The Erosion of Pharmacists’ Expanded Role Post-Pandemic
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The COVID-19 pandemic ushered in an era of progress for pharmacists, expanding their role from vaccinators to frontline public health providers, catalyzed by federal emergency measures. This evolution, which saved countless lives during the pandemic, is now facing critically important legal and operational setbacks. Recent federal policy shifts, which align with the perspective of US Department of Health and human Services (HHS) Secretary Robert F. Kennedy, Jr. and FDA Commissioner Marty Makary, MD, MPH, have created a chaotic surroundings that is directly undermining these advancements and creating a chilling affect on the profession.
Although these actions have been defended by officials like White House Press Secretary Karoline Leavitt and Commissioner Makary, in reality, progress toward pharmacy-based health care delivery is diminishing rapidly.1,2
The Pandemic As a Catalyst for Change
Pharmacists’ legal scope of practice (SOP) varies across the United States.3 Although pharmacists develop many skills and competencies through education and training, a pharmacist can only legally provide services when authorized by state law. In recent decades states have greatly expanded SOP for pharmacists to match their professional capabilities. Because 9 out of 10 Americans live within 5 miles of a community pharmacy, this expansion has helped address serious access barriers, provided an effective health care safety net across the country, and extended the medical home.4
One of the most visible examples of this shift has been vaccination. The role of pharmacies in immunization has grown steadily as the Centers for Medicare and Medicaid Services (CMS) began allowing roster billing under Medicare Part B for influenza vaccines in the 1990s, a policy later expanded to include other respiratory vaccines.5 Likewise, as new adult vaccines emerged and received coverage under Medicare Part D, also known as the pharmacy benefit, states further expanded SOP to align with these changes. the COVID-19 pandemic accelerated pharmacists’ role when the Trump administration again expanded pharmacist SOP to meet urgent public health needs.6
On febuary 2020,then-Secretary Alex Azar issued a Declaration under the public Readiness and Emergency Preparedness Act (PREP Act) for COVID-19,amended several times.7The Third Amendment (august 2020) authorized state-licensed pharmacists to administer CDC Advisory committee on Immunization Practices (ACIP)-recommended childhood vaccines to patients 3 to 18 years of age.8 The Seventh Amendment (March 2021) broadened who could give COVID-19 vaccines to include pharmacy technicians and interns under supervision, as well as pharmacists whose licenses had lapsed within the past 5 years.9 The Eighth Amendment (August 2021) allowed pharmacists, technicians, and interns to administer influenza vaccines to adults, while the ninth Amendment (September 2021) extended their authority to administer monoclonal antibody treatments for COVID-19.10,11
These Declarations leveraged the PREP Act’s preemptive power to override state-level SOP limitations and establish a federally unified SOP for certain vaccines. The PREP Act also provided liability protections for “qualified persons,” like pharmacists, administering these vaccines through the Countermeasures Injury Compensation Program, separate and apart from the Vaccine I
The transition of COVID-19 vaccines from Emergency Use authorization (EUA) to conventional FDA approval has inadvertently created a looming access crisis, particularly for healthy adults. While intended to normalize the vaccination landscape, the changes have substantially restricted who pharmacists can vaccinate and introduced ample legal risks, ultimately hindering vaccine availability.
The Shift from EUA to Traditional Approval
In May 2023, the FDA officially approved the first COVID-19 vaccines, signaling a shift from the EUA framework that had governed their distribution since December 2020.17 Together, the CDC’s Advisory Committee on Immunization Practices (ACIP) updated its recommendations to align with the FDA approvals, initially recommending the updated vaccines for individuals 6 months and older.18 however, subsequent ACIP guidance narrowed the recommendations, focusing on those at high risk of severe illness – specifically, individuals
With the revocation of the EUAs, there are no longer FDA-authorized COVID-19 vaccines and pharmacists must vaccinate according to the FDA label. Unlike physicians, who may generally prescribe “off-label” without consequence, pharmacists have little to no leeway to act outside these parameters. Doing so would strip them of PREP Act liability protections and could even expose them to state disciplinary action. The risk is heightened by the fact that COVID-19 vaccines are not covered by VICP, leaving pharmacists especially vulnerable to vaccine-related lawsuits.
To limit liability, pharmacists must stay within the confines of the narrowed FDA approval, meaning pharmacists must somehow determine whether a patient under 65 has an underlying health condition before ordering and administering a COVID-19 vaccine. Given the high demands already placed on pharmacists and lack of adequate resources, assessing underlying health conditions at the pharmacy counter is challenging, especially for more complex patient scenarios.
this is further complicated in pediatric patients because each commercially available COVID-19 vaccine has a different age indication, which may not align with the products the pharmacy has in stock. With COVID-19 vaccination volumes far lower than at the pandemic’s height, few pharmacies carry every brand and ordering habits are unlikely to change with these new limitations in place.22 Together,these factors significantly complicate pharmacy operations and result in diminished vaccine availability.
Additionally,while the current CDC ACIP immunization schedule includes a routine recommendation for healthy adults,this is likely to be curtailed at the next ACIP meeting in light of the recent FDA changes,further constraining pharmacy-based vaccination.23
Given this confluence of factors, pharmacists are finding themselves in a legal gray area and are erring on the side of caution to avoid liability risk. Consequently, many pharmacists will likely refer patients back to their physician for a prescription before vaccinating or urge patients to receive a vaccine in the physician’s office, an approach which risks patient frustration and attrition. in practice,absent persistent effort from patients,many individuals will forgo vaccination altogether.
After the August 2025 changes, a New York Times story revealed that Walgreens’ website requires a prescription for a COVID-19 vaccine in 16 states, and CVS has similar requirements in 13 states and DC.24 However,this remains a fluid situation.
Within the past week, several states have moved to expand pharmacist SOP to permit continued COVID-19 vaccination nonetheless of FDA approved indication or ACIP recommendations. Some now allow pharmacists to follow guidance issued by professional societies such as the American Academy of Pediatrics (AAP) and American College of Obstetricians and Gynecologists (ACOG). Such as, Massachusetts issued a new standing order for COVID-19 vaccines and the Pennsylvania Board of Pharmacy updated its regulations.25,26 Even though these are steps in the right direction, pharmacist SOP is more fractured than ever.
For years, pharmacists have stepped up to provide crucial access to vaccines, especially during the COVID-19 pandemic. but a significant change is coming. With the end of the Public Health Emergency (PHE), many of the temporary authorizations allowing pharmacists to administer immunizations are expiring. here’s what you need to know.
The public Readiness and Emergency Preparedness (PREP) Act, initially invoked in 2020, dramatically expanded the scope of practice for pharmacists. It allowed them to administer a wider range of vaccines – including childhood immunizations – and to do so across state lines. This was a game-changer, increasing vaccine accessibility and easing the burden on traditional healthcare settings. The initial declaration paved the way for these changes.
Subsequent amendments to the declaration continued to broaden this authority. The Eighth Amendment, for example, further clarified and extended these allowances. Pharmacists played a vital role in COVID-19 vaccine distribution, administering over half of all doses in some states. Studies demonstrate the significant contributions pharmacists made during the pandemic.
What Changes Now?
The PHE officially ended on May 11, 2023. This means the PREP Act’s broad authorizations for pharmacists are no longer in effect. Specifically, pharmacists will generally no longer be able to administer vaccines to children under the age of 3, or vaccines outside of the scope of their state-specific regulations. Partners for Kids highlights this shift, noting the impact on childhood immunization rates.
Here’s a breakdown of what’s happening:
- Reduced Scope of Practice: Pharmacists can only administer vaccines they are specifically authorized to give under state law.
- Age Restrictions: administering vaccines to younger children (typically under 3) is largely reverting to traditional healthcare providers.
- State-specific Regulations: Each state now dictates which vaccines pharmacists can administer and under what conditions.
What’s the Impact?
This change could lead to reduced access to vaccines, particularly in underserved communities.Pharmacists frequently enough provide a convenient and accessible option for vaccinations, and limiting their authority could create barriers to care. It’s crucial to understand that this isn’t a permanent loss of authority, but a return to pre-PHE standards, with variations based on individual state laws.
What’s Next?
Advocacy efforts are underway to permanently expand pharmacists’ immunization authority. Many argue that allowing pharmacists to continue providing a wider range of vaccines is essential for public health.The Ninth Amendment and the Twelfth Amendment demonstrate the ongoing adjustments to the PREP Act, suggesting potential for future changes.
For the most up-to-date information, check with your state’s Board of Pharmacy and public health department.Staying informed is key to navigating these changes and ensuring continued access to vital vaccinations.