Publications by authors named "Donald Klepser"

Community pharmacies have grown to be an increasingly important provider of CLIA-waived tests, just second to physician offices as the venue with the most waivers. Yet, individual variation is still observed across states with respect to the percentage of pharmacies holding a CLIA-waiver, with a reported range of 10.7% in Massachusetts to 87.

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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.

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As pharmacogenomic (PGx) testing becomes more commonplace in clinical practice, appropriate application of laboratory data to all relevant medications becomes necessary to maximize PGx value. However, many clinicians lack PGx knowledge and confidence, so prescribers may appreciate clinical support when applying PGx data to a patient's entire medication list. Pharmacists routinely provide PGx consult support, and asynchronous written consults may improve logistical simplicity, but specific process steps and time expectations are less settled.

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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.

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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.

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Background: In 2014, a change in the water source in Flint, Michigan, exposed residents to dangerous levels of lead in their drinking water. The concern for lead toxicity created the opportunity for pharmacies to provide quick and accessible blood lead testing services.

Objective: The primary objective was to create a pharmacy-based blood lead testing program through collaboration with the Michigan Department of Health & Human Services and community pharmacies in Flint, Michigan.

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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.

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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.

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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.

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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).

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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.

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Ordering urine cultures in patients without pyuria is associated with the inappropriate treatment of asymptomatic bacteriuria (ASB). In 2015, our institution implemented recommendations based on practice guidelines for the management of ASB and revised the urine culture ordering process to limit cultures in immunocompetent patients without pyuria. The purpose of this study was to determine how the treatment of ASB has changed over time since altering the urine culture ordering process to reduce unnecessary cultures at an academic medical center.

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To determine whether elimination of backward navigation during an examination resulted in changes in examination score or time to complete the examination. Student performance on six examinations in which backward navigation was eliminated was compared to performance on examinations administered to pharmacy students the previous year when backwards navigation was allowed. The primary comparison of interest was change in student performance on a subset of identical questions included on both examinations.

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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.

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: 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.

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The role of pharmacists in the treatment of HIV has expanded beyond medication dispensing to include a host of cost-effective, evidence-based strategies across the HIV prevention and care continuums. However, wide-scale adoption of pharmacy-based HIV prevention and treatment interventions has been slow. We conducted a systematic review to evaluate the evidence on the role of pharmacists across the HIV prevention and care continuums.

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Article Synopsis
  • The Clinical Laboratory Improvement Amendments (CLIA) of 1988 allowed for more access to low-risk tests through CLIA-waived facilities, with recent focus on COVID-19 testing capabilities within pharmacies.
  • As of 2020, the number of pharmacies with CLIA Certificates of Waiver increased significantly, with a growth of 4,865 new locations (45%) compared to previous years, reaching over 15,600 total locations.
  • Variability exists among states in the percentage of pharmacies holding a CLIA-waiver, ranging from about 3% to over 56%, indicating differing access levels across the country.
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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.

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The 2019-2020 Academic Affairs Committee was charged with identifying promising practices in academic-practice partnerships and professional pharmacy organization initiatives that are accelerating the transformation of a workforce prepared to assume responsibility for society's medication use needs in 2030 and determining the role AACP can plan in supporting these partnerships and initiatives. The committee identified a set of ideal principles, characteristics, and design elements of a high-quality, large-scale workforce development program. The committee also categorized current mechanisms for professional workforce development, in addition to identifying their strengths and weaknesses, with the realization that novel approaches are needed to accomplish the goal of large-scale workforce transformation.

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People Living with HIV (PLWH) remain disproportionately susceptible to vaccine-preventable illnesses due to increased morbidity and mortality from common pathogens, increased transmission related to epidemiologic factors, and decreased vaccination rates. We aimed to describe patient-specific predictive factors that may impact adherence to the CDC's recommended vaccination schedules in PLWH. We retrospectively evaluated adult PLWH in care at the University of Nebraska Medical Center's HIV clinic and collected information related to demographics, clinic visits, vaccination status, and measures of HIV disease control.

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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.

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Background: HIV pre-exposure prophylaxis (PrEP) substantially reduces the risk of HIV acquisition, yet significant barriers exist to its prescription and use. Incorporating pharmacists in the PrEP care process may help increase access to PrEP services.

Methods: Our pharmacist-led PrEP program (P-PrEP) included pharmacists from a university-based HIV clinic, a community pharmacy, and two community-based clinics.

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Background: Schizophrenia and psychotic disorders (SPDs)-related hospitalizations are the second leading cause of 30-day readmission. This study assessed the effect of patient and hospital-level factors on readmission costs following index hospital discharges for SPDs.

Methods: 2014 Nationwide Readmissions Database was used to identify SPD-related discharges between January 1, 2014, and November 30, 2014.

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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.

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