On September 14, 2021, HHS issued a ninth amendment (the “Ninth Amendment”) to the Declaration for medical countermeasures against COVID-19 (the “Declaration”) under the Public Readiness and Emergency Preparedness Act (“PREP Act”). This Amendment expands the scope of authority for licensed pharmacists along with qualified pharmacy technicians and interns relative to FDA-approved COVID-19 therapeutics. More specifically, it extends PREP Act liability protections to pharmacists who order/administer along with qualified pharmacy technicians and interns who, under the supervision of a licensed pharmacist, administer COVID-19 therapeutics that are Covered Countermeasures (as defined below). The Ninth Amendment follows an August amendment (the “Eighth Amendment”), which clarified that qualified pharmacy technicians, in addition to pharmacists and pharmacy interns, are authorized to administer certain childhood vaccinations and COVID-19 vaccinations, and that qualified pharmacy technicians and interns are authorized to administer seasonal influenza vaccines under the supervision of a pharmacist.
By extending PREP Act liability protection to pharmacists and qualified pharmacy technicians and interns, these amendments increase the available pool of providers to improve patient access to COVID-19 therapeutics and vaccinations. While the amendments inform decisions by state boards of pharmacy, pharmacies and pharmacists regarding potential expansion under state scope of practice regulations, a state-specific analysis should still be conducted to determine compliance with state licensure requirements and assess potential civil and criminal liability.
Background
On March 10, 2020, in response to the public health emergency created by SARS-CoV-2, HHS issued a Declaration under the PREP Act for medical countermeasures against COVID-19. The Declaration provides liability immunity to certain individuals and entities (“Covered Persons”) against any claim of loss caused by, arising out of, relating to or resulting from the manufacture, distribution, administration or use of medical countermeasures (“Covered Countermeasures”), except for claims involving “willful misconduct” as defined in the PREP Act. Covered Persons who are afforded liability immunity under this Declaration include “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents and employees, as those terms are defined in the PREP Act, as well as the United States. The Declaration was subsequently amended to expand the categories of qualified persons, Covered Countermeasures and the categories of disease, health conditions or threats for recommended administration or use of Covered Countermeasures.
Summary of the Eighth Amendment:
The Eighth Amendment, which took effect on August 4, 2021, added qualified state-licensed pharmacy technicians as qualified persons authorized to administer certain vaccines under the supervision of a licensed pharmacist. It also allowed both qualified state-licensed pharmacy technicians and interns to administer seasonal influenza vaccines to adults under the supervision of a licensed pharmacist. Therefore, as amended, the Declaration permits licensed pharmacists to order/administer and qualified pharmacy technicians and interns, acting under the supervision of a pharmacist, to administer:
- Advisory Committee on Immunization Practices (“ACIP”)-recommended vaccines for persons ages 3 through 18;
- ACIP-recommended seasonal influenza vaccine for persons ages 19 or older; or
- FDA-authorized or FDA-licensed COVID-19 vaccines to persons ages 3 or older.
Licensed pharmacists, pharmacy interns and technicians are qualified only if certain requirements are met, including:
- The administered vaccine must be FDA-authorized;
- The administration of vaccines must be consistent with ACIP recommendations standard immunization schedule, as applicable;
- The supervising pharmacist, the pharmacy intern and pharmacy technician must undergo approved training, have a current certificate in basic cardiopulmonary resuscitation and comply with applicable Centers for Disease Control and Prevention requirements; and
- The supervising pharmacist must complete a minimum of 2 hours of approved immunization-related continuing pharmacy education during each state licensing period, comply with certain recordkeeping and reporting requirements, inform adult caregivers of childhood-vaccination patients of the importance of well-child visits and refer patients as appropriate.
Summary of the Ninth Amendment:
The Ninth Amendment to the Declaration, which took effect on September 9, 2021, authorizes licensed pharmacists to order and administer and qualified pharmacy technicians and interns, under the supervision of a licensed pharmacist, to administer COVID-19 therapeutics that are Covered Countermeasures. The licensed pharmacist and qualified technicians and interns under their supervision are qualified persons only under the following conditions:
- The COVID-19 therapeutic is FDA-approved;
- The therapeutic must be ordered for subcutaneous, intramuscular or oral administration and in accordance with the FDA approval;
- The therapeutic must be administered subcutaneously, intramuscularly or orally in accordance with the FDA approval;
- The supervising pharmacist must be readily and immediately available to qualified pharmacy technicians administering COVID-19 therapeutics;
- The licensed pharmacist and qualified pharmacy technician and intern must complete a practical training program that is approved by the ACPE and meeting other requirements;
- The licensed pharmacist and qualified pharmacy technician and intern must have current certification in basic cardiopulmonary resuscitation;
- The licensed pharmacist must comply with state recordkeeping and reporting requirements, including informing the patient’s primary care provider when available and complying with requirements with respect to reporting adverse events; and
- The licensed pharmacist, the licensed or registered pharmacy intern and the qualified pharmacy technician must comply with any applicable requirements (or conditions of use) that apply to the administration of COVID-19 therapeutics.
HHS clarifies that licensed pharmacists, qualified pharmacy technicians and interns will be afforded liability protection in accordance with the PREP Act and the terms of the Declaration. Moreover, HHS emphasized that the Declaration preempts any state law to the extent it prohibits qualified persons from prescribing, dispensing or administering COVID-19 therapeutics or other Covered Countermeasures. HHS also clarifies that states remain free to authorize additional individuals to administer Covered Countermeasures within their jurisdiction.
Practical Takeaways
By amending the Declaration, HHS aims to mitigate the strain on U.S. hospitals and health care providers created by the COVID-19 pandemic as well as alleviate the potentially compounding impact that seasonal influenza could have on an already overwhelmed health care system. The Amendments have the potential to expand access to COVID-19 therapeutics to locations where access may otherwise be limited. However, qualified persons in each state must consider the potential implications under state law. As discussed in a prior alert, PREP Act immunity is an evolving area of law, including how preemption applies. HHS’s Office of Inspector General issued an Advisory Opinion earlier this year indicating that complete federal preemption applies with respect to application of the PREP Act. However, immunity is a separate issue that requires a fact and circumstance-specific analysis that takes into account state law issues. Accordingly, health care professionals seeking immunity should undertake a thorough assessment to determine whether they meet all of the conditions of the Declaration before relying on the PREP Act’s protection.
In short, the full scope of proposed activities related to administering COVID-19 therapeutics and vaccines should be assessed to determine the potential application of the Declaration.
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;
- Melissa Markey at (248) 740-7505 or mmarkey@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 be legal advice.
