Looming PREP Act Expiration Could Impact Health Care Access for Rural Patients

On April 14, 2024, the Department of Health and Human Services granted an extension to pharmacists, pharmacy technicians, and pharmacy students for certain authorities and associated liability protections under the Public Readiness and Emergency Preparedness (PREP) Act. The Act is set to end on December 31, 2024, affecting pharmacists’ abilities to administer COVID-19 tests, vaccines, and treatments distributed by the federal government. According to the extension, the HHS may extend coverage further, even after the products are fully commercialized.¹

PREP Act, COVID-19, Pandemic, Pharmacy, Immunization | Image Credit: ©dusanpetkovic1 | stock.adobe.com

The Act also allowed for the immunization of adults and children 3 years and older by pharmacists, pharmacy technicians, and pharmacy students, including routine childhood vaccines.¹

“The biggest implication right now is we're losing immunity. One of the things for vaccines in general, dating back decades, is that there is sort of this immunity associated with them because otherwise we wouldn't have vaccines; people would sue, and we would never have any of that availability,” Marilyn N. Bulloch PharmD, BCPS, FCCM, SPP, associate clinical professor and director of strategic operations at the Harrison College of Pharmacy at Auburn University, said in an interview. “We're losing that immunity for not just the vaccines, but for all of the counter measures, and we also [would] fully lose some of the authorizations that the Act gave us.”

Bulloch added that some of the biggest provisions that impacted pharmacy have already expired, so the expiration it will not hit pharmacies as significantly as when the COVID-19 public health emergency ended on May 11, 2023.² She added that pharmacists have been providing vaccines long before the COVID-19 pandemic, with costs of vaccine shifting to insurance before the public health emergency. Therefore, access to the vaccines and tests could be impacted for those who do not have insurance or lack access to medical providers.

“It really depends on the individual states and what's allowable related to vaccines and pharmacy services in general. I went to school in New Jersey; I have trained in and worked in Virginia, West Virginia, and Alabama, and all 4 of those states are very different in terms of what's allowed and what's not allowed,” Bulloch said. “I think in most, if not all states. . . pharmacists can provide adult vaccines, other non-vaccine services like test-and-treat if they're allowed in an area that's going to be impacted. That was a huge advancement for some pharmacists in states that maybe haven't been as progressive or advanced in their pharmacy services.”

Even if the states authorize it, the removal of liability protections, especially for non-vaccine services, could impact pharmacists providing those services. However, in the long-term, Bulloch stated that it is important for the general public to be aware of what pharmacists can do. She added that some patients didn’t know they could get vaccinated at a pharmacy or thought that getting vaccinated at the pharmacy was less optimal than a clinic. The services from the pandemic showed the general public what pharmacists can do and cemented them as members of the health care team, Bulloch said.

“One of the amendments to the Act was that it allowed pharmacists and interns to provide cross-state pharmacy services and vaccines, even if you weren't licensed in that state to really help, again, boost the manpower and the resources that were available,” Bulloch said. “I do think that it showed in times of emergencies [that] the ability to bring in resources like that without all the red tape can be very helpful to communities.”

She added that this has been the case in Florida and western North Carolina, which have both experienced hurricanes. Health care in those regions was severely impacted, and pharmacists that live in those communities were busy managing the crisis. She stated that being able to bring in more pharmacists could help to expand care and provide temporary relief for those effected by emergencies.

“I think one of the biggest lessons that was learned is that access is key. It has to be convenient in a lot of ways. I know that sounds, maybe, for those of us who are in health care, like it should be second nature that you would want some of these things, but to be fair, it's not always convenient to go get these things we're supposed to do,” Bulloch said. “We have to take time off work. Depending on where you live, you might have to drive a long distance. Maybe you don't have a car that will go that far. So when things are convenient and they're very easy to get to, and there's not a lot of red tape, it may be easier to convince people to do what we need them to do, both for their own individual health, but also for public health broadly.”

REFERENCES

1. HHS. HHS Amends the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19. 2024. Accessed November 26, 2024. https://mn.gov/boards/assets/Prep%20Act%20Extension_tcm21-580626.pdf

2.HHS Secretary Xavier Becerra Statement on End of the COVID-19 Public Health Emergency. News release. HHS. May 11, 2023. Accessed November 26, 2024.