FDA May Require Opioids to be Dispensed with Mail-Back Envelopes and Related Patient Education

The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back envelopes. Pharmacists would also be required to educate patients on the safe disposal of opioids. The requirement would apply to all OAs, including immediate, extended and long-acting formulations. The Notice can be found here. Comments are due by June 21, 2022.

Per the FDA, the suggested change is due to patients commonly reporting they have unused opioid analgesics following surgical procedures leading to possible nonmedical use, accidental exposure, and overdose. The FDA noted that most people reporting nonmedical use of prescription pain relievers obtained those unused prescriptions via friends, relatives, or their own prescriptions. The FDA hopes that proper disposal of unused opioid analgesics will reduce the amount of unused opioid analgesics in patients' homes.

Current disposal methods include 1) in-home disposal options by way of flushing or commercial disposal products; or, 2) disposal methods outside of the home by way of collection kiosks and takeback events. These options come with certain challenges and patients may not utilize them, leading the FDA to propose this change.

The FDA recognizes not all patients may benefit or utilize mail-back envelopes, but by providing another option for disposal of unused opioids it gives patients another tool in their chest for safe disposal of unused prescriptions, particularly because mail-back envelopes may pose fewer obstacles for many patients. Furthermore, the notice also states the FDA is actively encouraging drug manufacturers and others to innovate in this space.

The FDA does acknowledge mail-back envelopes would pose burdens on pharmacists and pharmacies. These burdens include 1) Risk Evaluation and Mitigation Strategy (REMS) training and certification; 2) implementation of complaint processes; and 3) documentation of compliance.

The FDA proposes two possible methods regarding how the mail-back envelope REMS requirement could be operationalized, and requests comments on possible alternative methods. The first method would require drug manufacturers subject to OA REMS to provide mail-back envelopes to outpatient pharmacies at no cost and create educational materials to assist pharmacists in counseling patients on safe storage and proper disposal of prescriptions. The pharmacies would then provide the mail-back envelopes and educational materials to patients based on their own policy and procedures.

The second method would require manufacturers to only distribute opioids to outpatient pharmacies certified in the REMS. Certification would require that mail-back envelopes, patient counseling, take-home materials, and follow-up reminders be provided according to the terms of the REMS. Thus, these activities would be required, and not dependent on certain pharmacy's policies and procedures. It would also require pharmacies to appropriately document these activities. Certification of pharmacies could include requiring pharmacy staff to complete specified training on how to counsel patients on safe storage and proper disposal. Similar to the first method, manufacturers would provide mail-back envelopes to outpatient pharmacies at no cost and create educational materials.

The proposed programs leave a considerable number of questions left open including:

• Will pharmacies choose not to dispense opioids to avoid the additional cost and time required for this program, reducing availability of legitimately prescribed opioids?
• Where do the drugs go to when mailed?
• Who pays for the drug disposal?
• Could these programs increase theft from the post office?
• Could these programs potentially contaminate other mailed drugs?

The FDA's authority stems from Section 3032 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), which provides the FDA with new authorities to address the opioid crisis. The notice states this is just one possible application of FDA’s new authorities.

The notice requests additional comments related to:

• The advantages and public health impacts of providing mail-back envelopes.
• Whether specific OA products would benefit more from a mail-back envelope requirement.
• How pharmacies can identify patients who are most likely to have unused opioids.
• How pharmacies could develop algorithms to determine when to provide a mail-back envelope.
• Whether a mail-back program should include requirements for patient counseling.
• What key educational messages regarding secure storage and safe disposal should be included in the patient education component.
• How a mail-back envelope requirement could be designed and implemented to help ensure that the disposal requirement minimizes the burden on pharmacies.
• Possible challenges, including technical and logistical challenges.
• The impact of a mail-back envelope REMS requirement on other stakeholders.
• How a mail-back envelope REMS requirement could be designed and operationalized.
• Possible negative impacts of a potential mail-back envelope REMS mandate.
• How manufacturers and the FDA could best assess the effectiveness of a mail-back envelope OA REMS requirement.
• How patients and others may perceive the environmental impact of a potential mail-back envelope requirement.
• Any existing programs that provide mail-back envelopes.
• Comment on other possible uses of the agency's REMS authority concerning disposal.
• Other actions the FDA could take in addition to, and in support of, a mail-back envelope disposal REMS requirement to increase the safe disposal of unused opioid analgesics.

If you have specific inquiries regarding comment submission on the possible opioid mail-back envelope and patient education change, please contact your local Quarles & Brady attorney, or:

• Susan Brichler Trujillo: (602) 229-5318 / susan.trujillo@quarles.com
• Shaylynn L. Veeder: (602) 229-5608 / shaylynn.veeder@quarles.com