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PREP Act Expanded to Include Recently Inactive Pharmacists and New Flexibility for Pharmacy Students

Breaking: News

March 12, 2021

On March 11, pursuant to the Public Readiness and Preparedness (PREP) Act and as recently requested by ASHP, the Department of Health and Human Services (HHS) expanded its guidance to include recently inactive (within the last five years) pharmacists and pharmacy interns in the list of clinicians who can administer COVID-19 vaccines. To order, dispense, or administer COVID-19 vaccines under the PREP Act authority, the inactive pharmacist must have had an active license in good standing within the previous five years, the license must not have been revoked or suspended due to an arrest, and he/she must not be debarred or suspended by the Centers for Medicare & Medicaid Services.

Additionally, the new amendment clears the way for pharmacy students to administer COVID-19 vaccines under the supervision of any healthcare professional. Previously, pharmacy students could administer vaccines only under the supervision of a qualified licensed pharmacist. This new supervision flexibility paves the way for pharmacy students to administer vaccines at vaccine sites, provided the following conditions are met:

  • The vaccine must be authorized, approved, or licensed by the Food and Drug Administration;

  • Vaccination must be ordered and administered according to the Advisory Committee on Immunization Practices' COVID-19 vaccine recommendation(s);

  • Healthcare professionals and students must have documentation of completion of the Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Training Modules and, if applicable, such additional training as may be required by the state, territory, locality, or tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

  • Healthcare professionals and students must have documentation of an observation period by a currently practicing healthcare professional experienced in administering intramuscular injections, and for whom administering intramuscular injections is in their ordinary scope of practice, who confirms competency of the healthcare provider or student in preparation and administration of the COVID-19 vaccine(s) to be administered and, if applicable, such additional training as may be required by the state, territory, locality, or tribal area in which they are prescribing, dispensing, or administering COVID-19 vaccines;

  • Healthcare professionals and students must have a current certificate in basic cardiopulmonary resuscitation;

  • Healthcare professionals and students 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, submitting the required immunization information to the state or local immunization information system (vaccine registry), complying with requirements with respect to reporting adverse events, and complying with requirements whereby the person administering a vaccine must review the vaccine registry or other vaccination records prior to administering a vaccine; and

  • Healthcare professionals and students must 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).

ASHP applauds HHS for expanding opportunities for pharmacists, pharmacy interns, and pharmacy students to administer COVID-19 vaccinations.

“ASHP is pleased that HHS answered our call to ensure that recently inactive pharmacists and current pharmacy students can assist in COVID-19 vaccine administration,” said Tom Kraus, ASHP vice president of government relations. “Fully engaging every qualified vaccinator is essential to getting vaccines to the public quickly and safely.”