Biden Administration One-Stop Test to Treat Program Raises Questions, Concerns for Pharmacists

Despite early excitement about the potential for pharmacists to prescribe COVID-19 oral antivirals, the program does not provide that ability.

Despite early excitement about the potential for pharmacists to prescribe COVID-19 oral antivirals, the Biden Administration’s newly announced one-stop test-to-treat program does not provide that ability. While many pharmacy organizations are expressing disappointment about this decision, other medical experts say that more of the program should be limited to physicians.

In the State of the Union address on March 1, President Joseph Biden announced new efforts to allow for rapid public access to both COVID-19 tests and treatments. Under the plan, pharmacy-based clinics, community health centers, long-term care facilities, and US Department of Veterans Affairs (VA) facilities will be able to test patients for COVID-19 and immediately prescribe oral medications for those who test positive. According to a White House news release, the sites will be operational by the end of March.1

“Pfizer is working overtime to get us a million pills this month and more than double that next month,” Biden said in the address. “And now we’re launching the test-to-treat initiative so people can get tested at a pharmacy and, if they prove positive, receive the antiviral pills on the spot at no cost.”2

In an interview with Pharmacy Times, David Pope, PharmD, chief innovation officer at OmniSYS, said the plan allows for pharmacists to test patients, refer them to a provider for a prescription, and then fill that prescription at the pharmacy.

“The test-to-treat program ultimately is a program where pharmacies who also have a physician’s practice, or a minute clinic if you will, or again, we have others out there as well that have a non-pharmacist practitioner inside that pharmacy, and they can prescribe like they normally do,” Pope said in an interview with Pharmacy Times. “[Patients] can ultimately get that prescription filled upon a positive test, and the government will make sure that those pharmacies are adequately stocked.”

The National Community Pharmacists Association (NCPA) released a statement noting that this effort is being facilitated through some partners in the Federal Retail Pharmacy Program. The plan is not expected to decrease existing allocations of oral antiviral medications to other states or pharmacies that are already receiving the medication.3 Kurt Proctor, PhD, RPh, senior vice president of strategic initiatives at NCPA, also expressed disappointment with the limited scope of the program.

“The concept of one-stop test-to-treat is what NCPA has been advocating for through allowing pharmacists to prescribe the oral antivirals,” Proctor said in an email to Pharmacy Times. “So far, the federal government has chosen to not allow that. The reach of the products being allocated now to test-to-treat locations will be very limited.”

Notably, the program will not be available in all pharmacies, a fact that was criticized in a press release by the American Pharmacists Association (APhA).

“Although we are pleased the administration recognizes the access and care pharmacies provide, we are disappointed that the current plan is narrow and does not enable any willing and able pharmacy to be a ‘test-to-treat’ pharmacy through this initiative,” APhA said in a press release. “We hope to see this program expand as the supply of COVID-19 oral antivirals increases, thereby allowing more pharmacies to participate, providing broader access to care.”4

Providing adequate supplies of both rapid COVID-19 tests and oral antiviral medications is another potential hurdle for the program. To address supply issues, the federal government partnered with Pfizer to develop PF-07321332 (Paxlovid), an oral antiviral to treat COVID-19, and has ordered 20 million courses, according to a White House press briefing by Jeff Zients, White House coronavirus response coordinator.5

Critiques of the program have also centered around its use of pharmacies and other community health centers rather than physician’s offices. In a statement from the American Medical Association (AMA) released March 4, AMA President Gerald E. Harmon, MD, said the lack of physician oversight is a cause for concern.6

In the statement, Harmon noted there are significant drug interactions associated with Paxlovid, including interactions that could require patients to hold, change, or reduce doses of other medications. Furthermore, he noted that the other oral antiviral medication indicated for COVID-19, molnupiravir, is not authorized for individuals under the age of 18 because it can impact bone and cartilage growth, and it should not be prescribed for pregnant or breastfeeding individuals.6

“This approach, though well-intentioned in that it attempted to increase access to care for patients without a primary care physician, oversimplifies challenging prescribing decisions by omitting knowledge of a patient’s medical history, the complexity of drug interactions, and managing possible negative reactions,” Harmon said in the press release.6

In response to these concerns, officials from the Biden Administration said that patients who have access to a primary care physician should contact their physician shortly after testing positive for COVID-19 to assess various treatment options.A follow-up statement by the AMA said they were reassured by this clarification from the Biden Administration.7

Rather than viewing the test-to-treat program as a competition for patients, the program should be approached as an opportunity for increased collaboration and increased patient access, according to Christina Madison, PharmD, FCCP, AAHIVP, also known as The Public Health Pharmacist.

“I hope that [the AMA] will revisit this statement and understand that it’s not about competition—it is about collaboration,” Madison said in an interview with Pharmacy Times. “And ultimately, we need to do our best to provide increased access in an equitable fashion to all patients.”

REFERENCES

1. White House. National COVID-19 Preparedness Plan. Accessed March 7, 2022. https://www.whitehouse.gov/covidplan/#protect

2. Remarks by President Biden in State of the Union Address. News release; White House. March 1, 2022. Accessed March 7, 2022. https://www.whitehouse.gov/briefing-room/speeches-remarks/2022/03/02/remarks-by-president-biden-in-state-of-the-union-address/

3. Biden mentions test and treat in pharmacies. News release. National Community Pharmacists Association; March 2, 2022. Accessed March 7, 2022. https://ncpa.org/newsroom/qam/2022/03/02/biden-mentions-test-and-treat-pharmacies

4. President Biden’s New “Test to Treat” Initiative Recognizes Pharmacies, But Barriers Should Be Removed. News release. American Pharmacists Association; March 3, 2022. Accessed March 7, 2022. https://pharmacist.com/APhA-Press-Releases/president-bidens-new-test-to-treat-initiative-recognizes-pharmacies-but-barriers-should-be-removed

5. Press Briefing by White House and HHS Public Health Officials. White House. March 2, 2022. Accessed March 7, 2022. https://www.whitehouse.gov/briefing-room/press-briefings/2022/03/02/press-briefing-by-white-house-and-hhs-public-health-officials-march-2-2022/

6. AMA statement on Administration’s test-to-treat COVID-19 plan. News release. American Medical Association; March 4, 2022. Accessed March 7, 2022. https://www.ama-assn.org/press-center/press-releases/ama-statement-administration-s-test-treat-covid-19-plan

7. AMA statement on test-to-treat COVID-19 program. News release. March 5, 2022. Accessed March 7, 2022. https://www.ama-assn.org/press-center/press-releases/ama-statement-test-treat-covid-19-program