Bruton tyrosine kinase inhibitor monotherapy in B-cell lymphoma and risk of infection: A systematic review and meta-analysis of randomized controlled trials.

Bruton's tyrosine kinase (BTK) inhibitors are important therapeutic advances with promising efficacy outcomes in the treatment of patients with chronic lymphocytic leukemia and other B-cell lymphoma subtypes. However, the utility of BTK inhibitors can be limited by adverse events such as infections. In this systematic review and meta-analysis, we aim to determine the risk of various infections associated with BTK inhibitor monotherapy in B-cell lymphoma patients. A comprehensive search was conducted in MEDLINE/PubMed, Embase, and Web of Science databases from their inception until October 2023. ClinicalTrials.gov, bibliographies, and relevant conference abstracts were also searched for additional records. Randomized controlled trials that included any B-cell lymphoma patients treated with BTK inhibitor monotherapy and reported infection were included. Meta-analysis was performed to calculate risk ratio (RR) using a random-effects model in R Statistical Software, version 4.3.2. Of 3292 studies retrieved, we included 12 studies in this systematic review and meta-analysis. The median age of patients across the study arms ranged between 64 and 73 years. The overall pooled RR for any grade upper respiratory tract infections (URTI) associated with BTK inhibitor treatment was 1.55 (95% Confidence Interval (CI) 1.22-1.97). The RR of grade ≥3 URTI was reported in 14 out of 1046 patients, yielding an RR of 1.46 (95% CI 0.61-3.54), which was not statistically significant. The pooled RR of any grade pneumonia was 1.20 (95% CI 0.68-2.10) and grade ≥3 pneumonia was 1.12 (95% CI 0.67-1.85), both of which were not statistically significant. Patients with B-cell lymphoma who are undergoing BTK inhibitor monotherapy face an elevated risk of developing URTI. Clinicians prescribing BTK inhibitors should be aware of the potential infectious events that may occur. Close monitoring and the implementation of effective prophylactic measures are essential for managing these patients.

Feasibility of reaching populations at high risk for HIV in community pharmacies.

BACKGROUND: Growing evidence has shown feasibility for HIV prevention service integration in pharmacies, including HIV testing and screening for pre-exposure prophylaxis (PrEP). Yet, further work is needed to determine whether pharmacies can effectively reach those at increased risk of HIV transmission. OBJECTIVES: We aimed to describe the HIV risk profiles and willingness to obtain HIV prevention services of a sample of pharmacy clients. METHODS: This was a cross-sectional pilot study aimed to develop a culturally appropriate pharmacy-based PrEP delivery model among Black men who have sex with men (MSM). Two pharmacies were recruited from low-income, underserved communities and participants were recruited within pharmacies for screener and social and behavioral surveys. Individuals were grouped by PrEP eligibility due to sexual risk, injection drug use risk, or both, and demographic and willingness measures were compared. RESULTS: Among 460 pharmacy clients, 81 (17.6%) would have been eligible for PrEP due to sex or injection drug use risk. Most were eligible due to sexual risk (58.0%), while a substantial proportion were eligible due to injection drug use (27.2%) or a combination of sexual and injection drug use risk behaviors (42.0%). Of these eligible, median age was 31 years (IQR=28,32) and most had ≥1 female (75.3%) or male (96.3%) partner in the past 6 months. There was high willingness to receive a free HIV test in a pharmacy (90.1%). Most were willing to screen for PrEP in a pharmacy (95.1%) despite these services not being available in the state where this study was performed. There were no differences in willingness to obtain pharmacy-based HIV prevention services across risk groups. CONCLUSION: This study shows that pharmacies in disadvantaged areas can serve a key role in preventing and decreasing the transmission of HIV by reaching populations with high HIV burden and providing HIV prevention services.

Adherence, clinical benefits, and adverse effects of endocrine therapies among women with nonmetastatic breast cancer in developing countries: A systematic review and meta-analysis.

BACKGROUND: Despite significant advances in breast cancer control and survival with endocrine therapies (ETs), treatment utilization and outcomes in developing countries have not been adequately explored. This review evaluated ET adherence, potential benefits, and harms in populations across developing countries. METHODS: A literature search was conducted through August 2023 in five databases: PubMed, Cochrane Library, Web of Science, Global Health, and WHO Global Index Medicus. Retrieved records were screened to identify observational research presenting at least one outcome in women with nonmetastatic breast cancer in developing countries who received ET (tamoxifen or aromatase inhibitors). A random effects model was used to compute the rates of adherence, discontinuation, adverse events (AEs), disease progression, and death. RESULTS: A total of 104 studies met the inclusion criteria. Risk of bias was low in most studies, and a large portion of the patients involved Asians. The overall heterogeneity between studies was partially attributed to variations in study design or outcome measurement method. Results showed a pooled adherence rate of 75% (95% confidence interval [CI], 67%-81%) and a discontinuation rate of 16% (95% CI, 10%-25%). Treatment side effects and young age consistently emerged as significant predictors of nonadherence. A wide range of AEs was identified in our analysis. The estimated average rates of cancer recurrence and mortality at 5-years were 16% and 8%, respectively. CONCLUSIONS: The findings of this study underscore suboptimal ET use in developing countries and provide comprehensive insights into treatment experiences in the real-world setting. Targeted strategies are warranted to enhance adherence and subsequently optimize treatment benefits.

Using the andersen healthcare utilization model to assess willingness to screen for prep in pharmacy-based settings among cisgender sexually minoritized men: results from the 2020 american men's internet survey.

BACKGROUND: Pre-exposure prophylaxis (PrEP) to prevent HIV is severely underutilized among sexually minoritized men (SMM). Inequitable access to PrEP-prescribing facilities and providers is a critical barrier to PrEP uptake among SMM. Integrating HIV prevention services, such as PrEP screening, into pharmacy-based settings is a viable solution to addressing HIV inequities in the US. We aimed to examine willingness to obtain PrEP screening in a pharmacy and its associated correlates, leveraging Andersen's Healthcare Utilization Model (AHUM), among a national sample of SMM in the U.S. METHODS: Data from the 2020 American Men's Internet Survey, an annual online survey among SMM, were analyzed. Drawing on AHUM-related constructs, we used a modified stepwise Poisson regression with robust variance estimates to examine differences in willingness to screen for PrEP in a pharmacy. Estimated prevalence ratios (PR) were calculated with 95% confidence intervals (CI95%). RESULTS: Out of 10,816 men, most (76%) were willing to screen for PrEP in a pharmacy. Participants were more willing to screen for PrEP in a pharmacy if they (1) had a general willingness to use PrEP (PR = 1.52; CI95% =1.45, 1.59); (2) felt comfortable speaking with pharmacy staff about PrEP (PR = 2.71; CI95% =2.47, 2.98); and (3) had HIV-related concerns (PR = 1.04; CI95% =1.02, 1.06). There were no observed differences in men's willingness to screen for PrEP in a pharmacy by race/ethnicity, education level, annual household income, nor insurance status. CONCLUSIONS: Strategically offering PrEP screening in pharmacies could mitigate access-related barriers to HIV prevention services among SMM, particularly across various sociodemographic domains. Importantly, this approach has vitally important implications for addressing broader inequities in HIV prevention. Future studies should examine strategies to successfully integrate PrEP screenings in pharmacies among diverse populations, especially among those at elevated risk for HIV.

Qualitative Assessment of Barriers to Buprenorphine Access: The Role of Pharmacies.

BACKGROUND: Patients continue to face challenges accessing medication for opioid use disorder (MOUD) despite attempts to loosen prescribing restrictions and streamline service provision. Past research has mainly focused on potential barriers surrounding prescribing practices for buprenorphine, but has had limited investigation into the role of pharmacies. OBJECTIVE: This study investigates the role of both pharmacists and pharmacies in creating or circumventing barriers to accessing buprenorphine for individuals in Georgia seeking medication for opioid use disorder (MOUD). METHODS: Semi-structured interviews of pharmacists across 12 access and no access pharmacies were used to create a codebook of 179 discreet statements. The (N = 12) 20-35-minute phone interviews included questions addressing substance use, pharmacy practices, treatment, harm reduction, and psychoeducation. RESULTS: Pharmacists widely agreed that opioid use has caused negative effects on community members (N = 11), that buprenorphine formulation stocking decisions are made based on patient needs (N = 11), and that buprenorphine is relatively easy to stock (N = 10). Additionally, respondents generally stated that buprenorphine is a helpful tool for treating opioid use disorder (OUD) (N = 12) but some reported positive experiences while others reported challenging or negative experiences with patients receiving buprenorphine (N = 7). Finally, few (N = 4) pharmacists agreed that they could benefit from extra training despite many asserting that training is important to inform their own practice (N = 8). CONCLUSION: Results from respondents generally show that training may be beneficial for pharmacists to develop an enhanced understanding of addiction and treatment. Enhanced effort to stock different formulations or dosages of buprenorphine and develop relationships with prescribers may increase community access.

Individual, interpersonal, and community factors associated with health outcomes in patients with type 2 diabetes mellitus treated at federally qualified health centers.

Purpose: To examine factors of influence in diabetes management and their association with self-reported health outcomes in patients with type 2 diabetes treated at Federally Qualified Health Centers (FQHCs). Methods: This cross-sectional study examined data from the 2014 Health Center Patient Survey (HCPS). Predictor variables were categorized across three levels of the National Institute on Minority Health and Health Disparities research framework. Outcome variables retrieved from HCPS included self-reports of blood glucose levels, and diabetes-related emergency department (ED)/hospital visits during past year. Results: A total of 936 patients with diabetes were included. Most (65%) participants received a diabetes self-management plan. During the previous year, 72% received > = 2 A1C checks, 52% reported high blood glucose levels, and 12% visited an ED/hospital. Multivariable results showed that insulin use and receiving a self-management plan were associated with high blood glucose levels and ED/hospital visits. Community factors of being unable to get medications and receiving a specialist foot exam were respectively associated with high blood glucose levels and ED/hospital visits. Conclusion: Different factors were associated with health outcomes in patients with diabetes treated at FQHCs. Identifying these factors can help with targeted screening and follow-up and assessing potential interventions to improve health outcomes. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-024-01388-5.

Innovation, affordability, access: Alzheimer disease drugs and the Inflation Reduction Act.

OBJECTIVES: This analysis examines the implications of new Alzheimer disease drugs in the era of the Inflation Reduction Act (IRA). It focuses on balancing innovation in Alzheimer disease treatment with affordability and access, assessing the impact on Medicare's budget, patient cost, and health care system readiness. STUDY DESIGN: A comprehensive review was conducted, synthesizing information from recent FDA drug approvals, drug pricing models, Medicare coverage policies, and the updated regulations under the IRA. This analysis reflects on the broader clinical and economic consequences of introducing new Alzheimer disease treatments. METHODS: The study employs a qualitative review of existing literature, policy documents, and economic data. It explores the implications of Alzheimer disease drugs on health care policy, analyzing the economic and clinical impacts within the current health care landscape in the US. RESULTS: The study highlights the economic challenges posed by the high costs of new Alzheimer disease drugs, contrasting with their moderate clinical benefits and potential risks. It discusses the limitations of the IRA in regulating drug prices and the resulting implications for Medicare's budget. Additionally, it examines disparities in health care access and system preparedness for these new treatments. CONCLUSIONS: The study findings underscore the need for a comprehensive approach to ensure fair pricing and equitable access to Alzheimer disease treatments. It suggests the application of frameworks such as the ISPOR Value Flower, focusing on diversity, equity, and comprehensive economic evaluations, to navigate the evolving landscape of Alzheimer disease treatment in the context of the IRA.

Implementation Science of Integrating Pre-Exposure Prophylaxis in Pharmacist-Led Services in the United States.

BACKGROUND: Racial inequities in HIV in the United States (US) are pervasive. Pre-exposure prophylaxis (PrEP) is one of the most effective yet underutilized HIV prevention strategies, and stark inequities in PrEP uptake exist. Lack of access to PrEP clinics is a major barrier to access that could be overcome by integrating pharmacists into the provision of PrEP services including prescribing and dispensing. METHODS: A number of reviews have shown promise in folding pharmacies into the expansion of PrEP services, but this review extends those by examining the implementation science evidence of pharmacist-led PrEP services in the US. We reviewed literature over the past five years of the implementation science of pharmacist PrEP services (2018-2023) and present seminal findings in this area. RESULTS: Only two studies are anchored within an implementation science framework despite all studies assessing common implementation science constructs. Overwhelming evidence supports feasibility and adoption of PrEP services in pharmacies yet gaps in workflow integration, scalability and sustainability exist. CONCLUSION: Continuing to build the implementation science evidence of pharmacy-based PrEP services is critical to standardize our measures across varying contexts and inform policy efforts that support pharmacy-based PrEP services.

The Association Between Type of Insurance Plan, Out-of-Pocket Cost, and Adherence to Antihypertensive Medications in Medicare Supplement Insurance Enrollees.

BACKGROUND: Medicare supplement insurance, or Medigap, covers 21% of Medicare beneficiaries. Despite offsetting some out-of-pocket (OOP) expenses, remaining OOP costs may pose a barrier to medication adherence. This study aims to evaluate how OOP costs and insurance plan types influence medication adherence among beneficiaries covered by Medicare supplement plans. METHODS: We conducted a retrospective analysis of the Merative MarketScan Medicare Supplement Database (2017-2019) in Medigap enrollees (≥65 years) with hypertension. The proportion of days covered (PDC) was a continuous measure of medication adherence and was also dichotomized (PDC ≥0.8) to quantify adequate adherence. Beta-binomial and logistic regression models were used to estimate associations between these outcomes and insurance plan type and log-transformed OOP costs, adjusting for patient characteristics. RESULTS: Among 27,407 patients with hypertension, the average PDC was 0.68 ±â€…0.31; 47.5% achieved adequate adherence. A mean $1 higher in 30-day OOP costs were associated with a 0.06 (95% confidence intervals [CIs]: -0.09 to -0.03) lower probability of adequate adherence, or a 5% (95% CI: 4%-7%) decrease in PDC. Compared with comprehensive plan enrollees, the odds of adequate adherence were lower among those with point-of-service plans (odds ratio [OR]: 0.69, 95% CI: 0.62-0.77), but higher among those with preferred provider organization (PPO) plans (OR: 1.08, 95% CI: 1.01-1.15). Moreover, the association between OOP costs and PDC was significantly greater for PPO enrollees. CONCLUSIONS: While Medicare supplement insurance alleviates some OOP costs, different insurance plans and remaining OOP costs influence medication adherence. Reducing patient cost-sharing may improve medication adherence.

Epidemiological trends and clinical outcomes of cryptococcosis in a medically insured population in the United States: a claims-based analysis from 2017 to 2019.

Background: Emerging risk factors highlight the need for an updated understanding of cryptococcosis in the United States. Objective: Describe the epidemiological trends and clinical outcomes of cryptococcosis in three patient groups: people with HIV (PWH), non-HIV-infected and non-transplant (NHNT) patients, and patients with a history of solid organ transplantation. Methods: We utilized data from the Merative Medicaid Database to identify individuals aged 18 and above with cryptococcosis based on the International Classification of Diseases, Tenth Revision diagnosis codes from January 2017 to December 2019. Patients were stratified into PWH, NHNT patients, and transplant recipients according to Infectious Diseases Society of America guidelines. Baseline characteristics, types of cryptococcosis, hospitalization details, and in-hospital mortality rates were compared across groups. Results: Among 703 patients, 59.7% were PWH, 35.6% were NHNT, and 4.7% were transplant recipients. PWH were more likely to be younger, male, identify as Black, and have fewer comorbidities than patients in the NHNT and transplant groups. Notably, 24% of NHNT patients lacked comorbidities. Central nervous system, pulmonary, and disseminated cryptococcosis were most common overall (60%, 14%, and 11%, respectively). The incidence of cryptococcosis fluctuated throughout the study period. PWH accounted for over 50% of cases from June 2017 to June 2019, but this proportion decreased to 47% from July to December 2019. Among the 52% of patients requiring hospitalization, 61% were PWH and 35% were NHNT patients. PWH had longer hospital stays. In-hospital mortality at 90 days was significantly higher in NHNT patients (22%) compared to PWH (7%) and transplant recipients (0%). One-year mortality remained lowest among PWH (8%) compared to NHNT patients (22%) and transplant recipients (13%). Conclusion: In this study, most cases of cryptococcosis were PWH. Interestingly, while the incidence remained relatively stable in PWH, it slightly increased in those without HIV by the end of the study period. Mortality was highest in NHNT patients.

Epidemiological trends of cryptococcosis in the US The epidemiology and outcomes of cryptococcosis across the United States have not been recently examined. This study analyzed an insured population from 2017 to 2019 and revealed a relatively stable incidence of cryptococcosis among people with HIV, while concurrently demonstrating a slightly increased incidence among individuals without HIV. Notably, mortality rates were highest among non-HIV-infected and non-transplant patients.

Collaborative drug therapy modification (CDTM): Facilitators, barriers, and perceptions of individual pharmacist participation in Georgia.

BACKGROUND: Georgia Board of Pharmacy (BOP) regulations permit pharmacists to engage in collaborative drug therapy modification (CDTM) with physicians, allowing them to perform patient assessments, adjust pharmacotherapy, and order laboratory tests. Pharmacist-led CDTM can positively affect health outcomes leading to reduced healthcare expenditures. CDTM is underutilized, with < 1% of Georgia pharmacists holding an active license to practice CDTM. OBJECTIVE(S): The objective of this study was to examine CDTM licensed pharmacists' perceptions of facilitators and barriers in providing CDTM. METHODS: Georgia-licensed CDTM pharmacists were invited to participate in a 60-minute qualitative interview. Interview questions were developed from electronic survey responses. The interview was designed to elicit information regarding perceived benefits and barriers to CDTM implementation. Guided by the Consolidated Framework for Implementation Research, thematic analysis was applied to identify themes using ATLAS.ti software to code. Themes were described qualitatively and prevalence of each was reported. RESULTS: Nine interviews were conducted, and data saturation was achieved at interview 6. After resolution of discrepancies, 100% coding agreement was reached among 2 independent researchers. Nine themes were identified, and each was categorized as a facilitator or barrier to establishing pharmacist-led CDTM in Georgia. Themes associated with facilitating were (prevalence %) (1) practice autonomy (100), (2) personal attributes (100), (3) having support (100), and (4) institutional logistics (88). Barrier themes included issues concerning (5) the Georgia BOP (100), (6) pharmacist autonomy (88), (7) lack of provider status (88), (8) institutional restrictions (75), and (9) personal development (e.g., confidence) (22). CONCLUSION: Facilitators to the establishment of pharmacist-led CDTM exist and pharmacists can capitalize on these to create successful CDTM programs. Barriers are varied, and it may be difficult to systematically address individual barriers such as pharmacist autonomy and personal development. Barriers associated with institutional restrictions, the Georgia BOP, and lack of provider status can likely be removed or addressed by policy.

Addressing buprenorphine supply barriers: A guidance commentary.

The current supply-side constraints limiting buprenorphine availability at pharmacies may reduce the potential impact of recent initiatives to improve medications for opioid use disorder (MOUD) access. The recent opioid litigation combined with existing federal regulation and enforcement has resulted in significant restrictions to the distribution and dispensing practices of pharmaceutical wholesalers and pharmacies countrywide. Previously discussed solutions to these problems do not seem to have produced actionable improvements to the current landscape. However, a novel solution to this problem may exist in the form of a Drug Enforcement Administration (DEA) guidance letter. These guidance letters allow the DEA to communicate directly to registrants, providing detailed interpretation and clarity regarding the DEA's expectations and enforcement realities. Recently, the DEA guidance letter portal was used to remind registrants that the DEA does not create quantitative thresholds or volume limits on controlled substance distribution. An additional guidance letter could be issued to ease the concerns about liability connected to the distribution and dispensing of buprenorphine. In particular, this guidance could acknowledge certain terms of the distributor settlement agreement as legal precedent and clarify that buprenorphine is not subject to the same restriction as other defined "highly diverted" controlled substances. Such guidance may also serve to provide both pharmaceutical wholesalers and pharmacies with assurance that an increase in buprenorphine distribution would not directly result in increased DEA scrutiny. This strategy represents an actionable step toward the goal of providing better access to MOUD by reducing existing supply-side limitations.

The availability of fentanyl test strips in Georgia community pharmacies.

BACKGROUND: Fentanyl test strips (FTS) are increasingly being used to test counterfeit pharmaceuticals and illicit drugs for fentanyl before consumption. On July 1, 2022, Georgia legalized the distribution of FTS. One strategy for expanding FTS distribution in the community involves leveraging community pharmacies. However, less is known about FTS distribution through community pharmacies. OBJECTIVES: This preliminary study aimed to assess the availability of FTS in Georgia community pharmacies and examine pharmacists' knowledge and attitudes regarding FTS provision. METHODS: This study used a cross-sectional design. A randomized telephone survey of 700 pharmacies, stratified by pharmacy type, was carried out from September 2022 to January 2023. Survey questions assessed FTS stock status, pharmacists' awareness of Georgia's FTS legalization, willingness to receive FTS information, and comfort in providing FTS education. Descriptive statistics and multivariate logistic regression analyses were used to analyze the data. RESULTS: Of the 376 survey respondents, the vast majority were not aware of the Georgia FTS legalization (82.71% [n = 311]) and did not have FTS stocked in their pharmacies (94.91% [n = 354]). While most participants were willing to receive FTS information (70.21% [n = 264]), only slightly over half reported feeling comfortable providing FTS education (54.70% [n = 205]). Multivariate analyses showed that female participants were less likely to feel comfortable providing FTS education to patients/clients at the pharmacy (adjusted odds ratio: 0.58; confidence interval: 0.36 to 0.92). CONCLUSION: Findings suggest that Georgia community pharmacies may not stock FTS and that pharmacists may be unaware of the state's FTS legalization, but they are willing to receive information about FTS. Future studies should use a representative sample to design and implement strategies to support pharmacists' provision of FTS, including a destigmatization approach for those not comfortable discussing FTS.

Racial and ethnic differences in patterns of use and discontinuation of long-acting injectable antipsychotics using Medicaid claims data.

Introduction: In general, racial and ethnic differences exist in antipsychotic prescription practices. However, little is known about such differences between individual long-acting injectable (LAI) antipsychotic formulations, specifically. This study's primary objective was to determine racial and ethnic differences among LAI antipsychotic use. Secondary objectives were to identify if discontinuation rates differed between agents and by race or ethnicity. Methods: International Classification of Diseases, 10th edition (ICD-10) codes were used to identify patients with schizophrenia and related disorders (18-64 years) who received an LAI antipsychotic between 2016 and 2020 using Merative Multi-State Medicaid databases. Using National Drug Code numbers for LAI antipsychotics, pharmacy claims were identified and data analyzed. Cochran-Mantel-Haenszel tests and odds ratio estimators were used to investigate conditional association between race or ethnicity and medication, while controlling for age, sex, health plan, and prescription year. Kaplan-Meier survival curves were examined, and stratified log-rank tests were conducted to compare the time until discontinuation distributions by race or ethnicity. Results: The analysis included 37 712 patients. Blacks received an LAI first-generation antipsychotic more often than Whites (OR: 1.64, 95% CI: [1.56, 1.73], Hispanics (OR: 1.46, 95% CI: [1.21, 1.75]) and others (OR: 1.44, 95% CI: [1.20, 1.73]). Aside from fluphenazine decanoate showing earlier discontinuation rates for Whites over Blacks (P = .02), no significant differences in discontinuation across race or ethnicity were identified. Discussion: Despite no significant differences in second-generation antipsychotic LAI discontinuation rates between Blacks and other racial or ethnic groups, Blacks received second-generation antipsychotic LAIs significantly less often than other groups. Further studies are needed to determine why differences may be occurring.

ART-related medication errors in hospitalized people with HIV in the INSTI-era: analysis from 2 health systems in South Georgia, U.S.

ABSTRACTART-related medication errors occur at high rates in hospitalized people with HIV (PWH), but few studies included modern regimens. As such, we evaluated ART-related medication errors in hospitalized PWH in an era where use of INSTI-based regimens dominate. This multi-center, retrospective cohort included PWH at least 18 years hospitalized in South Georgia, U.S. between March 2016 and March 2018. Of those eligible for inclusion, 400 were randomly selected and included. Three hundred sixty-three inpatient ART-related medication errors occurred in 203 patients during the study period due to incorrect scheduling (44%), an incorrect or incomplete regimen (27%), and drug-drug interactions (27%). Approximately 25% of errors persisted to discharge. Medication errors were more likely to occur in patients receiving NNRTI- or PI-containing multi-tablet regimens, whereas those receiving INSTI-containing multi-tablet regimens were less likely to experience a medication error. ART-related medication errors are less likely in patients receiving INSTI-containing multi-tablet regimens. Ensuring appropriate transition of ART throughout hospitalization remains an area in need of significant improvement.

Community pharmacists' naloxone counseling: A theory-informed qualitative study.

BACKGROUND: Opioid-related overdose (ORO) deaths have reached a record high in the United States. Naloxone is an opioid antagonist that can rapidly reverse an opioid overdose. Pharmacists are in an ideal position to provide naloxone and related counseling, given their accessibility and expertise. However, minimal research is available on community pharmacists' naloxone counseling. OBJECTIVES: The aim of this study was to investigate Georgia community pharmacists' naloxone counseling as well as explore their attitudes, subjective norms, and perceived behavioral control toward counseling. METHODS: Semi-structured telephone interviews were conducted to elicit pharmacists' beliefs and practices regarding naloxone counseling. The interviews were guided by open-ended questions based on the theory of planned behavior (TPB). Thematic analysis was performed to identify the modal salient beliefs expressed by the pharmacists. The Consolidated Criteria for Reporting Qualitative Research was used to report the study findings. RESULTS: A total of 12 community pharmacists participated. Pharmacists held mixed attitudes toward naloxone counseling. While they recognized it as a vital part of their profession to prevent ORO deaths, they also expressed concerns about offending patients. Regarding normative beliefs, pharmacists identified several groups, including regulatory agencies (e.g., Board of Pharmacy, CDC), managers, news/media, patients, and doctors, influencing their provision of naloxone counseling. Facilitators to counseling included receiving naloxone training and having access to counseling guidelines and resources. Reimbursement issues, high costs of naloxone, and lack of patient awareness were the most commonly cited barriers. Pharmacists reported participating in counseling and providing information on identifying signs of opioid overdose and administering naloxone. CONCLUSIONS: The TPB is a useful framework for understanding community pharmacists' beliefs and practices regarding naloxone counseling. Capitalizing on facilitators and targeting barriers related to pharmacists' reimbursement issues, high costs of naloxone, and increasing patients' awareness of naloxone use and benefits may enhance pharmacists' naloxone counseling.

Examination of HIV Preexposure Prophylaxis Need, Availability, and Potential Pharmacy Integration in the Southeastern US.

Importance: Daily preexposure prophylaxis (PrEP) use can prevent up to 99% of HIV infections; however, PrEP uptake is low due to poor access to PrEP-prescribing locations for populations at increased risk for HIV, especially in the southeastern US. Pharmacies are a feasible option to increase PrEP access, but little is known about how they could complement current PrEP-prescribing locations. Objective: To examine geographic distributions of current PrEP-prescribing locations compared with pharmacies and the facility to need ratios (PFNRs) according to HIV risk in the Southeast and describe the potential reach of pharmacies to expand PrEP access. Design, Setting, and Participants: Data for this cross-sectional study of PrEP-prescribing locations and pharmacies were compiled from January 1 to December 31, 2021. States or specific counties in the Southeast included in this study were jurisdictions identified as high-priority areas for the Ending the HIV Epidemic in the US (EHE) initiative. Exposure: Expansion of HIV prevention services to pharmacies. Main Outcomes and Measures: Choropleth maps of 5-year HIV risk per 100 000 persons were developed for EHE jurisdictions in the southeastern US. PrEP-prescribing locations (obtained from a national database of PrEP prescribers) and pharmacies (obtained from state pharmacy boards) were overlayed on HIV risk maps. The PFNRs by state were calculated as number of facilities (PrEP-prescribing locations or pharmacies) divided by 5-year HIV risk per 100 000 persons. Lower PFNRs indicated lower geographic availability of locations to meet the needs of the population at risk for HIV. The PFNRs for current PrEP-prescribing locations vs pharmacies were compared. Results: Among the 2 southeastern states and 13 counties in 4 southeastern states included, PrEP-prescribing locations were unequally distributed across EHE areas, with substantially fewer in areas at high risk for HIV. Pharmacies were evenly dispersed across areas regardless of HIV risk. The mean PFNR across all states for current PrEP-prescribing locations was 0.008 (median, 0.000 [IQR, 0.000-0.003]); for pharmacies, it was 0.7 (median, 0.3 [IQR, 0.01-0.1]). The PFNRs were at least 20.3 times higher for pharmacies compared with PrEP-prescribing locations. States with the greatest potential increase in PFNRs with expansion to pharmacies included Kentucky, South Carolina, and Tennessee. Conclusions and Relevance: The findings of this cross-sectional study suggest that expanding HIV prevention services to pharmacies in EHE areas in the Southeast could significantly increase capacity to reach individuals at increased risk of HIV transmission. Legislation aimed at allowing pharmacists to prescribe PrEP and provide HIV prevention services may be an important next step in ending the HIV epidemic.

Impact of patient-centered prescription medication labels on adherence in community pharmacy.

BACKGROUND: Prescription medication labels are often constructed in a manner which hinders safe and appropriate use of medicines. The United States Pharmacopeia released voluntary standards to revise medication labels in an effort to support patients' understanding and improve medication use. OBJECTIVE: To examine the impact of label changes on medication adherence before and after pharmacy implementation of the United States Pharmacopeia patient-centered prescription medication label standards. METHODS: This study used a retrospective pre-post cohort design. Prescription fill claims data were obtained from a community health plan serving Medicaid patients for 1 independent community pharmacy organization across 8 retail pharmacy sites. We calculated medication possession ratios (MPR) and proportion of days covered (PDC) for medications used for contraception, asthma, hypertension, and depression from 15 months before to 13 months after implementation of the label changes. RESULTS: Findings showed significant increases in mean MPR for asthma controller (increased by 0.111 [t = 0.290, P<0.0001]), antihypertensives (increased by 0.062 [t = 0.146, P < 0.0002]), and contraceptives medications (increased 0.133 [t = 0.209, P < 0.0001]) from preintervention to postintervention periods. Results also revealed increases in mean PDC for asthma controllers (increased by 0.193 [t = 0.267, P < 0.0001]), antihypertensives (increased by 0.067 [t = 0.175, P = 0.049]), and contraceptives (increased by 0.111 [t = 0.208, P < 0.0119]) from preintervention to postintervention periods. CONCLUSION: We report an association between a change to more patient-centered prescription medication labels and increased medication adherence based on MPR and PDC among Medicaid recipients.

Demographic and socioeconomic correlates to buprenorphine access in pharmacies.

BACKGROUND: Research has focused on buprenorphine prescribing with limited attention to the role of pharmacy access to buprenorphine for opioid use disorder. OBJECTIVE: This study examines demographic and socioeconomic correlates to buprenorphine access in Georgia pharmacies. METHODS: A 5-question (12 potential subqueries) telephone administered survey was used to investigate access and stocking patterns of specific dosages and formulations of buprenorphine in Georgia pharmacies (n = 119). Descriptive statistics characterized physician and pharmacy demographics and buprenorphine stocking practices. Correlations between various factors including buprenorphine stocking practices, geographic, and sociodemographic characteristics were identified using nonlinear regression models. RESULTS: The majority of pharmacies stocked the most commonly prescribed 8/2 mg dosage strength of buprenorphine/naloxone films and tablets (69.0% and 63.0%, respectively). Other strengths were less likely to be readily available. Pharmacies in Suburban Census tracts were 77.0% more likely to stock any type of buprenorphine monotherapy [odds ratio (OR) = 1.77, t = 2.37, P < 0.05] and 58.1% more likely to stock the 8 mg buprenorphine monotherapy formulation [OR = 1.58, t = 2.15, P < 0.05] than Urban tracts. Pharmacies in areas with above-average non-White populations were 29.6% more likely to stock a monotherapy product [OR = 1.30, t = 2.16, P < 0.05], and those in areas with above-average poverty rates were more likely to stock the 8 mg/2 mg buprenorphine/naloxone tablets [OR = 1.04, t = 2.02, P < 0.05]. There were no additional differences across the sample in formulation or dosage strengths. Pharmacists who endorsed challenges dispensing buprenorphine (23.3%) cited issues around insurance coverage, payment difficulty, prior authorization issues, and low stock of specific formulations. CONCLUSIONS: Results suggest that low availability of certain dosages or formulations of buprenorphine in local pharmacies could obstruct access for patients. Future research should address barriers to supplying buprenorphine and collaborative measures between pharmacists and prescribers to improve access.