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.

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.

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.

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.

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.

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.

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.