From Our Perspective: CDER’s Efforts to Expand Opioid Disposal Options
By: Marta Sokolowska, Ph.D., CDER Deputy Center Director for Substance Use and Behavioral Health
FDA is taking important measures to help patients remove unused opioids from their homes as one component of our multi-pronged efforts to address the overdose crisis.
The overdose crisis remains one of the most devastating public health epidemics to affect our country. Based on provisional Centers for Disease Control and Prevention (CDC) data, approximately 110,000 overdose deaths occurred in 2022, most of which involved opioids. The 2021 National Survey on Drug Use and Health estimates that 8.7 million people aged 12 or older misused prescription pain relievers in 2021. Furthermore, a recent study showed that opioids were the most common substances contributing to fatal poisoning among young children.
FDA’s Overdose Prevention Framework, launched in August 2022, aligns with the National Drug Control Strategy (NDCS) and the HHS Overdose Prevention Strategy. Under the framework’s “primary prevention” priority, we are taking a comprehensive approach to eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing. We are working to limit unnecessary opioid dispensing, such as by requiring safety labeling changes to encourage safer use of opioids and supporting development of clinical practice guidelines for acute pain indications.
Even with these efforts, there are large quantities of unused opioids that need to be safely disposed. In a recent systematic literature review examining patient-reported opioid analgesic use after surgical procedures, most studies reported 50 to 70 percent of tablets went unused. Accordingly, we are focused on removing unused opioids from patients’ homes. To do so, we must address patients’ needs and understand what makes people more or less likely to dispose of these medications. Thus, we are striving to provide diverse options for disposal and ensure equitable access for patients, pharmacies, and communities.
Ensuring different government agencies provide consistent guidance for the safe disposal of unused prescription drugs is specifically stated in the NDCS. As such, FDA is collaborating across governmental agencies, including with the CDC, the United States Postal Service, the Drug Enforcement Administration (DEA), and the Environmental Protection Agency, on this effort. It is our shared responsibility to address the significant risks of nonmedical use, accidental exposure, overdose, and death associated with unused opioids in patients’ homes.
Mail-back envelopes and in-home disposal options
Disposal options include the DEA’s National Prescription Drug Take Back Days, as well as collection kiosks in selected outpatient pharmacies and other locations. However, patients also need options that do not require them to leave their homes or hold onto unused opioids while waiting for the next take-back day. In-home disposal options include flushing; mixing opioids with unpalatable substances and disposing them in the trash; using commercially available in-home disposal products and disposing them in the trash; and having patients put unused opioids in mail-back envelopes that are transported to a facility for incineration (a waste treatment process that involves burning).
In April 2022, FDA sought public comment on a potential modification of the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) to require pharmacies and other dispensers to make prepaid mail-back envelopes available to patients. And this April, we announced that we are moving forward with this proposal.
However, we have heard feedback that many patients and health care providers prefer in-home disposal products disposed of in household waste to mail-back envelopes because the former are easier to use, less expensive, and less subject to diversion (i.e., theft). Furthermore, retail pharmacies have told FDA that patients are familiar with using in-home disposal products and appreciate receiving these products with their medications. Rural and tribal communities also raised concerns over limited access to the postal service for patients living in these communities, which would limit the use of mail-back envelopes.
Gathering scientific input and public feedback
To advance the conversation on ways to remove unused opioids from patients’ homes, FDA is participating in a workshop, Defining and Evaluating In-Home Drug Disposal Systems for Opioid Analgesics, convened by the National Academies of Sciences, Engineering, and Medicine. We also issued a Federal Register notice to seek information and public comments to help our assessment of in-home disposal methods. For more information and to submit comments, please refer to https://www.regulations.gov and docket number FDA-2023-N-0917. The docket will be open until Aug. 28.
At this time, we have not decided whether to expand the REMS to include in-home disposal products. We hope the workshop and request for comments will further inform us of the scientific and policy considerations surrounding potential in-home disposal product requirements. We are particularly interested in patients’ and healthcare providers’ beliefs and perceptions around in-home disposal products, including those related to the ease of use and environmental impact, especially since these beliefs and perceptions can impact willingness to use these products.
Ultimately, maintaining the status quo is not an option. We will continue to explore additional disposal options so that disposal is an easy, safe, and secure choice when patients need to remove unused and unwanted opioids. Together, we can save more lives by increasing disposal of unused opioids and reducing the risks of preventable exposure.