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.

Molecular point-of-care testing in the community pharmacy setting: current status and future prospects.

INTRODUCTION: Clinical Laboratory Improvement Amendments (CLIA)-waived point-of-care tests (POCTs) have been available since the late 1980s, but their use in community pharmacy has expanded over the last several years. Barriers exist for community-pharmacy-based CLIA-waived POC testing, including pharmacy workflow, pharmacist scope of practice, and reimbursement. As pharmacies work to reduce these barriers, the number of pharmacies participating in POCT programs has dramatically increased. There are several lateral flow and nucleic acid amplification CLIA-waived POC tests available for use in community pharmacy settings. The majority of data regarding pharmacy-based POC testing programs currently highlights the role of lateral flow testing for influenza and acute pharyngitis. AREAS COVERED: A comprehensive review of the current state of CLIA-waived rapid point-of-care infectious pathogen testing in community pharmacies is presented. EXPERT OPINION: Knowing which CLIA-waived rapid POCTs are available and understanding their key characteristics will be helpful in identifying the best tests to incorporate into individual pharmacies. Choices will also depend on specific pharmacy workflow patterns, local populations and insurances, and state regulations regarding pharmacist scope of practice. As nucleic acid amplification tests evolve, the business case and the framework for implementation for using molecular tests in community pharmacy will become clearer.

Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps.

Objective: To review published literature for biologic treatment of nasal polyps. Data Sources: PubMed search performed on February 16, 2022, using search terms: biologics, benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab AND nasal polyps, nasal polyposis, or chronic rhinosinusitis with nasal polyposis (CRSwNP). Inclusion criteria were English language, published randomized controlled trials, post hoc analyses, and meta-analyses evaluating biologics for nasal polyposis, with or without comorbid asthma, and no date limits. Additional studies were found through references of primary and tertiary literature. Study Selection and Data Extraction: Nineteen studies, including 8 randomized controlled trials, 2 meta-analyses, and 9 post hoc analyses, examined the efficacy and safety of biologics for nasal polyposis. Agents studied included benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab. Studies had similar inclusion (refractory and recurrent CRSwNP) and exclusion criteria. All studies included the use of an intranasal corticosteroid (mometasone or fluticasone) in addition to the biologic or placebo. The most commonly studied primary endpoint was change in endoscopic nasal polyp score. Data Synthesis: All studies, post hoc analyses, and meta-analyses found improvement in endoscopic, clinical, and/or radiographic endpoints with benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab in patients with CRSwNP with or without comorbid asthma. Dupilumab has the most published data. Dupilumab, mepolizumab, and omalizumab are the only biologics currently Food and Drug Administration-approved for CRSwNP. Conclusion: Biologics are beneficial for treating nasal polyps with or without comorbid asthma. The choice depends on patient and provider preference and insurance coverage.

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.

Comparison of Monoclonal Antibodies for Treatment of Uncontrolled Eosinophilic Asthma.

OBJECTIVE: To summarize the current literature for Food and Drug Administration (FDA)-approved monoclonal antibodies used as add-on maintenance therapy in uncontrolled eosinophilic asthma. DATA SOURCES: PubMed was searched on December 17, 2018 using keywords: asthma, eosinophilic asthma, omalizumab, reslizumab, mepolizumab, benralizumab, and dupilumab. STUDY SELECTION: Studies evaluating safety and efficacy of monoclonal antibodies for treatment of severe or eosinophilic asthma were included. RESULTS: Twenty-one randomized, double-blind, placebo-controlled trials evaluating the current FDA-approved monoclonal antibodies (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) for the treatment of uncontrolled eosinophilic asthma were included. The studies demonstrated clinically significant reductions in asthma exacerbations, symptoms, emergency room visits, eosinophil counts, and improvements in pulmonary function and asthma-related quality of life. CONCLUSION: Five monoclonal antibodies are available for uncontrolled eosinophilic asthma. Choice depends on patient factors. Future studies should focus on cost-effectiveness of treatment, drug-drug comparisons, and long-term efficacy and safety.

Comparative Review of Oral P2Y12 Inhibitors.

Current practice guidelines recommend dual antiplatelet therapy comprised of aspirin and a purinergic signaling receptor Y12 (P2Y12) for patients following acute coronary syndrome. This article compares the efficacy, safety, and other characteristics of the three available oral P2Y12 inhibitors-clopidogrel, prasugrel, and ticagrelor.

Addressing meaningful use and maintaining an accurate medication list in primary care.

OBJECTIVES: The primary objective of this project was to determine the difference in medication list accuracy between an initial and follow-up medication reconciliation visit in a primary care office. Secondary objectives were to identify the difference in medication-related problems most commonly encountered during the visits, factors that may influence patient understanding of their medication regimen, and physician perceptions of the medication review visit. SETTING: Quasi-experimental study part of a larger pilot project to address the ability of how health information technology can be used to maintain an active medication list. PRACTICE DESCRIPTION: Three family medicine residency clinics in the Midwest. Adult patients with diabetes or chronic obstructive pulmonary disease who had 6 or more long-term medications listed in the electronic health record (EHR) were recruited to participate. PRACTICE INNOVATION: An initial comprehensive medication reconciliation visit was conducted by a resident physician and a pharmacist with the goal of ensuring an accurate, easy-to-follow, electronically developed medication list. A follow-up visit with the pharmacist occurred 3-6 months after the initial visit. EVALUATION: Medication list accuracy and medication-related problems were assessed at the initial and follow-up visits. Patient-related factors that could affect medication understanding were collected at the initial visit with status of enrollment in the EHR patient portal. RESULTS: Fifty-seven of 65 patients completed the study. The number of patients with an accurate medication list increased from 40% to 49% (P = 0.38). The number of medication-related problems decreased from 146 to 91 (P < 0.001). The use of special tools (e.g., pillboxes) was associated with fewer medication regimen errors (P = 0.036). Patients enrolled in the EHR patient portal were more likely to know the purpose of their medications as compared with those not enrolled (P = 0.019). CONCLUSION: An intentionally scheduled medication review with a primary care provider and pharmacist did not significantly improve the accuracy of the medication list, but it was associated with fewer drug-related problems.

Efficacy and Safety of Alpha-Blockers for Kidney Stones in Adults.

Objective: To review the literature for α-blocker treatment of kidney stones. Data Sources: PubMed search performed November 15, 2017, using the following search terms: alpha-blocker, alfuzosin, silodosin, or tamsulosin AND kidney or ureteral stones. Additional studies found through references of primary and tertiary literature. Inclusion criteria included English language, randomized controlled trials (not included in meta-analyses), and meta-analyses evaluating US available alpha-blockers as medical expulsive therapy with or without lithotripsy in adults with renal or ureteral stones, and no date limits. Study Selection and Data Extraction: Seven randomized controlled trials (RCTs), 1 case-control trial, and 6 meta-analyses were found and included in this review. Two RCTs and 4 meta-analyses evaluated alpha-blockers without lithotripsy. Five RCTs, 1 case-control trial, and 2 meta-analyses evaluated their use post-lithotripsy. The primary endpoint was stone clearance rate in most studies. Data Synthesis: For ureteral stones ≤10 mm treated without lithotripsy, alpha-blockers increased clearance in all meta-analyses and one RCT versus control. For ureteral or renal stones treated with lithotripsy, 4 RCTs and all meta-analyses found benefit with alpha-blockers compared with control. When results were stratified by stone size, alpha-blockers performed better for stones 10 to 20 mm, while there was no difference for stones <10 mm. Conclusion: Alpha-blockers are beneficial without lithotripsy for ureteral stones 5 to 10 mm. They are beneficial post-lithotripsy for renal or ureteral stones >10 mm. They can be considered post-lithotripsy for stones 5 to 10 mm, but little benefit may be seen. Although all uroselective alpha-blockers have been found to be effective, most data are with tamsulosin 0.4 mg daily.

Tavaborole, Efinaconazole, and Luliconazole: Three New Antimycotic Agents for the Treatment of Dermatophytic Fungi.

Fungal diseases of the nail bed (onychomycosis) and epidermis are recurrent illnesses in the elderly and immunocompromised patients, which have few efficacious treatment options. Current treatment options for onychomycosis are limited to topical agents, laser treatment, and oral antifungals. Previous generations of topical agents were not efficacious, owing to poor penetration of the nail bed. Oral antifungal drugs, such as itraconazole, terbinafine, and fluconazole, not only give better response rates but also inhibit a host of CYP450 enzymes. Oral antifungals can exacerbate drug-drug interactions for patients taking other medications concurrently. Newer topical agents might recognize improved efficacy and provide therapeutic alternatives when the use of oral antifungal agents is contraindicated. Recently, the Food and Drug Administration (FDA) approved efinaconazole and tavaborole for the treatment of onychomycosis. Additionally, the FDA approved luliconazole for the treatment of tinea pedis, tinea cruris, and tinea corporis. This review examines the mechanism of action, spectrum of activity, pharmacokinetics, and clinical trials data and considers the place in therapy for these 3 new antimycotic agents.

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.

Identifying and locating pharmacist certificate programs, traineeships, and certification agencies.

OBJECTIVE: To provide a list of available certification and certificate programs that can be completed to enhance or validate pharmacists' knowledge and skills in the treatment of specific diseases. DATA SOURCES: Medline/PubMed searched using the terms "pharmacist" and "certification" or "pharmacist" and "credentialing"; Web sites of national pharmacy organizations. DATA SYNTHESIS: No information was found in Medline/PubMed about the value of certification or certificate programs for pharmacists. A comprehensive, but not exclusive, list of pharmacist certificate programs, traineeships, and certifications available is provided, as well as guidance on where to find information about such programs. CONCLUSION: Pharmacists have many opportunities for training in specialized areas that can broaden their knowledge and skills to improve patient care, provide credentialing for reimbursement, and advance their professional status.

Practical review of oral antihyperglycemic agents for type 2 diabetes mellitus.

This article gives a practical review of the pharmacology, clinical efficacy, safety, dosing, cost, and place in therapy for oral antihyperglycemic agents used in the treatment of type 2 diabetes mellitus. There are 5 classes of oral antihyperglycemic agents available in the United States: sulfonylurea secretagogues, biguanides, alpha-glucosidase inhibitors, thiazolidinediones, and nonsulfonylurea secretagogues. These agents have distinct characteristics that help in their selection for the treatment of type 2 diabetes.