Pharmacist Prescribing Models for HIV Pre-exposure and Post-exposure Prophylaxis.

State strategies for pharmacist prescribing exist on a continuum from most restrictive to least restrictive. Using human immunodeficiency virus (HIV) pre-exposure prophylaxis and post-exposure prophylaxis as a case study, there are 3 viable pharmacist prescribing models: (1) population-based collaborative practice agreements; (2) government protocols; and (3) standard of care prescribing. The advantages and disadvantages of these 3 models are reviewed.

Multiplex CLIA-waived point-of-care tests for SARS-CoV-2, influenza A and B, ± other respiratory pathogens: A systematic review.

BACKGROUND: Many multiplex CLIA-waived point of care tests are available in the United States for community pharmacists to incorporate into their practice. OBJECTIVE: To characterize the eleven multiplex CLIA-waived point of care tests available for detecting SARS-CoV-2 and influenza A and B ± other respiratory pathogens and summarize their performance characteristics from published studies. METHODS: Food and Drug Administration websites and databases were utilized to identify currently available tests. Literature searches were conducted and most recently updated through July 21, 2023 to identify studies examining the tests' performance. Primary literature was included if it reported positive and negative percent agreement (PPA and NPA, respectively) for SARS-CoV-2 or influenza A or B, had a comparator, and was conducted in a CLIA-waived environment. Relevant study characteristics, including number of samples, sample collection method, age of participants, comparator, PPA/NPA for SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) were extracted. Data extraction was performed by two authors with any discordant data reconciled by a third author. RESULTS: Twenty-eight studies met inclusion criteria. The PPA for SARS-CoV-2 ranged from 86.7% to 100%, and NPA ranged from 90.4% to 100%. The PPA for influenza A and B ranged from 92.9% to 100% and 95.3% to 100%, respectively, while NPA ranged from 96.6% to 100% and 98.2% to 100%, respectively. Both the Xpert Xpress Plus and SpotFire tests showed similar results for RSV with PPA ranging from 96.3% to 100% and NPA ranging from 98.4% to 100%. CONCLUSION: Currently available multiplex POCT for SARS CoV-2 and influenza A and B ± RSV have demonstrated efficacy in detecting multiple pathogens in a single test. Pathogen detection, costs, materials needed to perform the test (eg, readers), and study data (PPA and NPA) should be utilized to help determine which tests should be ordered for a particular practice setting.

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.

A systematic review comparing at-home diagnostic tests for SARS-CoV-2: Key points for pharmacy practice, including regulatory information.

BACKGROUND: Home-based rapid diagnostic testing can play an integral role in controlling the spread of coronavirus disease 2019 (COVID-19). OBJECTIVES: This review aimed to identify and compare at-home diagnostic tests that have been granted Emergency Use Authorizations (EUAs) and convey details about COVID-19 diagnostic tests, including regulatory information, pertinent to pharmacy practice. METHODS: The Food and Drug Administration (FDA) online resources pertaining to COVID-19 tests, EUAs, and medical devices were consulted, as were linked resources from FDA's webpages. Homepages of the 9 COVID-19 home tests with EUAs were comprehensively reviewed. PubMed literature searches were performed, most recently in May 2021, to locate literature about the identified home tests, as were searches of Google Scholar, medRxiv, and bioRxiv. Studies were included if they were performed at home or if subjects self-tested at study sites. Samples were collected by a parent or guardian for patients under 18 years of age. Positive percent agreement (PPA) and negative percent agreement (NPA) for the clinical diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus was evaluated. RESULTS: Limited data have been published for these home tests given that they are available through EUAs that do not require clinical trials. Fifteen studies were located from searching the literature, but only 2 met the inclusion criteria. Review of the home tests' websites yielded a single study for each test, with the 3 BinaxNOW platforms using the same study for their EUAs. The 9 COVID-19 home tests with EUAs as of May 7, 2021, include 3 molecular tests and 6 antigen tests. These tests had similar performance on the basis of PPA ranging from 83.5% to 97.4% and NPA ranging from 97% to 100%. CONCLUSION: The 9 SARS-CoV-2 home tests demonstrated satisfactory performance in comparison with laboratory real time reverse-transcription polymerase chain reaction tests. The convenience and ease of use of these tests make them well-suited for home-based rapid SARS-CoV-2 testing.

Assessment of antibiotic use and concordance with practice guidelines within 3 diverse ambulatory clinic systems.

OBJECTIVES: The objectives of this study were (1) to determine the rate of antibiotic prescribing at ambulatory clinics, and (2) to assess the concordance of antibiotic prescriptions with published guidelines and Food and Drug Administration-approved indications in terms of drug choices and dosing regimen. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: Patients of all ages receiving at least 1 prescription during ambulatory visits in 2016 to 2017 were observed. OUTCOME MEASURES: For each of the 3 clinic systems included in this study, oral antibiotic prescribing rates were estimated per patient and per ambulatory visit. Then, the concordance of oral antibiotic prescribing was assessed with respect to (1) choice of agent and (2) the dosing regimen by comparing it to the recommended therapeutic regimen (RTR). RESULTS: A total of 284,348 patients receiving at least 1 prescription were included in the analysis. Between clinics, 17.4 to 43.7 per 100 patients received antibiotics. Of the antibiotics prescribed, 48.9% in Clinic A, 48.0% in Clinic B, and 60.7% in Clinic C were considered to be discordant in terms of drug choice. When the dosing regimen was taken into account in addition to the choice of agent, 72.6% in Clinic A, 76.7% in Clinic B, and 81.6% in Clinic C were discordant based on drug choice or dosing regimen. Of the prescriptions written with a discordant dosing regimen, 91.2% in Clinic A, 79.6% in Clinic B, and 91.0% in Clinic C were at a higher dosage than RTR. CONCLUSION: Antibiotic prescribing rates vary by clinics, whereas discordant prescribing is consistently prevalent across clinics. More efforts should be put into ambulatory care to address antibiotic misuse problems, and our method could improve ambulatory antimicrobial stewardship programs.

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.

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.

A systematic review of rapid diagnostic tests for influenza: considerations for the community pharmacist.

OBJECTIVES: Rapid influenza diagnostic tests (RIDTs) have a potential role in community pharmacy to optimize influenza infection management. The U.S. Food and Drug Administration (FDA) proposed changes to the classification of RIDTs may affect their use in community pharmacy. We reviewed the performance and features of RIDTs likely to meet FDA-proposed reclassification requirements. DATA SOURCES: PubMed and Medline database searches were performed using the terms "Sofia Influenza A and B Fluorescent Immunoassay," "BD Veritor System for Rapid Detection of Flu A and B", and "Alere i Influenza A and B." STUDY SELECTION: All studies involving the use of the BD Veritor System for Rapid Detection of Flu A+B (BD Veritor, Sparks, MD), the Sofia Influenza A+B Fluorescent Immunoassay (Sofia FIA, San Diego, CA), and Alere i Influenza A&B (Alere i, Scarborough, ME) containing sensitivities and specificities with confidence intervals were considered for inclusion. DATA EXTRACTION: Patient demographics, specimen type collected, setting, sensitivities, specificities, true positives, true negatives, false positives, false negatives, positive predictive values, and negative predictive values were extracted. RESULTS: Of the 22 studies identified, 14 contained sufficient data to incorporate into this review. One study contained comparative data for BD Veritor and Sofia FIA, 1 study compared Alere i and Sofia FIA, 2 studies specifically included BD Veritor, 5 studies specifically included Sofia FIA, and 5 studies specifically included Alere i. Performance characteristics among the RIDTs varied; however, all 3 RIDTs consistently provided sensitivities and specificities >70%. CONCLUSION: BD Veritor, Sofia FIA, and Alere i RIDTs performed well compared with reverse transcriptase-polymerase chain reaction or viral culture. These RIDTs are likely to satisfy the proposed reclassification requirements. Pharmacists are considered the most accessible health care providers, and implementing RIDT services in community pharmacy may benefit health systems.

A call to action for outpatient antibiotic stewardship.

OBJECTIVES: To address the public health threat of antibiotic resistance, there has been an enhanced call for antibiotic stewardship programs throughout the health care continuum. SUMMARY: While antibiotic stewardship programs have been well described in the inpatient setting, data on effectiveness and guidance on implementing outpatient programs is scarce. Establishing stewardship practices in the outpatient setting is necessary because more than 60% of human antibiotic use occurs in this setting. CONCLUSION: In this article, we highlight the importance and need for stewardship in the outpatient setting, discuss strategies for the development of stewardship teams, and discuss potential metrics that can be used to assess effectiveness of antibiotic stewardship interventions.

Outpatient antibiotic stewardship: Interventions and opportunities.

Improving the use of antibiotics across the continuum of care is a national priority. Data outlining the misuse of antibiotics in the outpatient setting justify the expansion of antibiotic stewardship programs (ASPs) into this health care setting; however, best practices for outpatient antibiotic stewardship (AS) are not yet defined. In a companion article, we focused on recommendations to overcome challenges related to the implementation of an outpatient ASP (e.g., building the AS team and defining program metrics). In this document, we outline AS interventions that have demonstrated success and highlight opportunities to enhance AS in the outpatient arena. This article summarizes examples of point-of-care testing, policies and interventions, and education strategies to improve antibiotic use that can be used in the outpatient setting.

Potential for Pharmacy-Public Health Collaborations Using Pharmacy-Based Point-of-Care Testing Services for Infectious Diseases.

CONTEXT: Health care professionals must continually identify collaborative ways to combat antibiotic resistance while improving community health and health care delivery. Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived point-of-care (POC) testing (POCT) services for infectious disease conducted in community pharmacies provide a means for pharmacists to collaborate with prescribers and/or public health officials combating antibiotic resistance while improving community health and health care delivery. OBJECTIVE: To provide a comprehensive literature review that explores the potential for pharmacists to collaborate with public health professionals and prescribers using pharmacy-based CLIA-waived POCT services for infectious diseases. DESIGN: Comprehensive literature review. SETTING: PubMed and Google Scholar were searched for manuscripts and meeting abstracts for the following key words: infectious disease, community pharmacy, rapid diagnostic tests, rapid assay, and POC tests. INTERVENTION: All relevant manuscripts and meeting abstracts utilizing POCT in community pharmacies for infectious disease were reviewed. OUTCOME MEASURE: Information regarding the most contemporary evidence regarding CLIA-waived POC infectious diseases tests for infectious diseases and their use in community pharmacies was synthesized to highlight and identify opportunities to develop future collaborations using community pharmacy-based models for such services. RESULTS: Evidence demonstrates that pharmacists in collaboration with other health care professionals can leverage their knowledge and accessibility to provide CLIA-waived POCT services for infectious diseases. Testing for influenza may augment health departments' surveillance efforts, help promote rationale antiviral use, and avoid unnecessary antimicrobial therapy. Services for human immunodeficiency virus infection raise infection status awareness, increase access to health care, and facilitate linkage to appropriate care. Testing for group A streptococcal pharyngitis may curb inappropriate outpatient antibiotic prescribing. However, variance in pharmacy practice statues and the application of CLIA across states stifle collaboration. CONCLUSION: CLIA-waived POCT services for infectious diseases are a means for pharmacists, public health professionals, and prescribers to collaboratively combat antibiotic resistance and improve community health.

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.

Pharmacist-provided rapid HIV testing in two community pharmacies.

OBJECTIVE: To evaluate the acceptability and feasibility of pharmacist-provided rapid testing for human immunodeficiency virus (HIV) infection in community pharmacies. PRACTICE DESCRIPTION: A pharmacist-provided HIV testing model-including rapid HIV testing, counseling, and linkage to confirmatory HIV testing services-was developed and implemented. SETTING: Two independent pharmacies located in Michigan cities of different size and with different prevalence of HIV infection. MAIN OUTCOME MEASURES: Number of HIV tests performed, time required for HIV testing services, description of participants who received an HIV test, and pharmacist and participant perception of the HIV testing experience. RESULTS: From October 2011 to March 2013, pharmacists provided HIV tests to 69 participants. One (1.5%) participant had a reactive HIV test and was immediately referred to an appropriate health care provider for confirmatory testing. HIV testing services required a median time of 30 (range, 20-90) minutes. Participants had a median age of 23 (range, 18-61) years and were diverse by gender (59.4% women) and race (46.4% black; 39.1% white). This was the first HIV test for 42% of participants, many of whom reported high-risk behaviors in the prior 6 months. Participants and pharmacists reported favorable perceptions of the HIV testing experience. CONCLUSIONS: This project demonstrates the acceptability and feasibility of pharmacist-provided rapid HIV testing in two community pharmacies with distinct characteristics. Further development of HIV testing services in this practice setting is warranted.

Point-of-care testing for infectious diseases: opportunities, barriers, and considerations in community pharmacy.

OBJECTIVES To identify opportunities to perform point-of-care (POC) testing and/or screening for infectious diseases in community pharmacies, provide an overview of such tests and how they are used in current practice, discuss how the Clinical Laboratory Improvement Amendments of 1988 (CLIA) affect pharmacists performing POC testing, and identify and discuss barriers and provide recommendations for those wanting to establish POC testing for infectious diseases services in community pharmacies. DATA SOURCES PubMed and Google Scholar were searched from November 2012 through May 2013 and encompassed the years 2000 and beyond for the narrative review section of this article using the search terms rapid diagnostic tests, POC testing and infectious diseases, pharmacy services, CLIA waiver, and collaborative drug therapy management. All state boards of pharmacy in the United States were contacted and their regulatory and legislative websites accessed in 2012 and January 2013 to review relevant pharmacy practice laws. DATA SYNTHESIS POC testing for infectious diseases represents a significant opportunity to expand services in community pharmacies. Pharmacist education and training are addressing knowledge deficits in good laboratory practices and test performance and interpretation. Federal regulations do not define the qualifications for those who perform CLIA-waived tests, yet few pharmacists perform such services. Fewer than 20% of states address POC testing in their statutes and regulations governing pharmacy. CONCLUSION POC testing for infectious diseases could benefit patients and society and represents an opportunity to expand pharmacy services in community pharmacies. Existing barriers to the implementation of such services in community pharmacies, including deficits in pharmacist training and education along with state regulatory and legislative variance and vagueness in statutes governing pharmacy, are not insurmountable.

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.

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.

Pharmacists as important prescribers of coronavirus disease 2019 (COVID-19) antivirals.

Although pharmacists are key members of the healthcare team, they are currently ineligible to independently prescribe the oral coronavirus disease 2019 (COVID-19) antivirals. We report the roles pharmacists have undertaken during the COVID-19 pandemic and provide evidence for the support of independent oral COVID-19 antiviral prescribing.