June 21, 2022
National Center for Health Research’s Public Comment on Providing Mail-Back Envelopes and Education on Safe Disposal With Opioid Analgesics Dispensed in an Outpatient Setting
We are writing to express our views on a potential modification to the Opioid REMS, which would require that mail-back envelopes and education on safe disposal be provided with opioid analgesics dispensed in outpatient settings.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
We commend FDA’s efforts to address the opioid crisis by modifying the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS). We agree that although opioid prescriptions are decreasing, there are still too many prescriptions provided to patients each year, and that many of the pills prescribed are not used for the intended medical purpose. In 2020 alone, there were 142 million opioid prescriptions written for patients in the US.[1] Many studies indicate that between 50-70% of those opioid prescriptions are not used for the intended medical purpose, which provides a significant opportunity for abuse by the patient, family members, or others. As of 2020, prescription opioids were involved in more than 16,000 fatal overdoses per year. These harrowing statistics highlight the need to safely dispose of unused opioid medications that could provide opportunities for nonmedical use, accidental exposure, and/or overdose. Therefore, it is of the utmost importance to keep opioid analgesics out of circulation by making it easier for patients and caregivers to dispose of unused opioids.
In addition to permanent kiosks and take-back events, mail-back envelopes are an important public health strategy to make disposal easy and safe. We agree with FDA’s assessment that mail-back envelopes are currently underutilized, and postage-paid mail-back envelopes would provide a very convenient disposal option for patients and caregivers. A REMS-mandated disposal program for opioid analgesics focused on the provision of mail-back envelopes, together with education on multiple safe disposal options, could enhance important existing opioid disposal programs.
While we agree that these potential modifications are a great step forward in ensuring that unused medications are properly disposed of, overprescribing continues to be a major problem in the U.S. There should be continued efforts to educate physicians and pharmacists on reducing the number of opioids prescribed and providing alternatives to opioid analgesic prescriptions. While we appreciate the FDA’s efforts to increase the safe disposal of opioid analgesics, we also strongly urge the FDA to consider the following strategies:
- Periodic oversight and re-evaluation of the implementation of providing the mail-back envelopes and education materials is necessary to ensure that the program is effective, efficient, and enforced.
- Data indicate which locations are associated with questionable opioid prescriptions and overdoses. Mail-back envelopes and education materials should be especially focused on these centers.
- FDA should do more to discourage flushing as a disposal method. We recognize that the FDA primarily recommends disposing of opioids in permanent collections sites or at take-back events. However, the FDA does recommend flushing if either of these options are not readily available. The potential long-term health effects on our water supply of flushing opioids remain unknown, but are worrisome. Encouraging the use of mail-back envelopes would likely reduce flushing as a disposal method.
- FDA should ensure manufacturers take responsibility for the products they produce by making drug disposal kiosks available in more pharmacies and sponsoring drug “take-back” days.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.
References:
- U.S. Opioid Dispensing Rate Maps. Centers for Disease Control and Prevention. https://www.cdc.gov/drugoverdose/rxrate-maps/index.html. Published November 10, 2021. Accessed June 16, 2022.