Q&A with
Michael E. Klepser,
PharmD, FCCP

Pharmacy Purchasing & Products: What are the benefits of implementing rapid diagnostic testing in the outpatient pharmacy environment?
Michael E. Klepser: Initiating a rapid diagnostic testing program for outpatients will undoubtedly improve patient care and outcomes. These tests provide pharmacists on the front line with the tools needed for earlier identification of patients with certain diseases of interest, and thus enables pharmacy to ensure patients receive appropriate care more quickly. Patient-centered care improves when the window from presentation to treatment is shortened, and rapid diagnostic testing facilitates that. 

For example, antiviral treatment for influenza is most effective when initiated within 48 hours after the onset of symptoms. If a patient with influenza-like symptoms self-treats—as is common for patients experiencing fever, aches and pains, and associated symptoms—and then waits another day or two before seeing a physician, the treatment window has likely closed. However, if the pharmacist takes vital sign information and conducts a rapid test for influenza, treatment can be initiated immediately if the test is reactive. Shortened time to treatment can result in decreased symptom duration, shortened viral shedding, and decreased time to recovery. 

Another benefit of rapid testing is its potential contribution to improving public health, which is especially compelling for hepatitis C and HIV, as many individuals are unaware they are infected. Pharmacy screening has the potential to identify patients earlier in the course of the disease and link them to appropriate ambulatory clinics or inpatient settings to begin antiviral therapy. Once aware of their status, patients also will be less likely to infect others.

Since the majority of antibiotic use in the US occurs in outpatient settings, to truly impact antibiotic use, we will need community-based antimicrobial stewardship programs, and rapid testing could have a positive impact in optimizing antimicrobial use. Programs or treatment algorithms based on rapid diagnostic testing results could be developed under the purview of an infectious diseases-trained health-system pharmacist for implementation in a community setting.

Rapid testing can improve the efficiency of care delivery and reduce costs, particularly in an HMO or PPO system. Patients with infectious diseases who are diagnosed and treated early tend to respond more quickly to therapy and experience fewer complications. Rapid testing also can reduce disease burden by slowing or preventing the spread of illness through early diagnosis and treatment. Costs are reduced through fewer clinic visits and fewer hospital admissions, as well as improved outcomes. 

Implementing a rapid testing program is similar to implementing an immunization program, and the testing procedure is straightforward and time-efficient. Prior to offering services, pharmacy must develop protocols and train staff, but actually conducting the tests takes little time; for example, the influenza test takes approximately 15 minutes, and the pharmacist can attend to other tasks while awaiting test results.

PP&P: What tests are currently available for use in an outpatient pharmacy?
Klepser: First, it is important to note that rapid diagnostic tests for outpatient pharmacy use must have a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver. Infectious disease tests that are currently available include, but are not limited to, hepatitis C, HIV, group A streptococcus, influenza, Helicobacter pylori, and mononucleosis. For influenza and group A streptococcus, not only are the tests easy to perform, but the recommended treatments are also straightforward in the event a test is reactive.

PP&P: Can you provide more information on the CLIA Certificate of Waiver required to institute use of a rapid diagnostic test?
Klepser: A CLIA waiver indicates that the level of complexity and the quantity of specialized equipment needed to perform the test are sufficiently minimal that a facility does not need to be a licensed laboratory to perform the test. All CLIA-waived tests use methodologies that make the chance of erroneous results negligible or pose no reasonable risk of patient harm if performed incorrectly. A list of all CLIA-waived tests can be found on the FDA Web site: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm. In addition to the tests being CLIA-waived, any pharmacy wishing to implement the tests must complete a CLIA Application for Certification, which is available on the Centers for Medicare & Medicaid Services Website at http://www.cms.gov/cmsforms/downloads/cms116.pdf.

PP&P: How accurate are rapid diagnostic test results?
Klepser: Most commercially available tests are extremely accurate, although accuracy varies depending on the sensitivity and specificity of each test. Some rapid tests are effective at ruling out diseases, others are effective at ruling in diseases, and some are effective at both. A test’s positive predictive value is greater when the chance of disease is greater. For example, the influenza test’s positive predictive value is greater in the winter months, when the disease is more common. 

PP&P: How should pharmacists identify potential candidates for testing?
Klepser: Patients likely to benefit should be identified according to the disease prevalence within the pharmacist’s local patient population. Random or otherwise inappropriate use of rapid diagnostic tests must be avoided as it decreases a test’s positive predictive value. For example, if a state or local health department identifies an influenza outbreak in a particular area, it would be appropriate to initiate use of the rapid diagnostic test for influenza, as the positive predictive value will be high in such a situation. On the other hand, using the test in the summer when influenza is rare—and consequently the positive predictive value is low—will yield a significant number of false-positives. For group A streptococcus, pharmacists can make an initial assessment of the patient by collecting vital signs, temperature, and a description of symptoms. If the presentation is consistent with group A streptococcus, it is appropriate to employ rapid diagnostic testing.

More generic screenings, such as for HIV and hepatitis C, are appropriate for a broader group of individuals. The pharmacist should inquire about patients’ risk factors to assess the possibility of infection and identify appropriate candidates for testing.

PP&P: How should pharmacy determine which tests to implement first?
Klepser: The influenza test is the easiest to persuade other clinicians to use as its immediate value is obvious. Because the US tracks over-the-counter (OTC) drug sales information to identify influenza prevalence, we know that data indicate patients attempt self-treatment before visiting their physicians. If self-treatment fails to eradicate symptoms of illness, patients will usually then visit their physician; however, the window for effective treatment often will have passed by that time. Pharmacists should request more information from patients with influenza-like symptoms who are seeking OTC medications and, when indicated, conduct a rapid test. When results are reactive and treatment is initiated immediately, therapy is more likely to be effective, patients receive more efficient care, and the spread of disease is inhibited. 

The group A streptococcus rapid diagnostic test is also suitable for early adoption. The test is easy to administer and highly accurate, and the treatment is straightforward.

Following on the Centers for Disease Control’s recent Know Your Status project, initiating rapid testing for HIV supports public health priorities. The CDC recommends that everyone be tested at some point and that high-risk individuals be tested more frequently. Because HIV carries a stigma, it has always been challenging for health care professionals to motivate individuals to get tested. Offering HIV testing in the pharmacy makes it more readily accessible and may facilitate a higher comfort level than in a clinic setting. Efforts to facilitate increased hepatitis C testing will likely be similar to that of HIV. Offering both HIV and hepatitis C testing to patients concurrently may be a prudent course. 

PP&P: How should pharmacy manage the communication of reactive test results to patients?
Klepser: Following a reactive result, the subsequent steps differ depending on the test. A positive test result for influenza or group A streptococcus can be directly followed up with appropriate treatment, while managing results for hepatitis C and HIV is clearly more complex. The hepatitis C test is a screen for antibodies, and a reactive result requires follow-up with a quantitative RNA culture. Pharmacy should facilitate such follow-up by directing the patient to an appropriate care site or perhaps making an appointment for the patient. Rapid diagnostic test results for HIV are considered preliminary, and follow-up testing is required to confirm the diagnosis. As with the hepatitis C test, pharmacy should facilitate follow-up for patients preliminarily diagnosed with HIV. Currently, if we have a patient with a reactive HIV test result we contact our local health department and they send an employee to our facility immediately to collect a sample for confirmatory testing.

It is critical that pharmacists providing rapid testing for hepatitis C and HIV are cognizant of and sensitive to the charged emotions and negative associations surrounding these diagnoses. Clinicians offering rapid testing for these indications must be trained in appropriate ways in which to interact with patients.

PP&P: What training is available for pharmacists?
Klepser: Currently, pharmacy school education is not providing students with sufficient training for rapid diagnostic testing; an informal survey of pharmacy colleges revealed that only about 22% include training in their curricula on rapid diagnostic testing for infectious diseases. This is unfortunate, as rapid testing will likely become one of the next major developments in pharmacy services, similar to the emergence of pharmacy-based immunization in previous years. For rapid diagnostic testing to be successful, pharmacy programs must educate and properly train students. Key objectives of education should be to explain the specifics of the technology, identify its limitations, and train pharmacists to correctly collect test specimens, conduct tests, and interpret results. Pharmacy school graduates must have a clear understanding of concepts such as sensitivity, specificity, and positive and negative predictive values.

The Society of Infectious Diseases Pharmacists (SIDP) has taken a lead role in promoting the appropriate use of rapid diagnostic tests by pharmacists. SIDP is developing a white paper on the roles and limitations of testing, and is working with faculty at Ferris State University and the University of Nebraska Medical Center College of Pharmacy to develop a rapid diagnostic testing certificate program. The program should be introduced in late summer or early fall of this year, with the goal of replicating similar programs across the country. 

I am also working with the Michigan Pharmacists Association to educate state legislators about rapid diagnostic testing and the role pharmacy can play in implementing its use. Each year the association sponsors “Pharmacy Day” at the state capitol. This fall we hope to offer rapid testing screenings with the aim of increasing legislator knowledge and support of rapid diagnostic testing programs. 


PP&P: What is the future of rapid diagnostic testing in outpatient pharmacy practice?
Klepser: One scenario is that rapid diagnostic tests could be used to collect data in a patient-centered medical home model. In this model, pharmacists would collect data that could be uploaded into a patient’s medical record and used to direct care. 

Another possibility is that community antimicrobial stewardship activities will develop under the purview of an outpatient hospital pharmacy in a large health care system. A pharmacist trained in infectious diseases could potentially provide guidance to community practitioners on when to test, develop algorithms for managing the rapid testing program, determine appropriate therapies based on test results, and teach community pharmacists to interpret test results properly. These activities would be especially valuable considering the current shortage of pharmacy education on the topic. Outpatient pharmacists can have a significant influence on increasing the prevalence and volume of rapid diagnostic testing. 

Michael E. Klepser, PharmD, FCCP, is a professor of pharmacy at Ferris State University in Kalamazoo, Michigan. He received his pharmacy degree from the University of Michigan College of Pharmacy in 1992 and completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center, as well as a fellowship in infectious diseases at Hartford Hospital in Hartford, Connecticut.