Tennessee Pharmacists Association

PREP Act Amendment Extends Influenza Vaccination AuthorityAugust 9, 2021

On August 4, 2021, HHS issued its eighth PREP Act declaration, authorizing qualified pharmacy technicians and State-authorized pharmacy interns acting under pharmacist supervision to administer seasonal influenza vaccines in addition to COVID-19 vaccines and certain pediatric immunizations.

What does this declaration do? This PREP Act declaration authorizes qualified pharmacy technicians and pharmacy interns to administer seasonal influenza vaccines, acting under the supervision of a qualified pharmacist, that the Advisory Committee on Immunization Practices (ACIP) recommends to persons aged 19 and older according to ACIP’s standard immunization schedule. As a note, they are already able to give ACIP-recommended influenza vaccines to persons 3-18 under further guidance from the fourth amendment.

What does this mean? Pharmacy technicians and pharmacy interns are now able to give ACIP-recommended childhood vaccines, COVID-19 vaccines for those 3 years and older, and ACIP-recommended seasonal influenza vaccines for those 3 years and older. 

Where can I find more information on influenza vaccines?

  • For the PREP Act declaration announcement, click here.
  • For a complete list of ACIP-Recommended Vaccines, click here.
  • For more information about pharmacist-provided vaccines, click here

SUMMARY

What is the Public Readiness and Emergency Preparedness Act (PREP Act), and what does a PREP Act declaration provide to pharmacists and pharmacy professionals?

Per the HHS website: “The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a declaration (PREP Act declaration) that provides immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.”

Previous PREP Act Declaration Summaries

Authorization for Pharmacists to Order and Administer COVID-19 Tests

On April 8, 2020, HHS issued its first PREP Act declaration, authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized through Emergency Use Authorization (EUA). On May 19, the General Counsel for the HHS Office of the Secretary issued an advisory opinion further clarifying this PREP Act declaration and its preemption on local and state regulations that may conflict with the declaration.

What does this declaration do? This PREP Act declaration authorizes Tennessee-licensed pharmacists to order and administer COVID-19 tests that have been authorized by the FDA through its EUA process.

What does this mean? If a pharmacy has an active CLIA waiver, the pharmacist is granted the authority, and is covered under the liability protections of the PREP Act, to order and administer COVID-19 tests that have been approved as “waived” by the FDA through its EUA process.

Where can I find more information on COVID-19 tests?

  • For the PREP Act declaration announcement, click here.
  • For a complete list of FDA-authorized waived tests, click here (waived tests will have a “W” under the “Authorized Setting(s)” column).
  • For more information about how to obtain a CLIA waiver, click here.

Authorization for Pharmacists to Order and Administer (and Pharmacy Interns to Administer) ACIP-Recommended Childhood Vaccinations

On August 19, 2020, HHS issued its third PREP Act declaration, authorizing certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, any vaccine that the ACIP recommends to persons ages 3 through 18 according to ACIP’s standard immunization schedule (ACIP-recommended vaccines). On October 22, the General Counsel for the HHS Office of the Secretary issued an advisory opinion clarifying the PREP Act declaration and its preemption on local and state regulations that may conflict with the declaration, suspension of the collaborative pharmacy practice agreement (CPPA) requirement for childhood vaccines, and inclusion of epinephrine in the PREP Act as a covered countermeasure. 

What does this declaration do? This PREP Act declaration authorizes certain Tennessee-licensed pharmacists to order and administer, and pharmacy interns acting under the supervision of a Tennessee-licensed pharmacist to administer, any ACIP-recommended vaccine to persons 3 through 18 years of age. 

What does this mean? As long as a Tennessee-licensed pharmacist satisfies the requirements below, the pharmacist is granted the authority, and is covered under the liability protections of the PREP Act, to order and administer any ACIP-recommended vaccine to persons 3 through 18 years of age. In addition, any pharmacy intern acting under the supervision of a Tennessee-licensed pharmacist is granted the authority, and is covered under the liability protections of the PREP Act, to administer any ACIP-recommended vaccine to persons 3 through 18 years of age. 

How does this PREP Act declaration temporarily modify existing immunization CPPA requirements (also referred to as standing orders or protocols)?

  • Childhood vaccines: Under this declaration, an immunization CPPA is NOT required for pharmacists to order and administer ACIP-recommended childhood vaccines in Tennessee.
  • Adult vaccines: An immunization CPPA is still required for pharmacists to order and administer ACIP-recommended adult vaccines in Tennessee. 

Where can I find more information on pharmacist-provided vaccines?

  • For the PREP Act declaration announcement, click here.
  • For a complete list of ACIP-Recommended Childhood Vaccines, click here
  • For more information about pharmacist-provided vaccines, click here.  

Authorization for Pharmacists to Order and Administer (and Pharmacy Interns to Administer) COVID-19 Vaccinations

On September 3, 2020, HHS issued its fourth PREP Act declaration authorizing certain State-licensed pharmacists to order and administer, and pharmacy interns (who are licensed or registered by their State board of pharmacy and acting under the supervision of a State-licensed pharmacist) to administer, COVID-19 vaccinations to persons ages 3 or older.

What does this declaration do? This PREP Act declaration authorizes certain Tennessee-licensed pharmacists to order and administer, and pharmacy interns acting under the supervision of a Tennessee-licensed pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older.

What does this mean? As long as a Tennessee-licensed pharmacist satisfies the requirements below, the pharmacist is granted the authority, and is covered under the liability protections of the PREP Act, to order and administer COVID-19 vaccinations to persons ages 3 years or older. In addition, any pharmacy interns acting under the supervision of a Tennessee-licensed pharmacist are authorized to administer COVID-19 vaccinations to persons ages 3 years or older.

Where can I find more information on pharmacist-administered COVID-19 vaccines?

  • For the PREP Act declaration announcement, click here.

Authorization for Pharmacy Interns and Pharmacy Technicians to Administer Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Tests

On October 21, 2020, HHS issued further guidance regarding the administration of childhood vaccines, COVID-19 vaccines, and COVID-19 tests by pharmacy interns and pharmacy technicians.

What does this guidance do? This PREP Act guidance authorizes qualified pharmacy technicians and State-authorized pharmacy interns, acting under the supervision of a qualified pharmacist, to administer FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages 3 or older, to administer FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages 3 through 18 according to ACIP’s standard immunization schedule, as well as administration of COVID-19 tests.

What does this mean? Under this guidance, pharmacy interns in Tennessee and Tennessee-registered pharmacy technicians, acting under the supervision of a qualified pharmacist, are granted the authority, and are covered under the liability protections of the PREP Act, to:

  • Administer FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages 3 or older;
  • Administer FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages 3 through 18 according to ACIP’s standard immunization schedule; and
  • Administer COVID-19 tests

The pharmacist must order the vaccine or test, and the pharmacist must supervise the pharmacy intern or registered technician when administering any vaccine or COVID-19 test. 

Where can I find more information on pharmacist-administered COVID-19 vaccines?

  • For the PREP Act guidance for interns and technicians, click here.

REQUIREMENTS

NOTEThe requirements (listed below) for pharmacists, pharmacy technicians, and State-authorized pharmacy interns administering influenza vaccines and vaccines to children include completion of two hours of ACPE-approved immunization-related CE during each licensing period. Completion of TPA’s 2020 Annual Immunization and OSHA Update will fulfill this requirement, as will courses from TPA’s COVID-19 Vaccine Series

To Order and Administer COVID-19 Tests:

  • Pharmacists:
    • The pharmacy must have an active CLIA waiver.
    • The COVID-19 tests must be authorized through the FDA’s Emergency Use Authorization (EUA) process.
    • All test results, regardless of result, must be reported to the Tennessee Department of Health following their reporting guidance.
  • Pharmacy Technicians and State-Authorized Pharmacy Interns (may only administer):
    • Must comply with guidance for pharmacists above.
    • The COVID-19 test must be ordered by the supervising qualified pharmacist.
    • The COVID-19 test must be administered under the supervision of a pharmacist.

To Order and Administer Childhood Vaccinations and Administer Influenza Vaccines:

  • Pharmacists:
    • The vaccine must be FDA-authorized or FDA-licensed.
    • The vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices’ (ACIP) standard immunization schedule.
    • The licensed pharmacist must complete a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique, clinical evaluation of indications and contraindications of vaccines, and the recognition and treatment of emergency reactions to vaccines.
    • The licensed pharmacist must have a current certificate in basic CPR.
    • The licensed pharmacist must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during each state licensing period.
    • The licensed pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary-care provider when available, submitting the required immunization information to the State or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine.
    • The licensed pharmacist must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
  • Pharmacy Technicians and State-Authorized Pharmacy Interns (may only administer): 
    • Must comply with guidance for pharmacists above, except for different training requirements, listed below.
    • The vaccination must be ordered by the supervising qualified pharmacist.
    • The supervising qualified pharmacist must be readily and immediately available to the immunizing qualified pharmacy technician.
    • The qualified pharmacy technician or State-authorized pharmacy intern must complete a practical training program that is approved by the Accreditation Council for Pharmacy Education (ACPE). This training program must include hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.

To Order and Administer COVID-19 Vaccinations:

  • All of the above requirements for childhood and influenza vaccinations must be met.
  • PLUS, the licensed pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention (CDC) COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).