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Ferris State Team Looking to Expand Scope of Pharmacy-Based Lab Testing


NEW YORK – Researchers at the Ferris State University College of Pharmacy are launching a pilot project to explore pharmacy-based testing of patients to monitor hypertension and dyslipidemia.

The three-year study, funded in part by a $150,000 grant from the Michigan Department of Health and Human Services, aims to demonstrate the effectiveness of pharmacy-based testing for managing these conditions along with monitoring prescribing and dosing of relevant medications, said Michael Klepser, a professor of pharmacy at Ferris State and leader of the effort.

The work fits within the larger trend of a growing role for pharmacies in clinical testing, which has been driven over the last decade by the spread of point-of-care technologies as well as changes in state regulations and pharmacist education.

Pharmacy POC testing is distinct from other retail testing models like retail clinics such as CVS' MinuteClinic, which offers a relatively wide range of healthcare services (typically provided by a physician assistant or nurse practitioner), or collaborations between retailers and reference labs like Quest Diagnostics or Laboratory Corporation of America, where the retailers essentially serve as draw centers for these labs.

Pharmacy POC testing is done within pharmacies themselves, which are allowed to offer CLIA-waived tests provided they are registered as CLIA-waved laboratories. Around 10,000 pharmacies across the US are registered as such.

Thus far, the bulk of pharmacy testing has focused on infectious disease, with influenza and strep testing the most common followed by HIV and hepatitis C. Klepser said that he expects CLIA-waved tests for viral conjunctivitis will see growth in pharmacy testing in coming years.

The Ferris State project looks to demonstrate that pharmacies can expand beyond infectious disease and into management of more chronic conditions.

Klepser said the study, which launches in July, will start at a single pharmacy (he declined to name the company he was working with, noting that they were still finalizing the agreement) and then add locations throughout the duration of the project. The researchers will use Abbott's Piccolo Xpress analyzer to perform basically metabolic panels from patient blood samples.

"We're hoping to get information on how many patients make it to their goal with their blood pressure or cholesterol, and we'll be look at the numbers and types of interventions that the pharmacies are making and how much of that is driven by information from the lab" results, he said. "And then we'll be looking at some softer outcomes like patient satisfaction and physician satisfaction."

Klepser said the hope is that offering these lab services out of the pharmacies could prove a more efficient way of managing these patients than having patients go through a primary care physician for traditional lab testing.

"Typically when patients get started on an anti-hypertensive or a medication for their cholesterol they might have to go to a health system for dose adjustments and diagnostics," he said. "What we're hoping is that offering that in the pharmacy and managing that patient's medications and doses in the pharmacy will help get better control of their blood pressure or cholesterol and improve patient outcomes."

He added that such pharmacy-based testing could also prove useful for patients who don't have primary care providers, both in terms of providing them with lab results and for connecting them with the medical system and a primary care physician.

A 2015 report by Deloitte predicted that POC testing will surpass immunizations as a revenue driver for pharmacies, noting that "pressure from payers to detect high-cost diseases early will help speed up the growth of pharmacy-based diagnostic screening services."

There is interest from the provider side, as well, which Klepser said has increasingly seen the value of pharmacy-based medical care.

When pharmacies began providing vaccinations around two decades ago, "there was a lot of pushback," Klepser said. "Now I have seen that change quite a bit in terms of [doctors seeing] that pharmacists could be managing some of these patients that are at lower risk for complications."

"Especially when you start talking about the fact that 30 to 40 percent of individuals don't have a primary care provider, the physician groups would rather try to do something for those patients than nothing," he added.

Klepser said that the financial struggles of many rural healthcare systems had also heightened the relevance of pharmacies for lab testing.

"If you're in a small farming community, there probably aren't enough people to support even an urgent care clinic and one of the clinics in the pharmacy," he said. "But between the retail front and the prescriptions, there might be enough business there to support a pharmacy. And I think that you'll see some health systems realize that partnering with the pharmacy is a cost effective way to manage those patients."

In addition to the hypertension and dyslipidemia study, Klepser and his colleagues are in the middle of a study exploring use of the Piccolo Xpress in rural pharmacies for metabolic testing. He said they hope to publish results in the next 18 months.

They are also considering launching a study looking at whether pharmacies could operate HIV Pre-exposure prophylaxis (PrEP) therapy programs using POC chemistry analyzers to do lab testing to support management of patients on that therapy.

Additionally, they are in the middle of the study looking at implementing respiratory panels like the BioMérieux's BioFire FilmArray in pharmacies, with an emphasis on helping diagnose respiratory conditions among high-risk individuals to help determine whether they have an infection that needs additional medical treatment.