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. 2022 Aug;37(11):2624-2633.
doi: 10.1007/s11606-021-07356-6. Epub 2022 Feb 7.

Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial

Ingrid A Binswanger  1   2   3   4 , Deborah Rinehart  5   6 , Shane R Mueller  7 , Komal J Narwaney  7 , Melanie Stowell  6 , Nicole Wagner  7   5 , Stan Xu  8 , Rebecca Hanratty  5   9 , Josh Blum  5   9 , Kevin McVaney  9 , Jason M Glanz  7   10
Affiliations

Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial

Ingrid A Binswanger et al. J Gen Intern Med. 2022 Aug.

Abstract

Background: Although naloxone prevents opioid overdose deaths, few patients prescribed opioids receive naloxone, limiting its effectiveness in real-world settings. Barriers to naloxone prescribing include concerns that naloxone could increase risk behavior and limited time to provide necessary patient education.

Objective: To determine whether pharmacy-based naloxone co-dispensing affected opioid risk behavior. Secondary objectives were to assess if co-dispensing increased naloxone acquisition, increased patient knowledge about naloxone administration, and affected opioid dose and other substance use.

Design: Cluster randomized pragmatic trial of naloxone co-dispensing.

Setting: Safety-net health system in Denver, Colorado, between 2017 and 2020.

Participants: Seven pharmacies were randomized. Pharmacy patients (N=768) receiving opioids were followed using automated data for 10 months. Pharmacy patients were also invited to complete surveys at baseline, 4 months, and 8 months; 325 survey participants were enrolled from November 15, 2017, to January 8, 2019.

Intervention: Intervention pharmacies implemented workflows to co-dispense naloxone while usual care pharmacies provided usual services.

Main measures: Survey instruments assessed opioid risk behavior; hazardous drinking; tobacco, cannabis, and other drug use; and knowledge. Naloxone dispensings and opioid dose were evaluated using pharmacy data among pharmacy patients and survey participants. Intention-to-treat analyses were conducted using generalized linear mixed models accounting for clustering at the pharmacy level.

Key results: Opioid risk behavior did not differ by trial group (P=0.52; 8-month vs. baseline adjusted risk ratio [ARR] 1.07; 95% CI 0.78, 1.47). Compared with usual care pharmacies, naloxone dispensings were higher in intervention pharmacies (ARR 3.38; 95% CI 2.21, 5.15) and participant knowledge increased (P=0.02; 8-month vs. baseline adjusted mean difference 1.05; 95% CI 0.06, 2.04). There was no difference in other substance use by the trial group.

Conclusion: Co-dispensing naloxone with opioids effectively increased naloxone receipt and knowledge but did not increase self-reported risk behavior.

Trial registration: Registered at ClinicalTrials.gov ; Identifier: NCT03337100.

Keywords: naloxone; overdose; prescription opioids; risk compensation; substance use.

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Conflict of interest statement

Outside of the listed affiliations, I.B. reports royalties from UpToDate, and all remaining authors declare that they do not have a conflict of interest.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram of screening, enrollment, and follow-up of patients and survey participants
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