Accreditation Council for Pharmacy Education: 2021 Annual Report

President - John Clay Kirtley, PharmD, Executive Director, Arkansas State Board of Pharmacy (National Associate of Boards of Pharmacy (NABP));Vice-President - Reza Karimi, RPh, PhD, Dean & Professor, Pacific University School of Pharmacy (American Association of Colleges of Pharmacy, AACP);Secretary/ Treasurer - Amy L. Seybert, BS, PharmD, FASHP, FCCP, CHSE, Associate Professor and Chair of the Department of Pharmacy and Therapeutics at the University of Pittsburgh School of Pharmacy (American Pharmacists Association, APhA) Board Members. Marie A. Chisholm-Burns, PharmD, MPH, MBA, FCCP, FASHP, Dean at the University of Tennessee Health Science Center College of Pharmacy and Professor of Surgery in the College of Medicine (AACP);Gregory Gruener, MD, MBA, MHPE, Vice Dean for Education, Stritch School of Medicine, Loyola University Chicago, Ralph P. Leischner Jr., MD, Department of Medical Education, Professor, Neurology (American Council on Education, ACE);Kimberly S. Croley, PharmD, BCGP, FASCP, FAPhA, Director of Pharmacy and Clinical Pharmacist for Laurel Senior Living Communities (APhA);Winnie A. Landis, BS Pharm, CDE, FAPhA, Community Pharmacist, CVS Health (APhA);LuGina Mendez-Harper, PharmD, Director, Professional Practices, at Prime Therapeutics (NABP);Michael A. Mone, RPh, JD, FAPhA, Senior Legal Counsel, CVS Health (NABP);Sharon L. Youmans, PharmD, MPH, FAPhA, Vice Dean at the University of California San Francisco and Professor of Clinical Pharmacy (AACP) Continuing Pharmacy Education (CPE) Commission The CPE Commission met virtually, due to the COVID-19 pandemic, on May 11-13, 2021, and November 16-18, 2021. Crystal Carter, MPA, Louisiana Pharmacists Association;JoAnn Francis, BS Pharm, MBA, CHCP, American Society of Health System Pharmacists;Peter J. (P.J.) Hughes, PharmD, MSEd, BCPS, Samford University;Barbara Jolly, RPh, MPA, LDE, Sullivan University College of Pharmacy;Lindsay Kaster, PharmD, BCOP, Boise VA Medical Center;Nicholas Lehman, PharmD, BCACP, Drake University College of Pharmacy and Health Sciences and UnityPoint West Des Moines Family Medicine & Internal Medicine Clinics;Jennifer Pauley, PharmD, BCPS, BCOP, St. Jude Children's Research Hospital;Ginger Scott, RPh, MS, PhD, West Virginia University School of Pharmacy;Kathy Schott, PhD, CEimpact;Barbara Ellen Maguire Vick, JD, PharmD, BCSCP, North Carolina Board of Pharmacy;Diane Yoon, EdD, USC School of Pharmacy, Health Sciences Campus. For Purposes of Considering Continued Accreditation Status Creighton University School of Pharmacy and Health Professions·;Duquesne University School of Pharmacy;Florida Agricultural & Mechanical University College of Pharmacy and Pharmaceutical Sciences·;Howard University College of Pharmacy;Long Island University Arnold and Marie Schwartz College of Pharmacy and Health Sciences·;Mercer University College of Pharmacy Doctor of Pharmacy;Midwestern University College of Pharmacy·;Rosalind Franklin University of Medicine and Science College of Pharmacy;South College School of Pharmacy;University of Arkansas for Medical Sciences College of Pharmacy;University of California, San Francisco School of Pharmacy;University of Cincinnati James L. Winkle College of Pharmacy;University of Connecticut School of Pharmacy;University of Kansas School of Pharmacy;University of Louisiana at Monroe College of Health and Pharmaceutical Sciences School of Pharmacy;University of Utah College of Pharmacy Accredited with Probation Status Chicago State University College of Pharmacy For Purposes of Considering Advancement from Precandidate to Candidate Status American University of Health Sciences School of Pharmacy Removal of Accredited with Probation Status: None For Purposes of Considering: Application for Precandidate Status: California Health Sciences University College of Pharmacy (three year) (precandidate status denied) For Purposes of Considering: Continued Candidate Status None For Purposes of Considering: Continued Accredited Status (after initial two-year term) University of Texas at Tyler Ben and Maytee Fisch College of Pharmacy For Purposes of Considering: Advancement from Candidate to Accredited Status Larkin University College of Pharmacy (advancement denied;held at candidate status);SUNY Binghamton University School of Pharmacy and Pharmaceutical Sciences;University of Texas at El Paso College of Pharmacy;William Carey University School of Pharmacy Focused On-site Evaluation Visits Albany College of Pharmacy and Health Sciences School of Pharmacy and Pharmaceutical Sciences;D'Youville College School of Pharmacy;St. John Fisher Wegmans School of Pharmacy;Touro New York College of Pharmacy;University at Buffalo The State University of New York School of Pharmacy and Pharmaceutical Sciences;University of the Pacific Thomas J. Long School of Pharmacy;University of Tennessee Health Science

Humoral Immune Response Following COVID-19 Vaccination in Patients With Chronic Lymphocytic Leukemia and Other Indolent Lymphomas: A Large, Single-Center Observational Study

Background: Chronic lymphocytic leukemia (CLL) and other Non-Hodgkin's lymphomas (NHLs) are associated with broad immunosuppression, conferring a greater risk for infection-related morbidity and mortality. During the SARS-CoV-2 pandemic, patients with these conditions have been shown to be more susceptible to severe cases of infection. Vaccination against SARS-CoV-2 generally protects against severe disease, but there is scarce data on immune response in those with lymphoid malignancies. Our study aims to analyze antibody (Ab) response to vaccination against SARS-CoV-2 in patients with CLL, Waldenstrom macroglobulinemia (WM) and other NHLs. Methods: 398 patients with lymphoid malignancies seen between January and October 2021 were screened for eligibility. Ab titers using the Access SAR-COV-2 assay developed by Beckman Coulter Inc were obtained after the completion of a vaccination series with Pfizer (n=146), Moderna (n=90), Johnson & Johnson (n=1) or multiple brands (n=3). A response was defined as a positive total Ab or spike protein Ab. Groups were compared using chi-square tests, and a p-value of <0.05 was statistically significant. Results: 240 patients with postvaccination SARS-CoV-2 Ab results were included. Ab response was 50% in CLL, 67% in WM, and 71% in the remaining NHLs. In the CLL cohort (n=181), current or prior cancer therapy at any time led to a lower rate of positive Ab's compared to treatment-naïve patients (36% vs. 68%;p=0.000019), and response was particularly low in patients who had received anti-CD20 immunotherapy at any time (28% vs. 61%;p=0.000032). There was a trend towards lower Ab response in patients who received anti-CD20 agents within a year from vaccination compared to those who had these therapies more than one year prior (20% vs. 37%;p=0.14). For CLL patients, there was a significant difference in Ab response when receiving the Moderna series (61%) compared to Pfizer (44%) (p=0.028). More information is summarized in Table 1. Conclusions: This study provides data from a large cohort of patients with CLL and other NHLs on Ab response to SARS-CoV-2 vaccination. Active or prior therapy for CLL was associated with lower rates of Ab response to vaccination, especially when treated with anti-CD20 therapy, which is consistent with prior publications. However, we also found a significant increase in Ab response rates after Moderna SARS-CoV-2 vaccination in treated CLL patients compared to other vaccination series.

Safety and Immunogenicity of INO-4800, a COVID-19 DNA Vaccine as a Primary Series and Booster

Background. DNA vaccines are safe, tolerable, elicit humoral and cellular responses, allow for repeated dosing over time, are thermostable at room temperature, and are easy to manufacture. We present a compilation of Phase 1 and Phase 2 data of Inovio's US COVID-19 DNA Vaccine (INO-4800) targeting the full-length Spike antigen of SARS-CoV-2. A South Korean Phase 2 study is ongoing. Methods. Participants in the open-label Phase 1 trial received 0.5 mg, 1.0 mg or 2.0 mg intradermally (ID) followed by electroporation (EP) at Days 0 and 28. An optional booster dose was administered >6 months post-dose 2. The Phase 2 further compared the 1.0 mg and 2.0 mg doses against placebo in a total of 401 participants randomized at a 3:3:1:1 ratio. ClinicalTrials.gov identifiers: NCT04336410 and NCT04642638 Results. The majority of adverse events (AEs) related to INO-4800 across both trials were mild in severity and did not increase in frequency with age and subsequent doses. In Phase 1, 78% (14/18) and 84% (16/19) of subjects generated neutralizing antibody responses with geometric mean titers (GMTs) of 17.4 (95%CI 8.3, 36.5) and 62.3 (95% CI 36.4, 106.7) in the 1.0 and 2.0 groups, respectively (Figure 1). By week 8, 74% (14/19) and 100% (19/19) subjects generated T cell responses by Th1- associated IFNγ ELISPOT assay . Following a booster dose, neutralizing GMTs rose to 82.2 (95% CI 38.2, 176.9) and 124.7 (95% CI 62.8, 247.7) in the 1.0 mg and 2.0 mg groups, respectively, demonstrating the ability of INO-4800 to boost (Figure 2). In Phase 2, neutralizing antibody responses demonstrated GMTs of 93.6 (95%CI 77.3, 113.4) in the 1.0 mg dose group and 150.6 (95%CI 123.8, 183.1) in the 2.0 mg dose group (Figure 3). Conclusion. INO-4800 appears safe and tolerable as a primary series and as a booster with the induction of both humoral and cellular immune responses. In addition to eliciting neutralizing antibodies, INO-4800 also induced T cell immune responses as demonstrated by IFNγ ELISpot. Finally, as a homologous booster, INO-4800, when administered 6-10.5 months following the primary series, resulted in an increased immune response without increase in reactogenicity. The 2.0 mg dose was selected for Phase 3 evaluation.

INO-4800 DNA Vaccine Induces Neutralizing Antibodies and T cell Activity Against Global SARS-CoV-2 Variants

Background. Global surveillance has identified emerging SARS-CoV-2 variants of concern (VOC) associated with increased transmissibility, disease severity, and resistance to neutralization by current vaccines under emergency use authorization (EUA). Here we assessed cross-immune responses of INO-4800 vaccinated subjects against SARS-CoV-2 VOCs. Methods. We used a SARS-CoV-2 IgG ELISA and a pseudo neutralization assay to assess humoral responses, and an IFNγ ELISpot to measure cellular responses against SARS-CoV-2 VOC in subjects immunized with the DNA vaccine, INO-4800. Results. IgG binding titers were not impacted between wild-type (WT) and B.1.1.7 or B.1.351 variants. An average 1.9-fold reduction was observed for the P.1 variant in subjects tested at week 8 after receiving two doses of INO-4800 (Figure 1a). We performed a SARS-CoV-2 pseudovirus neutralization assay using sera collected from 13 subjects two weeks after administration of a third dose of either 0.5 mg, 1 mg, or 2 mg of INO-4800. Neutralization was detected against WT and the emerging variants in all samples tested. The mean ID50 titers for the WT, B.1.1.7, B.1.351 and P.1. were 643 (range: 70-729), 295 (range: 46-886), 105 (range: 25-309), and 664 (range: 25-2087), respectively. Compared to WT, there was a 2.1 and 6.9-fold reduction for B.1.1.7 and B.1.351, respectively, while there was no difference between WT and the P.1 variant (Figure 1b). Next, we compared cellular immune responses to WT and SARS-CoV-2 Spike variants elicited by INO-4800 vaccination. We observed similar cellular responses to WT (median = 82.2 IQR = 58.9-205.3), B.1.1.7 (79.4, IQR = 38.9- 179.7), B.1.351 (80, IQR = 40.0-208.6) and P.1 (78.3, IQR = 53.1-177.8) Spike peptides (Figure 2). Conclusion. INO-4800 vaccination induced neutralizing antibodies against all variants tested, with reduced levels detected against B.1.351. IFNγ T cell responses were fully maintained against all variants tested.

Six feet of separation: Physical distancing impacts on blind and low vision during COVID-19 pandemic

Purpose : Individuals with vision loss are experiencing new and unique challenges due to physical distancing during the COVID-19 pandemic. We conducted a cross sectional study to understand challenges and to learn about adaptive strategies employed. Methods : The Casey Eye Institute EHR (EPIC) was queried for patients meeting the following criteria: best corrected visual acuity of 20/70 or worse in the better seeing eye;age 18-100, and active email address. 762 requests for participation in completing a 23- question survey were emailed via REDcap and responses were received from 46 patients;19 male and 27 female. The data was analyzed using SPSS statistical software. Comparisons were made between age, duration of visual impairment, severity of visual impairment to effects of physical distancing and adaptive strategies. Comparisons were made using the chi-squared test. Results : 44% of participants reported that physical distancing impacted their willingness to run essential errands and 52% agree or strongly agree that they have difficulty maintaining physical distancing due to their visual impairment. 65% agree or strongly agree that changes to the layout of familiar places, to encourage physical distancing, makes navigating more difficult. There is an association between age and this difficulty with navigating due to changes to the layout (p<0.01). Younger participants rated navigating as more difficult with changes to the layout, not older participants. 72% agree or strongly agree that visual markers used to indicate 6 feet physical distance are helpful in public places. 39% of participants reported that they use strategies to maintain physical distancing when in public. The most common strategies included Sighted Guide or avoiding situations where others may be present. Individuals with vision loss for >10 years, but not since birth, are most likely to report using strategies to maintain physical distancing. Conclusions : The need to physically distance during a pandemic poses unique challenges for individuals with vision loss. Policies for physical distancing should consider this population. Visual markers on the ground to indicate 6 feet of separation can be helpful and it is important to be mindful when making changes to the environmental layout. Further research to learn more about the strategies utilized by this population to adapt to these challenges is needed.

Accreditation Council for Pharmacy Education: 2020 Annual Report

Marie A. Chisholm-Burns, PharmD, MPH, MBA, FCCP, FASHP, Dean at the University ofT ennessee HealthScience Center College ofPharmacy and Professor of Surgery in the College of Medicine (AACP);Gregory Gruener MD, MBA, MHPE, Vice Dean for Education, Stritch School of Medicine, Loyola University Chicago, Ralph P. Leischner Jr., MD, Department of Medical Education, Professor, Neurology (American Council on Education, ACE);Kimberly S. Croley, PharmD, BCGP, FASCP, FAPhA, Director ofPharmacy and Clinical Pharmacist for Laurel Senior Living Communities (American Pharmacists Association, APhA) (appointed effective August 2, 2020);Winnie A. Landis, BS Pharm, CDE, FAPhA, Community Pharmacist, CVS Health (APhA);LuGina Mendez-Harper, PharmD, Director, ProfessionalPractices, atPrimeTherapeutics (NABP);Amy L. Seybert, BS, PharmD, FASHP, FCCP, CHSE, Associate Professor and Chair of the Department of Pharmacy and Therapeutics at the University of Pittsburgh School of Pharmacy (APhA);Sharon L. Youmans, PharmD, MPH, FAPhA, Vice Dean at the University of California San Francisco and Professor of Clinical Pharmacy (AACP) (appointed effective August 2,2020) Continuing Pharmacy Education (CPE) Commission The CPE Commission met virtually, due to the COVID-19 pandemic, on May 12-14 and November 17-19, 2020. The appointed members of the Commission, the officers, and their affiliations were Tammie Armeni, RPh, PharmD (Therapeutic Research Center);JoAnn Francis, BS Pharm, MBA, CHCP (American Society of Health System Pharmacists);Peter J. (P.J.) Hughes, PharmD, MSEd, BCPS (Samford University);Barbara Jolly, RPh, MPA, LDE (Sullivan University College of Pharmacy);Lindsay Kaster, PharmD, BCOP (Boise VA Medical Center);Nicholas Lehman, PharmD, BCACP (Drake University College of Pharmacy and Health Sciences and UnityPoint West Des Moines Family Medicine & Internal Medicine Clinics);Jennifer Pauley, PharmD, BCPS, BCOP (St. Jude Childrens Research Hospital);Aaron D. Reich, PharmD (TRINU Healthcare);Ginger Scott, RPh, MS, PhD (West Virginia University School ofPharmacy);Barbara Ellen Maguire Vick, JD, PharmD, BCSCP (North Carolina Board of Pharmacy);Trish Wegner, BS Pharm, PharmD, FASHP (Illinois Council of Health-System Pharmacists);Diane Yoon, EdD (USC School of Pharmacy, Health Sciences Campus). On the basis of comprehensive, focused, and staff consultation evaluations conducted during the reporting year, communications received from the institutions, ongoing review of first- time NAPLEX® passingrates, entry class size, attrition, academic dismissals, withdrawals, and on-time graduation rates, and comments of the Public Interest Panel, the Board of Directors determined the accreditation status along with specified terms and conditions for various professional programs noted below. For Purposes of Considering Continued Accreditation Status Concordia University Wisconsin School of Pharmacy (2019-2021··) (2027-2028);D'Youville College School of Pharmacy (2019-2021··) (2027-2028);Husson University School of Pharmacy (2019-2021··) (2022-2023·);Loma Linda University School of Pharmacy (2020-2021) (2028-2029);North Dakota State University College of Health Professions (2019-2021··) (2027-2028);Oregon State University College of Pharmacy (2019-2020) (20272028);Philadelphia College of Osteopathic Medicine School of Pharmacy (2019-2020) (2027-2028);Presbyterian College School of Pharmacy (2019-2021··) (20272028);Roosevelt University College of Pharmacy (20192020)(2027-2028);Rutgers, the State University of New Jersey Ernest Mario School of Pharmacy (2020-2021) (2028-2029);University of California-San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences (20202021)(2028-2029);University ofFlorida College of Pharmacy (2020-2021) (2028-2029);University of Mississippi School of Pharmacy (2019-2020) (2027-2028);University of Nebraska Medical Center College of Pharmacy (20202021) (2028-2029);University ofNorth Carolina Eshelman School of Pharmacy 2019-2020) (2027-2028);University of Saint Joseph School ofPharmacy (2019-2021··) (20212022)·;University of Wyoming School of Pharmacy (2020-2021) (2028-2029);Western University of Health Sciences College of Pharmacy (2019-2021··) (20222023)·;Wilkes University Nesbitt School of Pharmacy (2020-2021)(2028-2029) Accredited with Probation Status Chicago State University College ofPharmacy (2020-2021) (2022-2023)· For Purposes of Considering Advancement from Precandidate to Candidate Status None Removal of Accredited with Probation Status University at Buffalo The State University of New York School ofPharmacy and Pharmaceutical Sciences (20192020) (2021-2022)· For Purposes of Considering: Application for Precandidate Status University of California at Irvine School ofPharmacy and Pharmaceutical Sciences For Purposes of Considering: Continued Candidate Status University of Texas at El Paso School ofPharmacy (20192021··) (2021-2021);William Carey University School ofPharmacy (2019-2021··) (2021-2021) For Purposes of Considering: Continued Accredited Status (after initial two-year term) Chapman University School ofPharmacy (2019-2021··) (2023-2024);Keck Graduate Institute School ofPharmacy and Health Sciences (2019-2021··) (2023-2024);West Coast University School of Pharmacy (2019-2021··) (2023-2024) For Purposes of Considering: Advancement from Candidate to Accredited Status High Point University Fred Wilson School of Pharmacy (2019-2021··) (2021-2022);Larkin University College of Pharmacy Candidate status continued.