On January 5, 2022, the Department of Health and Human Services (“HHS”) published an amendment to its Declaration for medical countermeasures against COVID-19 (the “Declaration”) under the Public Readiness and Emergency Preparedness Act (“PREP Act”). Under the amendment, PREP Act liability protections have been extended to eligible pharmacists who order and administer (and qualified pharmacy interns who administer) seasonal flu vaccinations in jurisdictions where the PREP Act applies in addition to jurisdictions where they are permitted to practice. HHS indicated that its goal in extending PREP Act liability protections to qualified pharmacists and interns administering flu vaccinations is to facilitate vaccination capability in response to pandemic-related challenges including staffing shortages. This creates additional opportunities for pharmacies and pharmacists to expand their flu vaccine programs. For more information on the scope of the prior Declaration amendments, please read our previous articles.
The new PREP Act amendment authorizes qualifying pharmacists and interns to prescribe, dispense or administer seasonal influenza vaccines in any jurisdiction where the PREP Act applies, excluding the state where the individual is licensed or certified. To be eligible for PREP Act liability protections under the amendment, a pharmacist must either hold an active state license or certification authorizing them to order or administer seasonal influenza vaccinations or be authorized to do so under specific guidelines set forth in the Declaration. Similarly, a pharmacy intern must be authorized under section V(d) of the Declaration and be authorized to administer seasonal influenza vaccinations in his or her state of licensure or certification to benefit from PREP Act liability protections under the amendment. Moreover, to qualify, the license or certification of the pharmacist or pharmacy intern must not have been suspended or restricted in any manner by any licensing authority. Finally, to be eligible, a pharmacist or pharmacy intern must not be on the List of Excluded Individuals/Entities maintained by the Office of Inspector General. Thus, provided a pharmacist or pharmacy intern meets the requirements under the Declaration, a pharmacist may order or administer, and a pharmacy intern may administer seasonal influenza vaccinations in any jurisdiction where the PREP Act applies, other than the jurisdiction(s) in which they practice under an active license or certification. This home jurisdiction carveout regarding the application of the PREP Act presumably stems from the fact that pharmacists and pharmacy interns should have professional liability coverage in states where they are licensed or certified and practice in accordance with state law. Therefore, relying on the PREP Act in a pharmacist or pharmacy intern’s home jurisdiction(s) rather than practicing in accordance with state law could raise complex preemption questions.
Practical Takeaways
By amending the Declaration, HHS aims to alleviate the strain that seasonal influenza could have on U.S. hospitals and health care providers already overwhelmed by the COVID-19 pandemic. The Declaration allows pharmacists and pharmacy interns additional options for providing care to communities in need, particularly those in states a pharmacist or pharmacy intern is not licensed, if they comply with PREP Act requirements. However, qualified persons (as defined by the PREP Act) in each state must consider the potential implications under state law. For example, a pharmacist or pharmacy intern may not be able to rely on the PREP Act protections when practicing in their own state, but they may be able to rely on its protections when practicing in another state where they otherwise would not have the authority to administer seasonal influenza vaccines.
As discussed in a prior article, PREP Act immunity is an evolving area of law, including how preemption applies. Accordingly, health care professionals and their employers seeking immunity should undertake a detailed assessment to determine whether they meet all of the conditions of the Declaration, as well as any applicable state scope of practice requirements before relying on the PREP Act’s protection, particularly given that the PREP Act offers certain liability protections but not necessarily from state licensure action. In other words, the PREP Act may provide immunity from liability for certain covered countermeasures (as defined by the PREP Act) but will not apply to liability arising from a violation of licensure rules enacted by a state board of pharmacy or medicine. For example, certain boards of pharmacy may restrict pharmacists or pharmacy interns from practicing in states other than the state(s) in which they are licensed. In such situations, a pharmacist or pharmacy intern could face a licensure action from their home state board of pharmacy for unprofessional conduct for practicing in another state without a license even if they comply with the requirements of the Declaration. Accordingly, we recommend undertaking a thorough and thoughtful analysis of the potential application of the PREP Act to adequately assess the interplay between state law and PREP Act coverage prior to allowing pharmacists and/or pharmacy interns to administer seasonal influence vaccines in states where they are not currently licensed or certified.
Hall Render is actively tracking all HHS guidance related to the COVID-19 pandemic. If you have any questions on the issues discussed in or related to this article, please contact:
- Todd Nova at (414) 721-0464 or tnova@wp.hallrender.com;
- Amy Poe at (919) 228-2404 or apoe@wp.hallrender.com;
- Lindsey Croasdale at (414) 721-0443 or lcroasdale@wp.hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would constitute legal advice.
