Patty Milazzo, R.Ph.
Patty Milazzo, R.Ph.
Logan Graham
Logan Graham

THE U.S. NATIONAL VACCINATION EFFORTS began in the spring of 2021, creating one of the fastest and largest operational shifts in pharmacy history. Retail pharmacies administered over 240,000 COVID-19 vaccinations in less than a year and have continued into 2022 with first and second boosters. Pharmacies were responsible for approximately 70% of all long-term care vaccinations and quickly became the nation’s frontline strategy as the primary provider of vaccinations. The U.S. government now considers pharmacy a prominent player in the delivery of healthcare, as evidenced by the recently announced “test to treat” initiative.

In the 2022 State of the Union Address, President Biden announced a new COVID strategy. Described as “test to treat” by Biden and by the Office of the Assistant Secretary for Preparedness and Response (ASPR), it allows patients to receive a rapid COVID test and oral antiviral treatments for COVID at their community pharmacy. The president’s goal is to create rapid access to the FDA (Food and Drug Administration)-approved COVID oral antivirals, Pfizer’s PAXLOVID (nirmatrelvir tablets; ritonavir tablets) and Merck’s LAGEVRIO (molnupiravir). The hope is that expanding and expediting access to these treatments may diminish the severity of COVID symptoms, reduce hospitalizations, decrease lost workdays, reduce long-term COVID impacts, and partially alleviate the enormous burden placed on primary care providers and hospital emergency departments. Unfortunately, even with accelerating vaccination rates and the availability of boosters, COVID cases continue to rise due to variants. The severity of a specific variant or subvariant widely fluctuates. Communities should be prepared to adjust mitigation strategies based on hospitalization increases. Retail pharmacy is a critical component of those mitigation strategies.

COVID care at pharmacies goes beyond vaccinations. The process of testing and treating patients in the pharmacy is more nuanced than the phrase “test to treat” suggests. Like the vaccination roll-out, operational, documentation, and technology requirements are not fully understood or yet implemented. Legal and regulatory concerns exist that must be addressed, as well as a need for technological support to streamline and document test-to-treat interventions. Pharmacies that participate also have procurement and distribution requirements from federal and state agencies and their wholesaler. The treatments, and the test-to-treat program, are currently available at some pharmacy-based clinics and long-term care pharmacies, but not necessarily available at all pharmacies. Patients wishing to access “test to treat” can visit this link to find a pharmacy nearby that does this.

Despite the challenges, positive outcomes from the test-to-treat initiative could lead to expansion of similar community pharmacy services in the future. As described in our column in the last issue of ComputerTalk, on the topic of “Rethinking Pharmacy Business Models,” pharmacy is rapidly evolving to include multiple types of healthcare functions.

COVID-19 Vaccine 1st and 2nd Dose Scheduling

One major hurdle to the test-to-treat initiative is the ongoing debate between pharmacists and physicians in parts of Europe, Asia, and South America. Currently the American Pharmacists Association offers a “Pharmacy-Based Test And Treat Certificate Training Program” for pharmacists. This includes hands-on training in throat swabs, oral fluid collection, nasal swabs, and finger-stick testing.

Because pharmacists have played a key role throughout the COVID pandemic, patients, regulators, and payers should trust pharmacists to continue to contribute to the efforts to curb the virus. Some states have approved pharmacists to perform prescribing in limited circumstances. As an example, Oregon allows pharmacists who have completed their board-approved training program to “prescribe hormonal contraceptives to a patient pursuant to the Oregon “Self-Screening Risk Assessment Questionnaire and Standard Procedures Algorithm,” where most states do not grant prescriptive authority of any kind to pharmacists.

President and CEO of the National Association of Chain Drug Stores, Steven C. Anderson, says the federal government should “recognize pharmacists to perform the test-to-treat function, much like nurse practitioners are recognized to provide routine care for other disease states.” Recognition of the capabilities of pharmacists to provide point-of-care testing and obtain a diagnosis will help a patient to receive treatment sooner. That difference in time could be the difference between being in the window for antiviral therapy or not.

DOCUMENTING AND SHARING

Once federal and state documentation requirements are known, pharmacies will require the necessary technology to document and share electronically the point-of-care testing results. Patient electronic health records will require documentation of diagnosis and treatment. Some pharmacies, such as certain Walgreens and CVS locations, have prescribers and pharmacists all under one roof but not necessarily a fully integrated workflow. Walmart uses Epic software in its health centers to share information with providers.

Walgreens has partnered with VillageMD to use its primary care-centered operating system, docOS, in their Village Medical clinics. This system was designed to extract clinical data elements from multiple EHRs (electronic health records) and practice management systems, including hospitals and skilled nursing facilities, to make them available to clinicians. These communication methods are more feasible for the larger chain pharmacies, but the explosive need for pharmacy clinical documentation should drive multiple vendor options soon.

Pharmacies may need to enhance current technologies or purchase ancillary software to support clinical services like test to treat. One solution for documentation of patient test results may be to use the medication therapy management (MTM) platform. MTM systems may lack connectivity with the pharmacy practice management system and the ability for pharmacists to share information directly with patients’ providers.

While not a requirement for test to treat, if expansion is to happen, information exchange between community pharmacists and providers needs to improve. Currently, pharmacists are often in the dark when it comes to lab values and diagnoses. Pharmacies can use their own systems to document notes about patients’ test results, which may be sufficient for use with collaborative practice agreements.

Pursuant to a collaborative practice agreement, some states allow pharmacists to test for and treat minor health conditions. Florida grants pharmacies the ability to enter into a collaborative practice agreement to test and treat “minor non-chronic health conditions” such as streptococcus infections, influenza, lice, and minor skin infections such as ringworm and athlete’s foot.

This type of practice may become more commonplace in community pharmacy, if successful implementation of test to treat for COVID can pave the way. So far, no technology has emerged as an ideal candidate to allow for widespread seamless information exchange between community pharmacies and providers, though limited applications such as chain and clinic partnerships do exist.

The federal government’s recognition of the benefits of test to treat in the community pharmacy could open the door for future expansion. One possibility is the management of patients whose physician has already diagnosed an episodic or chronic condition, such as migraines or diabetes.

Pharmacists have the clinical knowledge to adjust the pharmacotherapy of these patients based on subjective and objective criteria, such as patient assessments or blood glucose readings. While pharmacists may not currently have the authority in all states to adjust the therapies of patients with diabetes, it may be a real possibility to expand the scope of pharmacy practice.

Overall, test to treat is not without its challenges. The lack of current funding is affecting resources for COVID treatment. The federal government is expected to reduce state shipments of monoclonal antibody treatments by 30%, and the U.S. supply could be depleted soon. The challenge of rethinking the role of a pharmacist, as well as passing legislation that enables pharmacists to use their training, is still a hurdle, despite pharmacy’s national participation in COVID vaccination efforts.

The technology support required for test to treat, once established, will open new opportunities for pharmacists to use their knowledge to create positive patient outcomes, reduce the overall healthcare system costs, and improve a community’s COVID situation. These outcomes can become more of a possibility through advocacy for the expansion of the role of pharmacists in test to treat. CT

Patty Milazzo, R.Ph., is senior consultant, and Logan Graham is pharmacy intern at Pharmacy Healthcare Solutions. The authors can be reached at pmilazzo@phsirx.com and lgraham@phsirx.com

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