News & Media

FDA Opioid Mail-Back Proposal, if Expanded, Presents an Opportunity to More Effectively Combat Drug Diversion.

July 21, 2022

A recent Request for Comments from the FDA seeks input on a proposal to require that mail-back envelopes for returning unused drugs be provided with opioids dispensed in an outpatient setting.

While takeback systems, in any form, are important because they decrease the potential for diversion of unused prescription drugs, new takeback technology is being developed that is safer, less burdensome, and provides valuable data for prescribers and health systems that will help reduce overprescribing of dangerous drugs in the first place.

The FDA proposal should be expanded to encourage these intelligent takeback alternatives that render dangerous drugs non-retrievable at the beginning of the takeback process, rather than at the end, thereby eliminating many opportunities for theft and diversion.

The President’s Commission on Combating Drug Addiction and the Opioid Crisis, chaired by Governor Christie, recommended expanded collection of unused drugs in healthcare facilities, retail pharmacies and community settings. Specifically, the Commission noted:

“There is an opportunity to increase efforts by encouraging hospitals/clinics with onsite pharmacies and retail pharmacies to become authorized collectors. Authorized collectors provide a year-round opportunity for the public to properly dispose of their unused prescriptions. Onsite and retail pharmacies have a tremendous opportunity to aid increasing collection rates by considering incentivizing the public to drop off their unneeded prescriptions by offering store rebates.”

The Commission also recommended increased data collection regarding opioid overprescription and diversion:

“The Commission recommends that the FDA establish guidelines for post-market surveillance related to diversion, addition, and other adverse consequences of controlled substances. … The Commission recommends a federal effort to strengthen data collection activities enabling real-time surveillance of the opioid crisis at the national, state, local and tribal levels.”

Evaluating the FDA’s mail-back proposal in the context of the Commission’s recommendations, it becomes clear that proposed mail-back envelope system has several shortcomings that could be addressed through use of intelligent takeback systems:

  • It is challenging, if not impossible, to assess the effectiveness of a mail-back envelope program because under current DEA regulations, mail-back envelopes cannot be opened prior to destruction. Therefore, there is no way to determine how many pills are being disposed of in each prescription, let alone whether the disposed drug is even an opioid.
  • Similarities between mail-back envelopes will become obvious to potential diverters, even though the envelopes are required by the DEA to be nondescript.
  • Increased numbers of prescription opioids in the mail will increase opportunities for diversion and add to the ongoing risk of mail theft and even the potential for violence against USPS workers.
  • Mail-back envelopes create additional environmental impacts.

To address these concerns, and accelerate deployment of intelligent takeback systems, it is recommended that the FDA identify the preferred takeback method as one including the following characteristics:

  • The drug being disposed of is rendered non-retrievable as early as possible in the takeback process.
  • The system provides an incentive, like a small financial reward or charitable donation, when unused drugs are returned.
  • Data is compliantly compiled for use by prescribers, health systems and public health researchers to reduce opioid overprescribing.
  • Environmental impact is minimized.

Although mail-back envelopes would provide a route for some patients to dispose of unused drugs, a widespread mail-back program would also create risks. An intelligent takeback system would mitigate those risks, reduce diversion, and help prevent overprescription.