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

[This corrects the article DOI: 10.2196/54077.].

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

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.

Come back when you're infected: pharmacy access to sterile syringes in an Arizona Secret Shopper Study, 2023.

BACKGROUND: Pharmacies are critical healthcare partners in community efforts to eliminate bloodborne illnesses. Pharmacy sale of sterile syringes is central to this effort. METHODS: A mixed methods "secret shopper" syringe purchase study was conducted in the fall of 2022 with 38 community pharmacies in Maricopa and Pima Counties, Arizona. Pharmacies were geomapped to within 2 miles of areas identified as having a potentially high volume of illicit drug commerce. Daytime venue sampling was used whereby separate investigators with lived/living drug use experience attempted to purchase syringes without a prescription. Investigator response when prompted for purchase rationale was "to protect myself from HIV and hepatitis C." A 24-item instrument measured sales outcome, pharmacy staff interaction (hostile/neutral/friendly), and the buyer's subjective experience. RESULTS: Only 24.6% (n = 28) of 114 purchase attempts across the 38 pharmacies resulted in syringe sale. Less than one quarter (21.1%) of pharmacies always sold, while 44.7% never sold. Independent and food store pharmacies tended not to sell syringes. There emerged distinct pharmacy staff interactions characterized by body language, customer query, normalization or othering response, response to purchase request and closure. Pharmacy discretion and pharmacy policy not to sell syringes without a prescription limited sterile syringe access. Investigators reported frequent and adverse emotional impact due to pharmacy staff negative and stigmatizing interactions. CONCLUSIONS: Pharmacies miss opportunities to advance efforts to eliminate bloodborne infections by stringent no-sale policy and discretion about syringe sale. State regulatory policy facilitating pharmacy syringe sales, limiting pharmacist discretion for syringe sales, and targeting pharmacy-staff level education may help advance the achievement of public health goals to eliminate bloodborne infections in Arizona.

Insufficient Impact: Limited Implementation of Federal Regulatory Changes to Methadone and Buprenorphine Access in Arizona During COVID-19.

Introduction: This study examined the impact of federal regulatory changes on methadone and buprenorphine treatment during COVID-19 in Arizona. Methods: A cohort study of methadone and buprenorphine providers from September 14, 2021 to April 15, 2022 measured the proportion of 6 treatment accommodations implemented at 3 time periods: before COVID-19, during Arizona's COVID-19 shutdown, and at the time of the survey completion. Accommodations included (1) telehealth, (2) telehealth buprenorphine induction, (3) increased multiday dosing, (4) license reciprocity, (5) home medications delivery, and (6) off-site dispensing. A multilevel model assessed the association of treatment setting, rurality, and treatment with accommodation implementation time. Results: Over half (62.2%) of the 74-provider sample practiced in healthcare settings not primarily focused on addiction treatment, 19% practiced in methadone clinics, and 19% practiced in treatment clinics not offering methadone. Almost half (43%) were unaware of the regulatory changes allowing treatment accommodation. Telehealth was most frequently reported, increasing from 30% before COVID-19 to 80% at the time of the survey. Multiday dosing was the only accommodation substantially retracted after COVID-19 shutdown: from 41% to 23% at the time of the survey. Providers with higher patient limits were 2.5-3.2 times as likely to implement telehealth services, 4.4 times as likely to implement buprenorphine induction through telehealth, and 15.2-20.9 times as likely to implement license reciprocity as providers with lower patient limits. Providers of methadone implemented 12% more accommodations and maintained a higher average proportion of implemented accommodations during the COVID-19 shutdown period but were more likely to reduce the proportion of implemented accommodations (a 17-percentage point gap by the time of the survey). Conclusions: Federal regulatory changes are not sufficient to produce a substantive or sustained impact on provider accommodations, especially in methadone medical treatment settings. Practice change interventions specific to treatment settings should be implemented and studied for their impact.

SI-CBPAR: Towards structural indicators of community-based participatory action research.

INTRODUCTION: Structural aspects of community-engaged research are not well measured yet have critical implications for community research empowerment. This is particularly so with people who use drugs. We introduce the Structural Indicators of Community-Based Participatory Action Research (SI-CBPAR) to measure structural indicators of community-research entity relationships. METHODS: A three-phased process of iterative development, feasibility and applicability assessment was used to examine the instrument with community-engaged studies as a first stage of instrument development. The development team included people with university, non-government organisation and lived/ing drug use experience. Four studies on the health of people who use drugs were reviewed for indicator evidence followed by iterative discussion about construct and item discrepancies. Indicators were measured for the degree to which they were observed using a three-point scale. RESULTS: All but two constructs were confirmed for meaning. Constructs of 'community' and 'coalition' required revision and explanation. The need for further exploration of power differentials between community and community-based organisations was identified. Indicator evidence was found for all six categories across studies. The instrument was deemed applicable and easy to use. It was observed that categories could apply to studies with various degrees of community engagement and to other research focal areas. DISCUSSION AND CONCLUSIONS: SI-CBPAR applicability testing and initial category confirmation indicate its potential utility for community research collaboratives. The next phase of development involves cognitive interviewing with researchers from across community engaged research orientations, and with communities engaged in research beyond drug user health.

"As safe as possible": a qualitative study of opioid withdrawal and risk behavior among people who use illegal opioids.

BACKGROUND: Opioid withdrawal is a regular occurrence among many people who use illicit opioids (PWUIO) that has also been shown to increase their willingness to engage in risk-involved behavior. The proliferation of fentanyl in the illicit opioid market may have amplified this relationship, potentially putting PWUIO at greater risk of negative health outcomes. Understanding the relationship between withdrawal and risk-involved behavior may also have important implications for the ways that problematic drug use is conceptualized, particularly in disease models of addiction, which position risk behavior as evidence of pathology that helps to justify ontological distinctions between addicts and non-addicts. Examining withdrawal, and its role in PWUIO's willingness to engage in risk, may aid in the development of alternative theories of risk involvement and create discursive spaces for de-medicalizing and de-othering people who use illegal drugs. METHODS: This article is based on 32 semi-structured interviews with PWUIO in the New York City area who also reported recent withdrawal experience. Interviews were conducted remotely between April and August 2022 and recorded for later transcription. Data were then coded and analyzed based on a combination of inductive and deductive coding strategies and informed by the literature. RESULTS: Participants described a strong relationship between withdrawal and their willingness to engage in risk-involved behavior that was exacerbated by the proliferation of fentanyl. Yet, their descriptions did not align with narratives of risk as a product of bad decisions made by individuals. Rather, data demonstrated the substantial role of social and structural context, particularly drug policies like prohibition and criminalization, in the kinds of risks that PWUIO faced and their ability to respond to them. CONCLUSIONS: Withdrawal should be taken more seriously both from an ethical perspective and as an important catalyst of risk behavior. However, theories that position activities taken to avoid withdrawal as irrational and as evidence of pathology are poorly aligned with the complexity of PWUIO's actual lives. We recommend the use of less deterministic and less medicalized theories of risk that better account for differences between how people view the world, and for the role of socio-structural forces in the production of risk.

Opportunities and Challenges: Hepatitis C Testing and Treatment Access Experiences Among People in Methadone and Buprenorphine Treatment During COVID-19, Arizona, 2021.

Introduction: The purpose of this study was to characterize hepatitis C virus screening and treatment access experiences among people in treatment for opioid use disorder in Arizona during COVID-19. Methods: Arizonans receiving treatment for opioid use disorder from methadone clinics and buprenorphine providers during COVID-19 were interviewed about hepatitis C virus testing, curative treatment, and knowledge about screening recommendations. Interviews were conducted with 121 people from August 4, 2021 to October 10, 2021. Qualitative data were coded using the categories of hepatitis C virus testing, knowledge of screening recommendations, diagnosis, and experiences seeking curative treatment. Data were also quantitated for bivariate testing with outcome variables of last hepatitis C virus test, diagnosis, and curative treatment process. Findings were arrayed along an adapted hepatitis C virus cascade framework to inform program and policy improvements. Results: Just over half of the sample reported ever having tested for hepatitis C virus (51.2%, n=62) and of this group, 58.1% were tested in the past 12 months. Among those who were ever tested, 54.8% reported a hepatitis C virus diagnosis and 16.1% reported either being in treatment or having been declared cured of the hepatitis C virus. Among those who were diagnosed with hepatitis C, 14.7% indicated that they unsuccessfully tried to access curative treatment and would not attempt to again. Reasons cited for not accessing or receiving curative treatment included beliefs about treatment safety, barriers created by access requirements, natural resolution of the infection, and issues with healthcare coverage and authorization. Conclusions: Structural barriers continue to prevent curative hepatitis C virus treatment access. Given that methadone and buprenorphine treatment providers serve patients who are largely undiagnosed or treated for hepatitis C virus, opportunities exist for them to screen their patients regularly and provide support for and/or navigation to hepatitis C virus curative treatment.

Pilot implementation of the PharmNet naloxone program in an independent pharmacy.

BACKGROUND: The U.S. overdose epidemic has continued to escalate with more than 100,000 deaths per year in the past several years, most of which involve opioids. Widespread availability of naloxone is part of a national solution to the crisis, and community pharmacies are well-poised to facilitate such distribution and provide additional harm reduction services. OBJECTIVES: The primary objectives of this study were to (a) examine the usability of each of the separate intervention components prepared for PharmNet, (b) observe intervention fidelity through regularly scheduled site visits, and (c) explore the association between PharmNet implementation and the volume of naloxone sales and distribution in the pilot site. PRACTICE DESCRIPTION: Here, we describe a carefully designed and tailored pharmacy harm reduction intervention called PharmNet that is designed to maximize harm reduction impact while minimizing utilization of pharmacist resources. It is a pragmatic awareness, service provision, and referral program that was developed through careful, iterative feasibility studies with pharmacists. PRACTICE INNOVATION: PharmNet procedures include tools and steps to create awareness (e.g., yard signs and messaging for patients, reminder tools for pharmacists), facilitation of naloxone delivery from nonprofits, and provision of referral cards featuring local resources. EVALUATION METHODS: Evaluation included direct data collection and randomly scheduled fidelity site visits. RESULTS: The intervention was associated with an increase of 3.33 naloxone doses/mo being dispensed at cost (34.4% relative increase) and an overall increase of 9.33 naloxone doses/mo being dispensed via any mechanism (96.48% relative increase). Around 2.85 referral cards were issued to patients daily. Intervention fidelity was moderate, and the study provides valuable information for how to modify the study prior to a randomized trial. CONCLUSION: With modifications informed by this pilot study, the PharmNet intervention merits a randomized trial to determine whether it causes increased naloxone dispensing in independent community pharmacies.

Nothing really changed: Arizona patient experience of methadone and buprenorphine access during COVID.

OBJECTIVE: To understand patient experience of federal regulatory changes governing methadone and buprenorphine (MOUD) access in Arizona during the COVID-19 pandemic. METHODS: This community-based participatory and action research study involved one-hour, audio-recorded field interviews conducted with 131 people who used methadone and/or buprenorphine to address opioid use disorder at some point during COVID (January 1, 2020- March 31, 2021) in Arizona. Transcribed data were analyzed using a priori codes focused on federally recommended flexibilities governing MOUD access. Data were quantitated to investigate associations with COVID risk and services access. RESULTS: Telehealth was reported by 71.0% of participants, but the majority were required to come to the clinic to attend video appointments with an offsite provider. Risk for severe COVID outcomes was reported by 40.5% of the sample. Thirty-eight percent of the sample and 39.7% of methadone patients were required to be at the clinic daily to get medication and 47.6% were at high risk for COVID severe outcomes. About half (54.2%) of methadone patients indicated that some form of multi-day take home dosing was offered at their clinic, and 45.8% were offered an extra day or two of multi-day doses; but no participants received the federally allowed 14- or 28-day methadone take-home doses for unstable and stable patients respectively. All participants expressed that daily clinic visits interrupted their work and home lives and desired more take-home dosing and home delivery options. CONCLUSIONS: MOUD patients in Arizona were not offered many of the federally allowed flexibilities for access that were designed to reduce their need to be at the clinic. To understand the impact of these recommended treatment changes in Arizona, and other states where they were not well implemented, federal and state regulators must mandate these changes and support MOUD providers to implement them.

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

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.

Exploration of pharmacist comfort with harm reduction behaviors: Cross-sectional latent class analysis.

BACKGROUND: Pharmacists are positioned to play important roles in implementing evidence-based prevention and harm reduction approaches for opioid misuse and related health care outcomes such as human immunodeficiency virus (HIV) and hepatitis C. More research is needed to understand how best to facilitate harm reduction practices among pharmacists. OBJECTIVES: This hypothesis-generating study investigated (1) whether subgroups (latent classes) were observable among pharmacists based on self-reported comfort with specific harm reduction behaviors, (2) whether having reported expertise in key content areas was associated with any latent classes that might be identified, and (3) whether comfort and training were associated with actually having dispensed syringes for likely nonprescription drug use. METHODS: This was a statewide census of community managing pharmacists in Arizona conducted from December 2018 to May 2019. Participants reported their degree of comfort with 10 harm reduction behaviors, their expertise (e.g., recent continuing pharmacy education or specialization) in selected content areas, and their syringe dispensing behavior. Additional sociodemographic information was also collected. Subgroups related to harm reduction were computed using latent class analysis, and associations between study variables were assessed using the Fisher's exact tests. RESULTS: Data suggested the existence of 4 latent, comfort-based harm reduction classes: high comfort, moderate comfort, and clinical comfort, and opioid prevention only. Reported expertise in pre-exposure prophylaxis for HIV was likely associated with harm reduction class. However, class membership was not associated with reporting having dispensed nonprescription syringes, although the single comfort item for syringe dispensing, by itself, was associated therewith. CONCLUSION: Comfort with harm reduction likely clusters, so pharmacists may be broadly comfortable with topics or methods of harm reduction; however, comfort with a specific harm reduction pharmacy practice may be a better predictor of engaging in that behavior than harm reduction comfort class. In contrast, strategies to improve comfort, such as intervention development, might successfully be informed by pharmacists' latent class.

"The gatekeepers in prevention": Community pharmacist perceptions of their role in the opioid epidemic.

Background: Community pharmacists are at the frontline of patient care, yet their role in the opioid epidemic remains unclear. This qualitative study examines the perception of community pharmacists about their role in the opioid epidemic and challenges to fulfilling this role. Methods: A secondary analysis of cross-sectional survey data from an Indiana census of community managing pharmacists was conducted. Qualitative data were coded using a priori and emergent themes. A priori categories included the perceived role of pharmacists in the opioid epidemic and perception of practice barriers. Results: A total of 215 Indiana community managing pharmacists participated in this study. Pharmacists understood themselves as gatekeepers in preventing opioid misuse and overdose. Reported pharmacy practices included providing patient education and communicating with prescribers. Challenges to fulfilling this role included pharmacy structure and operation, lack of patient and provider clarity about pharmacist scope of practice, and pharmacist perception that that there is no available discretionary time to support additional services. Conclusion: Pharmacists believe they have a vital role in combatting opioid misuse and overdose but are hampered by structural aspects of pharmacy practice and lack of recognition of their role. Pharmacy associations and policy partners are encouraged to identify opportunities to address these barriers.

Perceived enablers and barriers of community engagement for vaccination in India: Using socioecological analysis.

BACKGROUND: There is high level policy consensus in India that community engagement (CE) improves vaccination uptake and reduces burden of vaccine preventable diseases. However, to date, vaccination studies in the country have not explicitly focused on CE as an outcome in and of itself. Therefore, this study sought to examine the barriers and enablers of community engagement for vaccination in India. METHODS: Employing qualitative methods, twenty-five semi-structured elite interviews among vaccine decisionmakers' were triangulated with twenty-four national-level vaccine policy documents and researcher field notes (December 2017 to February 2018). Data collected for this study included perceptions and examples of enablers of and barriers to CE for vaccination uptake. Concepts, such as the absence of formal procedures or data collection approaches related to CE, were confirmed during document review, and a final convening to review study results was conducted with study respondents in December 2018 and January 2019 to affirm the general set of findings from this study. The Social Ecological Model (SEM) was used to organize and interpret the study findings. RESULTS: Although decisionmakers and policy documents generally supported CE, there were more CE barriers than facilitators in the context of vaccination, which were identified at all social-ecological levels. Interviews with vaccine decisionmakers in India revealed complex systemic and structural factors which affect CE for vaccination and are present across each of the SEM levels, from individual to policy. Policy-level enablers included decisionmakers' political will for CE and policy documents and interviews highlighted social mobilization, whereas barriers were lack of a CE strategy document and a broad understanding of CE by decisionmakers. At the community level, dissemination of Social-behavioral Change Communication (SBCC) materials from the national-level to the states was considered a CE facilitator, while class, and caste-based power relations in the community, lack of family-centric CE strategies, and paternalistic attitude of decisionmakers toward communities (the latter reported by some NGO heads) were considered CE barriers. At the organizational level, partnerships with local organizations were considered CE enablers, while lack of institutionalized support to formalize and incentivize these partnerships highlighted by several decisionmakers, were barriers. At the interpersonal level, SBCC training for healthcare workers, sensitive messaging to communities with low vaccine confidence, and social media messaging were considered CE facilitators. The lack of strategies to manage vaccine related rumors or replicate successful CE interventions during the during the introduction and rollout of new vaccines were perceived as CE barriers by several decisionmakers. CONCLUSION: Data obtained for this study highlighted national-level perceptions of the complexities and challenges of CE across the entire SEM, from individual to systemic levels. Future studies should attempt to associate these enablers and barriers with actual CE outcomes, such as participation or community support in vaccine policy-making, CE implementation for specific vaccines and situations (such as disease outbreaks), or frequency of sub-population-based incidents of community resistance and community facilitation to vaccination uptake. There would likely be value in developing a population-based operational definition of CE, with a step-by-step manual on 'how to do CE.' The data from this study also indicate the importance of including CE indicators in national datasets and developing a compendium documenting CE best-practices. Doing so would allow more rigorous analysis of the evidence-base for CE for vaccination in India and other countries with similar immunization programs.

Insufficient Access: Naloxone Availability to Laypeople in Arizona and Indiana, 2018.

OBJECTIVES: To understand naloxone availability to laypeople in Arizona (Ariz.) and Indiana (Ind.). METHODS: Multi-source search conducted from May-December 2018 identifi ed the extent of naloxone availability to laypeople. Internet searches, email follow up, and phone interviews occurred with registered naloxone providers. RESULTS: Th ere were 89 naloxone providers in each state. Laypeople were ineligible for access for over half of registered naloxone providers in Ariz. (60.7%) and Ind. (55.1%). Naloxone access was mostly (67.4%) passive in Ariz. but was actively distributed in Ind. (67.4%). Syringe service programs (SSP) were the most frequently identifi ed providers of naloxone to laypeople in Ariz. (20.0%). In Ind., local health departments were most frequently identifi ed as layperson naloxone providers (75.0%). CONCLUSIONS: Less than half of registered naloxone providers allowed layperson access in Arizona and Indiana. Th e lack of layperson access highlights the need to review organization practice and state policy to ensure increased layperson access.

I don't even want to go to the doctor when I get sick now: Healthcare experiences and discrimination reported by people who use drugs, Arizona 2019.

BACKGROUND: People who use drugs experience severe health inequities created by structural and social barriers related to healthcare access. This includes stigma. OBJECTIVE: To characterize the experience of healthcare access among people who use drugs in Maricopa County, Arizona USA. METHODS: A 20-item guided survey with quantitative and qualitative items was fielded between October 23-November 5, 2019 among people who use drugs in community locations (public spaces, trap houses, drug copping areas). Surveys were administered face-to-face by community researchers with lived experiences. Survey recruitment included convenience sampling and social referral among respondents. Quantitative items were described and qualitative data were independently coded using an a priori coding scheme including reasons for healthcare seeking and healthcare-related stigma (anticipated, experienced, enacted). RESULTS: Over one-third (39.5%) of the185 person sample did not seek medical care in the past year. Of this group, 34.2% reported that they did not seek needed healthcare because they were afraid of being treated badly by medical providers for using drugs. The three major experiences reported by those seeking healthcare in the past year included 1) medical mistreatment (not addressing the primary medical complaint, providing wrong or inadequate treatment), 2) social mistreatment (disapproval, embarrassment, shaming) and 3) abusive behavior (verbal and physical) by healthcare providers. CONCLUSIONS: Efforts should create healthcare social and practice environments that assure appropriate and competent medical care and prohibit healthcare provider mistreatment of people who use drugs. Structural incentives such as healthcare finance, hospital accreditation and medical complaint registration should be considered.

A qualitative analysis of vaccine decision makers' conceptualization and fostering of 'community engagement' in India.

BACKGROUND: Globally, and in India, research has highlighted the importance of community engagement in achieving national vaccination goals and in promoting health equity. However, community engagement is not well-defined and remains an underutilized approach. There is also paucity of literature on community engagement's effectiveness in achieving vaccination outcomes. To address that gap, this study interviewed Indian vaccination decision makers to derive a shared understanding of the evolving conceptualization of community engagement, and how it has been fostered during India's Decade of Vaccines (2010-2020). METHODS: Semi-structured interviews were conducted with 25 purposefully sampled national-level vaccine decision makers in India, including policymakers, immunization program heads, and vaccine technical committee leads. Participants were identified by their 'elite' status among decisionmakers in the Indian vaccination space. Schutz' Social Phenomenological Theory guided development of an a priori framework derived from the Social Ecological Model. The framework helped organize participants' conceptualizations of communities, community engagement, and related themes. Inter-rater reliability was computed for a subsample of coded interviews, and findings were validated in a one-day member check-in meeting with study participants and teams. RESULTS: The interviews successfully elucidated participants' understanding of key terminology ("community") and approaches to community engagement propagated by the vaccine decision makers. Participants conceptualized 'communities' as vaccine-eligible children, their parents, frontline healthcare workers, and vaccination influencers. Engagement with those communities was understood to mean vaccine outreach, capacity-building of healthcare workers, and information dissemination. However, participants indicated that there were neither explicit policy guidelines defining community engagement nor pertinent evaluation metrics, despite awareness that community engagement is complex and under-researched. Examples of different approaches to community engagement ranged from vaccine imposition to empowered community vaccination decision-making. Finally, participants proposed an operational definition of community engagement and discussed concerns related to implementing it. CONCLUSIONS: Although decision makers had different perceptions about what constitutes a community, and how community engagement should optimally function, the combined group articulated its importance to ensure vaccination equity and reiterated the need for concerted political will to build trust with communities. At the same time, work remains to be done both in terms of research on community engagement as well as development of appropriate implementation and outcome metrics.

The Emerging Intersection Between Injection Drug Use and Early Syphilis in Nonurban Areas of Missouri, 2012-2018.

BACKGROUND: The national rate of syphilis has increased among persons who inject drugs (PWID). Missouri is no exception, with increases in early syphilis (ES), congenital syphilis, and PWID, especially in nonurban counties. METHODS: Disease intervention specialist records for ES cases in Missouri (2012-2018) were examined. Drug use was classified as injection drug use (IDU) (opioid or methamphetamine) or non-IDU (opioid, methamphetamine, or cocaine). Rates were compared based on residence, sex of sex partner, and drug use. RESULTS: Rates of ES in Missouri increased 365%, particularly in small metropolitan and rural areas (1170%). Nonurban areas reported a higher percentage of persons with ES who used injection drugs (12%-15%) compared with urban regions (2%-5%). From 2012 to 2018, women comprised an increasing number of ES cases (8.3%-21%); 93% of women were of childbearing age. Increasingly more women in rural areas with ES also reported IDU during this time (8.4%-21.1%). CONCLUSIONS: As syphilis increases in small metropolitan and rural regions, access to high-quality and outreach-based sexual health services is imperative. Healthcare policy to equip health departments with harm reduction services and drug treatment resources offers an opportunity to impact both syphilis increases as well as health outcomes associated with IDU.

Naloxone availability and dispensing in Indiana pharmacies 2 years after the implementation of a statewide standing order.

OBJECTIVES: This study examined changes in rates of pharmacy naloxone stocking and dispensing in Indiana between 2016 and 2018 and explored supplemental variables and factors that may have affected observed differences. METHODS: Researchers used data from 2 existing datasets that were collected from managing pharmacists who responded to statewide pharmacy censuses in 2016 and 2018. After identifying all cases in which a pharmacy's managing pharmacist responded in both 2016 and 2018 censuses, researchers conducted a nonparametric statistical comparison of naloxone stocking and dispensing rates in 107 Indiana pharmacies. Additional descriptive data regarding naloxone-related pharmacy policies and educational programs during those years were collected in 2019 from pharmacy corporations operating food stores or chain pharmacies in Indiana and from the Indiana Pharmacists Association. RESULTS: Pharmacy stocking and dispensing in Indiana increased from 2016 to 2018. In 2016, 57% of pharmacies reported stocking naloxone compared with 92.5% in 2018 (P < 0.001). Similarly, 23.4% of pharmacies reported dispensing naloxone in 2016 compared with 76.6% of pharmacies in 2018 (P < 0.001). All responding pharmacy corporations and the state pharmacy association reported offering self-directed volunteer-training programs regarding naloxone since 2016. In addition, they reported that company policy and procedures regarding naloxone were put into place in response to the 2016 statewide standing order. CONCLUSION: Pharmacy naloxone stocking and dispensing increased in the 2 years after the statewide standing order was issued. The effect of the order itself was likely moderated or mediated by corporate responses to the law. Research examining the impact of naloxone-availability policies on pharmacy practice and patient incomes should longitudinally examine data after policy implementation and with covariates that include type of pharmacy (e.g., chain or independent), location, and opioid overdose-associated mortality rates.

I could take the judgment if you could just provide the service: non-prescription syringe purchase experience at Arizona pharmacies, 2018.

BACKGROUND: Community pharmacies are important for health access by rural populations and those who do not have optimum access to the health system, because they provide myriad health services and are found in most communities. This includes the sale of non-prescription syringes, a practice that is legal in the USA in all but two states. However, people who inject drugs (PWID) face significant barriers accessing sterile syringes, particularly in states without laws allowing syringe services programming. To our knowledge, no recent studies of pharmacy-based syringe purchase experience have been conducted in communities that are both rural and urban, and none in the Southwestern US. This study seeks to understand the experience of retail pharmacy syringe purchase in Arizona by PWID. METHODS: An interview study was conducted between August and December 2018 with 37 people living in 3 rural and 2 urban Arizona counties who identified as current or former users of injection drugs. Coding was both a priori and emergent, focusing on syringe access through pharmacies, pharmacy experiences generally, experiences of stigma, and recommendations for harm reduction services delivered by pharmacies. RESULTS: All participants reported being refused syringe purchase at pharmacies. Six themes emerged about syringe purchase: (1) experience of stigma and judgment by pharmacy staff, (2) feelings of internalized stigma, (3) inconsistent sales outcomes at the same pharmacy or pharmacy chain, (4) pharmacies as last resort for syringes, (5) fear of arrest for syringe possession, and (6) health risks resulting from syringe refusal. CONCLUSIONS: Non-prescription syringe sales in community pharmacies are a missed opportunity to improve the health of PWID by reducing syringe sharing and reuse. Yet, current pharmacy syringe sales refusal and stigmatization by staff suggest that pharmacy-level interventions will be necessary to impact pharmacy practice. Lack of access to sterile syringes reinforces health risk behaviors among PWID. Retail syringe sales at pharmacies remain an important, yet barrier-laden, element of a comprehensive public health response to reduce HIV and hepatitis C among PWID. Future studies should test multilevel evidence-based interventions to decrease staff discrimination and stigma and increase syringe sales.

State statutes and regulations related to human papillomavirus vaccination.

A cross-sectional analysis of human papillomavirus (HPV) vaccine statutes and regulations from states and the District of Columbia in the United States (U.S.) was conducted from September-November 2018 to advance analyses of policy impact on HPV vaccination uptake. A search was conducted using WestlawNext, a legal research database. Statutes and regulations relevant to the study were analyzed and coded based on their legal attributes into ten broad coding questions and several sub-questions. Of the 212 laws identified by the initial search string, 93 (43.9%) reference HPV vaccination in statute or regulation. An additional three laws were added following subsequent review. There was a total of 52 statutes and 44 regulations from 34 states and the District of Columbia. Most laws were related to developing and distributing HPV vaccination materials for parents, and mechanisms to fund and reimburse for the vaccination. This study can be used by policymakers in jurisdictions that are considering establishing HPV vaccination promotion interventions in state law and highlighting the limited statutory and regulatory efforts that have been implemented to promote HPV vaccination. Importantly, this study can also be used to conduct evaluations of the efficacy of statutory and regulatory strategies in increasing HPV vaccination rates.