On January 30, 2023, the Biden Administration announced its intention to end the national Public Health Emergency (PHE) on May 11, 2023. In February, a roadmap was released to guide the transition, of which there were areas of confusion that would impact the profession of pharmacy. Our national pharmacy association colleagues pushed to obtain clarification to address these questions as May 11 quickly approaches.
Last week, the Department of Health and Human Services (HHS) announced they will extend certain PREP Act authorities for pharmacy personnel through December 2024. The HHS fact sheet can be found here, and key changes and features are below.
Key changes under the upcoming amended declaration include:
- Extending coverage for COVID-19 vaccines, seasonal influenza vaccines, and COVID-19 tests. PREP Act immunity from liability will be extended through December 2024 to pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines (to those individuals three and over, consistent with other requirements), and COVID-19 tests, regardless of any USG agreement or emergency declaration.
- Extending coverage through December 2024 for Federal agreements. This includes all activities related to the provision of COVID-19 countermeasures that are 1) provided based on a Federal agreement (including the vaccines and treatments purchased and provided by the USG), or 2) directly conducted by the USG, including by Federal employees, contractors or volunteers.
- Ending of coverage for certain activities. Once products are no longer distributed under a USG agreement, PREP Act coverage will no longer extend to the following activities:
- COVID-19 vaccination by non-traditional providers (e.g., recently retired providers and students); and
- COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.
- Ending of coverage for routine childhood vaccinations. Once there is no emergency in effect, PREP Act coverage will no longer extend to all routine childhood vaccinations by pharmacists, pharmacy interns, and pharmacy technicians.
Some of the key features that will not change under the amended declaration include:
- No immediate impact on USG distributed COVID-19 countermeasures. As noted above, the amended PREP Act declaration will not have any immediate impact on COVID-19 vaccines, treatments, and tests currently distributed by the USG–either now or when the COVID-19 PHE ends on May 11.
- No change to coverage for certain prescribing and dispensing of COVID-19 oral antivirals. The PREP Act will continue to offer liability immunity for pharmacists, pharmacy technicians, and pharmacy interns dispensing COVID-19 treatments, in accordance with a U.S. Food and Drug Administration (FDA) authorization, such as the oral antiviral treatments Paxlovid and Lagevrio. In the case of Paxlovid, pharmacists are permitted to prescribe the treatment under certain circumstances. These oral antiviral treatments are available at over 40,000 provider locations, including over 35,000 retail pharmacies.
- No change to the “Test to Treat” program. Pharmacists and other providers prescribing tests in the “Test to Treat” program will continue to receive liability protection under the PREP Act.
What does it mean for Tennesseans?
The PREP Act authorization for pharmacists and pharmacy interns to independently prescribe and administer routine childhood vaccinations will expire with the end of the public health emergency on May 11, 2023. If your practice setting has been providing childhood vaccinations due to the PREP Act, TPA strongly encourages you to update your immunization protocol to provide for this authority to occur after May 11, 2023.
Pharmacy technicians will be able to administer vaccinations under the PREP Act authority through December 2024. It is important to understand that TPA will work closely with the Tennessee Board of Pharmacy to update regulations due to the passage of 2022 Public Chapter 812, which updated the definition of pharmacy technician, and addresses the ability for trained and qualified pharmacy technicians to administer vaccinations in the state of Tennessee.
As noted above, the PREP Act extension will not, however, extend the federal authorization for COVID-19 vaccination by recently retired providers and students; nor will it extend the ability of pharmacists to administer COVID-19 vaccinations across state lines.
In addition, pharmacies can now register as full Vaccines for Children (VFC) providers with their collaborative practice agreement in place. The Tennessee Department of Health has a new additional option, in which they could allow pharmacies to be VFC providers, but ONLY provide influenza and COVID-19 vaccines. One of the requirements of VFC providers is that pharmacies stock ALL ACIP-recommended vaccines for VFC patients (free) and private patients (their expense).
Tennessee Department of Health/Vaccines for Children