NEW YORK — Proponents of pharmacy-based diagnostic testing want to build on the momentum generated during the COVID-19 pandemic.
While point-of-care testing has been a growth area for pharmacies before the pandemic, the centrality of pharmacies in specific initiatives such as the federal government’s Test to Treat program for COVID-19 and testing for COVID-19 in In general, their profiles as sites for diagnosing and treating a variety of conditions, said Michael Klepser, a professor of pharmacy at Ferris State College of Pharmacy.
“I think [the pandemic] has certainly raised awareness of what kinds of things can be done in pharmacies,” he said, noting that industry associations are now pushing for expanding pharmacies’ testing and prescribing powers.
According to Vince Stine, director of government affairs at the American Association for Clinical Chemistry, as of 2021 pharmacies comprised more than 8 percent of the country’s CLIA-exempt labs, second only to physician offices. He noted that there are currently more than 26,000 CLIA-exempt pharmacy labs, up from about 240 in 1995.
Rules governing the ability of pharmacists to offer tests and prescribe drugs based on the test results are largely handled at the state level, with state laws varying widely. According to the National Alliance of State Pharmacy Associations (NASPA), five states currently give pharmacists direct prescribing power, meaning they can prescribe medications for certain conditions (usually those that can be diagnosed through a CLIA-exempt test). Thirteen states currently allow pharmacists to prescribe medications for certain conditions diagnosed through CLIA-exempt testing, provided they have entered into a partnership agreement — a legal arrangement between a physician and a pharmacist (or other service provider) under which the physician certain aspects of medical practice.
With regulations varying from state to state, organizing a broad push for more pharmacy-based testing has been challenging, Klepser said. However, he suggested that the growing interest from major national pharmacy chains could further that effort.
Klepser said NASPA recently signed an agreement with “one of the major pharmacies in the country” to train about 2,400 pharmacists in point-of-care testing using a training program he and colleagues developed.
“Pharmacists were never really trained to collect samples – throat swabs, nasal swabs – to perform these tests, which is why we developed this program as a way to give pharmacists the confidence and experience to perform these tests and to provide disease management services. to develop that are supported by this [testing] activities,” he said.
Klepser noted that while a total of about 7,000 pharmacists completed the program, individual training sessions tended to be for relatively small numbers of pharmacists and limited to a single state. In contrast, the recent NASPA training agreement will involve thousands of pharmacists in multiple states.
“Usually, when we’ve trained with chains, it’s been like, ‘Okay, we can train the pharmacists in this state,'” Klepser said. “And they would choose one state, like Michigan or Florida, when this is a multi-state commitment.”
Major chains, he added, want to do it in several states once the program is rolled out. “They want to take it everywhere because it makes it easier for them,” he said. “So, if you get people like this involved, hopefully it puts the needle on some legislation and opportunities.”
According to a review of pending legislation published by NASPA in August, 167 bills related to the practice of pharmacists were introduced in 38 states by 2022, including some related to partnership agreements and point-of-care testing and prescription drug use. therapy.
At the federal level, the 21st Century Cures 2.0 accountIntroduced last November by U.S. Representative Diana DeGette, D-Colo., would provide coverage for pharmacogenetic consultations performed by pharmacists.
Klepser said that from his perspective, a state-level model scheme is similar to the one in Idaho, where pharmacists have direct authority to prescribe therapies for conditions that can be diagnosed or otherwise monitored using a CLIA-exempt test.
Collaboration agreements are “the next best thing,” he said, although he noted that finding doctors to work with on such agreements can be challenging, especially for smaller pharmacies. In addition, in some states, collaboration agreements only apply to patients of the physician with whom the pharmacy has contracted, making them somewhat limited instruments. That limitation also limits pharmacists’ interactions with individuals who don’t have a primary care provider, Klepser said.
Speaking at the Next Generation Dx Summit in August, Kenneth Hohmeier, an associate professor of clinical pharmacy and translational sciences at the University of Tennessee Health Science Center, suggested that an ongoing transition in major pharmacies’ business models is driving interest in pharmacy-based testing.
“There’s a really big shift going on in the C-suites of most chain pharmacies, and it’s the realization that the prescription product is not a viable business model,” he said, predicting that in the next 10 to 20 years, drug prescribing will increase. would no longer be an important part of the activities of these companies.
This has led to “a real urgent need to shift or at least diversify the way pharmacies get their bills paid,” he said.
Nicole Schreiner, owner of Streu’s Pharmacy in Green Bay, Wisconsin, also spoke at the Next Generation Dx Summit and suggested that independent operators view the situation similarly, noting that her company is “definitely looking to diversify revenues” and a point-of-care sees testing as a promising option.
“The typical community pharmacy has a very hard time making ends meet on a prescription-only basis,” she said. “So we have to be service oriented and we have to have a diversification of services.”
Schreiner said that prior to the COVID-19 pandemic, her pharmacy had “engaged in point-of-care testing for years,” offering hemoglobin A1C and cholesterol testing. During the pandemic, the pharmacy conducted COVID-19 testing using LumiraDx’s SARS-CoV-2 rapid antigen test. She said the store now plans to add flu, strep, hepatitis C, HIV and INR tests.
Hohmeier said another major shift within the industry has been an increase in the number of pharmacists holding doctoral degrees, driven by changes in licensing standards. This, he noted, has led to a population of highly skilled pharmacists, many of whom work “at the bottom of what their education allows them to do”.
This combination of a shift in business models, a highly skilled workforce, and the fact that, according to Hohmeier, the average American goes to the pharmacy more than twice as often as a traditional medical provider is creating a “kind of perfect storm” around pharmacy-based testing. , he said.
To date, pharmacy-based testing has largely focused on infectious diseases such as flu, strep throat, HIV, hepatitis C and, more recently, COVID-19. However, Hohmeier believes that pharmacies can play a greater role in areas such as medication and the management of chronic diseases and public health.
Hohmeier also highlighted a number of considerations for point-of-care providers looking to supply pharmacy labs, noting that these settings differed in important ways from more traditional settings such as doctors’ offices.
For example, he said the decentralized nature of the pharmacy business brings unique sourcing and procurement needs. A chain may have 50 or more locations in a major urban center, each with different and varying levels of demand, he said, noting that this requires more flexible inventory management solutions.
In addition, pharmacies are often looking for turnkey solutions, including technician training materials and workflows that are specifically adapted to the pharmacy environment, as opposed to a traditional medical office, Hohmeier said. “We really need some kind of soup-to-nut package because there just isn’t the time to put together a full implementation strategy.”