Washington, D.C.—A letter from 14 key pharmacy associations asked the White House to ensure their members can order the medications so that the "Test-to-Treat" initiative can work for all Americans.
The organizations urged President Joe Biden to set aside limitations currently keeping pharmacists from ordering oral antivirals and expand patient access to the initiative announced during the State of the Union.
Their letter was referring to how, when granting emergency use authorization of COVID-19 antivirals, the FDA included a limitation that prevents pharmacists from ordering the medications.
"Despite your statement during the State of the Union, Americans who test positive at a pharmacy will only be able to access time-sensitive oral antivirals, on the spot, from a limited number of pharmacies with in-house access to non-pharmacist prescribers, primarily in metropolitan areas," the groups noted. This means patients in rural and under-served areas will likely be left out, they added.
On the other hand, the American Medical Association (AMA) is strongly objecting to the Biden Administration's plan to have pharmacy-based clinics play a key role in its new National COVID-19 Preparedness Plan.
The Test-to-Treat initiative is expected to involve thousands of pharmacy clinics to provide Americans access to testing and treatment for free—all in one stop. Jeff Zients, the White House COVID-19 Response coordinator, advised recently that hundreds of one-stop sites will open across the country as early as this month and will be located at local pharmacy clinics, community health centers, long-term care facilities, and veterans' health centers.
In addition, as of March 8, 2022, media reports said that more than 1,000 in-pharmacy clinics across the United States had registered to participate in the initiative and to order shipments of COVID-19 antiviral medications.
Mr. Zients said a website will soon be available "that will be a go-to place where you can find vaccines and masks at easy and convenient locations, and where you can find the latest information on COVID-19 in your community."
He quoted the President as saying the nation has "reached a new moment in the fight against COVID-19."
"In addition to vaccines and boosters, we have filled our nation's medicine cabinet with effective treatments and therapeutics: monoclonal antibodies, antiviral pills, and preventive therapies for our most vulnerable," Mr. Zients noted. "These treatments work to prevent the worst outcomes of COVID-19. And we have more treatments available for the American people than ever before—millions of treatments each month."
"The AMA is pleased the administration is ramping up supply of antivirals so in the near future they will be broadly available. But, in the meantime, establishing pharmacy-based clinics as one-stop shopping for COVID-19 testing and treatments is extremely risky," stated Gerald E. Harmon, MD, AMA president. "Pharmacy-based clinics typically treat simple illnesses such as strep throat. Yet, COVID-19 is a complex disease and there are many issues to consider when prescribing COVID-19 antiviral medications."
Dr. Harmon did not address the issue of pharmacists' ability to order the medications, instead objecting to the role of nurse practitioners and others with prescribing authority. He stated that "leaving prescribing decisions this complex in the hands of people without knowledge of a patient's medical history is dangerous in practice and precedent. We urge patients who test positive for COVID-19 to contact their physician to discuss treatment options. COVID-19 is not strep throat—it is a complicated disease that has killed nearly 1 million people in the United States."
He called the White House plans "promising" to fight COVID-19 and prevent future pandemics but argued that "the pharmacy-based clinic component of the Test-to-Treat plan flaunts patient safety and risks significant negative health outcomes. 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."
The AMA president specifically discussed the antiviral Paxlovid, which he said "is 88 percent effective at preventing hospitalization and death. But it also has six pages of drug interactions, including interactions that may require a patient to hold, change, or reduce doses of other medications. Molnupiravir, the other oral antiviral medication, is not authorized for people under 18 because it can affect bone and cartilage growth, and it should not be used during pregnancy or while breastfeeding."
Citing the effectiveness of COVID-19 vaccines and the new antivirals, Dr. Harmon suggested that "we must marshal our resources smartly and effectively, which means under the guidance and supervision of physicians with expertise to deal with complex medications."
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