The Biden administration's new test-to-treat program is simple on the surface: if you feel like you may have COVID-19, go to a pharmacy, get tested, and, if positive, get treated with an antiviral medication on the spot.
But the program is not that simple to groups representing doctors and pharmacists.
One large doctors’ group is concerned that the program leaves doctors on the margins, and may put patients at risk if there are side effects from the drugs. Pharmacists groups, on the other hand, say the program is too restrictive, according to an article by the research group Advisory Board.
The White House announced last week that more than 1,000 pharmacy clinics across the United States had registered to participate in the initiative, according to CNN.
Besides retail clinics in chain pharmacies, the antivirals will also be available in community health centers, long-term-care facilities, and Veterans Health Administration clinics, according to the Department of Health and Human Services.
The two antiviral pills the FDA has authorized include Pfizer's Paxlovid, for people 12 and older, and Merck's molnupiravir, for adults. Either drug has to be taken within 5 days after symptoms appear to be work to prevent serious illness..
The need for speed is a major reason why the government chose to work with retail clinics that are more accessible than most primary care offices. However, the American Medical Association (AMA), the National Community Pharmacists Association (NCPA), and the American Pharmacists Association (APhA) have criticized the administration's approach.
The pharmacists' groups are concerned that the program is limited only to pharmacies with clinics on site, thus restricting the number of pharmacies qualified to participate. Fourteen pharmacy groups have also urged the White House to make it easier for pharmacies to order the drugs.
The groups also want permission as "clinically trained medication experts" to prescribe the drugs and ensure their safe use.
The AMA on March 4 took issue with the prescribing component, saying "the pharmacy-based clinic component of the test-to-treat plan flouts patient safety and risks significant negative health outcomes."
In the AMA's view, prescribing one of the new antiviral drugs without a patient's doctor being present poses a risk for problems with drug interactions, as neither the nurse practitioners in retail clinics nor the pharmacists who dispense the drugs have full knowledge of a patient's medical history.
The next day, the AMA released another statement, saying it was reassured by comments from administration officials "that patients who have access to a regular source of care should contact their physician shortly after testing positive for COVID-19 to assess their treatment options."
'Traditional Doctor-Only Approach’
Having patients call their doctors after testing positive for COVID-19 in a pharmacy "strikes me as unnecessary in the vast majority of cases, and it will delay treatment," Robert Wachter, MD, professor and chair of the department of medicine at the University of California San Francisco, says. "In this case, it seems like the AMA is taking a very traditional doctor-only approach. And the world has changed. It's much more of a team sport than an individual sport, the way it was years ago."
Wachter said he has the utmost respect for pharmacists' ability to screen prescriptions for adverse drug interactions.
"We're required to do medication reconciliation when patients see us," he says. "And in many hospitals, we delegate that to pharmacists. They're at least as good at it if not better than physicians are."
While it's essential to know what other medications a patient is taking, he says, pharmacies have computer records of all the prescriptions they've filled for patients. In addition, pharmacies have access to complete medication histories through Surescripts, the company that enables electronic prescribing transactions between prescribers and pharmacies.
Drug Interactions 'Not Trivial'
Preeti Malani, MD, the chief health officer and a professor of medicine at the University of Michigan , says the potential interactions between the antiviral drugs and some other medications are "not trivial."
However, she says, "The really dangerous drugs are the ones for people who have had organ transplants and the like. Those aren't individuals who are going to shop at a pharmacy."
Besides the antirejection drugs, Wachter says, there can be serious interactions with cholesterol-lowering medications. If a person is taking Lipitor, for instance, "someone would have to make the decision on whether it's ok for me to stop it for a while, or to lower the dose. But I trust the pharmacist to do that as well as anybody."
Except for these potential drug interactions, the antiviral medications are "quite safe," he says, adding that being able to treat people who test positive for COVID-19 right away is a big advantage of the test-to-treat program, considering how difficult it is for many people to get access to a doctor.
That delay could mean that the antivirals are not prescribed and taken until they are no longer effective.
Both Wachter and Malani say the widespread distribution of pharmacies and their extended hours are other big pluses, especially for people who can't easily leave work or travel far to visit a doctor.
Malani cautions that there are still kinks to work out in the test-to-treat program. It will be a while before the retail clinics all have the antiviral drugs, and many pharmacies don't have clinics on site.
Still, she says people can still go to their physicians to be tested, and presumably those doctors can also write antiviral prescriptions. But it's not clear where the antivirals will be available in the near term.
"Right now, we're playing catch-up," Malani says. "But pharmacies are an important piece of the puzzle."
Looking at the big picture, she says, "We know that neither vaccination nor natural infection provides long lasting immunity, and so there will be a role for antivirals in order to make this a manageable illness. And when you're talking about millions of cases, as we were having a few months ago, the health system can't field all those patients. So we do need a system where I can go to a pharmacy and get a test and treatment."