Covid-19 and the PREP Act
Over the past several months, the U.S. Department of Health and Human Services (HHS) has issued several Public Readiness and Emergency Preparedness Act (PREP Act) declarations and guidance documents related to pharmacy-based COVID-19 care and services.
These declarations have granted significant regulatory flexibility and new authorities to pharmacists, student pharmacists (referred to as pharmacy interns), and pharmacy technicians. With everything going on these days, it can be challenging to keep track of it all, so here’s a summary of these HHS announcements and the requirements that pharmacists must satisfy before ordering and administering COVID-19 tests and vaccines, and requirements that pharmacy interns and pharmacy technicians must satisfy before administering vaccines, pursuant to these PREP ACT declarations.
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.
Importantly, the PREP Act also preempts state law in conflict with any authorization made pursuant to the PREP ACT during the period of emergency.
Authorization for Pharmacists to Order and Administer COVID-19 Tests
On April 8, HHS issued its 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 Georgia-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 non waived tests a pharmacy may still serve as a specimen collection station for CLIA certified laboratories during the period of emergency.
How to obtain a CLIA Waiver
1. Go to CMS CLIA website: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/How_to_Apply_for_a_CLIA_Certificate_International Laboratories
2. Print out CMS-116 Form
3. Send application to:
Department of Community Health
Healthcare Facility Regulation Division
Diagnostic Services Unit
2 Peachtree Street NW Suite 31-447
Atlanta, GA 30303
Attn: Christel Benn Griffith
Authorization for Pharmacists to Order and Administer (and Pharmacy Interns to Administer) ACIP-Recommended Childhood Vaccinations
On August 19, HHS issued its Third Amendment to the Declaration under the Prep Act 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 Advisory Committee on Immunization Practices (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 and inclusion of epinephrine in the PREP Act as a covered countermeasure.
What does this declaration do?
This PREP Act declaration authorizes certain Georgia-licensed pharmacists to order and administer, and pharmacy interns acting under the supervision of a Georgia-licensed pharmacist to administer, any ACIP-recommended vaccine to persons 3 through 18 years of age.
What does this mean?
As long as a Georgia-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 Georgia-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 Vaccine Protocol Agreements?
• Childhood vaccines: Under this declaration, Vaccine Protocol Agreement is NOT required (and not allowed) for pharmacists to order and administer ACIP-recommended childhood vaccines in Georgia.
• Adult vaccines: A Vaccine Protocol Agreement is still required for pharmacists to order and administer adult vaccines (pneumococcal; influenza, meningitis, shingles) in Georgia.
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 in Georgia, click here.
Authorization for Pharmacists to Order and Administer (and Pharmacy Interns to Administer) COVID-19 Vaccinations
On September 3, HHS issued guidance 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 Georgia-licensed pharmacists to order and administer, and pharmacy interns acting under the supervision of a Georgia-licensed pharmacist to administer, COVID-19 vaccinations to persons ages 3 or older.
What does this mean?
As long as a Georgia-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 Georgia-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, HHS issued 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 Georgia and Georgia-registered pharmacy technicians, acting under the supervision of a qualified pharmacist and subject to certain other requirements, 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 for Georgia-Licensed Pharmacists
To Order and Administer COVID-19 Tests:
- 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 Georgia Department of Public Health:
- Method 1: The preferred method of reporting test results to public health is via an electronic laboratory result message that is based on the HL7 standard that is securely transmitted to DPH via an automated process from the provider’s laboratory information system or electronic medical record system.
- Method 2: Record results in a spreadsheet and securely upload into DPH’s SendSS system for processing. The key data to report are: (1) Patient Demographics (Patient Identifier, Name, DOB, Telephone, Email, Address, Sex, Race, Ethnicity), (2) Test Results (Date of Test, Name/Type of Test, Test Result); and (3) any other screening info available (symptoms, underlying medical conditions)
To Order and Administer Childhood Vaccinations:
- 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 inform his or her childhood vaccination patients 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.
To Order and Administer COVID-19 Vaccinations:
- All of the above requirements for childhood 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).
Requirements for Georgia Pharmacy Interns and Georgia-Registered Pharmacy Technicians
To Administer COVID-19 Tests:
- 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 Georgia Department of Public Health (see 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 Administer Childhood or COVID-19 Vaccinations:
- 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 technicians.
- The vaccine must be FDA-authorized or FDA-licensed.
- In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).
- In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
- 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.
- The qualified pharmacy technician or State-authorized pharmacy intern must have a current certificate in basic cardiopulmonary resuscitation.
- The qualified pharmacy technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
- The supervising qualified 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 and submitting the required immunization information to the State or local immunization information system (vaccine registry).
- The supervising pharmacist is responsible for complying with requirements related to reporting adverse events.
- The supervising qualified pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern.
- The qualified pharmacy technician and State-authorized pharmacy intern 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.
- The supervising qualified pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s)
