Washington, DC—New federal guidance authorizes pharmacy technicians and state-authorized pharmacy interns to administer childhood vaccines, COVID-19 vaccines when approved, and COVID-19 tests. Under the initiative, qualified pharmacists will be required to provide very close supervision.
Per the Public Readiness and Emergency Preparedness Act (PREP Act), the U.S. Department of Health and Human Services issued the guidance with several requirements. Those include that the pharmacy intern must be authorized by the state or board of pharmacy in which the internship occurs, although 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,” explained Assistant Secretary for Health Adm. Brett P. Giroir, MDM. “Together with pediatricians and family physicians, they are ensuring that Americans receive the vaccines they need where they need it.”
In September, HHS guidance was issued 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, those vaccines with certain restrictions. Recipients must be age 3 years or older, the COVID-19 vaccinations must have been authorized or licensed by the FDA and other conditions must be met, thereby making pharmacy employees “covered persons” under the PREP Act with respect to this activity.
Now, the new guidance authorizes both 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 and to administer FDA-authorized or FDA-licensed ACIP-recommended vaccines to persons ages 3 years through 18 years according to ACIP’s standard immunization schedule.
HHS requires that the vaccination be ordered by the supervising qualified pharmacist, who must be readily and immediately available to the immunizing qualified pharmacy technicians. All vaccines administered must be FDA-authorized or FDA-licensed, and, in the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to the Advisory Committee on Immunization Practice’s (ACIP) COVID-19 vaccine recommendation(s). Childhood vaccines must be ordered and administered according to ACIP’s standard immunization schedule.
Other requisites include:
• 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 emergency treatment of 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 new authorization also dictates very specific mandates for supervising qualified pharmacists, including that they:
• Comply with recordkeeping and reporting requirements of the jurisdiction in which the pharmacist administers vaccines, including informing the patient’s primary care provider when possible and submitting the required immunization information to the State or local immunization information system (vaccine registry).
• Are responsible for complying with requirements related to reporting adverse events.
• 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.
• Inform the accompanying parent or adult caregiver of patients 18 or younger of the importance of a well-child visit with a pediatrician or other licensed primary care provider and refer patients as appropriate. That also applies to the state-authorized pharmacy interns.
• Comply with any applicable requirements (or conditions of use) as set forth in the CDC COVID-19 vaccination-provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).
The HHS 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.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.