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, FNAPDean and ProfessorLoma Linda University School of PharmacyPresident, APhA

Host and Moderator

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Today’s Focus:

Discuss antibody testing, how to evaluate antibody tests, and implications for pharmacists.

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Paul C. Herrmann, MD, PhDProfessor and ChairDepartment of Pathology and Human AnatomyLoma Linda University School of Medicine

Guest Speaker

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Daniel Zlott, PharmD, BCOPVice PresidentProfessional Education ResourcesAmerican Pharmacists Association

Guest Speaker

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Ilisa BG Bernstein, PharmD, JD, FAPhASenior Vice President, Pharmacy Practice and Government AffairsAmerican Pharmacists Association

Subject Matter Expert: Q&A

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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

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Presentation by Dr. Daniel Zlott

An overview of COVID-19 infection and the immune response

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Overview of COVID-19 Virus• 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 of1

• 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)

• Accessory proteins (ORF, and others)3D Printed Model of COVID-19; Image Credit: NIAID-RML

1. Mousavizadeh, et al. J Microbiol Immunol Infect. 2020; DOI: https://doi.org/10.1016/j.jmii.2020.03.022

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COVID-19 Antigens

Scanning electron migrograph of SARS-CoV-2; Image Credit: NIAID-RML

• There are a number of potential epitopes that have been confirmed or are hypothesized to generate an immune response1,2:• S protein• N protein• M protein• Nsp3, nsp4• ORF3a, ORF8

• These epitopes have been confirmed or hypothesized to generate both T- and B-cell responses1,2

• For the purposes of today’s discussion, we will be focusing on B-Cell responses

1. Grifoni, et al. Cell Host & Microbe. 2020; DOI: https://doi.org/10.1016/j.chom.2020.03.0022. Grifoni, et al. Cell. 2020; DOI: https://doi.org/10.1016/j.cell.2020.05.015

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General Review of Antibody DevelopmentUnderstanding antibody development1:

• 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, 11th Ed. McGraw Hill, 2019

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General Review of Antibody Development• Understanding antibody development1:

• It takes time to develop an antibody response once exposed to antigen1

• 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, neutralizing pathogen

1. Zlott, et al. ‘Function and Evaluation of the Immune System’, in Dipiro, et al. Pharmacotherapy: A Pathophysiologic Approach, 11th Ed. McGraw Hill, 20192. Guzman, et al. Nature Reviews Microbiology 2010;8:S7-S16.

Image: Immunoglobulin response curve upon exposure to Dengue Fever.2

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Do People Generate an Antibody Response to COVID-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

1. Long, et al. Nature Medicine. 2020; DOI: https://doi.org/10.1038/s41591-020-0897-1

Figure 1a from Long, et al.1

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Presentation by Dr. Paul Herrmann

An overview of how antibody testing works and considerations for pharmacists

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Enzyme-Linked Immunosorbent Assay(ELISA)

socratic.org

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antibioticresearch.org.uk

Lateral Flow Test

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Instrument Validation

Must Demonstrate:• Precision• Accuracy• Reproducibility• Limits of Detection/Range• Correlation to Existing Method• Relevant Reference Range

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COVID-19 IgM/IgG Testing within 5 days of Positive PCR

COVID-19 IgM/IgG Testing within 14 Days of Positive PCR

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Unusual Regulatory 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.

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Finding a Good Test

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Timeline for Bringing in a Lab Test

New TestBuy Install Validate Go Live Monitor

Don’t forget there will also need to be a supply chain for:

reagents and supplies for instrumentspecimen collection materialsstaff to run the test in addition to everything else they were already doing

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My pharmacy practice site is considering offering antibody testing when it becomes available:

A. Yes

B. No

C. Not applicable to my practice

Polling Question

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• 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.

Open Forum Ground Rules

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Open Forum Discussion: A Minute for Your Thoughts

Comments, Questions, Feedback

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Review of APhA’s Ongoing Activities and What’s Coming

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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-19http://elearning.pharmacist.com/products/6106

/15-on-covid-19-05-14-2020-anticoagulation/

Episode 17: Antibody Development and Reinfectionhttp://elearning.pharmacist.com/products/6110/15-on-covid-19-05-18-2020-antibody-development-and-reinfection

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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!

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“…states and localities may not ‘establish, enforce, or continue in effect’ any legal requirement that prohibits or effectively prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests.”

G

https://www.hhs.gov/sites/default/files/advisory-opinion-20-02-hhs-ogc-prep-act.pdf

U.S. Health and Human Services Office of the General Counsel Advisory Opinion 20-02, May 19,2020

Pharmacist Testing

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actioncenter.pharmacist.comGO TO:

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• Weekly webinar will be on Thursday, May 28th, from 1-2 pm ET

• The webinar recording and slides will be available within 24 hours

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https://www.pharmacist.com/coronavirus/resources-training