Co-use of Opioid Medications and Alcohol Prevention Study (COAPS)

Abstract

While there is limited research in the field regarding the various dimensions of co-use of alcohol and opioid medication, particularly related to co-use and levels of severity, our research has shown 20–30% of community pharmacy patients receiving opioid pain medications are engaged in co-use. Co-use of alcohol and opioid medications is a significant risk factor for opioid-related overdose. Community pharmacy is a valuable yet underutilized resource and setting for addressing the US opioid epidemic, with an untapped potential for identification of and intervention for risks associated with co-use of alcohol and opioids. This commentary describing the “Co-use of Opioid Medications and Alcohol Prevention Study (COAPS)” offers an innovative and promising approach to mitigating serious risks associated with co-use of alcohol (risk and non-risk use) and opioids in community pharmacy. COAPS aim 1involves adapting an existing opioid misuse intervention to target co-use of alcohol and opioid mediations. COAPS aim 2 involves testing the adapted intervention within a small-scale pilot randomized controlled trial (N=40) to examine feasibility, acceptability and preliminary efficacy of the intervention vs. standard care. COAPS aim 3 involves conducting key informant interviews related to future implementation of larger scale studies or service delivery in community pharmacy settings.

Background

Opioids and Alcohol

There have been important declines in opioid prescribing in recent years.¹ Nevertheless, enough opioids were dispensed in 2018 to supply 51.4 prescriptions per 100 Americans.² This continued use has contributed to trends in opioid-related adverse events. The most severe repercussions of the continued epidemic include overdose: in 2021, 66% of the more than 106,699 fatal drug overdoses involved an opioid.^3,4 Opioid medication involved overdose remains the second leading type of opioid involved overdose in the US, accounting for 14% of deaths.⁵ Emerging reports indicate spikes in opioid overdose in the aftermath of the COVID-19 pandemic.^3,4

Among the significant risks for overdose that persist among those prescribed opioid medications is co-use of alcohol. Increased risk stems from increased abuse liability^6,7 and the potentiating analgesic effects of these substances to produce possible severe sedation, hypoxia, respiratory depression,^8–13 and thus heightened overdose risk.^14,15 Consequently, labeling by the Food and Drug Administration (FDA) of marketed formulations of opioid medications contains strong warnings advising against concomitant use of opioids and any other central nervous system depressants, specifically citing alcohol.^10–12,16 The Centers for Disease Control and Prevention concludes: “The risk of harm increases with the amount of alcohol consumed, but there is no safe level of alcohol use for people using opioids.”¹⁷ Thus, based on this previous research evidence, FDA labeling, and federal agency instructions—there is not a clear threshold for safe vs. unsafe use of alcohol and opioid medications. Further research is needed to understand these risks and possible interventions.

The literature documenting various co-use patterns in terms of severity of alcohol and opioids is somewhat limited. However, what literature is available shows a variety of patterns of use and notable prevalence. For example, previous research has documented that more than 1 in 5 individuals with alcohol use disorders (AUD) also have opioid use disorder (OUD)—with some studies showing as high 40% having an OUD.^18,19 Further, among those individuals seeking alcohol treatment, nearly 70% reported opioid medication misuse in the month before treatment initiation,²⁰ and half of those with binge alcohol use also report opioid medication misuse in the last month.²¹ Combined use of alcohol and opioid medication is not only found among those with AUD and aberrant opioid use patterns, such as misuse and OUD. Our research has shown co-use of alcohol and opioid medications is also common among patients filling opioid medications in community pharmacies, which health care service setting is the focus on this study.

Specifically, in a small-scale randomized trial testing a pharmacist-led opioid medication misuse intervention for patients filling opioid mediations in two community pharmacies in one state, 19% of 32 participants reported current risk drinking (based on gender scoring) at baseline based on the Alcohol Use Disorders Identification Test-C (AUDIT-C).²² Further, in a cross-sectional study that screened patients filling opioid medications in 4 community pharmacies in one state, our results showed 22.4% of 344 participants reported current risk alcohol use (based on gender scoring) on the AUDIT-C.²³ In an additional cross-sectional study that screened patients filling opioid medications in 19 community pharmacies in two states, 31% of 1,523 participants filling opioid medications reported current risk drinking on the Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) Tool.²⁴ Examining specific survey items showed 87.1% reported use of alcohol in the past 3-months, and 67.7% of males and 50.2% of females reported binge use in the last 3-months. Altogether, these results demonstrate participants in these studies engaged in regular, and often, risky drinking.

Community Pharmacy to Address Co-Use of Opioid Medications and Alcohol

The opioid epidemic in the US continues to claim the lives of tens of thousands of Americans each year. Further, there is continued nationwide misuse of prescribed opioid medications (>9 million individuals annually).²⁵ These facts call for continued efforts to expand the continuum of care. Given the evidence presented above about the risks of co-use of alcohol and opioids, particularly among community pharmacy patients, and the need to expand services to address this issue, community pharmacy is an important resource and service setting for identification and intervention to address co-use of opioid medications and alcohol. Possibly adding such responsibilities to prescribers contributes to excessive burden to these professionals given that prescribers continue to report high levels of burden and burnout from the myriad of clinical duties.²⁶ Thus, collaborating with auxiliary health care professionals to support opioid prescribing and patient management is paramount. As the last healthcare professional encountered before opioid dispensation, the pharmacist is critical in addressing risks of co-use of alcohol and opioids. Moreover, while pharmacists may benefit from training in evidence-based approaches to address alcohol misuse and dependence, they have unmatched training in drug-drug interactions, medication safety, and counseling in the safe and effective use of medications.²⁷ Specifically, their expertise in the delivery of medication therapy management services has been shown to improve health outcomes for population and public health concerns.^28–31

In addition to the strengths of pharmacists, community pharmacies are primary locations where patients legally fill opioid prescriptions that are often taken concurrently with alcohol^22,32,33 or are misused by patients.^34,35 Community pharmacies are abundant nationally,³⁶ providing easy access for patients—including those in rural areas—while creating a platform for population-level impact. Previous research has shown patients are willing to receive behavioral health information from these professionals,³⁷ and pharmacists are ranked among the top 2 most trusted professionals in the US.³⁸ More than 40% of community pharmacies have been documented to have private counseling rooms (often used for counseling or vaccination administration) where pharmacists can discretely provide care and maintain confidentiality.³⁹ Further, use of such spaces and services has grown markedly during the COVID-19 pandemic.⁴⁰ Given costs of opioid misuse and abuse exceeding $50 billion annually,⁴¹ these specialized service settings and professionals are positioned to make an unparalleled impact in identifying patients currently engaged in co-use of alcohol and opioid medication. Pharmacy professionals in community pharmacy settings are uniquely positioned to aid patients in making changes to alcohol consumption during opioid treatment or aid them to substitute their opioid pain treatment (in consultation with their prescriber) with a non-opioid alternative. Yet, limitations for services to address co-use of alcohol and opioids are largely rooted in the lack of empirical evidence supporting interventions delivered in this setting; other limitations stem from barriers that prevent clear identification of implementation pathways.

Model for Intervention

Notwithstanding the clear need for intervention services for co-use of opioids and alcohol and the potential impact of engaging community pharmacies, no current models exist for deployment in these settings. Therefore, our team has targeted adaptation of an intervention we previously developed for opioid medication misuse (called Brief Intervention-Medication Therapy Management [BI-MTM]). This adapted intervention would therefore be prepared to address co-use of opioid medications and alcohol.⁴² The original BI-MTM intervention that targeted opioid misuse was based on a Screening, Brief Intervention, and Referral to Treatment framework in connection with patient navigation services for pharmacy patients with opioid medication misuse.⁴² The BI-MTM intervention was developed using a stakeholder engaged process⁴² that built upon preliminary research that showed patients were willing to screen for behavioral health conditions in community pharmacy settings and discuss behavioral health needs with their pharmacist.^23,43 Further, brief interventions for alcohol have a robust evidence base spanning many decades.^44–47 Evidence supporting this original BI-MTM intervention was based on a small-scale randomized clinical trial that showed improvements in opioid misuse, depression, and pain compared to controls (all p<0.05)—with strong trends for reductions in opiate toxicology (p=0.05) for participants.²²

Current Study

Given the existence of a candidate intervention that can be adapted and delivered to this patient population in an era of heightened prevalence of co-use of alcohol and opioid medications, and given the opportunity to screen patients for co-use at point-of-dispensing within community pharmacies—our team proposed the current study to accomplish three specific aims (NCT05599672). The aims of this study and its protocol have been approved by the University of Utah Institutional Review Board.

The first aim of this study was to adapt and manualize an alcohol-targeted brief intervention-medication therapy management intervention. We utilized the ADAPT-ITT (Assessment, Decision, Administration, Production, Topical Experts, Integration, Training, and Testing)⁴⁸ framework to modify and manualize our original pharmacist-led opioid medication misuse intervention, BI-MTM, for delivery to community pharmacy patients with co-use of alcohol (both risk level and non-risk level alcohol use) and opioid medications (called Alcohol-targeted Brief Intervention-Medication Therapy Management [ABI-MTM]). Completion of SA1 has produced a manualized protocol for clinical trial evaluation.

The second aim of this study is to test the feasibility, acceptability, and preliminary efficacy of ABI-MTM for community pharmacy patients with concomitant alcohol and opioid medication use. We will conduct a small-scale trial in 3 community pharmacies and enroll those with/without at-risk drinking, with a stratified randomization to ABI-MTM (1:1 ratio; risk use n=10; non-risk use n=10) or standard medication counseling (SMC; risk use n=10; non-risk use n=10). Feasibility will be established through delivery of both ABI-MTM components to 85% of ABI-MTM recipients. Acceptability will be demonstrated through patient satisfaction^49,50 and participant retention (targeted at 85%) at study completion. We will also demonstrate preliminary efficacy by patients either eliminating or reducing alcohol use during opioid treatment or by pharmacists aiding patients to find an opioid medication alternative for pain management with their prescriber. We hypothesize intent-to-treat analyses will specifically show greater proportions of ABI-MTM recipients will eliminate or reduce co-use of alcohol (risk and non-risk alcohol use) and opioid medications compared to SMC, as assessed by Timeline Follow-Back and urine toxicology.^51–53 Accomplishing SA2 will demonstrate ABI-MTM is positioned for a subsequent fully-powered multisite randomized trial.

The third aim of this study is to identify pharmacy setting/practice-level barriers and facilitators for universal alcohol screening/intervention among opioid recipients. Employing the Consolidated Framework for Implementation Research (CFIR)^54,55 and Organizational Readiness to Change Assessment (ORCA),⁵⁶ we will develop a mixed methods assessment guide to interview pharmacy technicians (N=20), pharmacists (N=20), and corporate pharmacy leaders (N=20).^57,58 Open ended survey items will draw on the Intervention Characteristics, Inner Setting, Characteristics of Individuals, and Process CFIR domains. Primary domains assessed by the ORIC instrument include respondents’ perceptions of their ability and that of an organization to support implementation of a change.⁵⁶ In all, interviews will gather perceptions towards screening/intervention, internal organizational challenges, and processes related to ABI-MTM implementation for large-scale research/practice.⁵⁵ Results will provide critical insights into strategies for executing a subsequent powered trial, including an evidence-based implementation strategy, and possible future system/practice-level implementation.

Discussion and Conclusion

Among the highest-risk behaviors for those taking opioid medications is co-use with alcohol. Conducting this study is critical to the field given that, to our knowledge, there are no existing pharmacist-led intervention to specifically target co-use of alcohol and opioid medications. Further, a study aiming to develop and test an intervention while gleaning an understanding of the organizational context of implementation of such an intervention has not heretofore been conducted. Results of this study will create an opportunity to leverage community pharmacists’ unique expertise in medication management, including medication interactions and safety. These results will further address a significant gap in the literature regarding the untapped potential for community pharmacist interventions that build on their trusting relationships with patients. Indeed, results will: (1) inform a subsequent powered multisite trial examining the impact of the ABI-MTM intervention on reducing co-use of opioid medications, (2) establish a research-based prevention intervention targeting possible future system-level implementation, and (3) subsequently have the potential to improve public health nationally. Thus, this study is critically important given its novelty in the field and that it will establish needed data for building a viable community pharmacy-based response to preventing opioid overdose and related adverse events through mitigating co-use of alcohol and opioid medications.