A care carousel
Pharmacists have been allowed to dispense vaccines, monoclonal antibodies and coronavirus tests throughout the pandemic. Now pharmacists and pharmacy advocacy groups say they should also be allowed to prescribe antiviral pills.
Pharmacy associations, from those representing small independent retail stores to those lobbying on behalf of national chains, are actively pushing the Biden administration to change the Food and Drug Administration’s decision that blocks pharmacists from selling the antiviral drugs to prescribe. They argue that allowing pharmacists to prescribe antiviral pills will break down treatment barriers and put pills in the hands of those who need them, just as they did when they received emergency authorization to dispense vaccines, monoclonal antibodies and coronavirus tests.
The National Association of Chain Drug Stores (NACDS), which represents some of the country’s largest pharmacies, has gone so far create an illustration that it has shared with members of the administration to show the current care carousel that patients must go through to receive the antivirals.
The one-page document also shows how allowing pharmacists to prescribe the drugs could keep patients away from unnecessary healthcare facilities like overwhelmed hospitals and emergency centers. It could also discourage Covid-positive patients from traveling to multiple places to try and get a prescription, and then potentially visiting multiple pharmacies in hopes of filling that prescription.
“Currently there is a gap between what the PREP Act allows pharmacists to do and what emergency use authorization is [of the antivirals] doesn’t allow them to do so, essentially fragmenting the patient journey,” said Sara Roszak, senior vice president of health and wellness strategy and policy at NACDS, referring to the Public Readiness and Emergency Preparedness Act of 2005. “We believe that this increases frustration and delays the use of drugs that need to be given to patients really quickly to be effective.”
Chanapa Tantibanchachai, a spokesman for the FDA, said in an emailed statement that the agency has determined that only “traditional” prescribers — such as doctors, nurses and advanced-practice physician assistants — should be given prescribing authority over the two antiviral drugs “based on multiple factors.”
Those factors, she said, included “the side-effect profile of the drugs, the need to evaluate the potential for drug-drug interactions, the need to evaluate potential kidney function problems (including the severity of potential problems), and the need to screen patients for pre-existing conditions.” existing conditions that may put them at high risk for progression to severe COVID-19, including hospitalization or death.”
Tantibanchachai did not respond when asked whether the need to screen high-risk patients “for progression to severe COVID-19” was made to limit the use of the antivirals for reasons of supply, or whether any efforts were made to ensure that prescribers do so keep this in mind when writing recipes for them.
Drugs are currently in short supply in the USA. In the first month of 2022, the federal government distributed about 600,000 courses of molnupiravir, 160,000 of Paxlovid and 230,000 of Evusheld, an antibody treatment, according to a health ministry Website that tracks the distribution of the therapeutics.
Will Gavin, a lobbyist for the law firm Buchanan, Ingersol & Rooney who has often worked with the FDA, said the agency’s concern about the supply of drugs likely influenced their decision about who could prescribe them. Leaving prescribing powers in the hands of doctors would put up barriers, he said, but the aim is to ensure that very sick or immunocompromised patients could receive treatment while supplies remain limited.
It’s likely that the FDA is aware that this current rollout will leave many outside of the traditional healthcare system without access to the drugs, Gavin said, but the agency is managing the moment as best it can.
“Unfortunately, the FDA is often faced with these difficult decisions where there is no perfect solution and there are many compromises,” he said, noting that the agency’s view could change. “They think, ‘What’s the best compromise given the current situation?’ And I think right now they believe that for a lot of therapies, the best option is, ‘Okay, let’s prescribe a doctor.'”
“The same old litany of injustice”
The current barriers, medical experts and ethicists said, only exacerbate a pandemic response that leaves only those who have the time and money to respond to the virus and seek treatment. From the cost and availability of Covid testing to access to vaccines, they said, the pandemic has increasingly stratified those who can afford the means to fight the disease and those who cannot.
“Through all of this, we’ve seen that the communities most in need are those with the least access, and that certainly includes low-income people and communities of color,” said Dr. Taison Bell, the director of the University of Virginia Health’s medical intensive care unit, who has spoken out about the fairness of the pandemic response. “These antiviral drugs are not currently available in large quantities and until there is better accessibility it is something that worries me and everyone else with an eye for justice.”
Bell said the FDA would need to meet people where they are so the antiviral drugs can help people in low-income communities who have health needs. In some cases, this may be at a pharmacy they have a committed relationship with, rather than a doctor they don’t know, can’t afford, or have trouble getting an appointment with.
Even monoclonal antibodies that pharmacists are allowed to administer have been unfairly supplied, according to a CDC Covid-19 Response Team study published last month which examined November 2020 and August 2021.
During that period, Hispanic patients who tested positive for Covid received monoclonal antibody treatments 58 percent less often than non-Hispanic patients. Black patients who tested positive received it 22 percent less often than white patients, and Asian patients received it 48 percent less often.
Arthur Caplan, a professor of medical ethics at New York University’s Langone Medical Center, agreed, noting that people in the US may lack insurance, a family doctor, or even the internet — and they may be far from one, too prescribing doctor live. He said it is the responsibility of state and national governments to address these issues, rather than assuming people have easy access to the current healthcare system or know how to use it.
While the Biden administration has sent about 15 percent of drug supplies directly to federally-qualified health centers that provide health care to low-income communities across the country, Kaplan said the problems within the U.S. health care system are bigger than these quick fixes are addressing.
“It’s the same old litany of injustice we’ve tried to patch like a flat tire through the pandemic by simply patching the hole, not realizing we have to replace the tire on the roads because the infrastructure is broken,” he said.
Companies like Color — a tech company that has operated thousands of vaccine and testing sites across the country — are trying to address that infrastructure. Alicia Zhou, Color’s chief science officer, said the pandemic has shown how fragmented the US healthcare system has become.
While companies like hers have sought to bring an element of innovation and connectivity to the healthcare system, she said it was undeniable that the same setbacks would come into play if the country rolled out another tool to combat the pandemic.
“Covid has really shown us that there are a lot more functions throughout the system, and they’re sort of redundant functions built up because of the isolated location,” she said. “I think there are new ways to think about the delivery of care, but certainly one of the challenges is that there are different regulations about who has the ability to prescribe and provide care.”
But until some of these novel avenues become a reality and Americans who have been locked out of the healthcare system find greater access to them, those working on justice for the low-income and uninsured population said each new breakthrough discovery is aimed at helping Covid slowly finding its way to the economically weakest in the country.
But Bell continues to hope that will change.
“For all the crap, for all the suffering we’ve been through, we have to learn a lesson from this – there has to be something to hold onto for the future,” he said. “For me, that really means prioritizing health equity and thinking about healthcare in a very different way than before.”
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