HHS to Allow Pharmacists to Order and Administer COVID Vaccines

On September 9, 2020, the Department of Health and Human Services (HHS) announced that it had published guidance authorizing state-licensed pharmacists to order and administer COVID-19 vaccinations to persons age 3 and up, subject to certain requirements.  The authorization preempts any state and local laws that prohibit those who satisfy the HHS requirements from ordering or administering COVID-19 vaccines. These requirements include, among other things:

  • The vaccine must be U.S. Food and Drug Administration (FDA)-authorized or 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 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 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 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).

Pharmacists Authorized by HHS to Administer Vaccines

On August 19, 2020, the Department of Health and Human Services (HHS) announced that it had amended the March 17, 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) concerning the COVID-19 Public Health Emergency to increase accessibility of lifesaving childhood vaccines in order to control preventable outbreaks and diseases and mitigate additional strains on the healthcare system. The directive authorizes state-licensed pharmacists to administer, without a doctor’s prescription, vaccines to children ages 3 to 18, pursuant to certain conditions and restrictions. Twenty-eight states already allow pharmacists to administer vaccinations to children. On August 20th, HHS also announced it was expanding the PREP Act’s liability immunity provisions to protect pharmacists and pharmacy interns from liability for alleged harm arising from their administration of vaccines to children.

The amended Declaration can be reviewed here. The American Academy of Pediatrics published an announcement opposing the HHS action, calling it “incredibly misguided” and arguing that pediatricians are the best and safest administrators of childhood vaccinations.