On Monday, the FDA announced a change to the REMS for opioids to include a requirement “to make prepaid mail‑back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients.”  As part of the new, revised REMS requirement, “all manufacturers of opioid analgesics used in outpatient settings are required to submit the proposed modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) within 180 days of the date of the notification letter.  The agency anticipates approval of the modified REMS in 2024.”  The notice further states that “[W]hen implemented, outpatient pharmacies and other dispensers will have the option to order prepaid mail‑back envelopes from opioid analgesic manufacturers, which they may then provide to patients prescribed opioid analgesics.”  The announcement also mentioned that additional educational materials will be developed on safe disposal of opioids; these materials will be sent to pharmacies for distribution to patients receiving opioid prescriptions.

For more information on the REMS program and the revised aspects, click here.  Also, see the April 21st Federal Register notice that asked for comments on the proposal here.

Well, this sounds like a fine idea!  Having more options for properly disposing of unused opioids through take‑back programs and proper disposal… what could go wrong?  First, let me say that I believe this program will, in some way, help the opioid epidemic facing this country.  However, recent announcements by the U.S. Postal Service, which I found in a Yahoo news article (here), highlight an issue that could throw a monkey wrench into the program, which I fear could make mail theft, not only from your unlocked mailboxes but also from the infamous and ubiquitous U.S. Postal Service’s big blue mailboxes, more alluring.  We’ve been warned that thieves are rifling through our mail, not only trying to steal our identities but to wash our checks and cash them; now, throw into the mix junkies and pushers, along with common criminals, looking to make a drug score.  The Yahoo article cited above notes, “‘The biggest variable enticing these criminals to steal are customers depositing mail into blue collection boxes after the last collection of the day or during Sundays and Federal holidays,’ USPS said in a release.  ‘If customers simply used retail service or inside wall drop slots to send their U.S. Mail, instead of depositing it to sit outside overnight or through the weekend, blue collection boxes would not be as enticing after business hours to mail thieves for identity theft and check-washing schemes.’”

Now, with an ever‑enticing chance of finding narcotics in mail‑back envelopes, we could see an increase in the amount of fishing (using rope with tape or some other sticky substance to fish out a thief’s ransom) from the big blue boxes or even in raiding your unlocked mailbox to steal goodies while the mail is awaiting the postman’s pick up.  Hopefully, the return envelopes will be plain and nondescript, with no indication of what the contents might be, but once the process starts, there had better be some good eyes on what’s happening so the law of unintended consequences doesn’t rear its ugly head.  And that’s today’s thought, which should keep the DEA, local police departments, mothers and fathers, as well as the Postal Service, up at night.  Boy, do I hope I’m wrong, but I’ve been watching the war on drugs for a long time and it really seems like we’re still losing.