October 21, 2020
Trump Administration Takes Action to Further Expand Access to Vaccines, COVID-19 Tests
Today, under the leadership of President Trump, the U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Health (ASH), issued guidance* under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when made available, and COVID-19 tests, all subject to several requirements. This guidance clarifies that the pharmacy intern must be authorized by the State or board of pharmacy in the State in which the practical pharmacy internship occurs, but this authorization need not take the form of a license from, or registration with, the State board of pharmacy.
"Pharmacists and their staff are critical to the COVID-19 response," said Assistant Secretary for Health ADM Brett P. Giroir, M.D. "Together with pediatricians and family physicians, they are ensuring that Americans receive the vaccines they need where they need it."
Childhood and COVID-19 Vaccines
On September 3, 2020, the Assistant Secretary for Health issued guidance authorizing state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, to persons ages three or older, COVID-19 vaccinations that have been authorized or licensed by the Food and Drug Administration (FDA), provided that certain conditions are met—thereby making them “covered persons” under the PREP Act with respect to this activity.
This guidance authorizes both qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist to administer to FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages three or older and to administer FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages three through 18 according to ACIP’s standard immunization schedule, if the requirements listed below are satisfied:
- 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 a 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).
This guidance also authorizes qualified pharmacy technicians and State-authorized pharmacy interns to administer COVID-19 tests, including serology tests, that the FDA has approved, cleared, or authorized.
Information on the Third Amendment to the PREP Act declaration.
Information on Operation Warp Speed
Clinical resources on vaccines, including continuing education training on best practices
* Persons using assistive technology may not be able to fully access information in this file. For assistance, please contact the Office of the Assistant Secretary for Health at [email protected].