Mail carriers could play a key role in reducing opioid misuse, according to researchers and regulators.
One strategy under consideration by the US Food and Drug Administration (FDA) would require that opioid analgesics be dispensed with prepaid mail-back envelopes so patients can return leftover medication.
Another approach — which is not part of the FDA proposal but some researchers believe may be more convenient for patients and better supported by available evidence — involves sending patients at-home disposal kits following surgery.
The kits include a condiment-sized packet of powder that can be added to pill bottles and mixed with water to neutralize leftover medicine before it is thrown away.
Mailing these kits may double the odds of patients getting rid of their unused opioids, according to a study published online May 6 in JAMA Network Open.
“I was pleased to see that such a simple ‘snail mail’ approach could change behavior and promote self-reported disposal,” the study’s lead author, Anish K. Agarwal, MD, MPH, with the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, said in a statement.
Agency Seeking Comments
The FDA announced the potential mail-back envelope mandate in April. The agency is accepting public comments on the proposal until June 21.
Leftover opioids can lead to nonmedical use, accidental exposure, overdose, and new cases of opioid addiction.
“Since many Americans gain access to opioids for the first time through friends or relatives who have unused opioids, requiring a mail-back envelope be provided with each prescription could reduce the amount of unused opioid analgesics in patients’ homes,” according to the agency.
Mail-back envelopes avoid the need to mix substances, and the drugs would be incinerated to keep them from entering the water supply or landfills, where they have been shown to affect wildlife.
Existing policies and regulations ensure that this delivery method is safe and secure, according to the FDA.
The mail-back envelopes would complement existing options, such as flushing, in-home disposal products, collection kiosks, and takeback events.
Agarwal’s study of the in-home disposal approach included 235 patients who were prescribed opioids after orthopedic or urologic procedures. The researchers randomly assigned some participants to receive at-home disposal kits in the mail about 4-7 days after surgery, when patients were likely to have finished taking the medication. The other participants received a text message with a link to nearby disposal locations.
Patients who got the kits were two times more likely than those who got the text to report disposing of their unused opioids (odds ratio, 2.01; 95% CI, 1.2 – 3.4). Of participants who answered all study questions, 42.7% who received a text vs 60% who received a disposal kit reported they had disposed of their extra medicine.
The researchers estimate an additional 480 opioid tablets were disposed of in the disposal-kit group.
“The process of mailing the disposal kit is simple, inexpensive (approximately $1.50 per mailed kit), and scalable,” the study authors write.
“It was an easy solution delivered at the right time,” Agarwal told Medscape Medical News. “I think these FDA mail-back programs are a good alternative but may be perceived as more work for some patients.”
A Stubborn Problem
Lyen C. Huang, MD, MPH, with the University of Utah in Salt Lake City, has studied barriers to having patients dispose of leftover opioids after surgery.
He said he leans toward home disposal kits over other methods.
“When the University of Utah considered the types of mailers proposed by the FDA, we were concerned that the seemingly small inconvenience of mailing something might be enough to keep some people from disposing,” Huang told Medscape. We chose to use a home disposal kit because people could neutralize and dispose safely in the privacy of their home.”
Data on home disposal kits have been mixed, and the studies of the approach so far have been relatively small. Data on mail-back envelopes are lacking, he said.
“Before we commit to the mailers as a requirement, I’d like to see more studies about the effectiveness of the mailers and how they are perceived by patients,” Huang said. “The mailers will work, but will they work as well as the home disposal kits? I don’t know.”
Promising real-world data on home disposal kits may be forthcoming.
“The University of Utah started distributing free home disposal kits to every patient filling an opioid and benzodiazepine prescription in August 2020,” Huang said. “We’ve given out thousands of these and are getting ready to publish our real-world experience. Our intervention has been really effective, but whether these programs can be started and sustained in other health systems remains to be seen.”
Agarwal and colleagues used kits that were donated by DisposeRx, and their research was supported by the FDA. Some authors disclosed ties to federal agencies, nonprofit organizations, and a pharmaceutical company. Huang has disclosed no relevant financial relationships.
JAMA Netw Open. Published online May 6, 2022. Full text