Board of Pharmacy Response to HHS Guidance Related to Administration of Immunizations and COVID-19 Tests

Date: 
Tuesday, November 3, 2020

On October 20, 2020, the Secretary of the Department of Health and Human Services (HHS) issued Guidance which added “qualified pharmacy technicians” and “state-authorized pharmacy interns” to the list of individuals authorized to administer immunizations and COVID-19 tests under the PREP Act.

“Qualified Pharmacy Technicians” and “State-Authorized Pharmacy Interns” Defined

In Iowa, a “qualified pharmacy technician” includes an Iowa-registered, certified pharmacy technician whose registration is current and active. A “State-authorized pharmacy intern” means an Iowa-registered pharmacist-intern whose registration is current and active.

Authorization for Immunization Administration

The HHS Guidance authorizes qualified pharmacy technicians and State-registered pharmacy interns to administer, under the supervision of a qualified pharmacist:

  • FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages three or older or

  • ACIP-recommended childhood vaccinations to persons ages three through 18.

Requirements for Immunization Administration

In order to qualify as a “covered persons” under the PREP Act, qualified pharmacy technicians (“technicians”) and State-registered pharmacy interns (“interns”) must comply with the following requirements: 

  • The vaccination must be ordered by the supervising qualified pharmacist (“pharmacist”),

  • The pharmacist must be readily and immediately available to the immunizing 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 standard immunization schedule.

  • The technician or 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 technician or intern must have a current certificate in basic cardiopulmonary resuscitation. 

  • The technician must complete a minimum of two hours of ACPE-approved, immunization-related continuing pharmacy education during the registration renewal period.

  • The pharmacist must comply with Iowa recordkeeping and reporting requirements, including informing the patient’s primary care provider when available and submitting the required immunization to the state’s vaccine registry (IRIS).

  • The pharmacist is responsible for complying with requirements related to reporting adverse events.

  • The pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the technician or intern.

  • The technician or 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 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).

Authorization for COVID-19 Test Administration

The HHS Guidance authorizes qualified pharmacy technicians (“technicians”) and State-registered pharmacy interns (“interns”) to administer COVID-19 tests, including serology tests, that the FDA has approved, cleared, or authorized following an order issued by a qualified practitioner (such as a qualified supervising pharmacist). Qualified individuals are directed to the Board’s April 23 Guidance and FAQs for additional guidance relating to COVID-19 testing.

Printed from the Iowa Board of Pharmacy website on December 04, 2020 at 6:30pm.