Return to Sender: WIll Anyone Use FDA’s New Opioid Mail-Back Program?
/By Crystal Lindell
The DEA has been hosting drug “Take Back Days” for over a decade, collecting over 9,200 tons of unwanted or expired prescriptions and over-the-counter medicines. The take-back program is seen as a key effort to prevent drug diversion and opioid addiction.
Now the Food and Drug Administration is expanding its own drug collection program – essentially making every day an opioid take-back day.
Starting on March 31, 2025, drug makers participating in the FDA’s Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) – which means every company that makes and sells opioids – will be required to provide pre-paid, drug mail-back envelopes “upon request” to pharmacies that dispense opioids. The pharmacies then have to give the envelopes to patients and caregivers who ask for them, so they can mail back any unwanted opioids.
The fact that both pharmacies and patients have to request these envelopes makes me skeptical about how much this program will actually be used.
The press release from the FDA includes a quote that sounds surprisingly pro-patient though. So even if the program doesn’t have a high use-rate, perhaps an extra measure of safety will make it easier for patients to get opioid prescriptions.
“We want to ensure patients have access to opioid analgesics in their pain management regimens and that they are educated about methods available to safely dispose of any leftover medicines, which could pose a real danger to their loved ones and pets,” said Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health at the FDA Center for Drug Evaluation and Research.
It’s the part about ensuring that “patients have access to opioid analgesics” that stands out to me. Patients certainly need access to opioid pain meds. And if programs like this help doctors and medical professionals feel more comfortable prescribing opioids, then I fully support them.
But I’m skeptical about whether that will be the actual outcome. The real question is whether anyone will use the mail-back program.
The DEA has never released a full breakdown of the medications returned during its drug take-back days. But an analysis of the drugs returned at a take-back day in Lansing, Michigan in 2013 provides some insight.
Of the nearly 2,500 medication containers that were returned, only 304 were for a controlled substance like opioids – about 12% overall. The most common types of medication returned were for pain/spasm, cardiovascular, and mental health conditions.
While hydrocodone/acetaminophen combinations (Norco) were the most returned medication at that 2013 event, it represented just 4.4% of all returned containers.
The second most-common drug returned was ibuprofen (Advil) in 2.2% of the containers. Acetaminophen (1.7%) and aspirin (1.3%) also made the top ten list of most-returned medications.
Something tells me that Advil isn’t what organizers had in mind when they asked people to bring in their unused drugs.
In the end, the FDA’s new mail-back program will likely have a greater impact as a public relations initiative to make the agency look good, rather than keeping unwanted opioids off the street.
In a world where doctors are so reluctant to prescribe opioids, I don’t blame people for wanting to hold on to the opioids they’re able to get. In a PNN survey of thousands of pain patients, nearly a third (32%) admitted hoarding their unused opioids because they’re unsure if they’ll be able to get them in the future
If we’re lucky, the program will accomplish at least one of the goals that the FDA’s Sokolowska laid out: “We want to ensure patients have access to opioid analgesics.”
Given the federal government's abysmal track record with opioids and pain care in general, I’ll believe that when I see it.
