Point-of-care testing in the pharmacy: how is the field evolving?

KEYWORDS:

• Pharmacy
• point of care testing
• influenza
• pharyngitis
• collaborative practice agreement

1. Introduction

From urgent care centers and retail clinics to telemedicine and concierge services, the past decade has seen a dramatic shift in how patients receive health care. We have gone from a centralized, rigid model that creates time and location barriers to models that allow patients access to care when they need it and where they want. With approximately 60,000 community pharmacies in the United States, many open nights, weekends, and holidays, the community pharmacist has long been recognized as the most accessible of health-care providers. Additionally, it has been estimated that 91% of Americans live within 5 miles of a community pharmacy [1]. As part of the trend toward improved patient access to care, pharmacists have begun to develop and provide clinical services beyond safeguarding of, dispensing of, and counseling on prescription medications.

2. Pharmacist-provided patient care services

Today’s pharmacy graduate enters the profession with a Doctor of Pharmacy degree that prepares them to be more directly involved in patient care activities. As an example of how the role of the pharmacist has rapidly evolved, one has to look no further than influenza vaccinations. Less than two decades ago, pharmacy-based immunization programs were rare; however, as state-level statute changes occurred allowing more pharmacists to provide vaccinations, the number of vaccinations administered in community pharmacies increased dramatically. In fact, 25% of adult influenza vaccinations are now administered by community pharmacists [2]. Owing to the success of immunization programs, community pharmacists have begun expanded medication therapy management services, play a larger role in disease screening, and incorporating point-of-care tests (POCT) into disease management services. Although use of Clinical Laboratory Improvement Amendment (CLIA)-waived POCT in pharmacies is not new, there has been a recent surge in interest as the types of tests have expanded and the technology improved. A recent study reported that over 10,000 (~16%) of community pharmacies possessed certificates of waiver under CLIA [3].

3. Pharmacy-based laboratory testing

Community-pharmacy-based laboratory testing falls into one of broad three models. In the first model, the pharmacy with the certificate of waiver houses a retail clinic or other provider, who is conducting the POCT as part of their direct patient care activities. For example, a nurse practitioner may run a test for group A streptococcus as part of their care for a patient presenting to the retail clinic with acute pharyngitis. In the second model, the pharmacy may serve as a specimen collection site for a laboratory. For example, Walgreens and Labcorp recently agreed to have the lab place staff in the pharmacy to collect specimens and send them to the central laboratory for processing and reporting back to the patient’s physician [4]. Unlike the first two models, where the pharmacy is just a convenient site for POCT, the third model utilizes the pharmacist to offer a complete disease management service that includes patient assessment, conducting the test, and providing care based on the test result. This is the area where we see the most opportunity for POCT in pharmacies to improve patient care as part of the patient-centered health-care team.

In the inpatient and clinic settings, it is common for a prescriber to delegate the authority to initiate, adjust, or discontinue therapy to pharmacist [5]. In many cases, the pharmacist utilizes available laboratory data to decide what clinical action is appropriate. Delegation of authority in these settings typically is accomplished via standing orders and protocols. A total of 49 states currently have some form of statute that allows for similar delegation of prescriptive authority between a community prescriber and pharmacists. In many states, outpatient delegation of authority is accomplished by the parties entering into a collaborative practice agreement (CPA). A CPA can outline the types of conditions, tests, and care the pharmacist can provide to patients. CPAs have been widely used for the management of patients with conditions such as diabetes and dyslipidemias. Additionally, CPAs have provided the framework in many states to allow pharmacists to provide immunizations.

Within the past decade, a shortage of primary care providers and improvements in POCT technology have created an opportunity to utilize pharmacists in an expanded role with respect to types of disease management and screening services. Acute conditions such as acute pharyngitis and influenza-like-illness are examples where CPAs have been utilized to allow pharmacists to screen and manage appropriate patients based on CLIA-POCT results. Published reports have highlighted the safety and efficacy of these CPA-based disease management programs [6–8]. Additionally, these reports revealed that pharmacists managing patients according to evidence-based CPAs had lower rates of inappropriate antimicrobial use compared to published data [8]. Examples of pharmacy-based screening for chronic infections such as HIV and hepatitis C have also been described [9,10]. In these instances, the pharmacist does not initiate therapy based on test results; rather, they have worked collaboratively with health departments and providers to facilitate a warm handoff of clients with reactive tests. This model was developed to not only provide screening to more people but to help close the gap that currently exists in many traditional screening programs where as many of 50% reactive patients are lost to care before they can initiate therapy [11]. A similar model was recently described to provide blood lead testing to residents of Flint, Michigan who did not have primary care provider and/or who were untrusting of the ‘system’ following contamination of drinking water in that city [12].

4. Barriers

Like most new services and products, change in health care is often met with resistance. In our experience, the programs described above have been no exception. Some prescribers are reluctant to enter into a CPA for these programs because they are unfamiliar with statues and pharmacist capabilities. Insurers are often hesitant to pay for new services until value and demand have been demonstrated. Patients do not know that these services are available at pharmacies. Even some pharmacists have been slow to adopt these models owing to unfamiliarity with POCT technology and the practice acts that afford them these opportunities. Fortunately, many of these barriers have begun to erode as more data are published and experience is amassed.

5. Opportunities

It has been estimated that, in the near future, revenue generated by community-pharmacy-based CLIA-waived POCT services will surpass revenue generated by immunization programs [13]. This growth will likely be fueled by demand from patients and prescribers and the continued expansion of available tests. CLIA-waived tests for pharmacogenetic testing to provide information on drug metabolism, sexually transmitted infections, and serum chemistries to support optimization of drug therapies are on the horizon.

6. Conclusions

Pharmacists are respected, knowledgeable, and accessible members of the health-care team. The technology in the outpatient setting is finally providing them with the tools they need to fully realize their potential. However, pharmacists are not on this journey alone. Pharmacists, prescribers, laboratorians, insurers, public health officials, and patients all will play a role to identify and develop the types of POCT-based services that are appropriate and sustainable in the community pharmacy. Additional research in this area is warranted to assure that high-quality services are being delivered.

Declaration of Interest

DG Klepser is a developer of NACDS POCT Certificate Program, has acted as a consultant for Force Diagnostics and Arkray Inc and discloses research support from Roche Diagnostics and NACDS Foundation. ME Klepser is a developer of NACDS POCT Certificate Program, has acted as a consultant for Force Diagnostics and Arkray Inc and discloses research support from Roche Diagnostics and NACDS Foundation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.