Time and motion study of hepatitis C virus point-of-care testing in community pharmacies.

BACKGROUND: Point-of-care (POC) testing for hepatitis C virus (HCV) is readily available for implementation in community pharmacies, but it is unknown how feasible administration of the tests would be in the current community pharmacy model. OBJECTIVE: The primary objective of this study was to describe time associated with each step in a pharmacy HCV screening program and compare the results to influenza management in the pharmacy workflow. METHODS: For this time and motion study, the process was broken into 10 categories. A standardized patient was used for each location to accurately assess and compare the integration of HCV testing in the various workflows. Data were collected for each category during 2 random visits at each of 6 community pharmacies. Times were averaged, and a standard deviation calculated for each specific category. The data were then compared to previous time-in-motion values collected for influenza management. RESULTS: The average total time (patient identification to completion of visit) to complete the HCV POC test was 59 minutes 44 seconds (+/- 9:23). The average time that pharmacists and technicians actively spent with each patient was 10 minutes 23 seconds and 11 minutes 20 seconds, respectively. The average labor cost per patient for pharmacists and technicians were $11.55 and $3.75, respectively. CONCLUSION: The hands-on time requirements and workflow associated with offering HCV screening in a pharmacy using the Oraquick HCV rapid antibody test were similar to those noted with other pharmacy based POC testing services. Labor costs could be lessened by delegation of some non-clinical functions to a qualified pharmacy technician. We suggest an HCV rapid antibody test can be incorporated into pharmacy workflow with reasonable efficiency.

Implementation and Evaluation of a Collaborative, Pharmacy-Based Hepatitis C and HIV Screening Program.

INTRODUCTION: Pharmacy-based HIV and hepatitis C virus (HCV) screening services developed in conjunction with state and local health departments can improve public health through increased access to testing and a linkage-to-care strategy. The objective of this study was to evaluate the impact of implementing HIV and HCV screening in community pharmacies. METHODS: This prospective, multicenter implementation project was conducted from July 2015 through August 2018. Sixty-one pharmacies participated in 3 US regions. We assessed the effectiveness of point-of-care testing, counseling, and disease education for populations at increased risk for HIV and HCV infection through screening programs offered in community pharmacies. Pharmacy customers were offered screening with point-of-care HIV and/or HCV tests. Reactive test results were reported to state or local health departments for disease surveillance. RESULTS: A total of 1,164 patients were screened for HIV, HCV, or both at the 61 participating pharmacies; the average number of patients screened per pharmacy was 19. Pharmacists conducted 1,479 HIV or HCV tests among the 1,164 patients. Five of 612 (0.8%) HIV tests yielded a reactive result, and 181 of 867 (20.9%) of HCV tests yielded a reactive result. CONCLUSION: Patients at increased risk of HIV or HCV can benefit from screening for infection at community pharmacies. Ease of accessibility to testing coupled with a strategy for linkage to care designed for the local community can improve patient care and improve the course of treatment for HIV and HCV.

Support and perceived barriers to implementing pre-exposure prophylaxis screening and dispensing in pharmacies: Examining concordance between pharmacy technicians and pharmacists.

OBJECTIVES: Recent legislation to expand pre-exposure prophylaxis (PrEP) screening and dispensing in pharmacies may significantly improve PrEP access for people at a high risk of human immunodeficiency virus (HIV) transmission. Studies have shown that pharmacists show wide support for PrEP expansion in pharmacies. However, pharmacy technicians are often the first point of contact for patients in pharmacies and are required to implement many of the tasks to ensure patients of a pharmacy receive adequate services. The purpose of this study was to assess pharmacists' and pharmacy technicians' perspectives regarding the implementation of PrEP screening and dispensing. METHODS: We qualitatively examined whether pharmacy technicians' (n = 6) support and perceived barriers to screening and dispensing PrEP in pharmacies were concordant with those of pharmacists (n = 7). Pharmacy staff were recruited from high-risk HIV neighborhoods in Atlanta, GA using AIDSVu (Atlanta, GA). Two independent coders used MAXQDA (Berlin, Germany) and performed thematic data analysis and unitization to determine agreement. RESULTS: Pharmacists and pharmacy technicians expressed strong willingness and support for screening and dispensing PrEP in pharmacies. Both groups expressed concerns about the time and the resources needed to perform PrEP screening and dispensing. Technicians, however, also reported concerns about privacy for patients, the need for community support and awareness of pharmacy-based PrEP screening, and recommended scheduling of PrEP screening activities during a limited part of the day to facilitate screening. Pharmacists reported fewer barriers but reported a need for more training of pharmacy staff to assist with PrEP screening and dispensing implementation. CONCLUSION: Pharmacy technicians discussed more barriers compared with pharmacists who were largely centered around practical considerations (i.e., logistics and workflow) that may affect the success of PrEP screening and dispensing. Given technicians' pivotal role in the pharmacy, implementation of pharmacy-based PrEP services should address technicians' perceived barriers in addition to those of pharmacists.

Predictors and Costs of 30-Day Readmissions After Index Hospitalizations for Alcohol-Related Disorders in U.S. Adults.

BACKGROUND: In 2015, the Hospital Readmissions Reduction Program mandated financial penalties to hospitals with greater rates of readmissions for certain conditions. Alcohol-related disorders (ARD) are the fourth leading cause of 30-day readmissions. Yet, there is a dearth of national-level research to identify high-risk patient populations and predictors of 30-day readmission. This study examined patient- and hospital-level predictors for index hospitalizations with principal diagnosis of ARD and predicted the cost of 30-day readmissions. METHODS: The 2014 Nationwide Readmissions Database was used to identify ARD-related index hospitalizations. Multivariable logistic regression was used to estimate patient- and hospital-level predictors for readmissions, and a 2-part model was used to predict the incremental cost conditional upon readmission. RESULTS: In 2014, 285,767 index hospitalizations for ARD were recorded, and 18.9% of ARD-associated hospitalizations resulted in at least one 30-day readmission. Patients who were males, aged 45 to 64 years, Medicaid enrollees, living in urban and low-income areas, or with 1 to 2 comorbidities had high risk of readmission. Index hospitalization costs were higher among readmitted patients ($8,840 vs. $8,036, p < 0.01). Predicted mean costs for readmissions on index stay with ARD were greater among those aged 45 to 64 years ($1,908, p < 0.001), Medicare enrollees ($2,133, p < 0.001), rural residents ($1,841, p < 0.01), living in high-income areas ($1,876, p < 0.001), with 4 or more comorbidities ($2,415, p < 0.001), or admitted in large metropolitan hospitals ($2,032, p < 0.001), with large number of beds ($1,964, p < 0.001), with government ownership ($2,109, p < 0.001), or with low volume of ARD cases ($2,155, p < 0.001). CONCLUSIONS: One in 5 ARD-related index hospitalizations resulted in a 30-day readmission. Overall, costs of index hospitalizations for ARD were $2.3 billion, of which $512 million were spent on hospitalizations that resulted in at least 1 readmission. There is a need to develop patient-centric health programs to reduce readmission rates and costs among ARD patients.

Evaluation of a community pharmacy-based influenza and group A streptococcal pharyngitis disease management program using polymerase chain reaction point-of-care testing.

OBJECTIVES: The purpose of this study was to demonstrate the feasibility of implementing a Clinical Laboratory Improvement Amendments-waived real-time polymerase chain reaction (PCR) molecular test into a community pharmacy setting as part of a collaborative influenza and group A Streptococcus (GAS) disease management program. SETTING AND PARTICIPANTS: Two community pharmacy sites in Tennessee. PRACTICE DESCRIPTION: Patients presenting to the pharmacy with symptoms consistent with influenza or GAS from November 1, 2016, to April 30, 2018. PRACTICE INNOVATION: Influenza and GAS management programs based on previously developed protocols occurred at 2 community pharmacies in Tennessee. Pharmacies used the Cobas Liat testing system (Roche Diagnostics). Based on test results and under a collaborative practice agreement, pharmacists dispensed prescription medications for patients with a positive test: oseltamivir for influenza and amoxicillin for GAS. Patients with negative tests were treated with over-the-counter (OTC) medications or referred. Patients testing negative for GAS were asked to consent to having a second throat swab sent for culture. EVALUATION: Number of patients tested, point-of-care test results, and treatment received. RESULTS: Two hundred and two patients received care at the 2 pharmacies (116 for influenza, 46 for GAS, and 43 for both). Sixty (38%) tested positive for influenza, with 51 receiving an antiviral prescription, and 16 (18%) tested positive and were treated for GAS. No patient testing negative for either or positive for influenza was dispensed an antibiotic. For patients consenting to a follow-up culture, all GAS cultures sent for confirmatory testing were negative. CONCLUSION: A protocol-driven community pharmacy-based disease management program using real-time PCR testing for influenza and GAS was able to offer appropriate treatment to patients without overuse of antibiotics.

Time and motion study of pharmacist prescribing of oral hormonal contraceptives in Oregon community pharmacies.

OBJECTIVES: The aim of this time and motion study was to evaluate the procedural time and steps of performing an oral hormonal contraceptive pharmacist prescribing service in an Oregon community pharmacy. METHODS: A standardized patient seeking oral hormonal contraception visited 13 community pharmacies throughout February 2018 in the tri-county Portland, Oregon, metropolitan area for pharmacist-prescribed hormonal contraception services for a total of 26 patient encounters. An observer was present at each encounter to record the time for each step and the total encounter time. Each pharmacist was asked to perform assessment procedures and prescribing for each of 2 standardized patient presentations: in cohort 1 (n = 13), the pharmacist's assessment resulted in a hormonal contraception prescription written; in cohort 2 (n = 13), pharmacist's assessment detected contraindications and resulted in a medical referral to another health care prescriber. RESULTS: The average total patient time from arrival at the pharmacy to the generation of either a written prescription for hormonal contraception or referral to another health care provider was 17.9 and 14.1 minutes, respectively. Without accounting for documentation or dispensing the prescription, the average total pharmacist time to perform the service and issue a prescription, or refer the patient, was 7.8 and 5.4 minutes, respectively. CONCLUSION: The results indicate that the pharmacist prescribing service for oral hormonal contraception requires a modest amount of pharmacist time. Incorporation of practice into regular workflow appears to have an impact similar to other clinical services, such as immunizations and point-of-care testing. The patient time spent with the pharmacist was similar to other health care provider visits.

Pharmacist-Provided Pharmacogenetic Point-of-Care Testing Consultation Service: A Time and Motion Study.

Background: With recent advances in pharmacogenomics (PGx) comes the potential to customize medication use based on genetic data. Support for PGx has found practical limitations in terms of workflow and turnaround time of a test. However, with the expansion of point-of-care testing (POCT) in pharmacy practice models comes opportunity for PGx testing in the pharmacy setting. Objective: The purpose of this study is to quantify the amount of time spent during each step of a PGx POCT encounter in a community pharmacy setting. Methods: A time and motion study was conducted using a mock community pharmacy space for a simulated PGx-focused encounter to manage antiplatelet therapy following hospital discharge. PGx POCT was conducted using the Spartan RX instrument. Simulated patient encounters were divided into 7 categories. Time spent in each step, as well as total time spent, was tracked. Results: A total of 54 simulated PGx POCT encounters took place with an average time of 9.49 minutes (SD ± 1.38 minutes). Instrument run time adds 60 minutes to the total time required to obtain a result. Duties that could be performed by an appropriately trained pharmacy technician totaled 6.86 minutes. Conclusions: PGx POCT would require 9.49 minutes of pharmacy staff hands-on time for the encounter, which could be reduced to 2.64 minutes of pharmacist time with appropriate pharmacy technician involvement. Time requirements for PGx POCT are similar to that of community pharmacy-based immunizations. Future studies could explore how practice could change if PGx testing were routinely performed in the pharmacy.

Community pharmacist-physician collaborative streptococcal pharyngitis management program.

OBJECTIVES: To describe patient outcomes associated with a community pharmacy-based, collaborative physician-pharmacist group A Streptococcus (GAS) management program. SETTING: Fifty-five chain and independent community pharmacies in Michigan, Minnesota, and Nebraska. PRACTICE INNOVATION: Pharmacists screened clinically stable adult patients who presented with signs and symptoms consistent with GAS pharyngitis from October 1, 2013, to August 1, 2014, by means of Centor criteria, and performed a physical assessment followed by a rapid antigen detection test (RADT) for eligible patients. Patients were treated according to a collaborative practice agreement (CPA) with a licensed prescriber or a physician consult site model. Pharmacists followed up with patients 24-48 hours after the encounter to assess patient status and possible need for further intervention. EVALUATION: Number of patients screened, tested, and treated, and health care utilization. RESULTS: Of 316 patients screened, 43 (13.6%) were excluded and referred for care. Of 273 patients (86.4%) eligible for testing, 48 (17.6%) had positive test results and 46 (16.8%) received amoxicillin or azithromycin per the CPA. Of those tested, 43.2% had no primary provider and 43.9% visited the pharmacy outside of traditional clinic office hours. CONCLUSION: Pharmacists demonstrated the ability and capacity to provide care for patients seeking treatment for pharyngitis. The number of patients without a primary care provider and seen at the pharmacy outside of normal office hours highlights the improved access that community pharmacy-based care offers.

Effectiveness of a pharmacist-physician collaborative program to manage influenza-like illness.

OBJECTIVES: To examine the effectiveness of collaborative physician-community pharmacist programs to treat influenza-like illness (ILI) with respect to clinical outcomes and health care utilization. DESIGN: Prospective multicenter cohort study. SETTING: Fifty-five pharmacies in Michigan, Minnesota, and Nebraska. PATIENTS: Adult patients presenting to the pharmacy with ILI during the 2013-14 influenza season (October 1, 2013 to May 30, 2014). INTERVENTION: Pharmacists screened adult patients presenting with ILI, completed a brief physical assessment, performed a point-of-care rapid influenza diagnostic test (RIDT), and provided appropriate referral or treatment per an established collaborative practice agreement (CPA) with a licensed prescriber. Pharmacists followed-up with patients 24 to 48 hours after the encounter to assess patient status and possible need for further intervention. MAIN OUTCOME MEASURES: Number of patients screened, tested, and treated for influenza. RESULTS: Of the 121 patients screened, 45 (37%) were excluded and referred to their primary care provider or an urgent care facility for management. Of the 75 patients (62%) eligible for participation, 8 (11%) had a positive RIDT and were managed according to the CPA. Of the patients tested, 34.6% had no primary care physician and 38.7% visited the pharmacy outside of normal office hours. Only 3% of patients reported feeling worse at follow-up. CONCLUSION: This study describes a physician-pharmacist collaborative model for treating ILI. Using an evidence-based CPA, pharmacists were able to provide timely treatment to patients with and without influenza.

Consumer interest in community pharmacy HIV screening services.

OBJECTIVE: To evaluate consumers' interest in pharmacist-provided human immunodeficiency virus (HIV) screening and to evaluate potential barriers and facilitators to HIV screening in the community pharmacy setting. METHODS: Cross-sectional survey of adult patients who presented to one of five community (chain and independent) pharmacies from November 2010 to August 2011. RESULTS: Based on 380 usable surveys, 135 (35.8%) participants were interested in pharmacy-based HIV screening. Independent predictors of interest in HIV screening identified in multivariate analysis (reference groups: ages 30 to 49 years old and white, non-Hispanic race) included younger age (18 to 29 years old) (odds ratio [OR], 2.48; 95% confidence interval [CI], 1.31 to 4.71); black, non-Hispanic race (OR, 2.37; CI, 1.40 to 4.03); and other race (OR, 4.58; CI, 1.63 to 12.87). Lack of perceived risk for HIV was the most commonly cited barrier to HIV screening; and free, rapid, or confidential HIV testing were identified as potential facilitators. CONCLUSION: Interest in pharmacy-based HIV screening was high among participants representing age and race groups disproportionately affected by HIV. Expansion of HIV screening efforts to community pharmacies warrants further consideration.

Initial Employment Plans of PharmD Graduates from Ten Public Colleges/Schools of Pharmacy, 2018-2022.

OBJECTIVE: Since 2009, the Big Ten Pharmacy Assessment Collaborative has surveyed their Doctor of Pharmacy (PharmD) graduates regarding their first employment plans. The current study updates the results from 2013-2017, since which the nationwide demand for pharmacists decreased, then increased again due to COVID-19. METHODS: Quantitative first-position employment data from 2018-2022 were tracked among 6687 Big Ten PharmD graduates. Outcomes included job/residency/fellowship placement; satisfaction with placement; salary; time spent searching; and perceived difficulty finding placement. RESULTS: Over the study period, 5276 usable surveys were received (survey participation rate 79%). Respondents who reported applying for employment (2699) spent nearly 3 months searching for a position, although 64% had received employment offers before graduation. Annual salaries in pharmacy positions of at least 32 h per week (excluding residencies or fellowships) trended downward from $113,754 in 2018 to $99,175 in 2021, rebounding to $114,097 in 2022. Approximately 42% of respondents who applied for jobs reported difficulty finding a position in 2018 and 2019, decreasing to 20% in 2022. In total, 73% of respondents were satisfied with the offers they received, with 72% finding positions in their preferred job setting. An average of 57% applied for residencies from 2018 to 2022, nearly 10% higher than 2013-2017, with 76% of applicants matching. An additional 19% planned to pursue additional academic degrees, fellowship training, or both. CONCLUSION: From 2018 to 2022, Big Ten PharmD graduates found pharmacy-related first positions to the same extent as did Big Ten PharmD graduates from 2013-2017, at similar salaries.

Pharmacy-based CLIA-waived testing in the United States: Trends, impact, and the road ahead.

BACKGROUND: Federal authorization of the use of Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived point-of-care tests for SARS-CoV-2 by pharmacists during the pandemic resulted in a dramatic rise in the number of community pharmacies that became CLIA-waived test sites. Now as we exit the pandemic, the wide-ranging expansion of the scope of practice facilitated currently by the PREP Act is set to expire in fall 2024. As a result, American pharmacists' ability to offer CLIA-waived testing services will revert to a patchwork of state laws. OBJECTIVE: This study aims to examine both the number of pharmacies in the United States with CLIA Certificates of Waiver before and after the SARS-CoV-2 pandemic and the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver. METHODS: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015, August 4th, 2019, November 26th, 2020, October 6th, 2021, November 23rd, 2022, and December 4th, 2023. The website allows for the exportation of demographic data on all CLIA-waived facilities by state. RESULTS: The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.9%) locations in 2015 to 12,157 (21.4%) locations in 2019, to 15,671 (27.6%) locations in 2020, and to 29,011 (51.6%) locations in 2023. States demonstrated considerable variability in the percentage of pharmacies possessing a CLIA certificate of waiver in 2023, with a range of 10.7%-87.9%. CONCLUSIONS: Use of CLIA-waived tests in pharmacies has grown by 140% since 2019. The time period from 2019 to 2021 witnessed a 92.5% increase in pharmacies that possessed a certificate of waiver which was largely driven by the pandemic. Interestingly, from 2021 to 2023 the was continued growth in the market of 31.6%. This suggests that pharmacies continue to see opportunity in offering CLIA-waived testing services beyond those that had been extended as a result of the pandemic.

Proton pump inhibitors and acute kidney injury: a nested case-control study.

BACKGROUND: Proton pump inhibitors (PPI) are a widely-used class of drugs for the treatment of gastro-esophageal reflux disease and other acid-related disorders of the gastrointestinal tract. As a class, PPIs have demonstrated a favorable safety profile. However, case reports have suggested that this class of drugs may be linked to acute kidney injury, which may in turn lead to chronic injury or failure. The objective of this study was to determine if an association between PPIs and kidney failure exists and to estimate an effect size for the relationship between PPI use and renal disease. METHODS: A nested case-control study was conducted in a privately insured population in a single Midwestern state including a total of 184,480 patients aged 18 years or older who were continuously enrolled with the insurer for at least 24 months between September 2002 and November 2005. RESULTS: Renal disease was positively associated with PPI use (odds ratio [OR] 1.72, 95% confidence interval [CI] 1.27, 2.32, p < 0.001) even after controlling for potential confounding conditions. After removing patients with potential confounding disease states from the study population, the number of cases (195 of the 854) and controls (607) was lower, but the relationship between renal disease and PPI use remained consistent (OR 2.25, CI 1.09-4.62, p < 0.001). CONCLUSIONS: Patients with a renal disease diagnosis were twice as likely to have used a previous prescription for a PPI. Therefore, it is necessary for physicians to increase recognition of patient complaints or clinical manifestations of this potentially harmful event in order to prevent further injury.

COVID-19 host genetic risk study conducted at community pharmacies: Implications for public health, research and pharmacists' scope of practice.

Community pharmacists serve a large, diverse population of patients, resulting in the potential to utilize community pharmacies as recruitment sites for clinical research. Beyond traditional roles as one of the most accessible health care professionals in the US healthcare system, pharmacists have played a major role in the response to the COVID-19 pandemic, administering hundreds of thousands of vaccines and tests. However, less emphasis is placed on the ability to leverage community pharmacies as research-focused partners for clinical studies. In this study, we demonstrate the feasibility and workflow of recruiting study participants from community pharmacies and confirm genetic markers of COVID-19 susceptibility. Specific genetic markers include those associated with COVID-19 infection risk (ACE2, TMEM27, and RAVER1), difficulty breathing (NOTCH4), and hospitalization (OAS3). In addition, collaboration with a clinical laboratory allowed for a more seamless consenting process without substantial training needs or workflow disruption at the community pharmacy site. The COVID-19 pandemic has demonstrated that the expansion of pharmacists' scope of practice is a key factor in managing the population health crisis; this study demonstrates that pharmacies can also advance clinical research studies by serving as sites for patient recruitment from a large, diverse, and ambulatory study population.

Implementing community pharmacy-based influenza point-of-care test-and-treat under collaborative practice agreement.

BACKGROUND: Early and accessible testing for influenza with point-of-care testing (POCT) can be a critical factor for deciding to begin antiviral treatment. More than 10,000 pharmacies across the USA offer Clinical Laboratory Improvement Amendments-waived POCT for infectious diseases, such as influenza A/B. Knowledge of barriers and facilitators to large-scale POCT implementation may be useful in scaling POCT for influenza test-and-treat services (Flu POCT). The objective of this study was to explore the experiences of pharmacists who were early adopters of Flu POCT and treatment under collaborative practice agreement in community pharmacy settings. METHODS: Qualitative research design with in-depth, semi-structured virtual video interviews of licensed US community pharmacists. Interview questions were derived from the Consolidated Framework for Implementation Research (CFIR). Interviewees were selected via a purposeful sampling of pharmacists who were enrolled in a nationwide clinical trial involving pharmacy-based influenza test-and-treat under a collaborative agreement. Interviews were recorded and transcribed. A deductive analytic approach was used via constructs from the CFIR. RESULTS: Six pharmacists were interviewed. Interviews ranged from 28 to 70 min, with an average length of 46 min. Four broad themes emerged from the data, and each had corresponding subthemes and supporting quotes: influence of the Flu POCT service characteristics on pharmacy implementation, influence of factors outside of the pharmacy setting in Flu POCT implementation, factors within the pharmacy setting influencing implementation, and process of implementing Flu POCT. A novel pharmacy-based Flu POCT implementation framework is presented. CONCLUSIONS: Implementation of community pharmacy-based Flu POCT services is feasible; but, a thorough understanding of both barriers and facilitators to their implementation is needed to increase the spread and scale of these programs. Specifically, pharmacy stakeholders should focus efforts on increasing patient and provider awareness, pharmacist acceptance, leadership support, and support of health providers external to the pharmacy to improve implementation success.

Integrating and Disseminating Pre-Exposure Prophylaxis (PrEP) Screening and Dispensing for Black Men Who Have Sex With Men in Atlanta, Georgia: Protocol for Community Pharmacies.

BACKGROUND: Black men who have sex with men (BMSM) suffer from alarmingly high rates of HIV in the United States. Pre-exposure prophylaxis (PrEP) can reduce the risk of HIV infection by 99% among men who have sex with men, yet profound racial disparities in the uptake of PrEP persist. Low PrEP uptake in BMSM is driven by poor access to PrEP, including inconvenient locations of PrEP-prescribing physicians, distrust of physicians, and stigma, which limit communication about PrEP and its side effects. Previous work indicates that offering HIV prevention services in pharmacies located in low-income, underserved neighborhoods is feasible and can reduce stigma because pharmacies offer a host of less stigmatized health services (eg, vaccinations). We present a protocol for a pharmacy PrEP model that seeks to address challenges and barriers to pharmacy-based PrEP specifically for BMSM. OBJECTIVE: We aim to develop a sustainable pharmacy PrEP delivery model for BMSM that can be implemented to increase PrEP access in low-income, underserved neighborhoods. METHODS: This study design is a pilot intervention to test a pharmacy PrEP delivery model among pharmacy staff and BMSM. We will examine the PrEP delivery model's feasibility, acceptability, and safety and gather early evidence of its impact and cost with respect to PrEP uptake. A mixed-methods approach will be performed, including three study phases: (1) a completed formative phase with qualitative interviews from key stakeholders; (2) a completed transitional pilot phase to assess customer eligibility and willingness to receive PrEP in pharmacies during COVID-19; and (3) a planned pilot intervention phase which will test the delivery model in 2 Atlanta pharmacies in low-income, underserved neighborhoods. RESULTS: Data from the formative phase showed strong support of pharmacy-based PrEP delivery among BMSM, pharmacists, and pharmacy staff. Important factors were identified to facilitate the implementation of PrEP screening and dissemination in pharmacies. During the transitional pilot phase, we identified 81 individuals who would have been eligible for the pilot phase. CONCLUSIONS: Pharmacies have proven to be a feasible source for offering PrEP for White men who have sex with men but have failed to reach the most at-risk, vulnerable population (ie, BMSM). Increasing PrEP access and uptake will reduce HIV incidence and racial inequities in HIV. Translational studies are required to build further evidence and scale pharmacy-based PrEP services specifically for populations that are disconnected from HIV prevention resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35590.

Short-term cost-effectiveness of oral semaglutide for the treatment of type 2 diabetes mellitus in the United States.

BACKGROUND: Oral semaglutide is the first orally administered glucagon-like peptide-1 receptor agonist (GLP-1RA) approved by the FDA. Clinical trials found that oral semaglutide 14 mg had a greater reduction in hemoglobin A1c (A1c) compared with empagliflozin 25 mg and sitagliptin 100 mg and was noninferior to liraglutide 1.8 mg. However, US cost-effectiveness data for oral semaglutide are limited and do not consider the costs of adverse events. OBJECTIVE: To assess the short-term cost-effectiveness of oral semaglutide compared with empagliflozin, sitagliptin, and liraglutide in patients with type 2 diabetes. METHODS: A decision analysis over a 52-week time horizon was used to evaluate the incremental cost-effectiveness of oral semaglutide vs empagliflozin, sitagliptin, and liraglutide from a US health care payer's perspective. Data on efficacy, adverse events, and discontinuation were derived from 52-week data from phase 3, head-to-head clinical trials (PIONEER 2, 3, and 4). Costs included drug and administration cost and treatment of gastrointestinal adverse events. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in cost over the difference in A1c reduction between oral semaglutide and comparators. RESULTS: In the base-case analysis, 52-week treatment costs with oral semaglutide were $2,660 and $3,104 higher and $2,337 less than empagliflozin, sitagliptin, and liraglutide, respectively. Incremental (greater) A1c reductions were seen with oral semaglutide at 0.40%, 0.50%, and 0.30% vs empagliflozin, sitagliptin, and liraglutide, respectively. ICERs per 1% reduction in A1c for oral semaglutide were $6,650 and $6,207 vs empagliflozin and sitagliptin, respectively. Oral semaglutide was dominant vs liraglutide (ICER of -$7,790). CONCLUSIONS: Oral semaglutide was dominant relative to liraglutide, offering a cost-saving GLP-1RA oral alternative. While there is not a recognized willingness-to-pay threshold for a 1% reduction in A1c, oral semaglutide may be cost-effective relative to empagliflozin and sitagliptin if a decision maker's willingness-to-pay threshold exceeds $6,650 and $6,207, respectively. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to declare.

Pharmacy-Based Point-of-Care Testing: How a "Standard of Care" Approach Can Facilitate Sustainability.

COVID-19 spurred rapid expansion of pharmacy-based point-of-care testing (POCT). This growth was aided, in part, by federal guidance that removed state-level regulatory uncertainty surrounding the ability of pharmacists to administer, interpret, and act on the results of tests. Surveys suggest there is considerable confusion about the legality of these services by state regulators. To ensure the sustainability of POCT services over time, states should consider adopting a standard of care approach to regulation, allowing a flexible framework for practice innovation and expansion over time.

Impact of COVID-19 on prevalence of community pharmacies as CLIA-Waived facilities.

BACKGROUND: The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Recently, the 2019 novel coronavirus (COVID-19) pandemic has shined a spotlight on CLIA-waived diagnostic testing. To meet this increased patient demand for diagnostic testing, the U.S. Department of Health and Human Services (HHS) authorized licensed pharmacists to order and administer FDA authorized COVID-19 tests. OBJECTIVE: This study aims to update the previous national benching report and examine both the number of pharmacies in the United States with CLIA Certificates of Waiver before and after the SARS-CoV-2 pandemic and the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver. METHODS: Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website May 3rd, 2015, August 4th, 2019 and November 26th, 2020. The website allows for exportation of demographic data on all CLIA-waived facilities by state. RESULTS: Pharmacies exhibited the largest growth both in number (4865 new locations) and by percent (45%) of CLIA-waived facilities between 2015 and 2020. The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.94%) locations in 2015 to 12,157 (21.43%) locations in 2019, to 15,671 (27.63%) locations in 2020. States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a range of 2.92%-56.52%. CONCLUSIONS: Pharmacies have become an increasingly important location for patients to access CLIA-waived tests in the United States, now serving as the second largest provider of CLIA-waived tests by the total number of locations. Most of this growth occurred between 2019 and 2020 due to the COVID-19 pandemic, and concentrated efforts will be necessary to sustain this momentum.