Pilot implementation of the PharmNet naloxone program in an independent pharmacy

Eldridge, Lori; Meyerson, Beth E.; Agley, Jon

doi:10.1016/j.japh.2022.09.004

Cited by 6 publications

(19 citation statements)

References 34 publications

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“…The PharmNet pilot trial will be a cluster randomized trial consisting of 2 parallel groups and a 4:3 allocation ratio of intervention to control. The independent pharmacy organization participating in the project consists of 8 pharmacies, of which 1 was the pilot and feasibility test site [ 32 ]. The remaining 7 pharmacies will be allocated using a web-based random sequence generator (conducted by author LAE), such that 4 pharmacies will be selected to implement PharmNet, and 3 pharmacies will serve as controls (pharmacy practice as normal).…”

Section: Methodsmentioning

confidence: 99%

“…The proposed study will be a pilot randomized controlled assessment of the effectiveness of PharmNet, a harm reduction intervention for community pharmacies focused on naloxone distribution, awareness building, and referral. As described in the write-up of our single-site pilot study, “the intention was to study procedures that have as minimal an impact as possible on pharmacy costs and operational functioning while maximally facilitating harm reduction from opioid overdose—in other words, to find an optimal intersection point of those concerns” [ 32 ]. In brief, the intervention includes [ 32 ]:…”

Section: Introductionmentioning

confidence: 99%

“…As described in the write-up of our single-site pilot study, “the intention was to study procedures that have as minimal an impact as possible on pharmacy costs and operational functioning while maximally facilitating harm reduction from opioid overdose—in other words, to find an optimal intersection point of those concerns” [ 32 ]. In brief, the intervention includes [ 32 ]:…”

Section: Introductionmentioning

confidence: 99%

“…Our previous single-site pilot study found that during the intervention, compared to the mean of the 3 months of practice prior to the intervention, the monthly rate of naloxone sold had a relative increase of 34.4% (+3.33 doses/month), and the overall naloxone dispensing rate through any mechanism (eg, including newly added no-cost dispensing) increased 96.48% (+9.33 doses/month) [ 32 ].…”

Section: Introductionmentioning

confidence: 99%

“…Much of this work was conducted in conjunction with academic and community-based pharmacists and involved data collection from hundreds of managing pharmacists in 2 states [ 27 , 28 , 34 - 42 ]. The single-site pilot itself was informed by independent community pharmacists at a more granular level to maximize likely acceptability and feasibility [ 32 ].…”

Section: Introductionmentioning

confidence: 99%

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The PharmNet Harm Reduction Intervention for Community Pharmacies: Protocol for a Pilot Randomized Controlled Trial

et al. 2022

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Background The overdose epidemic in the United States has continued to worsen despite substantial 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 multipronged 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 (the prior 3 months) compared to a control condition. This pilot trial is intended to determine whether it is appropriate to invest the substantial 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 2 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 the 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 pretest-posttest 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 2 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. International Registered Report Identifier (IRRID) PRR1-10.2196/42373

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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The PharmNet Harm Reduction Intervention for Community Pharmacies: Protocol for a Pilot Randomized Controlled Trial

et al. 2022

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ASAP: A pharmacy-level intervention to increase nonprescription syringe sales to reduce bloodborne illnesses

Meyerson,

Agley,

Crosby

et al. 2024

Research in Social and Administrative Pharmacy

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Implementation Documentation and Process Assessment of the PharmNet Intervention: Observational Report

Eldridge,

Meyerson,

Agley

2024

JMIR Form Res

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Background The number of overdose deaths in the United States involving opioids continues to exceed 100,000 per year. This has precipitated ongoing declarations of a public health emergency. Harm reduction approaches, such as promoting awareness of, ensuring access to, and fostering willingness to use naloxone to reverse opioid overdose, are a key component of a larger national strategy to address the crisis. In addition, overdose reversal with naloxone directly and immediately saves lives. Because of pharmacies’ ubiquity and pharmacists’ extensive clinical training, community pharmacies are well-positioned, in principle, to facilitate naloxone access and education. Objective In 2022, a single-site pilot study of PharmNet, a community pharmacy intervention incorporating naloxone distribution, awareness building, and referral, showed promising outcomes for both naloxone and resource distribution in the community. As a next step, this study was intended to be a pilot randomized controlled trial of PharmNet in 7 pharmacies. However, due to circumstances outside of the study team’s control, data collection was unable to be fully completed as planned. In keeping with open research standards, we transparently report all available data from the study and discuss trial barriers and processes. We do so both to provide insights that may inform similar studies and to avoid the “file-drawer” (publication bias) problem, which can skew the aggregated scholarly literature through nonpublication of registered trial results or selective publication of findings affirming authors’ hypotheses. Methods This paper reports an in-depth implementation study assessment, provides the available observational data, and discusses implementation considerations for similar studies in independent (eg, nonchain) community pharmacies. Results Retrospective assessment of study outcomes and fidelity data provided for robust discussion around how resource differences in independent community pharmacies (vs well-resourced chain pharmacies), as well as high demands on staff, can affect intervention implementation, even when leadership is highly supportive. Conclusions Community pharmacies, particularly independent community pharmacies, may require more support than anticipated to be successful when implementing a new intervention into practice, even if it might affect estimates of real-world effectiveness. Further implementation science research is needed specific to independent community pharmacies. All study elements are outlined in the International Registered Report Identifier (IRRID) PRR1-10.2196/42373. Although this paper reports results associated with that registration, results and conclusions should not be given the weight assigned to findings from a preregistered study. International Registered Report Identifier (IRRID) RR2-10.2196/42373

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Pilot implementation of the PharmNet naloxone program in an independent pharmacy

Cited by 6 publications

References 34 publications

The PharmNet Harm Reduction Intervention for Community Pharmacies: Protocol for a Pilot Randomized Controlled Trial

The PharmNet Harm Reduction Intervention for Community Pharmacies: Protocol for a Pilot Randomized Controlled Trial

ASAP: A pharmacy-level intervention to increase nonprescription syringe sales to reduce bloodborne illnesses

Implementation Documentation and Process Assessment of the PharmNet Intervention: Observational Report

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