The 2018 SUPPORT for Patients and Communities Act included a provision directing the federal General Accounting Office (GAO) to review and report on ultimate-user options for safe and effective disposal of unused opioids. In 2019, the agency released its report to Congress. One section discussed why “federal agencies recommend take-back options as the preferred disposal method” for unused/unwanted opioids.
The same study also explained that no federal regulatory agency had evaluated the safety and efficacy of any in-home drug disposal product. In fact, the report noted that a lack of reliable testing data from product manufacturers raised “questions about the studies’ conclusions that the products are effective for disposing of opioids.”
Regulatory Involvement of DEA, FDA, and EPA in Ultimate-User Disposal of Opioids
No federal law or regulation specifies how ultimate users should dispose of unused opioids, but there are best practices recommendations. As the GAO study noted, “the DEA, FDA, and EPA all have authorities and initiatives related to patient disposal of opioids.”
DEA regulations support three drug take-back options for ultimate users:
- Drug take-back events: Many communities host semi-annual National Prescription Drug Take-Back Days. The April 25, 2020 event was postponed due to concerns about COVID-19. The next event is currently scheduled for October 24, 2020, but check with your local community collection point.
- Permanent collection sites: In many communities, law enforcement agencies, hospitals, pharmacies, and other locations have secure drug collection kiosks available to the public. Our MedSafe medication collection kiosks are currently located in over 5,000 sites in most states.
- Mailback programs: These offer ultimate users a safe, DEA-compliant way to return unused/unwanted opioids and other drugs from home. For example, ultimate users can use our TakeAway Medication Recovery System envelopes to return non-prescription and prescription drugs (Schedules II-V) through the USPS.
The EPA and FDA drug disposal recommendations differ slightly.
- The FDA notes that medication take-back programs are the preferred option.
- EPA guidelines focus on the potential public health and environmental dangers of flushing drugs. GAO study authors reported, “EPA officials told us that most wastewater treatment facilities are not designed to eliminate opioids from wastewater streams. Further, measurable concentrations of opioids have been reported in surface and ground water sources around the world.”
While individual households aren’t subject to federal regulations, flushing some prescription medications or disposing of them in the trash may violate state or local regulations. For example, several counties in Washington State prohibit it. They initiated county-led drug take-back programs that include collection receptacles and no-cost mailback envelopes.
In-Home Disposal Solutions: Concerns about Safety and Efficacy
In-home drug disposal products, such as chemical decomposition pouches, use proprietary formulations that are supposed to render unused drugs (including opioids) non-retrievable. Users mix their unused drugs with the product and place it in regular household trash. Some pharmacies supply in-home disposal kits to patients at no cost.
There are questions about the products’ effectiveness. In-home disposal of opioids is particularly challenging, according to DEA officials, “because the drugs have a variety of chemical and physical properties and potencies.”
In 2017, Community Environmental Health Strategies, LLC provided a comprehensive review of eight in-home disposal products for the San Francisco Department of the Environment. The GAO study cited that report, noting that it “raised concerns about the credibility of vendors’ evaluations and concluded that additional independent laboratory analysis is needed to fully examine product performance and assess how well these products achieve stated goals.”
GAO study authors also indicated uncertainty about whether in-home disposal products meet the DEA’s standard for destruction. Substances must be rendered non-retrievable, which means that the “physical and chemical conditions of the controlled substance must be permanently altered, thereby rendering the controlled substance unavailable and unusable for all practical purposes.” The study quoted DEA officials, who said that incineration is the only method currently used to meet this standard.
EPA officials expressed concerns about the safety and effectiveness of in-home disposal – both mixing medications with unpalatable substances and in-home disposal products. Although these methods remove the drugs from the home, “the drugs still may be available for misuse. Drugs that are disposed in the trash ultimately are introduced to landfills, where they can escape landfill containment and enter wastewater streams or ground water sources.”
Importance of Ultimate-User Education
Ultimately, it doesn’t matter which disposal methods are considered the safest and most effective if ultimate users don’t use them. Most ultimate users don’t use any federally recommended method for opioid disposal, the study found. The GAO report authors reviewed two studies of in-home disposal products, which found that those who used them were more likely to dispose of their unused opioids. However, the study warned:
“Use of in-home disposal products—which may not be effective at permanently destroying drugs—may deter patients from using federally recommended options, like take-back, that have been proven effective.”
Healthcare providers must take time to educate ultimate users about the most effective medication disposal options available to them. Recent research shows that those who receive education and counseling about the importance of safe disposal of opioids are more likely to use approved disposal methods.
The FDA’s “Remove the Risk” toolkit includes fact sheets and other tools to raise awareness about safe opioid disposal methods.