Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Jul 11, 2023)
Date Submitted: Sep 9, 2022
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Electronic real-time monitoring reveals limited adherence to long-term opioid prescriptions in pain patients.
ABSTRACT
Background:
Pain management physicians are increasingly focused on limiting unnecessary opioid prescribing and reducing harmful use, yet existing tools for monitoring opioid adherence have limited accuracy. Medication event monitoring systems (MEMS), such as “smart bottles”, are an emerging technology for tracking medication usage in real-time, but have not been tested in chronic pain patients on long-term opioid regimens.
Objective:
We conducted a preliminary clinical trial to investigate the utility of MEMS for monitoring opioid adherence and compared to traditional adherence monitoring methods.
Methods:
Opioid-maintained patients (OMPs; n=28) were randomly assigned to either receive MEMS bottles containing their opioid medication for a 90-day period or track their own medication usage via self-report diaries. Additional data regarding physician-rated adherence and urine drug screen (UDS) results were collected.
Results:
OMPs who received MEMS demonstrated highly heterogenous dosing patterns, with a substantial number of patients rapidly using excessive amounts of medication and/or “stockpiling” unused medication. MEMS data did not correlate with physician-rated adherence (p = 0.24) and UDS results (p = 0.77). Our hypothesis that MEMS data would reveal greater non-adherence than self-report data was supported, as scores from MEMS were significantly lower than scores from diaries from participants in the MEMS condition (p < 0.001) as well as from participants in the control condition (p < 0.001).
Conclusions:
These results highlight the stark contrast between traditional indices of opioid adherence and actual medication usage as well as underscore how real-time monitoring could be used to improve patient outcomes, minimize harm, and aid in clinical decision-making. The findings also demonstrate the limits in our understanding of naturalistic patterns of opioid medication use when administered as needed and the importance of future research on innovative technology-based strategies to limit opioid misuse and diversion. Clinical Trial: This study was preregistered on ClinicalTrials.gov (NCT03752411).
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