Scope of Practice
Loren Bonner
If there’s a single event that has affected pharmacists’ scope of practice, it is without a doubt the COVID-19 pandemic. Because of the expansion of pharmacists’ authority to vaccinate during this time, millions of Americans received a vaccine from a pharmacist. In over 18 months, pharmacists have been responsible for getting hundreds of millions of vaccine doses into arms when Americans were unable—or unwilling—to visit a physician.
Currently, the PREP Act gives pharmacists, pharmacy technicians, student pharmacists, interns, and retired or inactive pharmacists and interns the authority to administer COVID-19 vaccines, Advisory Committee on Immunization Practices–recommended childhood vaccines, COVID-19 tests, and COVID-19 therapeutics under certain conditions and with certain training requirements met. However, these flexibilities could all disappear when the COVID-19 public health emergency ends.
(As this story went to press, the Biden administration was expected to extend the public health emergency beyond the July 15, 2022, deadline.)
Pharmacy access to increase vaccination rates
Robert Popovian, PharmD, chief science policy officer at the Global Healthy Living Foundation, said the latitude given to pharmacists to administer vaccinations during the COVID-19 pandemic should be made routine practice.
Not only are pharmacists currently administering more than two-thirds of COVID-19 vaccinations during this time, he said, but vaccinations for influenza also surged at pharmacies during the 2021–2022 cycle, topping the volume of vaccinations at physicians’ offices and demonstrating the potential reach of pharmacies beyond the pandemic.
Popovian and colleagues authored a recent study in JAPhA about the accessibility of adult immunizations in low-income communities in pharmacies compared to those in physicians’ offices.
They found that lower-income families had greater access to pharmacies than to physicians’ practices. Not only does this expand immunization access—especially for adult patients who historically have lower vaccination rates in the United States—but the study authors write that it warrants consideration of policy reforms to enhance the authority of pharmacists administering vaccinations.
“State-level potential reforms could include expanding and harmonizing laws governing pharmacist[s’] authority to deliver such services[;] creating health enterprise zones[;] and granting special tax breaks, regulatory exemptions, or public assistance to encourage the establishment of physician offices and pharmacies in low-income communities,” the researchers wrote.
While the results of the study are more confirmatory with what is already known, Popovian said data are necessary to back up assumptions. “You need data to support talking points for policy issues,” he said.
In the study findings, two states—New York and Pennsylvania—had the most significant positive pharmacy access in low-income communities but the most restrictive laws for pharmacists to administer vaccines. Popovian said with policy changes in states like these, patients could benefit greatly.
Turf wars heat up
Expansion of pharmacists’ authorities has recently led to turf wars between pharmacists and physicians. For instance, the American Medical Association (AMA) began pushing back on the Biden administration’s test-to-treat initiative, which allows individuals with COVID-19 symptoms to go to select pharmacies for a COVID-19 test and, if they test positive, receive a prescription for and be dispensed an antiviral COVID-19 drug. “[E]stablishing pharmacy‐based clinics as one stop shopping for COVID-19 testing and treatments is extremely risky,” AMA wrote in a March 4, 2022, statement.
APhA said in a press statement shortly afterward that “AMA’s policies directly conflict with contemporary standards of practice and pharmacists’ extensive training and expertise. These policies impede the ability of health care professionals to work together to address health equity and provide accessible care to vulnerable populations. The pandemic has highlighted the tremendous health disparities in our nation, and pharmacists are able to directly address these disparities among socially disadvantaged and underserved communities.”
This turf war battle is something the AMA has been trying to win for years. Last year, they were successful in defeating scope of practice expansions bills in several states.
Nurse practitioners and physician assistants have also been fighting for an expanded scope of practice in light of COVID-19.
After H.R. 7213, the Equitable Community Access to Pharmacist Services Act (ECAPS), was introduced in April 2022, AMA sent a letter to Representatives Ron Kind (D-WI) and David McKinley (R-WV) opposing the legislation. They said that the bill “would inappropriately expand Medicare payment for pharmacists in limited but significant ways and undermine state scope of practice laws and the ability of states to regulate pharmacists.”
ECAPS is intended to advance access to health care for Americans by permitting Medicare payments for pharmacists in limited but significant ways—all in accordance with state scope of practice laws while preserving the ability of states to regulate pharmacists.
AMA has also opposed allowing pharmacists to give vaccines to children younger than 18 years, a move necessary to address the public health threat of declining childhood-vaccination rates.
Popovian argues that providing vaccines is not a diagnosis, which is the main concern most medical societies have. ■
PREP Act basics
- PREP stands for Public Readiness and Emergency Preparedness.
- The PREP Act authorizes the secretary of the Department of Health and Human Services to issue a declaration that provides immunity from liability to groups, businesses, or individuals who are involved in developing, manufacturing, testing, distributing, or administering products designed to be used as countermeasures against a public health threat (e.g., COVID-19 vaccines, tests, and therapeutics).
- The declaration under the PREP Act for Medical Countermeasures Against COVID-19 was issued in February 2020 and currently has 9 amendments detailing what is covered under the declaration.
- For a full list of training requirements and who and what is covered under the PREP Act, see APhA’s practice resource “Authority to Immunize during COVID-19” (aphanet.pharmacist.com/sites/default/files/audience/APhACOVIDAuthoritytoImmunize_0321_web.pdf).