August 1, 2024 | Evidence is mounting that public health in the U.S. could get a big boost by better engaging community pharmacists in providing acute and chronic care services. These are highly trained clinicians in “extremely accessible” locations no more than five miles from the home of 95% of Americans, according to Kenneth Hohmeier, Pharm.D., professor and vice chair for education in the department of clinical pharmacy and translational science at the University of Tennessee Health Science Center.
As “reimagined,” community pharmacists will be doing a lot more point-of-care testing (POCT)—much as they did extensively during the COVID pandemic—and be integral members of a patient’s healthcare team, he says. Moreover, these pharmacy settings would serve as additional data collection points for tracking infectious pathogens circulating in a region.
“It is going to take a village to figure out how to best utilize the space to bolster the holes [and] pain points in the patient’s experience in getting better healthcare,” says Hohmeier. But some of the answers will be shared in a series of presentations at the upcoming Next Generation Dx Summit, where he is chairperson for the decentralized testing stream on the role of POCT at the pharmacy level.
Currently, he says, the biggest demand patients place on community-based pharmacists, above and beyond dispensing drug products and immunizations, is for acute clinical services such as the diagnosis of infectious conditions like influenza and strep throat using Clinical Laboratory Improvement Amendment (CLIA)-waived POCT devices. “I don’t believe that’s necessarily the full picture for the future.”
Rather, the provision of acute care services will likely be the “first step forward into a large, scalable national service like what we saw with vaccines for adults... 20 years ago,” Hohmeier continues. That effectively marked the beginning of the movement to delegate to community pharmacists the services bogging down urgent care clinics and provider officers so they can focus on efficiently treating higher acuity conditions.
Per the recommendations of the Advisory Committee on Immunization Practices, community pharmacists are now routinely administering vaccinations to individuals down to age 6 months and even younger in some states, says Hohmeier. It begins with patient demand for pharmacist-delivered clinical services, which in turn raises public awareness of the value in having these omnipresent professionals be part of the patient care picture.
If there was a “silver lining” to the pandemic, it was that it served as an accelerant to the pharmacist-delivered POCT space, Hohmeier says. In the prior decade, many pilot programs were established as allowed by state boards of pharmacy that helped build the base of literature demonstrating pharmacists could meet the required quality standards to take this on—and patients were willing to pay for it.
As with retail clinics (e.g., CVS MinuteClinic), these services in the pharmacy usually start as a cash-based business and as demand solidifies transition to a mostly third-party payer model, Hohmeier explains. When the pandemic hit, pharmacy-delivered vaccine services were in the middle of the later phases of nationwide implementation and acute POCT services were just getting off the ground. “It shined a bright light on the fact that pharmacy was already meeting this public health demand” by virtue of being a convenient healthcare access point.
Many patients had by then come to view their local pharmacies as options for basic acute care services. More importantly, he says, government officials and payers in the U.S. could readily see how they could be of “major value” to existing networks. They were recognized as underutilized resources, something countries in Europe and Africa had known and tapped for years, especially in non-urban settings with a shortage of healthcare providers.
Long before the pandemic hit, state and national pharmacy associations had been advocating for a future model of pharmacy-based care whereby clinical services would be delivered under a collaborative pharmacy practice agreement, much like other mid-level practitioners such as nurse practitioners, physician assistants, and optometrists, says Hohmeier. The agreements, which are well vetted and accepted, specify which patient care functions are being delegated to the pharmacist by a collaborating prescriber.
As with pharmacist-delivered flu vaccines, uptake of these agreements has not been an “all-at-once phenomenon,” he adds. Currently, at least 23 states have the authority to provide tests-and-treat services for COVID-19 and influenza versus 13 before the pandemic. The practice has been most popular in states with a “large felt need for more access points for patient care” due to provider shortages in either a certain geographic location or an area of practice like endocrinology.
“In states where there are those gaps it is really easy to make the case to add pharmacists to the patient care team, and that is really what we are doing—adding, not removing folks,” says Hohmeier. “Certainly, just the calling to mind the actual limitation that happened during the pandemic has been critical in advocacy efforts to expand these services.”
Up to then, “pharmacy technicians were really not thought of in a major way by regulators and government officials as individuals who can participate in patient care delivery services,” he says. But given the need for both vaccines and POCT to be delivered during COVID, federal rules came out allowing them to step into the gap under the supervision of a pharmacist.
Use of CLIA-waived tests in pharmacies reportedly grew by 140% since 2019, shares Hohmeier. In the period from 2019 to 2021, the number of pharmacies possessing a certificate of waiver increased by 92.5% because of the pandemic. Almost 30,000 pharmacies nationwide possess a certificate of CLIA-waiver to act as laboratories.
While the federal rules that empowered pharmacy techs has expired, they have effectively been adopted by many state boards of pharmacy and medical laboratory boards in the U.S. based on the community benefit everyone witnessed firsthand from the practice.
The evidence supporting the safety and effectiveness of pharmacist-delivered acute care POCT services has been built primarily on studies by a handful of mostly academic-affiliated organizations, says Hohmeier. He is currently involved in an industry-sponsored study looking also at the factors affecting implementation, scalability, and sustainability of the approach by chain and independent pharmacies in three different regions (west, northwest, and south) of the country.
The primary investigator for the capstone research project is Donald Klepser, Ph.D., professor and senior associate dean for academic affairs in the College of Pharmacy at University of Nebraska Medical Center. The study, which was launched just before the pandemic, is only now wrapping up. Preliminary results on the nationwide study on influenza POCT in U.S. community pharmacies will be covered in detail by Hohmeier on August 21 at the Next Generation Dx Summit. This will include implementation barriers and facilitators, reach of these services, and factors that help drive their availability in both types of community-based pharmacy practices.
Klepser and his brother, Michael Klepser, Pharm.D., professor at the Ferris State University College of Pharmacy, did a lot of the early pilot work on this front, says Hohmeier. Both will be speaking at the upcoming conference.
From a historical perspective, the training and education of community pharmacists has never been so high, Hohmeier notes. In 2006, the National Association of Boards of Pharmacy made a Doctor of Pharmacy (Pharm.D.) degree the minimum requirement for a pharmacist to receive a license to practice.
With so many doctoral-level trained pharmacists, together with their older and credentialed counterparts, “we now have this very large bolus of clinically trained licensed pharmacists across the United States,” says Hohmeier. Instead of having a handful of pharmacists delivering clinical care services at institutions like St. Jude Children’s Research Hospital, professionals of the same academic caliber can now be found virtually everywhere.
Eventually, the pharmacist-delivered care model will integrate both chronic care and acute care services, he predicts. There is certainly no shortage of POCTs to aid in the diagnosis and management of patients.
The greatest challenge when it comes to POCT by community pharmacists is the same one faced by other alternative care practitioners—namely, questions about whether the practice will push people outside of their normal healthcare home, how a constant flow of communication back to their primary care physician will be maintained, and how data will be reported to the relevant health department within the state, says Hohmeier. “From the patients’ perspective, I think the biggest question is how do we deliver this service in a way that is cost effective for [them].”
Once a large network of providing pharmacists is established, “we want to get this to the stage that our retail clinics have where third-party payment is constant,” he says. “We want to make sure this is accessible to all patients regardless of their ability to pay for the service.”
As will separately be discussed during a conference presentation by Adam Chesler, Pharm.D., senior vice president of pharmacy integration and strategic alliances for VillageMD (majority owned by Walgreens), POCT can also be a potent means to empower pharmacists to enhance patient care. The focus will be on how these practices can elevate value-based care.
Community pharmacists have historically been “siloed out of the medical picture” physically, because they weren’t co-located within medical clinics and hospitals, says Hohmeier. Downstream, that meant they had no connectivity to patients, for example via electronic health records.
Consequently, they also do not bill for services in the same way, he continues. While pharmacists on the outpatient side bill for prescription products, medical clinics and hospitals—and prescribers therein—bill for their services. The push is now on to start placing financial value in their role in test ordering and interpretation, both of which they have been trained to do, instead of the support services they provide from a product perspective only.
This is possible under value-based care models where reimbursement is tied to the quality of service delivered, Hohmeier says. And that’s the revenue supporting VillageMD and other care models involving a pharmacist as an integral member of the care team.
Unfortunately, “innovation in healthcare is extremely challenging, especially with the inflation pressures that exist across the country,” he adds. Many innovative care models have faced “strong headwinds” impeding their economic viability, including a network of health clinics recently shuttered by Wal-Mart. As was widely reported, Walgreens earlier this year also announced it was closing 160 of its VillageMD clinics to focus on sites in densely populated areas.
Hohmeier says he commends efforts to introduce new ways of providing high-quality care, “in a way that incentivizes that care to continue.” But the U.S. healthcare system as it is built today requires “marketplace experiments” that don’t all work immediately everywhere.
In another presentation during the same decentralized testing stream at the Next Generation Dx Summit, attention will pivot to antimicrobial stewardship—specifically, the appropriate use of POCTs to fuel these efforts and tracking antibiotic use via the Collaboration to Harmonize AntiMicrobial Registry Measures (CHARM) project. The session is being presented by Benjamin Pontefract, Pharm.D., assistant professor in the College of Pharmacy at Ferris State University and director of research for CHARM.
The business of “choosing the right medication to match the antimicrobial offender” depends on testing, says Hohmeier, but in the acute care setting providers treat empirically based on their clinical judgment and experience while awaiting the results. Community-based pharmacists could be providing data about what is circulating in their area to inform the decision-making of prescribers.
Just imagine having a national chain, a regional chain, and half of the independent pharmacies in a metropolitan area providing acute care services for infectious diseases, he says. “You now have at the ready financially sustainable centers for porting data on the circulating microbial agents into a central repository... the [same] pathogens that are likely causing the infections in most of your inpatient stays and urgent care visits. You have a much wider net that you’re casting to figure out what’s happening.”