Protocol for the development of a consensus practice guideline To address clinical and regulatory barriers to buprenorphine dispensing in community pharmacy.

BACKGROUND: Less than half of community pharmacies in the United States stock buprenorphine products indicated for the treatment of opioid use disorder. This lack of access to buprenorphine in community pharmacies is a significant barrier to care. To address this issue, this protocol outlines a comprehensive approach to develop a practice guideline aimed at improving access to safe and effective opioid use disorder treatment in community pharmacies. METHODS: The guideline development process will proceed in three phases, following a technique closely aligned with the Institute of Medicine's guidance on guideline development. The first phase will involve conducting qualitative interviews with pharmacists in three states to identify their beliefs toward buprenorphine dispensing. As limitations on buprenorphine supply are related to constraints at all levels of the drug supply and regulatory system, the second phase, we will recruit representatives from regulatory agencies, pharmacy organizations, the Drug Enforcement Administration, pharmaceutical wholesalers as well as addiction medicine physicians and psychiatric pharmacists to develop consensus recommendations through a modified Delphi design. This will be followed by a public comment period and external expert review of the recommendations led by the National Association of Boards of Pharmacy. Finally, in the third phase, a national, mixed media dissemination campaign will be led by the National Community Pharmacists Association (NCPA) to convey recommendations to practicing pharmacists. DISCUSSION: The guideline development process aims to incorporate the perspectives of multiple stakeholders and emphasize the importance of addressing the regulatory and pharmacy-specific aspects of care in addition to clinical evidence and guidance. The development of this guideline will provide targeted, multidisciplinary guidance for pharmacists, improving access to safe and effective opioid use disorder treatment in the community setting. PREREGISTRATION: This protocol was registered with the Open Science Framework in March of 2023. Registration may be found at: https://doi.org/10.17605/OSF.IO/6S9DY .

Relationships Between Stigma, Risk Tolerance, and Buprenorphine Dispensing Intentions Among Community-Based Pharmacists: Results From a National Sample.

BACKGROUND: Concerns have been raised that pharmacists sometimes act as barriers to patients with opioid use disorder (OUD) accessing buprenorphine treatment. The present research explores how community pharmacists' endorsement (vs non-endorsement) of stigmatizing beliefs about patients taking buprenorphine relate to intentions, comfort, and decisions regarding dispensing buprenorphine for OUD. In addition, we assessed attitudes toward risk in pharmacy practice as a novel correlate of dispensing intentions and decisions. METHODS: A sample of 207 active community-based pharmacists practicing in the United States responded to survey items measuring stigma, risk tolerance, and intentions to dispense buprenorphine. The survey included 2 vignettes in which patients presented to the pharmacy with a prescription for buprenorphine, and respondents rated their comfort with dispensing and decisions regarding dispensing in the vignette. RESULTS: Results suggest that both stigma toward patients taking buprenorphine to treat OUD and tolerance for risk in pharmacy settings are related to differences in pharmacists' intentions to and willingness to dispense buprenorphine for OUD. CONCLUSIONS: Findings support the need for interventions to reduce stigma associated with buprenorphine use among pharmacists and suggest that risk tolerance is an important determinant of pharmacists' behavior that merits further study.

Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy.

In the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD. The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes. Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.

Reducing the harms of xylazine: clinical approaches, research deficits, and public health context.

OBJECTIVES: Xylazine has emerged as a consistent part of the unregulated drug supply in recent months. We discuss major domains of xylazine's harm, current knowledge deficits, clinical and harm reduction strategies for minimizing harm, and xylazine's public health and policy context. As an interdisciplinary team from across the USA, we have pooled our knowledge to provide an overview of xylazine's current and emerging contexts. METHODS: To inform this essay, the pertinent literature was reviewed, clinical knowledge and protocols were shared by multiple clinicians with direct expertise, and policy and public health context were added by expert authors. RESULTS: We describe xylazine's major harm domains-acute poisoning, extended sedation, and wounds, along with anemia and hyperglycemia, which have been reported anecdotally but lack as clear of a connection to xylazine. Current successful practices for xylazine wound care are detailed. Understanding xylazine's epidemiology will also require greater investment in drug checking and surveillance. Finally, approaches to community-based wound care are discussed, along with an orientation to the larger policy and public health context. CONCLUSIONS: Addressing the harms of xylazine requires interdisciplinary participation, investment in community-based harm reduction strategies, and improved drug supply surveillance. The relatively unique context of xylazine demands buy-in from public health professionals, harm reduction professionals, clinicians, basic science researchers, policymakers and more.

Independent community pharmacists' attitudes and intentions toward dispensing buprenorphine/naloxone for opioid use disorder.

BACKGROUND: Buprenorphine/naloxone (BUP/NX) for opioid use disorder (OUD) is associated with positive health outcomes; however, challenges accessing prescribed BUP/NX at community pharmacies have been identified. OBJECTIVE: The theory of planned behavior was applied to determine whether independent community pharmacists' attitudes toward dispensing BUP/NX for OUD predict intentions to dispense. METHODS: A 40-item survey was administered to 185 Texas Community Pharmacy Enhanced Services Network pharmacists. The survey assessed intentions to dispense BUP/NX (3 items), attitudes toward BUP/NX (24 items), current barriers to dispensing BUP/NX (2 items), and demographics (10 items). Inferential statistics determined associations among pharmacists' attitudes, practice setting characteristics, and intentions to dispense BUP/NX. Regression analysis determined whether attitude predicted intention to dispense BUP/NX, controlling for practice setting and demographic characteristics. RESULTS: Responses were obtained from 82 community independent pharmacists (response rate = 44%). Respondents were predominantly non-Hispanic white (45.8%) and women (56.6%) and practiced in pharmacies with an average 1129.1 (± 1034.5) dispensed prescriptions/week. Pharmacists had positive intentions (6.2 ± 3.5) and attitudes (14.4 ± 24.9) toward dispensing BUP/NX and attitudes did not predict intentions to dispense (P = 0.330). Positive drivers of attitude were related to improving patient outcomes, fulfilling a community need, and absence of conflicts with pharmacists' personal and religious beliefs. A negative driver of attitude was financial reimbursement/loss. Pharmacists dispensing 2000 or more prescriptions/week had higher intentions (b = 3.22, P = 0.014) to dispense than those dispensing less than 500 prescriptions/week. The most common barrier to dispense BUP/NX was "refill was too soon" (54.8%). CONCLUSION: Community independent pharmacists had positive attitudes toward and intentions of dispensing BUP/NX for OUD. However, attitudes did not predict intentions to dispense. Negative drivers of attitudes were related to factors not within pharmacists' control, such as time to refill or financial reimbursement.Future studies focused on community pharmacy-based access to BUP/NX are warranted to elucidate issues that are impactful in improving pharmacists' dispensing intentions and behavior.

Prescribing Syringes to People Who Inject Drugs: Advancing Harm Reduction in Primary Care.

Access to new syringes can reduce the risk of HIV and hepatitis C transmission, skin and soft tissue infections, and infectious endocarditis for people who inject drugs (PWID). Syringe service programs (SSPs) and other harm reduction programs are a good source of syringes. However, they are sometimes not accessible due to limited hours, geographic barriers, and other factors. In this perspective, we argue that when PWID faces barriers to syringes physicians and other providers should prescribe, and pharmacists should dispense, syringes to decrease health risks associated with syringe re-use. This strategy is endorsed by professional organizations and is legally permissible in most states. Such prescribing has numerous benefits, including insurance coverage of the cost of syringes and the sense of legitimacy conveyed by a prescription. We discuss these benefits as well as the legality of prescribing and dispensing syringes and address practical considerations such as type of syringe, quantity, and relevant diagnostic codes, if required. In the face of an unprecedented overdose crisis with many associated health harms, we also make the case for advocacy to change state and federal laws to make access to prescribed syringes uniform, smooth, and universal as part of a suite of harm reduction efforts.

The impact of the mainstreaming addiction treatment act and associated legislative action on pharmacy practice.

The recent passage of the Mainstreaming Addiction Treatment (MAT) Act will expand access to treatment for opioid use disorder (OUD) by eliminating prescriber registration requirements introduced as part of the Drug Abuse Treatment Act (DATA) of 2000. Without the X-Waiver, and Drug Enforcement Administration (DEA) registered prescriber can now prescribe buprenorphine. Eliminating DATA-2000 registration is the first step in improving access to buprenorphine, but additional barriers, including unclear restrictions on wholesale buprenorphine supply and insurance coverage, remain. Recently, the DEA formally clarified that suspicious order monitoring programs were managed entirely by wholesalers and manufacturers and that DEA does not set suspicious order monitoring limits. In this commentary, we address the somewhat conflicting implications of the MAT Act and recent DEA guidance on buprenorphine dispensing in community pharmacies. We also discuss innovative practice models that leverage pharmacists' cognitive skills to manage pharmacotherapy for persons with OUD. Recent policy changes and emerging evidence suggest that pharmacists are better positioned than ever to provide low-barrier access to treatment for OUD and to show their value in this practice area by actively engaging patients with prescribed buprenorphine.

Description and Evaluation of a Pilot Advanced Pharmacy Practice Experience in Addiction Medicine.

Objective. To assess the impact of a pilot advanced pharmacy practice experience (APPE) on fourth-year (P4) Doctor of Pharmacy (PharmD) students' knowledge and confidence related to substance use disorder, harm reduction, and co-occurring psychiatric conditions.Methods. Beginning in 2020, a 62-item assessment was developed and administered to P4 students at the beginning and end of the six-week APPE. The assessment tested knowledge in 10 content areas related to substance use disorder, harm reduction, and co-occurring disorders. Students also ranked their confidence in providing care related to each content area. The post-assessment included a free-text (open-ended) item to provide feedback on the APPE experience. Descriptive statistics and paired t tests were used to analyze the data.Results. Complete pre- and post-assessments were obtained from all participating students (N=7). The mean cumulative knowledge score increased from 55.2% to 81.5%, and the mean cumulative confidence score improved from 34.2% to 81.8%. Free-text responses garnered positive feedback from students, who indicated that the APPE allowed them to immerse themselves in all stages of the recovery process, gain confidence in presentation skills with patients, and solidify their passion for addiction medicine.Conclusion. A novel APPE in addiction medicine addressed a current gap in pharmacy education, earned positive evaluations from student pharmacists, increased student knowledge and confidence related to substance use disorder, harm reduction, and co-occurring disorders, and supported the development of new interprofessional collaborations. United States colleges of pharmacy that do not yet offer APPEs in this clinical domain should consider this model.

A qualitative exploration of unintentional versus intentional exposure to fentanyl among people who use drugs in Austin, TX.

BACKGROUND: The prevalence of deaths involving synthetic opioids has historically been lower in Texas than most U.S. states but more than quadrupled from January 2020 to January 2022. This paper explores the emergence of fentanyl in a drug supply where black tar heroin predominates, a factor considered protective against fentanyl adulteration, through the perspectives of people who use drugs (PWUD). OBJECTIVES: We describe experiences of unintentional exposure to fentanyl, illustrate how some people identify fentanyl in their supply, and present harm reduction strategies that PWUD use to avoid overdose. METHODS: Thirty rapid assessment interviews were conducted in July 2021 at 2 mobile outreach sites of a harm reduction organization in Austin, Texas. The brief semistructured interviews were designed to assess participant fentanyl exposure experiences. RESULTS: Participants were clients who reported using heroin or fentanyl in the past week and had lived in Texas for at least 6 months. Seventeen participants identified as male, 10 as female, and 3 as nonbinary. Half identified as white; other participants were Latinx (6), black (2), American Indian (1), and mixed race (6). Two-thirds were unhoused or in transitional housing. The drug supply in Texas has evolved; most participants reported that the heroin and other drugs they obtained contain fentanyl. Participants detected differences by observing changes in the physical characteristics of the drug, experiencing unexpected effects, and using fentanyl test strips. Many had been unintentionally exposed to fentanyl and expressed concerns about fentanyl's presence. The presence of fentanyl had negative unintended consequences for participants, including adverse effects and developing a dependence on opioids. CONCLUSION: PWUD in Austin, Texas, report increasing prevalence of unintentional fentanyl exposure, despite the predominance of black tar heroin. Pharmacists can provide crucial supplies and education to safeguard the health of this vulnerable population.

A wound care and immunization needs assessment for participants of a mobile syringe services program in Austin, TX.

BACKGROUND: People who inject drugs (PWID) are subject to injection-related harm, including skin and soft tissue infections. Syringe services programs (SSPs) provide sterile syringes, disposal of used syringes, and other supportive services. Given their contact and credibility with PWID, SSPs could facilitate triage and treatment of wounds and access to immunizations for communicable diseases. OBJECTIVE: This work aimed to assess wound care and immunization needs among participants accessing mobile SSP services in Austin, TX. METHODS: A 21-item mixed-methods survey was created to assess frequency and severity of wounds, wound care approaches, and vaccination status. Participants were included if they reported injection drug use and experienced a related wound in the previous 6 months. Interview sections included screening, demographics, wound care, and immunization status. RESULTS: A total of 21 participants completed the semistructured interview. A majority identified as male (n = 13, 61.9%), white (n = 12, 57.1%), and were unhoused (n = 12, 57.1%). The primary drug of injection was heroin alone (n = 14, 66.7%). Many avoided seeking wound care from health care providers (n = 16, 76.2%) owing to stigmatization (n = 13, 61.9%) and previous negative experiences (n = 7, 33.3%). Self-treatment of wounds included over-the-counter medications (n = 10, 47.6%), over-the-counter supplies (n = 10, 47.6%), and antibiotics (n = 9, 42.8%). In the past 5 years, few had received vaccination for hepatitis A and B (n = 3, 14.3%) or tetanus (n = 7, 33.3%), and many expressed interest in receiving vaccinations through the SSP. Interest for other expanded services included access to antibiotics, an on-site provider, wound care supplies, and education. CONCLUSIONS: PWID may avoid professional health care for wound care or immunizations owing to perceived stigma. Expanding availability of wound care services and immunizations directly through mobile SSPs is desired by participants and could positively affect public health.

Perceptions, policies, and practices related to dispensing buprenorphine for opioid use disorder: A national survey of community-based pharmacists.

BACKGROUND: Increasing buprenorphine prescribing for opioid use disorder (OUD) has been a major focus of U.S. opioid response efforts. However, concerns related to dispensing buprenorphine have been identified among pharmacists. OBJECTIVES: This study aimed to describe perceptions, policies, and practices reported by community-based pharmacists in relation to dispensing buprenorphine for OUD and to compare these responses by practice setting. METHODS: A cross-sectional online survey was administered to a random sample of 6376 pharmacists. Responses were collected anonymously from October 16, 2021, to November 7, 2021. RESULTS: A response rate of 5.1% was achieved with 325 responders, and 281 were eligible to complete the survey. Most reported practicing in a chain (50.9%) or independent pharmacy (34.7%) as a staff pharmacist (39.7%) or pharmacist-in-charge (37.0%). Most (68.1%) indicated they could usually or always fill a buprenorphine prescription promptly. The most common pharmacy policies related to buprenorphine dispensing were checking the prescription drug monitoring program (71.3%), validating the prescriber's X-waiver (44.9%), accepting only local prescribers (37.4%), and prohibiting refills more than one day early (35.8%). Policies limiting buprenorphine access to local prescribers, local patients, and established patients varied by practice setting and were most common in independent pharmacies. The strongest barriers to buprenorphine dispensing were insurance prior authorization, difficulty reaching prescribers with questions, and concerns about buprenorphine diversion. The strongest facilitators of buprenorphine dispensing were increased communication with prescribers, increased trust with prescribers, increased trust with patients, and increased education for pharmacists. CONCLUSION: Most respondents indicated they were willing and able to dispense buprenorphine products for OUD promptly. However, they also reported discomfort dispensing when factors representing potential risk of diversion are present. Mitigating this hypersensitivity to diversion risk among pharmacists should be a focus of regulatory agencies and professional organizations. Efforts to address the unique concerns of independent pharmacists will also be essential to improve access.

Naloxone accessibility without an outside prescription from U.S. community pharmacies: A systematic review.

BACKGROUND: Recent evidence has identified limited naloxone accessibility in community pharmacies. OBJECTIVES: To summarize current literature regarding naloxone accessibility without an outside prescription from U.S. community pharmacies and discuss implications on community pharmacists' ability to mitigate the opioid overdose epidemic. METHODS: A systematic review was developed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. PubMed was searched up to May 12, 2022. References from articles chosen for inclusion were subsequently reviewed to identify additional relevant studies. Peer-reviewed publications reporting new data regarding the accessibility of naloxone from U.S. community pharmacies without an outside prescription (e.g., standing order, protocol) were included. Review articles and articles written in a non-English language were excluded. Individual study data were reported, along with a qualitative discussion of limitations of individual studies and in aggregate. When possible, naloxone accessibility data were also pooled and reported as overall accessibility and further stratified by chain versus independent pharmacies and urban versus rural settings. RESULTS: Thirty studies were included. Naloxone was in stock in 6867 of 10,934 (62.8%) pharmacies, though this varied greatly between studies (range, 26.4%-96.1%). Chain pharmacies were more likely to stock naloxone than independents (69.7% [range, 35.4%-89.1%] vs. 36.4% [range, 19.1%-89.7%], P < 0.0001). Stocking did not significantly differ between urban and rural locations. A total of 5660 of 8999 (62.9%; range, 23.5%-97%) pharmacies audited were willing to dispense without a prescription, with chain (67.4% vs. 22.2%, P < 0.0001) and rural (69.3% vs. 40.7%, P < 0.0001) pharmacies more likely than independent and urban, respectively. Key access barriers identified included naloxone not stocked, high naloxone cost, and pharmacist misinformation or stigma. CONCLUSION: Though limited by study heterogeneity, analysis of thirty U.S. studies revealed naloxone was available without a prescription in less than two-thirds of community pharmacies. Availability varied significantly by study and pharmacy type.

Availability of buprenorphine/naloxone films and naloxone nasal spray in community pharmacies in 11 U.S. states.

BACKGROUND: Prompt access to prescribed buprenorphine/naloxone films (BUP/NX) and naloxone nasal spray (NNS) is vital for patients with opioid use disorder (OUD), but multiple studies have documented pharmacy-level barriers. METHODS: A cross-sectional secret shopper telephone audit was conducted in a sample of 5734 actively licensed pharmacies in 11 U.S. states from May 2020-April 2021. Primary outcomes included availability of 14 generic BUP/NX 8/2 mg and one unit of NNS 4 mg. Outcomes were compared by pharmacy type, county metropolitan status, state Medicaid expansion status, and state drug overdose death rate. RESULTS: Data from 4984 pharmacies (3402 chain and 1582 independent) were analyzed. Both medications were available in 41.2 % of pharmacies, BUP/NX was available in 48.3%, and NNS was available in 69.5%. Chain pharmacies were significantly more likely than independent pharmacies to have both medications available, to have each medication available individually, and to be willing to order BUP/NX. Pharmacies in metropolitan counties were more likely to have BUP/NX available than pharmacies in non-metropolitan counties, pharmacies in Medicaid expansion states were more likely to have both medications available and to have NNS available than pharmacies in non-expansion states, and pharmacies in states with high drug overdose death rates were more likely to have NNS available than pharmacies in states with low drug overdose death rates. CONCLUSIONS: BUP/NX and NNS are not readily accessible in many U.S. pharmacies. Deficits in access are most pronounced in independent pharmacies, though county- and state-level factors may also influence availability of these essential medications.

Opioid harm reduction: A scoping review of physician and system-level gaps in knowledge, education, and practice.

Background: Harm reduction includes treatment and prevention approaches rather than abstinence, as a public health strategy for mitigating the opioid epidemic. Harm reduction is a new strategy for many healthcare professionals, and gaps in knowledge and practices may lead to barriers to optimal treatment. Our objective was to identify and describe gaps in physicians' knowledge, education, and practice in harm reduction strategies related to opioid overdose. Methods: We searched the PubMed, CINAHL, and Web of Science databases for articles published between 2015 and 2021, published in English, containing empirical evidence, addressing opioid harm reduction, and identifying gaps in physicians' knowledge, education, or practice. Results: Thirty-seven studies were included. Studies examined how physicians' perceptions or stigma influenced harm reduction efforts and addressed clinical knowledge gaps in overdose treatment and prevention and OUD treatment. Less than half of the studies addressed access issues at the system level, above the individual healthcare professional. Conclusion: Individual-level interventions should be addressed with professional continuing education and curricular-based changes through experiential and interprofessional education. System-level gaps can be remedied by increasing patient access to care, creating policies favorable to harm reduction, and extending resources to provide harm reduction strategies.

Policies regarding use of medications for opioid use disorder in professional recovery programs: A scoping review.

Background: In the U.S., medications for opioid use disorder (MOUD) include methadone, buprenorphine, and naltrexone. Despite substantial evidence of efficacy, the use of MOUD by health professionals remains controversial. This scoping review sought to identify and describe policies related to the use of MOUD by physicians, pharmacists, and nurses in professional health programs (PHP). Methods: A systematic search of PubMed, Medline, Web of Science, and Google Scholar was performed in August 2020 to identify pertinent articles from the U.S. which were then evaluated for inclusion by a team of trained reviewers. Results: Nine articles were ultimately identified for inclusion, and their years of publication ranged from 1984 to 2012. The treatment of physicians was addressed in seven articles, nurses in four, and pharmacists in two. Data from one veterinarian and several dentists could not be disaggregated from three studies. Naltrexone was the most commonly accepted form of MOUD within PHPs. A 2011 survey of physician and nurse PHP administrators found that 11/22 (50%) physician programs and 15/33 (45%) nursing programs forbade practice reentry while taking buprenorphine with the remainder indicating it could be allowed under some circumstances. The use of methadone within PHPs was extremely rare, and no specific details regarding PHP policies related to its use or practice reentry could be identified. No articles reported specifically on practice reentry policies for pharmacists. Conclusions: This scoping review identified one article detailing explicit policies concerning MOUD use in the target professions. Implicit policies extrapolated from other articles found that naltrexone was the most commonly accepted form of MOUD, with methadone and buprenorphine being avoided due to dubious concerns of impairment. A unified, contemporary, comprehensive survey of current PHP policies and evaluation of actual treatment data to ascertain real-world practices is needed.