PREP Act Amendment - Health Care Providers Authorized to Vaccinate against COVID-19
The U.S. Department of Health and Human Services (HHS) has amended the federal PREP Act to add recently retired pharmacists, and inactive pharmacists and pharmacy interns to the list of health care professionals authorized to vaccinate against COVID-19. The authority applies to pharmacists and interns who have held active licensure in the past 5 years and students under certain conditions. The PREP Act provides liability immunity to the professionals it covers.
Retired and inactive pharmacists and pharmacy interns: The PREP Act amendment applies to pharmacists and pharmacy interns who have “held an active license or certification under the law of any state within the last 5 years,” but whose licenses are now inactive, expired, or lapsed. To be eligible to prescribe, dispense, or administer COVID-19 vaccines, the license or certification: must have been active and in good standing; was neither revoked nor surrendered following an arrest; and the individuals must not appear on the Officer of the Inspector General’s List of Excluded Individuals/Entities.
Student pharmacists/interns: The PREP Act amendment authorizes pharmacy students/interns and other health care professionals who have appropriate training in administering vaccines to administer COVID-19 vaccines under the supervision of a healthcare professional with specific training, whether a qualified licensed pharmacist or not. This addresses the problem that student pharmacists were facing in that they wanted to help at vaccination clinics and sites but the existing PREP Act authority only allowed them to vaccinate under the supervision of a qualified licensed pharmacist. This new amendment provides student pharmacists with more opportunities to administer vaccines.
- The vaccine must be authorized, approved, or licensed by FDA.
- The vaccine must be ordered and administered according to ACIP’s COVID-19 vaccine recommendations.
- To be eligible, the health care professionals and students must provide documentation proving they have completed CDC’s COVID-19 Vaccine Training Modules. If applicable, the individuals must have completed additional training as required by the state, territory, locality, or tribal area where they will vaccinate against COVID-19.
- The health care professionals and students must provide documentation proving they have undergone a period of observation by a health care professional who:
- is currently practicing;
- is experienced in administering intramuscular injections;
- for whom administering intramuscular injections is within their ordinary scope of practice; and
- who can confirm the individual they’ve observed is competent in the preparation and administration of the COVID-19 vaccines they’ll provide.
- The health care professionals and students must have a current certificate in basic cardiopulmonary resuscitation.
- The health care professionals and students must comply with the recordkeeping and reporting requirements of the jurisdiction where they administer COVID-19 vaccines. Such requirements may include:
- reviewing vaccine registries or other vaccination records before administering the COVID-19 vaccine.
- complying with requirements with respect to reporting adverse events; and
- submitting the required information to state or local immunization information systems or vaccine registries;
- informing the patient’s primary-care provider when possible;
- The health care professionals and students must comply with applicable requirements or conditions of use that are set forth by the CDC COVID-19 vaccine provider agreement and any other applicable federal requirements