Mandate would undermine at-home disposal solution and education programs of pharmacies and other providers already in place across the nation
SANFORD, NC – June 16, 2022 – In response to the United States Food and Drug Administration’s (FDA) call for public comment on the potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy, DisposeRx, Inc. offered a thoughtful review of concerns to the FDA via public submission.
The change would mandate that mail-back envelopes be dispensed and education on safe disposal provided with opioid prescriptions in an outpatient setting–suggesting that patients mail back their excess opioid medications under a confusing, costly and burdensome process.
“For pharmacies this proposed mandate would undermine the critical progress made with current at-home disposal solution and education programs such as our vast network of more than 35,000 pharmacies and many hospitals and health plans across the country,” said William Simpson, DisposeRx president and chief executive officer.
The disruption to pharmacies with established programs would be significant–requiring retraining of pharmacists and pharmacy technicians and altering their workflow. Moreover, the United States Drug Enforcement Administration (DEA) has raised serious concerns about this approach due to the risks of diversion associated with mail-back programs.
At-home medication disposal packets and accompanying education for patients are effective as evidenced by recent peer-reviewed studies published in the JAMA Network Open by researchers at Penn Medicine and the Journal of the Pediatric Orthopaedic Society of North America by researchers at Shriners Hospitals for Children.
While DisposeRx agrees with the DEA concerns and the FDA recommendation to use all of the tools in the disposal tool kit, we respectfully request the FDA abandon the mail-back mandate consideration and continue to allow proven at-home disposal options that are manufactured in the United States, such as DisposeRx.
Given the potential disruption to pharmacies and existing opioid stewardship programs across the nation, we encourage others to communicate their concerns before the June 21 public comment deadline.
About DisposeRx Packets
DisposeRx at-home medication disposal packets are comprised of materials that are FDA-approved for oral medications and provide a simple, convenient and effective solution for the disposal of unused or expired medications. The active ingredient in the medication is chemically and physically sequestered in a polymer gel when water and the DisposeRx powder are added to a prescription vial and shaken. Patients can use the patented product with pills, tablets, capsules, liquids and powders and can then throw away the vial in the household trash.
About DisposeRx, Inc.
North Carolina-based DisposeRx, Inc. is dedicated to decreasing the risks of drug diversion, overdoses, suicides, accidental poisonings and antibiotic resistance by facilitating medication safety behavior change and eradicating the misuse of leftover medications. DisposeRx’s market-leading, patented medication disposal packets and education programs are currently available at 60% of retail pharmacies, 90% of wholesale distributors, and through health plans and provider organizations across the U.S. The company has donated more than 750,000 packets to approximately 450 community non-profits since 2018. For more information, visit DisposeRx.