Point-of-care testing: Emerging market, opportunity for pharmacists

Point-of-care tests can be part of an innovative patient care model

In August, Cambridge Healthtech Institute hosted Leveraging Pharmacies for Rapid Diagnostics—an inaugural conference that brought together point-of-care test manufacturers and pharmacy professionals to explore partnership potential and provide education on the services available in this emerging area. 


The conference came on the heels of the National Association of Chain Drug Stores’ (NACDS) 12-city summer tour to launch its point-of-care testing certificate program, which trains pharmacists to conduct CLIA-waived lab tests in their pharmacies. Both events highlighted this emerging market and opportunity for pharmacists to demonstrate the value they add to the health care system.


“As more people have health care coverage, and cost and access are gaining focus, there is new thinking that point-of-care testing could be more widespread,” said Krystalyn K. Weaver, PharmD, director of policy and state relations at the National Alliance of State Pharmacy Associations. “People are looking to pharmacy as a solution as they are becoming aware that pharmacists are capable of providing more services than they do now.”


What is point-of-care testing?


Pharmacists have been performing laboratory tests, such as glycosylated hemoglobin (A1C) and cholesterol screenings, for years. The APhA Foundation’s Project IMPACT, for example, put lipid tests in pharmacies in 2000. Known as CLIA-waived tests, they are exempt from the Clinical Laboratory Improvement Amendments that regulate laboratory testing and require clinical laboratories to be certified by their state and CMS before they can accept human samples for point-of-care testing. Though they are not error-proof, CLIA-waived tests must be simple and pose little risk of erroneous results. 


A1C and cholesterol screenings aren’t the only labs that fall into this category that a pharmacist could perform at the pharmacy. The more than 120 tests in the CLIA-waived list represent a previously untapped market of potential clinical pharmacy services. 


“The notion of pharmacists running CLIA-waived tests is not a new one. What’s different now is that we’re moving into infectious disease,” said Michael Klepser, PharmD, FCCP, a professor of pharmacy practice at Ferris State University College of Pharmacy in Kalamazoo, MI. “CLIA-waived analytes range from serum creatinine in the liver function, to strep and influenza, hepatitis C and HIV.” An analyte is a substance or chemical constituent that is undergoing analysis.


Klepser researches the outcomes and workflow of point-of-care testing in pharmacies. 


He and his colleagues ran a pilot study that demonstrated the feasibility of offering HIV testing in community pharmacies. The results were published in the January/February 2015 Journal of the American Pharmacists Association.

Patients are open to seeing a pharmacist for this type of service. Ninety-six percent of participants in Klepser’s pilot said they were comfortable letting a pharmacist perform the finger-stick test. This was similar to the number of participants comfortable allowing a physician or physician’s office personnel to perform the test. Pharmacists, too, were comfortable performing the tests and answered all participants’ questions. Among participants, about one in three said they infrequently or never see a health care provider. This speaks to pharmacy’s potential for increasing access to HIV and other tests. 


Klepser and his colleagues are now running a pilot in which community pharmacists in eight stores in Lansing, MI, offer hepatitis C testing to patients. Nationwide, community pharmacists are beginning to offer a number of other types of screenings for acute and chronic conditions as well as labs that monitor the efficacy of medications. More than 100 pharmacies in 12 states are part of an NACDS study to measure the impact of these services. 


Some pharmacies are partnering with CLIA-certified labs to offer other types of laboratory tests. For example, Walgreens has contracted with CLIA-certified lab Theranos to offer labs to patients in its Phoenix and Palo Alto stores. The chain drug store will serve as a specimen collection site for the partnering Theranos lab. “That’s not necessarily the pharmacists running the tests,” said Klepser. 


Other Walgreens stores are bringing phlebotomists on site to conduct hepatitis C tests. A Walgreens pilot program that launched last month will attempt to screen 11,250 patients at 60 stores. The study will measure the program’s efficacy in screening and linking patients to care. “If it works out, we should definitely consider whether there’s something [the health care system is] not providing that a community pharmacist could provide,” said Marcelo Kugelmas, MD, the principal investigator on the study.


Taking action on test results 


Point-of-care tests are one type of patient care service and can be a component of an innovative patient care model. Before a pharmacist runs a test on one patient, the pharmacist collects histories and vital signs to determine who is a candidate for the test. For those patients who go on to receive the test and get a positive result, pharmacists take the next steps in that patient’s care.


“In some of the models that we have run, you may screen hundreds of patients but only run the test on a small fraction of them, and then a much smaller fraction tests positive—and you manage those with a prescription medication under a collaborative practice agreement,” Klepser said.


This last step—taking action on a positive test result—is crucial. “Pharmacists’ ability to act on those test results is absolutely vital to the success of point-of-care testing in the community pharmacy,” said Kenneth Hohmeier, an assistant professor of clinical pharmacy at the University of Tennessee Health Science Center’s College of Pharmacy. Hohmeier researches perceptions of pharmacy among leaders in the point-of-care testing industry. 


Collaborative practice agreements can allow pharmacists to initiate the appropriate therapy, under the direction of the physician- or prescriber-driven protocol, after a positive strep or influenza test, for example. “If you don’t have the authority to perform an actionable service based on the results of the test, then it will have less value to the patient,” Weaver said. Because of convenience and accessibility, strep and influenza tests are particularly suited to pharmacies, Weaver added. 


Community pharmacy workflow


Testing workflow is similar to that of an immunization. Patients could spend up to 45 minutes at the pharmacy, but the pharmacist’s time with the patient might last only 5 minutes, which allows the model to fit into community pharmacy workflow. Pharmacy technicians can prescreen patients to determine if they are candidates for the test. The technician can then generate an appropriate placeholder prescription that will go into the work queue. The pharmacist will then conduct the test and provide the results and, in the event of a positive test, prescription counseling. Patients usually pay cash for tests. Pharmacies, in some cases, can bill insurance for the labs. Some health plans, Klepser said, are looking into reimbursing pharmacies for tests. 


Raising pharmacy’s profile


Point-of-care testing can reduce geographic barriers to point-of-care tests. “I see this working very much the same way that immunizations have,” Hohmeier said, “which has raised our status in patients’ view to show that we are a real easy, convenient way to access health care in their community.”


Through referrals to prescribers based on test results, the model also has the potential to bring earlier diagnosis and subsequent medical action—crucial in the outcomes of conditions ranging from influenza to HIV. Further, it could improve antibiotic and medication stewardship. 


About 75% of adults who see a doctor for sore throat get a prescription for antibiotics, though fewer than 5% have strep, according to Annals of Internal Medicine. Pharmacists working under collaborative practice agreements, however, cannot prescribe antibiotics in the absence of a positive strep test. “What we are seeing is seemingly much more appropriate use of antibiotics,” Klepser said. NACDS plans to evaluate point-of-care testing’s impact on antibiotic stewardship by the end of 2016.


This service can raise pharmacy’s profile among patients and bolster pharmacists’ case to be called providers, Hohmeier said. “I think this will continue to highlight the important role that pharmacists play in public health.”




Is industry ready to partner with pharmacy?


As point-of-care testing emerges in community pharmacy, Kenneth Hohmeier, PharmD, set out to learn about pharmacy’s potential partners in the point-of-care testing industry. “The initial research question was what are the point-of-care testing industry’s thoughts, feelings, and perceptions of the community pharmacy market segment,” Hohmeier said of the qualitative study that he and colleagues will publish later this year. 


More than 18 hours of interviews with eight organizations revealed that industry professionals were mostly unaware of the community pharmacy as a potential market segment. “Many didn’t understand that the pharmacist is able to perform these services or that it was even a possibility within their workflow.”


But after learning more, representatives of the industry were enthusiastic about pharmacists as potential new partners, according to Hohmeier. “The attractiveness of the market was seen by all.” Previously unaware of the concept of collaborative practice agreements, professionals whom Hohmeier interviewed were pleased to learn that pharmacists have a means to take action on positive test results. 


Industry professionals in the cohort see pharmacists as fully competent to administer point-of-care tests. “There was not a single individual that had anything to say about the need for more education other than technical expertise for the individual equipment that they would have to use. In other words, the perception of our clinical knowledge base was that we should be able to do this—no problem.”