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.

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.

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.

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.

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.

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.

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.

Performance of the BD Veritor system SARS-CoV-2 antigen test among asymptomatic collegiate athletes: A diagnostic accuracy study.

BACKGROUND: COVID-19 testing strategies and determining the accuracy of tests is crucial for the prevention of disease in asymptomatic communities. OBJECTIVE: To determine the positive predictive value for the BD Veritor System for rapid detection of SARS-CoV-2 (BD Veritor System) among asymptomatic athletes and athletic staff in a University setting. Secondarily, a cost savings analysis was conducted to evaluate the benefits of a rapid antigen testing strategy over a universal PCR-based strategy. METHODS: Asymptomatic athletic personnel at Ferris State University tested using the BD Veritor System from November 4, 2020-February 15, 2021. Individuals whose antigen test was positive immediately had specimen collected for confirmatory PCR testing. These results were used to determine the positive predictive value (PPV) for the BD Veritor System. A cost-savings analysis was conducted from the University's perspective to determine the value of this rapid antigen testing strategy over a universal PCR-based strategy. RESULTS: A total of 3352 antigen tests were performed on 359 individuals during the study period. During this period, 21 positive antigen tests were obtained of which 5 individuals had a positive reflex PCR result. The calculated PPV of the BD Veritor System among asymptomatic individuals was 25%. According to the mandated athletics testing schedule, the University spent $67,475.76 on BD Veritor System tests and $1785 on confirmatory PCR tests. In contrast, if a solely PCR-based approach had been continued, the same testing strategy would have cost the University $284,920. By employing a 2-tiered testing strategy with the BD Veritor System with reflex PCR testing, the University realized a cost savings of $215,659.24 during the 3-month period. CONCLUSIONS: Despite sub-optimal PPV associated with the BD Veritor System among asymptomatic athletes, the University was able to effectively use an antigen-based testing program to comply with collegiate testing requirements and realize $215,659.24 cost savings per quarter over a PCR-based strategy.

Pharmacist Prescriptive Authority for Acne: An Evidence-Based Approach to Policy.

The diagnosis of acne is typically straightforward and based on physical signs and symptoms. Some jurisdictions in Canada, the United Kingdom, and United States have enabled a pharmacist treatment model to diagnose and manage patients with mild acne using prescription medications. Studies have found the model to be safe and effective, while simultaneously increasing more timely access to care for patients which may reduce the potential adverse impacts of acne. Further, use of a standardized protocol may alleviate some of the concerns expressed over the model. This paper summarize answers to frequent questions to help policymakers consider the objective evidence for their jurisdiction.

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.

The impact of the COVID-19 pandemic on addressing common barriers to pharmacy-based point-of-care testing.

Introduction: Pharmacy-based point-of-care testing has long had the potential to improve patient access to timely care, but adoption has been slowed by financial and regulatory barriers. The COVID-19 pandemic reduced or temporarily eliminated many of the barriers to pharmacy-based testing. This review examines how the changes brought on by may impact pharmacy-based testing after the pandemic.Areas covered: This review searched peer-reviewed, lay, and regulatory literature to explore the implementation of pharmacy-based COVID-19 testing. This includes a review of regulatory and financial changes that removed barriers to testing. Additionally, it reviews the literature related to the growth of pharmacy-based testing.Expert opinion: It is clear that the COVID-19 pandemic created an awareness and opportunity for pharmacy-based point-of-care testing. The changes made in response to the pandemic have the potential to increase the role of pharmacy-based testing, but additional regulatory changes and wider pharmacy adoption are still needed to maximize the value of such services.

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.

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.

Pharmacy-Based Assessment and Management of Herpes Labialis (Cold Sores) with Antiviral Therapy.

Herpes labialis, commonly known as cold sores, is an infection of the mouth and surrounding area. Antiviral therapy can be used to block viral replication, which shortens the duration of symptoms, facilitates resolution of lesions, and lessens the risk of spreading the virus. Increasing access to antivirals targeted against herpes labialis by allowing assessment and prescribing by a pharmacist may decrease time to treatment for HSV-1, and improve patient satisfaction. Experience from Canada, Australia, New Zealand and the United States demonstrate that pharmacist management of cold sores has a safe track record and may be considered by other jurisdictions.

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.

Pharmacy-based management of influenza: lessons learned from research.

Recently, several jurisdictions have pursued legislative and regulatory changes to allow pharmacy-based influenza management models in which pharmacists can initiate appropriate antiviral therapy in community pharmacy settings. While studies have been published in Canada, Japan, New Zealand, Norway and the United States, concerns have been expressed over pharmacist training, the accuracy of rapid influenza diagnostic tests, and the potential impact on antimicrobial resistance, among others. Studies have demonstrated that pharmacists provide safe and effective influenza management, with high rates of patient satisfaction, while maintaining or improving antimicrobial stewardship.

The Roles of Pharmacy Schools in Bridging the Gap Between Law and Practice.

Progressive pharmacy laws do not always lead to progressive pharmacy practice. Progressive laws are necessary, but not sufficient for pharmacy services to take off in practice. Pharmacy schools can play critical roles by working collaboratively with community pharmacies to close the gap between law and practice. Our experiences launching pharmacy-based point-of-care testing services in community pharmacy settings illustrate some of the roles schools can play, including: developing and providing standardized training, developing template protocols, providing workflow support, sparking collaboration across pharmacies, providing policy support, and conducting research.

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.

Observation of a Pharmacist-Conducted Group A Streptococcal Pharyngitis Point-of-Care Test: A Time and Motion Study.

BACKGROUND: Acute pharyngitis is among the most common infectious diseases encountered in the United States, resulting in 13 million patient visits annually, with group A streptococcus (GAS) being a common causative pathogen. It is estimated that annual expenditures for the treatment of adult pharyngitis will exceed US$1.2 billion annually. This substantial projection reinforces the need to evaluate diagnosis and treatment of adult pharyngitis in nontraditional settings. OBJECTIVE: The objective of this research is to quantify the amount of pharmacist time required to complete a point-of-care (POC) test for a patient presenting with pharyngitis symptoms. METHODS: A standardized patient with pharyngitis symptoms visited 11 pharmacies for POC testing services for a total of 33 patient encounters. An observer was present at each encounter and recorded the total encounter time, divided into 9 categories. Pharmacists conducted POC testing in 1 of 2 ways: sequence 1-pharmacists performed all service-related tasks; sequence 2-both pharmacists and pharmacist interns performed service-related tasks. RESULTS: The average time for completion of a POC test for GAS pharyngitis was 25.3 ± 4.8 minutes. The average pharmacist participation time per encounter was 12.7 ± 3.0 minutes (sequence 1), which decreased to 2.6 ± 1.1 minutes when pharmacist interns were involved in the testing (sequence 2). CONCLUSION: Although additional studies are required to further assess service feasibility, this study indicates that a GAS POC testing service could be implemented in a community pharmacy with limited disruption or change to workflow and staff.