Continuing Pharmacy Education / CE Master List / Immunization: It is Now Time to Make it Unclear: Reconciling Differences between Public Health Vaccine Recommendations and FDA Product Labeling-RECORDED WEBINAR
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Immunization: It is Now Time to Make it Unclear: Reconciling Differences between Public Health Vaccine Recommendations and FDA Product Labeling-RECORDED WEBINAR

About this Course

This course is a recorded (home study version) of the CE Finale Encore Webinars.

 

Learning Objectives

Upon completion of this application based CE Activity, a pharmacist will be able to:

1. Compare and contrast the roles & activities of the Center for Biologics Evaluations and Research (CBER), US Food & Drug Administration (FDA), Centers for Disease Control & Prevention (CDC), and the Advisory Committee on Immunization Practices (ACIP) during the development and clinical use of vaccines in the United States.
2. Describe one specific example where the routine clinical use of a vaccine may differ from FDA-approved product prescribing information due to the following:

(a) costs, (b) disease epidemiology, (c) public acceptance, (d) vaccine supplies.

Release and Expiration Dates

Released:  December 15, 2023
Expires:  December 15, 2026

Course Fee

$17 Pharmacist

ACPE UAN

0009-0000-23-042-H06-P

Session Code

23RW42-KXV39

Accreditation Hours

1.0 hours of CE

Additional Information

 

How to Complete Evaluation:  When you are ready to submit quiz answers, go to the BLUE take test/evaluation button.

Accreditation Statement

The University of Connecticut School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Pharmacists and Pharmacy Technicians are eligible to participate in this application-based activity and will receive up to 1.0 CE Hours (or 0.1 CEUs)  for completing the activity ACPE UAN 0009-0000-23-042-H06-P, passing the quiz with a grade of 70% or better, and completing an online evaluation. Statements of credit are available via the CPE Monitor online system and your participation will be recorded with CPE Monitor within 72 hours of submission.

Grant Funding

There is no grant funding for this activity.

Faculty

Jeffery Aeschlimann, PharmD
Associate Clinical Professor-Infectious Disease Specialty
University of Connecticut School of Pharmacy
Storrs, CT  

Faculty Disclosure

In accordance with the Accreditation Council for Pharmacy Education (ACPE) Criteria for Quality and Interpretive Guidelines, The University of Connecticut School of Pharmacy requires that faculty disclose any relationship that the faculty may have with commercial entities whose products or services may be mentioned in the activity.

  • Dr. Aeschlimann consults with F2G, Inc. but there is no crossover in the topics, so all issues have been mitigated.

Disclaimer

The material presented here does not necessarily reflect the views of The University of Connecticut School of Pharmacy or its co-sponsor affiliates. These materials may discuss uses and dosages for therapeutic products, processes, procedures and inferred diagnoses that have not been approved by the United States Food and Drug Administration. A qualified health care professional should be consulted before using any therapeutic product discussed. All readers and continuing education participants should verify all information and data before treating patients or employing any therapies described in this continuing education activity.

Content

Handouts

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Post Test

 

    Immunizations (Aeschlimann) – Post-Test Questions

     

     

    1. If asked, which of the following activities would the Food and Drug Administration decline to do and send to another agency?

     

    1. Verify appropriate vaccine manufacturing processes
    2. Approve advertising for vaccine products Reporting System (VAERS)
    3. Determine the strategy for public use of vaccines in the U.S.

     

     

    2.) Which of the following items would you expect to always/very-commonly see in the FDA-Approved product labeling for a vaccine product?

     

    1. Instructions for preparation of the product and route of administration
    2. Comparative effectiveness data for people taking chronic steroid therapy
    3. Recommendations for use of lower doses in case of product shortages

     

     

    3.) Which of the following is a correct example of a vaccination situation for which ACIP has issued “Shared Clinical Decision-making” (SCDM) guidance?

     

    1. Intranasal influenza vaccine administration in immunocompromised persons
    2. Respiratory syncytial virus vaccination for adults aged 60 years and older
    3. Human papillomavirus vaccination for persons aged 16-21 years

     

     

    4.) Which entity ultimately approves the content for FDA vaccine product labeling?

     

    1. The Vaccines and Related Biological Products Advisory Committee
    2. The Center for Biologic Evaluation & Research
    3. The Center for Drug Evaluation and Research

     

     

    5.) Which of the following people would be allowed to sit in the CDC’s Advisory Committee on Immunization Practices (ACIP)?

     

    1. A member of a vaccine manufacturer’s current Board of Directors
    2. A college professor whose expertise is mechanical engineering
    3. A practicing physician who is an expert in virology and vaccine safety

     

     

    6.) What does ACIP recommend after healthcare providers receive a full series of hepatitis B immunizations?

     

    1. Serologic testing for all healthcare providers at high risk for occupational percutaneous or mucosal exposure to blood or body fluids.
    2. Serologic testing for immunocomproised healthcare providers at high risk for occupational percutaneous of any type.
    3. Molecular testing for all healthcare providers at high risk for occupational percutaneous or mucosal exposure to blood or body fluids.

    VIDEO