JMIR Publications

ABSTRACT

Background:

The overdose epidemic in the United States has continued to worsen despite significant efforts to mitigate its harms. The opioid antagonist naloxone has been identified as a key means of reducing the prevalence of fatal overdoses. An important evidence-based approach to optimizing naloxone’s impact is to seed it throughout the community because bystanders are often able to reverse overdoses more quickly than first responders, and sometimes are the only possible means of overdose reversal. As part of a multi-pronged approach to distributing naloxone nationwide, community pharmacies have been identified as ideal venues for naloxone dispensing, especially under standing orders. However, dispensing rates remain surprisingly low, and there is a need to understand how best to engage community pharmacies in naloxone-based harm reduction services.

Objective:

The objective of this trial is to determine whether a tailored, pragmatic pharmacy intervention (PharmNet) results in greater naloxone dispensing relative to baseline (prior 3 months) compared to a control condition. This pilot trial is intended to determine whether it is appropriate to invest the significant resources that would be required to conduct a full-scale randomized, controlled study of PharmNet.

Methods:

We will conduct a 3-month randomized, controlled pilot trial consisting of two parallel groups with a 4:3 allocation ratio. A group of 7 independent pharmacies from rural areas in Indiana will be randomly assigned to either the PharmNet intervention arm (n=4) or the control arm (n=3). The primary outcome will be overall naloxone dispensing (both at cost and free), and secondary outcomes will include distribution of referral cards and multiple variables at the level of individual staff members. Dispensing data will be collected for the 3 months prior to the intervention and the 3 months of the intervention, and all other data will be collected using a pre- and post-test design. The primary analysis will be a generalized linear mixed model with a Poisson distribution with fixed effects for group, time, and their interaction, and a random effect for pharmacy ID to account for repeated measures within pharmacies.

Results:

This study was approved by the Indiana University Institutional Review Board in two phases (August 2, 2021 and April 26, 2022), and was funded by the Indiana University Grand Challenge: Responding to the Addictions Crisis.

Conclusions:

If this study produces evidence that the PharmNet intervention results in increased naloxone dispensing relative to control pharmacies, it will be both appropriate and important to study it in a large, full-scale randomized, controlled trial.