Innovations-Magazine-May-2023 - 4

POLICY PERSPECTIVES
As Pharmacists' Expanded Scope of Practice Winds Down
Post-PHE, What Stays and What Goes?
Larissa Morgan, JD, MBE
Faegre Drinker Biddle &
Reath LLP
Nisha K. Quasba, MPH
Faegre Drinker Biddle &
Reath LLP
The temporary removal of regulatory barriers
through waivers, guidances, and other federal
authorities during the coronavirus disease
2019 (COVID-19) pandemic enabled
pharmacists to serve a critical role in curbing
the spread of the virus. Through these
relaxed regulations, pharmacists were able
to test, educate, and administer vaccines,
effectively expanding access to lifesaving
care during a dire public health crisis. From
December 2020 through September 2022,
pharmacists administered more than 50%
of COVID-19 vaccinations received and
provided over 100,000 antibody treatments
to patients. The COVID-19 public health
emergency (PHE) revealed the many ways
in which pharmacy professionals can be vital
providers of health care beyond COVID-19
by addressing disparities in access to care
for underserved populations and increasing
other types of routine vaccination.
However, some of the authorities that
enabled pharmacists to expand their scope
of practice will end with the forthcoming
expiration of the PHE on May 11, 2023,
while others will temporarily survive
beyond the PHE's expiration through
the Public Readiness and Emergency
Preparedness Act (PREP Act) Declaration,
which will, in part, remain in effect through
September 30, 2024. As the United States
prepares for the PHE's forthcoming
expiration, stakeholders are advocating
for permanence of pharmacists' increased
responsibilities - but the path to endurance
still remains uncertain.
PREP Act: Source of Pharmacists'
Increased Authority
The PREP Act has served as the primary
source of pharmacy professionals' expanded
scope of authority. The law authorizes the US
Department of Health and Human Services
(HHS) secretary to issue a declaration
that provides liability immunity for
manufacturers, distributors, administrators,
and other entities against claims caused
by, arising out of, or relating to medical
countermeasures - such as drugs, biologics,
or devices - designed to respond to public
health threats.
In February 2020, the HHS secretary
issued a declaration (the Declaration) under
the PREP Act in response to COVID-19
and has since issued 10 corresponding
amendments that further expanded
PREP Act liability protections for certain
" qualified persons " engaging in COVID-19
countermeasures. The Third Amendment
to the PREP Act identifies state-licensed
pharmacists and pharmacy interns as
qualified persons covered under the PREP
Act, thereby authorizing them to take certain
actions otherwise considered out of their
scope of practice, such as administering
vaccines without a prescriber's order.
Given the importance of mass vaccination
amid dynamic, uncertain circumstances,
the PREP Act grants pharmacists and other
pharmacy professionals the following authorities:
* Ordering and Administering
COVID-19 Testing, Vaccinations,
and Other Therapeutics: The PREP
Act authorizes pharmacists to order
and administer Food and Drug
Administration (FDA)-authorized
COVID-19 tests, vaccines for individuals
ages three and older, and other
COVID-19 therapeutics. Pharmacy
interns and technicians are also authorized
to administer these countermeasures
under the supervision of a pharmacist.
Both pharmacists and other pharmacy
professionals are subject to certain
requirements, such as certification, record
keeping, and licensure standards.
2 | MAY 2023
* Ordering and Administering Routine
Vaccinations: Many states permit
pharmacists and trained professionals
under a pharmacist's supervision to
administer vaccines to children of all
ages. However, the PREP Act and its
corresponding amendments expanded
pharmacy professionals' ability to
administer childhood vaccines,
preempting existing state restrictions and
thereby increasing vaccine accessibility
across the US.
The Third Amendment to the PREP
Act authorizes state-licensed pharmacists
to order and administer - and pharmacy
interns and technicians acting under the
supervision of a pharmacist to administer -
to individuals ages three through 18 vaccines
recommended by the Advisory Committee
on Immunization Practices, including
FDA-authorized and approved COVID-19
vaccines and seasonal flu vaccines.
The Eighth Amendment to the PREP
Act further expands the scope of pharmacy
professionals' authority by granting
pharmacy technicians and interns the
ability to administer seasonal flu vaccines
to individuals age 19 and older under the
supervision of a licensed pharmacist.
Finally, the Tenth Amendment increases
the authority of licensed pharmacists to order
and administer - and qualified pharmacy
interns to administer - seasonal flu vaccines
regardless of age, prescriber order, or other
state-based restrictions.
These flexibilities also require
pharmacists and pharmacy interns to
undergo certain training and certification
requirements and mandate that pharmacists
make certain disclosures to patients and
their guardians regarding vaccination and
routine well-child visits.
These two authorities granted under
the PREP Act will survive the PHE's
expiration and last through September 30,
2024. However, some PREP Act liability
protections unrelated to any US government
Innovations-Magazine-May-2023

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