It Is Time for a Third Category of Devices, Medications, and Tests

it is hard to believe that it has been 8 months since the US Department of Health & Human Services (HHS) sent out a notice declaring that pharmacists can order and perform coronavirus disease 2019 (COVID-19) testing nationwide.

It feels so recent, perhaps because of its gravity. Subsequent expansions of service authorizations have happened since then with testing and now vaccine administration. And why not? There are 65,000 pharmacies in communities across the United States that are perfectly capable of such activities essential to the pandemic response.

WHAT STAYED OPEN BESIDES EMERGENCY DEPARTMENTS AND HOSPITALS? PHARMACIES

I anticipate that we will see some interesting studies and white papers produced in 2021 that analyze health care use patterns in 2020, particularly in the last 2 weeks of March. When everything else shut down, patients still went to pharmacies, and many pharmacies responded with agile innovations, from curbside pickup to rearranging foot traffic to telepharmacy, long before retailers and medical clinics initiated these needed changes. Hundreds of millions of Americans conditioned themselves during those early weeks of the pandemic to think of pharmacies as accessible, trusted services providers, not retailers.

A NO-BRAINER: PHARMACIES AS MASS VACCINATORS, SCREENERS, AND POINT-OF-CARE TESTERS

How do we reach 350 million Americans with COVID-19 vaccinations over the course of a couple months? Ask every one of the 65,000 community pharmacies in the country to administer 90 vaccinations every day for 60 days. That is not on the hard pile. The potential scale of mass screening, testing, and vaccinating by pharmacists practicing in pharmacies is unparalleled.

NEW AT-HOME TESTING BUT NOT WITHOUT THE ORDER AND THE SERVICE

New FDA-authorized home testing kits for severe acute respiratory syndrome coronavirus 2 are now available. Convenience and safety are king, but the need for ordering and counseling remains. The trend toward at-tome testing (see Cologuard and others) and at-home devices (eg, remote patient monitoring) will continue long after the pandemic has abated, but the friction between easy procurement in the community and navigating a complex, expensive system of providers of care to get devices, medications, and now even computer programs (yes, there is one for children with attention disorder) remains. The procurement and use are the easy parts, but getting the prescription is the pain in the butt.

EXPANDING AND PRESERVING THE ROLE OF RAPID-RESPONSE CARE DELIVERY (UNDER PROTOCOL)

Fortunately, pharmacists have received the authority to order COVID-19 testing and have procured blanket authorizations for initiating immunizations across the country. And consumer expectations have changed to the point of no return, despite any future expiration of emergency authorization. Pharmacies are in an ideal position for screening, testing, and triaging the most straightforward ailments and making referrals when necessary. It’s Public Health 101: accessible, engaging, trained, and trusted.

MEDICATIONS TOO

Yes, the third rail of internecine health care professional politics is the initiation of pharmacotherapy, the final frontier. It seems so silly though, right? Pharmacists can do most everything except the thing they were best trained for: selecting medications and counseling on their use. Why do we continue this charade? Physicians have been so defensive about pharmacist-initiated therapy for so long, even when involving a limited set of medications under a strict set of circumstances and criteria, that they lost sight of the tens of thousands of nurse practitioners (NPs) and physician assistants (PAs) displacing them at breakneck speed. Physicians should be partners with pharmacists, not adversaries, and the same goes for NPs and PAs.

YES, MEDICATIONS TOO. READ ON BEFORE FREAKING OUT. REMEMBER LORATADINE BY PRESCRIPTION?

Examples abound, from the mildly counterintuitive to the patently absurd circumstances where medications come to market as prescription only, with very little risk for mis-prescribing, and yet pharmacists are not allowed to initiate them. Remember Claritin by prescription? I remember a few decades ago watching a rather large meeting of industry and provider panelists conclude that Claritin should not be moved OTC because doing so would pose a threat to public safety. The panelists argued that despite Claritin’s impeccable adverse effect profile, too many individuals would not be seen for more serious conditions that may lie beneath the sneeze if such a product were accessible without a health care professional’s evaluation. Then it went generic, immediately went OTC, and we never heard concerns again. There was no public health crisis.

AND DIPHENHYDRAMINE? WHAT IS THE EXCUSE FOR KEEPING THAT OTC?

Meanwhile, diphenhydramine, a medication that is dangerous without proper assessment of patient risk and ongoing monitoring, remains widely available. Diphenhydramine has a long rap sheet of “do not use” advisories, such as the Beers Criteria for older adults. Yet it continues to be available to anyone, anywhere, without a health care professional’s consultation. Why was loratadine so dangerous that pharmacists could not initiate it, but diphenhydramine is not?

TIME FOR A REEVALUATION

The health care system is long overdue for a renewed discussion of a third class of devices, medications, and tests that can be initiated or ordered by multiple health care professionals, including pharmacists. There are myriad reasons for allowing pharmacists to serve their communities in this way—the growth of health savings accounts that require a prescription for needed coverage, large swaths of the population that avoid traditional care, the loss of primary care in rural areas, underserved populations that cannot access or afford traditional care, or a pandemic. It makes economic and moral sense, and now because of COVID-19, it is making a lot more sense to the average health care consumer.

Troy Trygstad, PharmD, PhD, MBA, is the vice president of pharmacy provider partnerships for Community Care of North Carolina, which works collaboratively with more than 1800 medical practices to serve more than 1.6 million Medicaid, Medicare, commercially insured, and uninsured patients. He received his PharmD and MBA degrees from Drake University and his PhD in pharmaceutical outcomes and policy from the University of North Carolina at Chapel Hill. He also serves on the board of directors for the American Pharmacists Association Foundation and the Pharmacy Quality Alliance.