ABSTRACT
The opioid epidemic is a public health emergency, and 91% of misused opioids originate from provider
prescriptions. Left-over post-operative opioids are a major source of misuse and diversion: 70% of pills
prescribed go unused, but only 9% are disposed appropriately. Interventions to date have focused on limiting
prescription duration, implementing prescription guidelines, and strategies to promote disposal of unused pills.
These piecemeal approaches have shown mixed efficacy in studies and clinical practice and are insufficient in
isolation. A more all-encompassing solution would ideally limit prescription size, securely store pills, provide
guidance on safe opioid use and tapering, and offer an easy method for unused pill disposal to prevent diversion.
In partnership with Addinex Tech, we have developed a novel pill-dispensing system (PDS) for post-operative
opioid use, centered around an inexpensive, password-protected device. The mechanical device is associated
with a smartphone application (app) that provides patients with one-time passwords to dispense opioid tablets
from the device as needed, on a prescriber-defined schedule. The app also provides clinical guidance for pain
management based on patient-reported pain levels and suggests opioid tapering strategies when indicated.
When patients no longer require opioids for pain, the device can be mailed in a prepaid envelope for disposal.
In a pilot study of 30 patients who underwent major cancer-related surgery, 24 (80%) returned the device. Out
of 567 total opioid pills prescribed, 397 (70%) went unused, and 332 (84%) of those were disposed of by mail.
Building off these encouraging results, and in response to Program Announcement (PA-21-110) we propose a
prospective cohort study of this technology in 140 patients who undergo major cancer-related surgery. Since our
pilot study, we have expanded the reach of our PDS: the app is now supported by multiple operating systems
and is available in Spanish. These improvements will enable the enrollment of a more diverse patient cohort and
will increase the generalizability of the findings. We will assess rates of device return and unused pill disposal,
as well as the impact of the PDS on reducing opioid consumption and refills. We will concomitantly evaluate the
PDS from the patient perspective, in terms of pain control quality, implementation science measures of
acceptability, and qualitative measures of patient satisfaction. Our cost-effective PDS has the potential to
meaningfully reduce post-operative opioid misuse and diversion while preserving pain control. The results of this
study will inform a large, randomized trial of our system.
