Crisis: An Open Forum Webinar Series for Pharmacists May 21, 2020 - PowerPoint PPT Presentation

American Pharmacists Association Addressing the COVID-19 Crisis: An Open Forum Webinar Series for Pharmacists May 21, 2020

American Pharmacists Association Michael D. Hogue, PharmD, FAPHA, FNAP Dean and Professor Loma Linda University School of Pharmacy President, APhA Host and Moderator

American Pharmacists Association Today’s Focus: Discuss antibody testing, how to evaluate antibody tests, and implications for pharmacists.

American Pharmacists Association Paul C. Herrmann, MD, PhD Professor and Chair Department of Pathology and Human Anatomy Loma Linda University School of Medicine Guest Speaker

American Pharmacists Association Daniel Zlott, PharmD, BCOP Vice President Professional Education Resources American Pharmacists Association Guest Speaker

American Pharmacists Association Ilisa BG Bernstein, PharmD, JD, FAPhA Senior Vice President, Pharmacy Practice and Government Affairs American Pharmacists Association Subject Matter Expert: : Q&A

American Pharmacists Association Format for Today’s Webinar 1:00 pm: Introductions 1:05 pm: Presentation by Dr. Daniel Zlott, Vice President, Professional Education Resources, American Pharmacists Association 1:15 pm: Presentation by Dr. Paul Herrmann, Professor and Chair for the Department of Pathology and Human Anatomy, Loma Linda University School of Medicine 1:25 pm: Open Forum: A Minute for Your Thoughts 1:50 pm: Wrap Up: Review of APhA’s Ongoing Activities and What’s Coming

American Pharmacists Association Presentation by Dr. Daniel Zlott An overview of COVID-19 infection and the immune response

American Pharmacists Association Overv rview of COVID-19 Vir irus • COVID-19 is caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) – for the sake of simplicity, we’ll call it the COVID -19 virus • The COVID-19 virus is an enveloped RNA virus • The COVID-19 virus consists of 1 • Spike proteins (S protein) • Envelope (lipid membrane) • Envelope (E) and Membrane (M) proteins • Nucleocapsid • Nucleoproteins (N protein) • Genetic material (RNA) • Miscellaneous proteins • Non-structural proteins (nsp) 3D Printed Model of COVID-19; Image Credit: NIAID-RML • Accessory proteins (ORF, and others) 1. Mousavizadeh, et al. J Microbiol Immunol Infect. 2020; DOI: https://doi.org/10.1016/j.jmii.2020.03.022

American Pharmacists Association COVID-19 Antigens • There are a number of potential epitopes that have been confirmed or are hypothesized to generate an immune response 1,2 : • S protein • N protein • M protein • Nsp3, nsp4 • ORF3a, ORF8 • These epitopes have been confirmed or hypothesized to generate both T- and B-cell responses 1,2 • For the purposes of today’s discussion, we will be focusing on B-Cell responses Scanning electron migrograph of SARS-CoV-2; Image Credit: NIAID-RML 1. Grifoni, et al. Cell Host & Microbe. 2020; DOI: https://doi.org/10.1016/j.chom.2020.03.002 2. Grifoni, et al. Cell. 2020; DOI: https://doi.org/10.1016/j.cell.2020.05.015

American Pharmacists Association General Review of Antibody Development Understanding antibody development 1 : • Antibodies are produced by activated B-cells (also called plasma cells) • B-lymphocytes recognize their targets through immunoglobulins present on the cell surface (B-cell receptor) • Once a B-lymphocyte recognizes its target, it must also be activated by CD4+ T-cells (helper T-cells), which secrete B-lymphocyte growth factors • Activated B-cells become plasma cells or memory B-cells • Each plasma cell makes a single type of antibody • There are 5 general classes of antibody (immunoglobulins) • IgA • IgD • IgE • IgM • IgG 1. Zlott, et al. ‘Function and Evaluation of the Immune System’, in Dipiro, et al. Pharmacotherapy: A Pathophysiologic Approach, 11 th Ed. McGraw Hill, 2019

American Pharmacists Association General Review of Antibody Development • Understanding antibody development 1 : • It takes time to develop an antibody response once exposed to antigen 1 • IgM: Initial antibody produced upon initial exposure to antigen • IgM appears 4-7 days after initial exposure, and peaks 7-10 days after initial exposure • IgG: Longer term antibody produced upon initial exposure – provides long term protection against pathogen • IgG appears 7-10 days after initial exposure, and peaks 10-14 days after initial exposure • Upon re-exposure, memory B-cells rapidly reactivate plasma cells, which produce IgG, Image: Immunoglobulin response curve upon exposure to Dengue Fever. 2 neutralizing pathogen 1. Zlott, et al. ‘Function and Evaluation of the Immune System’, in Dipiro, et al. Pharmacotherapy: A Pathophysiologic Approach, 11 th Ed. McGraw Hill, 2019 2. Guzman, et al. Nature Reviews Microbiology 2010;8:S7-S16.

American Pharmacists Association Do People Generate an Antibody Response to COVID-19? 19? • Yes! • A cross-sectional study from 3 hospitals which included 285 pts demonstrated that 100% of pts develop either IgM, IgG, or both within 19 days of symptom onset • All pts were confirmed to be COVID-19+ by PCR • Serum Ig levels tested by ELISA Figure 1a from Long, et al. 1 1. Long, et al. Nature Medicine . 2020; DOI: https://doi.org/10.1038/s41591-020-0897-1

American Pharmacists Association Presentation by Dr. Paul Herrmann An overview of how antibody testing works and considerations for pharmacists

American Pharmacists Association Enzyme-Linked Im Immunosorbent Assay (E (ELISA) socratic.org

American Pharmacists Association Lateral Flo low Test antibioticresearch.org.uk

American Pharmacists Association In Instrument Validation Must Demonstrate: • Precision • Accuracy • Reproducibility • Limits of Detection/Range • Correlation to Existing Method • Relevant Reference Range

American Pharmacists Association

American Pharmacists Association COVID-19 IgM/IgG Testing within 5 days of Positive PCR COVID-19 IgM/IgG Testing within 14 Days of Positive PCR

American Pharmacists Association Unusual Regulatory ry Climate • Ordinarily a test is developed by a company. Then the FDA evaluates and approves it after extensive testing. Clinical labs do a quick validation to make sure everything is working correctly on site. • Due to current situation, FDA issued Emergency Use Authorization (EUA). High complexity CLIA certified labs just inherited all the work, liability and risk of what FDA used to do for us. • Antibody testing was turned loose by FDA even before EUA issuance. Even more imperative that lab validation be performed carefully and correctly.

American Pharmacists Association Fin inding a Good Test

American Pharmacists Association Tim imeline for Bri ringing in in a Lab Test Buy Install Validate Go Live Monitor New Test Don’t forget there will also need to be a supply chain for : reagents and supplies for instrument specimen collection materials staff to run the test in addition to everything else they were already doing

American Pharmacists Association Polling Question My pharmacy practice site is considering offering antibody testing when it becomes available: A. Yes B. No C. Not applicable to my practice

American Pharmacists Association Open Forum Ground Rules • Use the Questions field on the GoToWebinar toolbar to submit comments and questions related to the topic discussion • Individuals whose submissions are selected will be asked by the moderator to state the comment or question for the audience. The line for the individual will be unmuted to read their comment or question. • To maximize the number of questions/comments addressed, a 60-second time limit will be in effect for everyone to state their question or comment. • We will try to get to as many comments and questions as possible. We have created a new forum for COVID-19 discussions where further discussion post-webinar. Information on participating in this forum will be provided at the end of the open forum.

American Pharmacists Association Open Forum Discussion: A Minute for Your Thoughts Comments, Questions, Feedback

American Pharmacists Association Review of APhA’s Ongoing Activities and What’s Coming

American Pharmacists Association NEW Episodes – APhA’s 15 on COVID -19 An education series designed to help you sort COVID-19 fact from fiction. Each episode is 15-20 minutes and provides CPE. Episode 16: Anticoagulation in COVID-19 http://elearning.pharmacist.com/products/6106 /15-on-covid-19-05-14-2020-anticoagulation/ Episode 17: Antibody Development and Reinfection http://elearning.pharmacist.com/products/6110 /15-on-covid-19-05-18-2020-antibody- development-and-reinfection

American Pharmacists Association Check out the practice resources here • COVID-19 Fraudulent Medical Products and Scams • Demystifying Testing for SARS-CoV-2 Virus: Frequently Asked Questions • Vaccines in Development for COVID-19 • New resources weekly!