The U.S. Department of Health and Human Services (HHS), through the Assistant Secretary for Health, has issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they are made available, according to a press release. This guidance authorizes state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to persons ages three or older, subject to certain requirements.
"This action builds upon our Administration's progress toward delivering a safe, effective, and widely available vaccine by 2021," said Assistant Secretary for Health ADM Brett P. Giroir, M.D. "Allowing pharmacists to order and administer COVID-19 vaccines will greatly expand convenient access for the American people."
To qualify as "covered persons" under 42 U.S.C. § 247d-6d((i)(8)(B) when administering COVID-19 vaccines authorized or licensed by the U.S. Food and Drug Administration (FDA) to persons ages three or older, state-licensed pharmacists and pharmacy interns licensed or registered by their state board of pharmacy must satisfy the following requirements:
· 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) COVID-19 vaccine recommendation.
· 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 or registered pharmacy intern must complete a practical training program that is approved by the ACPE.
· The licensed pharmacist and licensed or registered pharmacy intern 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 reviewing 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.
· The licensed pharmacist and the licensed or registered pharmacy intern must comply with any applicable requirements (or conditions of use) as set forth in the Centers for Disease Control and Prevention COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
· The authorization preempts any state and local laws that prohibit or effectively prohibits those who satisfy these requirements from ordering or administering COVID-19 vaccines as set forth above. The authorization does not preempt state and local laws that permit additional individuals to administer COVID-19 vaccines to additional persons.
