FDA, AMA Deem Pharmacists Unsafe for Test and Treat

Restricting Pharmacists

The Public Readiness and Emergency Preparedness (PREP) Act helped bring accessible, effective, and efficient care to hundreds of millions of people.

Millions of vaccines were administered at pharmacies under the direct care or supervision of a pharmacists, who also played a significant role in COVID-19 testing and even ordering and infusion delivery. With high levels of accuracy and services being provided to disproportionately rural, socially vulnerable, and underserved populations, pharmacies demonstrated quite clearly that they are an essential part of the infrastructure necessary to respond to pandemics and infectious diseases.

Authorities gained under broadly vetted protocols grounded in evidence and safe selection and administration by a pharmacist are a first step in the successful implementation of medication-related population health efforts.

FDA Explicitly Limits Pharmacist Ordering, Citing Safety Concerns

As oral antivirals came to the market under emergency use authorizations (EUAs), the FDA took the unprecedented step of enumerating the type of health care providers who could order the newest COVID-19 treatments. It informally cited condition and drug interactions as the rationale for doing an about-face against the PREP Act expansions of pharmacist authorities, limiting ordering to 3 types of licensed providers: physicians, nurses, and physician assistants.^1-3

Decisions about scope of practice privilege are typically left to state government and licensure boards. One wonders how policies and regulations about device ordering, medication, and testing policies will trend now that the federal government has stepped in twice, first to empower pharmacists and others under the PREP and now to disempower them.

Add the direct purchase of medications, testing supplies, and vaccines by the federal government, and this seems like a trend. And that does not take into account the upcoming tidal wave related to Medicare price negotiations.

Vertically Integrated Companies Lobby for Test-to-Treat Model Using Pharmacy and Convenience Care Footprint to Achieve Medication Ordering and Medical Visit Billing

Not long after EUAs for oral antiviral drugs were issued, concerns started pouring in from pharmacies. Providers empowered to order the drugs did not know what to order, what medications patients were taking, what interactions to watch for, or what products were available. Of course, these problems are far more common across many conditions and medications than the average patient knows or providers want to admit. It soon became evident, especially given the need for quick administration of medications after positive tests, that more test-to-treat models as “one-stop shops” would be essential for an effective pandemic response. Imagine if COVID-19 vaccines required appointments with physicians; the system would grind to a halt and vaccination rates would be far lower than they are now.

Pharmacy chains have invested billions of dollars colocating billable providers who have few to no restrictions on medication and test ordering. And because the federal government controls the supply of oral antiviral drugs, it behooves these companies to emphasize the proximity of these prescribers to dispensing pharmacists and promote the idea that test-to-treat models would accelerate the still-lagging throughput and use of treatments.

American Medical Association Says "Not So Fast" to Convenience Care as Preferred Access Point

It may be that giving pharmacies an anchor role in the pandemic response has worked too well. Policies and public realization that pharmacists can provide safe and effective care at accessible sites have challenged the status quo. Interestingly, the American Medical Association (AMA) issued a statement expressing concern about quality and continuity of care, citing safety concerns not by type of health care provider but by setting, namely, pharmacy-based clinics.⁴ Fearmongering about pharmacists has now extended to the workplace. There was also a time when the physician lobby also said pharmacists ordering and administering vaccinations could endanger patients.

Ironically, the AMA’s position seems to be, at least in part, that only its members have accurate and comprehensive records with respect to medication regimens. In 20 years of practice and 22 years of implementing coordination of care programs with primary care providers, I have never encountered an instance in which a prescribing physician’s medication list aligned with the medication a patient with multiple conditions was taking. Not once. Over literally millions of patient list comparisons, using hundreds of care managers, data information gatherers, and pharmacists, the best average concordance was 65%.⁵

In most cases, pharmacies are the most accurate sources of information about dispensing and prescribing history, and even their records could be improved and updated, given the growth of mail order and specialty pharmacies. Indeed, it was the Primary Care Collaborative that cited a finding that the average Medicare recipient with multiple chronic conditions sees 13 different prescribers each year and fills 50 unique medications during the same time period.⁵

Pharmacy Associations Respond With a Joint Public Statement in Support of Pharmacist-Supervised Test-to-Treat

In response to these EUAs, which conflicted with prior US Department of Health and Human Services guidance on allowing pharmacists to order COVID-19 treatments, 14 pharmacy associations released a statement urging the Biden administration to reverse course, citing lack of access, especially in rural and underserved areas.

Where Does This Kerfuffle Leave Community Pharmacy Practice?

Do the physicians and scientists at the FDA really think pharmacist-initiated treatment, even under published protocol or supervision, is unsafe practice? Because the FDA is an evidence- and science-based agency, I would ask its physicians and scientists to provide evidence that patients are at risk when pharmacists are empowered to act under a well-defined and widely adopted protocol. Never has pharmacist expansion of practice led to a string of safety incidents at a rate greater than that for other health care providers. Never.

Pharmacists are medication nerds by nature and training, groomed from the first time they put on a white coat to follow evidence-based guidelines and prescriptive instructions. Physicians should know, as pharmacists are the ones who call with all those nitpicky, follow-the-rules prescription changes and clarifications that drive them crazy. From a policy perspective, the public good needs an agency to step in and provide funding, literature reviews, and research to answer this question: Could it be that it is safer for patients and produces better overall outcomes to let pharmacists order medications under protocol than to rely entirely on the current standard of practice?

Troy Trygstad, PharmD, PhD, MBA, is the executive director of Community Pharmacy Enhanced Services Network (CPESN) USA, a clinically integrated network of more than 3500 pharmacies.

REFERENCES

1. Evusheld. Prescribing information. AstraZeneca; 2021. Accessed March 17, 2022. https://www.fda.gov/media/154701/download

2. Paxlovid. Prescribing information. Pfizer; 2021. Accessed March 17, 2022. https://www.covid19oralrx-patient.com/files/Final-Emergency-Use-Full-Prescribing-Info-HCP-Fact-Sheet-COVID-19-Oral-Antiviral.pdf

3. Molnupiravir. Prescribing information. Merck; 2021. Accessed March 17, 2022. https://www.fda.gov/media/155054/download

4. AMA statement on administration’s test-to-treat COVID-19 plan. American Medical Association. March 4, 2022. Accessed March 17, 2022. https://www.ama-assn.org/press-center/press-releases/ama-statement-administration-s-test-treat-covid-19-plan

5. Olson MD, Tong GL, Steiner BD, Viera AJ, Ashkin E, Newton WP. Medication documentation in a primary care network serving North Carolina Medicaid patients: results of a cross-sectional chart review. BMC Fam Pract. 2012;13:83. doi:10.1186/1471-2296-13-83