breakdown of patient/provider relationship.”

Further studies are needed, Brummett said, to identify effective disposal tools and effective ways to influence or incentivize disposal behavior, and he suggested looking to the field of behavioral economics.

Resources and Initiatives from a Community Network

In closing, Brummett referred participants to Michigan’s OPEN initiative, which has educational resources that are free to anyone, including materials about the safe disposal of opioids, sharps, and liquids.³ OPEN

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³ See https://michigan-open.org (accessed November 18, 2023).

will also insert a practice’s or health system’s logo on the front page of the materials for their use, and Brummett said there are “several hundred health systems around the country using our materials.” There is a toolkit for setting up a local opioid take-back event and a guide for implementing a permanent disposal box, and OPEN staff are available to provide guidance and support.

In addition to safe disposal, OPEN is working to promote appropriate opioid prescribing while ensuring pain management needs are met for surgical, dental, and emergency medicine patients. Other initiatives focus on ethical approaches to screening patients for substance use disorders and transitioning patients to care; statewide distribution of naloxone; provider, patient, and community education; and informing policy making.

REAL-WORLD EXPERIENCE

Following the presentation, Brummett was joined by five panelists for a discussion of the issues surrounding the implementation and use of in-home opioid disposal systems in real-world settings. Panelists included Tamar Krishnamurti, assistant professor of medicine and clinical and translational science in the Department of Medicine Center for Research on Health Care at the University of Pittsburgh; Eleanor T. Lewis, deputy director of the Program Evaluation and Resource Center at the U.S. Department of Veterans Affairs (VA); Kevin Nicholson, vice president of public policy, regulatory, and legal affairs at the National Association of Chain Drug Stores (NACDS); James Shamp, vice president for data intelligence and program analytics at United BioSource LLC; and CDR Andrea Tsatoke, injury prevention specialist, IHS Headquarters. The discussion was moderated by Mark Bicket, assistant professor, director, pain & opioid research, Department of Anesthesiology, Institute for Healthcare Policy and Innovation at the University of Michigan Medical School.

Providing Multiple Opioid Disposal Options to Meet Patient Needs

Nicholson shared the retail pharmacy perspective on disposal of unused opioids, speaking on behalf of NACDS. “Providing the public with numerous disposal options can help to reduce the unused opioid medications that might otherwise sit in the patient’s medicine cabinet,” Nicholson said. He described the recent REMS modification on mail-back envelopes as “a good first step in improving access to drug disposal tools” and said NACDS “encourage[s] FDA to further leverage its REMS authorities to expand drug disposal offerings available to the public to include in-home disposal systems.” Brummett agreed and said, “Multiple options are critical.”

and liquid medication. This in-home disposal option was believed to have complemented other approaches being implemented and evaluated (e.g., secure collection sites and medication lockboxes for safe in-home storage).

REMS Implementation Challenges

Shamp discussed what he said are the two biggest challenges for implementation of a modified REMS, communicating the changes and motivating the desired behaviors. He explained that REMS communication plans have not changed since FDA was first granted REMS authority in 2007. REMS requirements are disseminated via email and U.S. mail, and through outreach to professional societies. Based on his nearly two decades of experience in REMS design and implementation, he said that “that type of communication does not work,” and letters frequently go unopened. Clinicians now consume information on smart phones and devices, he said. Communication methods to reach patients must consider the intended audience, he said. For example, he said his 80-year-old mother and his 34-year-old son would both need to receive the same information, but the method would need to be tailored to how they consume information, which is quite different. For all audiences, communications need to be timely and meaningful to recipients, providing specific information so they understand what actions need to be taken, Shamp said.

With regard to motivating prescribers in response to REMS communications, Shamp said, “You typically do not get the behavior you are expecting until it is absolutely necessary, until someone hits a pain point.” As an example, he said that providers must become certified and enrolled to prescribe a drug with a REMS. In his experience, he said providers generally do not take these steps until a patient presents in the office in need of the drug. The challenge is how to motivate the necessary prescriber actions before the patient is in need.

There can also be patient requirements in REMS. For example, Shamp said some REMS require that patients have laboratory tests done before receiving a prescription for the drug, as well as after completion of treatment. In such cases, the motivation to have the testing done before prescribing is high. But there is no motivation to do the posttreatment testing, he said, and there can be disincentives, such as co-payments or the need to take action such as driving to the testing site. The challenge for opioids is also motivating patients to take an action after completion of treatment (in this case, destroying the drug).

Lewis also discussed the need to motivate patients to dispose, whether using existing options or increasing the number of options available to

them.⁴ She said that “even when patients are motivated to dispose of extra medications, there may be barriers to engaging in safe disposal using the primary available options.” As discussed, people retain unused opioids for a host of reasons, from the sense of security they get from having the drug “just in case,” to practical reasons such as the inconvenience or inaccessibility of a prescriber or a pharmacy, or the cost of a refill.

Shamp added that a key element of REMS implementation is assessment of the efficacy of the mitigation, and it will be necessary to determine how to measure whether in-home disposal systems are effective.

Elements of Effective Consumer Communications

Krishnamurti discussed developing effective consumer communications on safe and effective use of in-home disposal systems from a behavioral science perspective. As has been mentioned, “communications need to be both accessible and actionable,” she said. They need to first reach the target audience, and then provide the information needed for making decisions and taking action. Actionable messaging must consider the different ways people will perceive the risks and benefits of acting given their situation (e.g., perceptions of the risks and benefits of retaining unused opioids by someone who has had oral surgery will likely differ from those of someone who has cancer).

Explaining why specific actions are recommended is also important. To illustrate, Krishnamurti shared an anecdote in which she asked three people why mixing pills into kitty litter was recommended prior to discarding. Responses were (1) as a deterrent to those who might ingest them, (2) to neutralize environmental impacts when disposed, and (3) to mask them in the trash. If the person who thought it was a neutralizer does not happen to have kitty litter, that person might decide to retain the opioids, not knowing of any alternative substance to use. The person who thought it was to mask appearance might use a similar substance that achieves the same masking result. “If someone is just not sure why they are being asked to do something, the easiest thing is to do nothing at all,” she said.

Information communicated should be clear and concise and be delivered by a trusted source, Krishnamurti continued. She noted that doctors are generally a trusted source, but as discussed, patients can be overwhelmed with the volume of information they receive in a health care encounter, even more so when under the stress of discussing a serious health situation. She also highlighted the need to be transparent about any uncertainties regarding the interventions being implemented. Public

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⁴ Lewis spoke from her own experience and did not speak on behalf of the VA.

trust can be undermined by contradictory messaging and presentation of uncertain information as fact, she said.

When developing and framing communications, Krishnamurti said it can be very valuable to have a trusted source ask people about their experiences. This can help to expose logistical and psychosocial barriers to action that people might be facing (e.g., feeling stigmatized when attempting to dispose of medications at a police station). Interdisciplinary teams are also essential when developing communications and other behavioral interventions, she said. People with relevant experience should be included on teams from the start to help shape the questions to be asked and to identify needs.

Finally, and perhaps most importantly, Krishnamurti said that “any intervention or any communication has to be pretested, often iteratively, before there is any kind of wide scale roll-out.” Testing need not be lengthy, complex, or expensive, she noted. Her research has shown how messages that experts think are obvious and clear might not be interpreted in the same way by non-experts (e.g., there are some perceptions that “FDA approved” means the agency recommends the product). She suggested that systematic pretesting of communications about REMS modifications should be required.

Motivating Disposal Behavior

A theme throughout the discussion of how to motivate people to dispose of unused opioids was the importance of making disposal easy. Brummett said studies and anecdotal reports suggest that “making something in-home and easy just seems to be the strongest and most important factor.” Shamp concurred and noted the need to communicate to patients that disposal is easy. He added that making the process simple applies to motivating prescriber behavior as well. For example, there has been broad adoption of online registration for REMS prescriber certification versus the old method of filling out a paper form and faxing it. For online registration, prescribers enter their national provider identifier (NPI) and the webform is automatically populated with information from the NPI registry. Tsatoke agreed that ease of disposal is very important and said that disposal behavior in rural communities can be impacted by transportation-related issues. For the pilot study she discussed, having a community health representative visit patients at home and show them how to use the disposal bag made it very easy. She added that messaging about disposal should be tailored to the population (e.g., presented in Tribal languages with culturally appropriate graphics). Krishnamurti agreed and said the focus has been on the patient, but it is also important to consider the larger context, specifically opportunities for social support

and how the role of a patient’s support circle in motivating disposal might be made easier.

Lewis said that education is another key component in increasing motivation to dispose. This includes raising awareness about the potential for misuse and diversion of unused opioids and highlighting the community benefit aspect of safe disposal. She pointed out that there can be “more than just one lever” to increase motivation and highlighted the need for a toolkit of strategies to motivate disposal behaviors.

Near-Term Actions

Panelists discussed near-term actions that could make an impact now, while longer-term strategies are developed (i.e., not letting the perfect be the enemy of the good), and opportunities for evaluating interventions.

Nicholson reiterated the opinion of NACDS that the best short-term solution is having a variety of disposal options available to consumers and providing education about those options, particularly how and why to use them. He observed that uptake of some options is better than others and perhaps real-world testing of what solutions consumers prefer could be done. He referred to the Iowa program again as a model as it provided financial motivation not only for patients (free disposal systems) but also for pharmacies (reimbursement for disposal systems and patient education services).

Brummett said the RCTs he discussed showed about 60 percent uptake of a provided in-home disposal kit (somewhat higher in the pediatric study), which was a positive finding versus controls, but also shows there are opportunities for improvement. He proposed studying how best to “nudge people into higher compliance” and identifying the many touchpoints in the health system where information about opioid disposal could be imparted (e.g., following surgery). He said many programs are already in place in which opioid disposal options are being promoted or dispensed and that these could be leveraged for studies in the shorter term. He suggested that studies could be done by overlaying randomization with regard to type of intervention or behavioral nudge used to better understand what motivates uptake and use in the intended population (i.e., not in patients prescribed opioids for chronic pain management). Participants and panelists discussed that RCTs comparing uptake of mail-back envelopes to other disposal options, including in-home disposal systems, would be informative for FDA.

Lewis agreed that there are many touchpoints in the course of patient care that could be leveraged to evaluate how a particular intervention might improve uptake of opioid disposal (e.g., does discussion of opioid disposal options during post discharge follow-up increase the likelihood

of disposal?). She also highlighted the need to “be attentive to potential unintended outcomes” when implementing and evaluating an intervention. As an example, Lewis said the VA has implemented a requirement for a risk review when prescribing an opioid to an opioid-naïve patient for more than a 5-day supply of an opioid. “Knowing that they will have to do a risk review if they prescribe more than 5 days has vastly decreased the number of prescriptions that are more than 5 days,” she said.

Krishnamurti said there are multiple touchpoints in the health care system following a procedure for which a patient is prescribed an opioid that present opportunities for communication about in-home disposal (e.g., interactions with prescribing physicians, pharmacists, physical therapists, home health aides conducting follow-up visits). “Some of those touchpoints are going to be more effective than others, but just pairing that behavior with something that is going to happen anyway is going to be a high-yield opportunity,” she said. Discharge nurses are an example of a trusted follow-up touchpoint, observed Brummett. He suggested that providing a disposal system and associated education might be more readily protocolized as part of the work of the discharge nurse or the pharmacist dispensing the opioid, or possibly included in a postoperative phone call. Nicholson raised the issue of whether an ICD-10 code would be needed for protocolization of these services. Lewis said, “The VA has 139 different health care systems” and is a ready partner for research and evaluation on this issue.

Tsatoke reiterated that the community health representatives in Tribal communities are trusted touchpoints in the spectrum of health services. They conduct follow-up visits as well as many other health-related activities (e.g., helping to correctly install a car seat). This presents near-term opportunities to work with partners to implement pilot programs encouraging opioid disposal. For example, in-home disposal systems could be distributed through Tribal behavioral health programs that work with parents and caregivers of teens at high risk for misuse of opioids. Tsatoke encouraged participants to engage Tribal representatives as partners in these initiatives and in discussions of resources.

Nicholson said there are examples of pharmacies partnering with community organizations to implement a drug disposal kiosk in the pharmacy. Funding from states and from manufacturer product stewardship programs can also support pharmacies in providing patient education about opioid disposal. Nicholson also highlighted the need to engage health plans and payers as they could have a role in changing patient behavior by providing reimbursement to prescribers and dispensers for services related to educating patients about opioids.

Shamp pointed out that developing a REMS modification is generally not a simple task, and implementation and evaluation occurs over the

longer term. Shamp also suggested partnering with payers as they have information on who has been prescribed opioids. As another near-term action, payers could text these patients at regular intervals to remind them of how they can dispose of any unused opioids from their prescription. As discussed, it can be very difficult for patients to find useful information about disposal, and this would be one way to make disposal easy.

Sharon Wrona, a pediatric nurse practitioner, said there is a need for educational materials that are targeted to families. She referred participants to a video about home opioid safety from Nationwide Children’s Hospital that is shown on their inpatient video system and that they share nationally through the GetWellNetwork.