After a $15.6 billion funding bill collapsed in Congress this month, the Biden administration warned of devastating consequences to the pandemic mitigation efforts: an impending lack of boosters and variant specific vaccines; an inability to purchase life-saving monoclonal antibody treatments; low testing capacity; and more. The Washington Post reports that without new funding, “key parts of the U.S. [Covid-19] response will need to be scaled back or halted.”
Of particular concern is that the funding blockage has led to a delay in the Biden administration’s purchase of antiviral pills––a key aspect of the president’s new “Test to Treat” initiative, in which Americans can get tested at a local pharmacy and receive immediate, free antiviral pills in the case that their test is positive. In his State of the Union address, President Biden promised to obtain one million pills for Americans this month. Overall, Biden’s plan has been predicated on obtaining 20 million doses of Paxlovid, Pfizer’s antiviral pill. Currently, however, the administration is only contracted for 835,000 doses. The administration “is still reviewing whether it will have the funds” to obtain the rest of the doses.
Media has already begun cautioning that even if the administration is able to secure the promised number of pills, access may not be expanded for the most vulnerable, including those in rural areas, as the FDA has still not authorized pharmacists to prescribe the pills themselves. Further, as the Denver Channel reports, “the treatments aren’t available at every pharmacy. Certain medical personnel must be on-site to administer the treatments.” Of further concern is that plans relying on antiviral treatments ignore the fact that they may carry the risk of significant drug interactions.
Practicing pharmacists and physicians have their own objections to the Test to Treat approach.
ZACKARY BERGER, MD, PhD. zberger1@jhmi.edu, @DrZackaryBerger
Berger is Associate Professor in the Johns Hopkins Division of General Internal Medicine and Core Faculty at the Johns Hopkins Berman Institute of Bioethics, with joint appointment in the Johns Hopkins Bloomberg School of Public Health.
Dr. Berger said today: “The Biden administration’s decisions [to move to Test to Treat] mean abandoning even previous insufficient attempts to make antivirals available to our most vulnerable.”
DANYA QATO, PharmD, MPH, PhD. dqato@rx.umaryland.edu, @danyaqato.
Qato is a practicing pharmacist, epidemiologist, and health services researcher at the University of Maryland, Baltimore’s School of Pharmacy and School of Medicine.
Dr. Qato said: “Taken generously, the test to treat/trace approach should be just one tack among many happening concurrently to address the spread and impact of Covid-19. It’s certainly not a panacea since it does not address challenges and disparities to access to healthcare more broadly and places a heavy burden on an already taxed pharmacy profession, many of whom practice in pharmacies without clinics and without the ability to prescribe. In addition, the test to treat plan does not address the following: racial disparities in access to pharmacies and other healthcare sites; inequitable and inadequate access to health insurance, healthcare and essential pharmaceuticals; the fact that not all pharmacists have wide prescriptive authority that would enable them to prescribe antivirals even if the [Emergency Use Authorization] was revised to authorize pharmacists as prescribers; pharmacists and pharmacy technicians are currently reporting unprecedented levels of stress and burnout due to the expansion of their roles and responsibilities during COVID-19 without adequate staff support and safeguards; the fact that those who are already sick, high-risk or immunocompromised, should not feel compelled to enter pharmacies or other treatment sites for testing or treatment, when most if not all of the mask mandates have been lifted.
“There are [also] significant potential drug interactions and contraindications associated with Paxlovid, and these should not be overlooked. Other medications that either enhance or inhibit the metabolic activity of the CYP3 enzyme will impact Paxlovid levels in the body. If the benefits of using Paxlovid outweigh the risk in patients taking these other medications, a pharmacist may recommend changing the dosing regimen of other therapies. In the case of antiarrhythmics like amiodarone, Paxlovid is contraindicated due to potentially serious or life-threatening interactions, and should not be taken. The risk versus benefit to any individual patient of taking any antiviral concurrently with other medications or with specific health conditions should be evaluated by a pharmacist or other trained healthcare provider with access to a patient’s full pharmacy and medical history before prescribing.”
However, it is still unclear whether the FDA is expected to revise the Emergency Use Authorization from the authority to prescribe Covid antivirals, including Paxlovid. Dr. Qato says that the EUA “specifically excluded pharmacists from the authority to prescribe [Paxlovid]. It’s unclear if the FDA will revise the EUA to enable pharmacists with independent prescriptive authority or as part of collaborative practice agreement to prescribe. Expansion of prescriptive authority is typically legislated at the state level, either through state legislatures or state boards of pharmacy. Expanding prescriptive authority, especially for chronic disease treatments and in public health states of emergency such as the one ushered in by the COVID-19 pandemic, has long been championed by pharmacists. Pharmacists are more than just the ‘drug experts’; they undergo rigorous holistic clinical training in 4-year pharmacy programs before they are able to be licensed to practice. They are at the frontlines of healthcare provision as the most accessible healthcare professionals and––though their contributions are often ignored––pharmacists are at the frontlines of the COVID-19 vaccination efforts.”
