Low-income and uninsured people face barriers to getting Covid antivirals
A care carousel
Throughout the pandemic, pharmacists have been authorized to administer vaccines, monoclonal antibodies and coronavirus tests. Now pharmacists and pharmacist 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 prevents pharmacists from prescribing drugs. antivirals. They argue that allowing pharmacists to prescribe antiviral pills will remove barriers to treatment and get the pills into the hands of those who need them, just like when they received emergency clearance to dispense vaccines, antibodies monoclonals and coronavirus tests.
The National Association of Chain Drug Stores (NACDS), which represents some of the nation’s largest pharmacies, went so far as to create an illustration that it shared with members of the administration to display the current care carousel that patients have to work their way through to get the antivirals.
The one-page document also shows how allowing pharmacists to prescribe the drugs could prevent patients from accessing unnecessary healthcare facilities, such as overcrowded hospitals and urgent care centers. It could also prevent Covid-positive patients from going to multiple places to try and get a prescription and then potentially visiting multiple pharmacies in hopes of filling that prescription.
“There is currently a gap between what the PREP law allows pharmacists to do and then what the emergency use authorization [of the antivirals] does not allow them to do so, essentially breaking the patient journey,” said Sara Roszak, senior vice president of health and wellness strategy and policy at NACDS, referring to the 2005 Health and Wellness Act. public preparedness and civil protection. “We believe this increases frustration and delays the use of drugs that need to be delivered very quickly to patients to be effective.”
Chanapa Tantibanchachai, a spokesperson for the FDA, said in an emailed statement that the agency has determined that only “traditional” prescribers – such as physicians, advanced practice registered nurses and physician assistants – should have the authority to prescribe the two antiviral drugs “based on multiple factors.”
These factors, she said, included “the side effect profiles of the drugs, the need to assess the potential for drug interactions, the need to assess potential problems with kidney function (including the severity potential problems) and the need to assess patients for pre-existing conditions that may put them at high risk of progression to severe COVID-19, including hospitalization or death.
Tantibanchachai did not respond when asked if the need to assess high-risk patients “for progression to severe COVID-19” was made to limit problems with the use of out-of-stock antivirals. , or whether efforts had been made to ensure prescribers kept this in place. be careful when writing prescriptions for them.
The drugs are currently in short supply in the United States. 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 Department of Health and Human Services website that follows the distribution of the therapy.
Will Gavin, a lobbyist with the law firm Buchanan, Ingersol & Rooney who has often worked with the FDA, said the agency’s concern for drug supply likely influenced his decision on who could prescribe it. . Keeping prescribing powers in the hands of doctors would remove barriers, he said, but the goal is to ensure that very ill or immunocompromised patients can receive treatment while supplies remain limited.
The FDA is likely aware that this current rollout will leave many people outside the traditional healthcare system without access to drugs, Gavin said, but the agency is navigating as best it can.
“Unfortunately, the FDA is often faced with these difficult decisions where there is no perfect solution and where there are a lot of trade-offs,” he said, noting that the agency’s perspective could change. “They ask themselves: ‘What is the best compromise given the current situation?’ And, right now, I think they think that for many therapies the best option is, “OK, let a doctor prescribe.”
“The same old litany of iniquities”
Medical experts and ethicists say the current hurdles only exacerbate a pandemic response in which only those with the time and money can respond to the virus and seek treatment. From the cost and availability of Covid tests to access to vaccines, they said, the pandemic has increasingly stratified those who can afford the tools to fight the disease and those who cannot.
“Through it all, we’ve seen that the communities that need it the most are the ones that have the least access, and that certainly includes low-income people and communities of color,” said Dr. Taison Bell, director of the intensive medical unit. care unit at the University of Virginia Health, which spoke out on the equity of the pandemic response. “These antivirals are not in large supply at the moment and until there is greater accessibility, that is something that concerns me and anyone else concerned about equity.”
Bell said that for antivirals to help people in low-income communities who have health needs, the FDA should meet people where they are. In some cases, this may be at a pharmacy where they have an established relationship, rather than with a doctor they don’t know, can’t afford, or have trouble getting to. an appointment.
Even monoclonal antibodies, which pharmacists are authorized to administer, were delivered inequitably, according to a CDC Covid-19 Response Team study published last month that examined November 2020 and August 2021.
During this period, Hispanic patients who tested positive for Covid received monoclonal antibody treatments 58% less often than non-Hispanic patients. Black patients who tested positive received it 22% less often than white patients, and Asian patients received it 48% less often.
Arthur Caplan, a professor of medical ethics at New York University Langone Medical Center, agrees, noting that people in the United States may lack insurance, a primary care physician, or even a Internet – and they may also live far from a prescriber. He said it was the responsibility of states and national governments to address these issues, rather than assuming that people have easy access to the current healthcare system or know how to use it.
While the Biden administration sent about 15% of the drug supply directly to federally qualified health centers, which provide health care to low-income communities across the country, Kaplan said the problems at the within the US healthcare system are more important than what these quick fixes can address.
“It’s the same old litany of inequities that we tried to plug like a flat tire during the pandemic by simply plugging the hole without realizing that we have to replace the tire on the roads because the infrastructure is broken” , did he declare.
Companies like Color — a tech company that has operated thousands of vaccine and testing sites across the country — are trying to fix that infrastructure. Alicia Zhou, chief scientific officer of Color, said the pandemic has shown just how fragmented the US healthcare system has become.
While companies like hers have tried to introduce an element of innovation and connectivity into the healthcare system, she said there’s no denying that the same setbacks occur every time the country rolls out another tool to fight the pandemic.
“Covid has really shown us that there’s a lot more capacity in the system, and it’s redundant capacity in some ways that’s been built in because of the way it’s been siloed,” she said. . “I think there are new ways of thinking about care delivery, but certainly one of the challenges is that there are different regulations around who has the ability to prescribe and who has the ability to provide care.”
But until some of these new methods become a reality and Americans who have been shut out of the health care system have better access to them, those concerned about fairness for the low-income and uninsured population have said every new landmark discovery aimed at defeating Covid is making its way to the country’s most economically vulnerable nations in a slow drip.
But Bell continues to hope that will change.
“For all the bullshit, for all the pain we’ve been through, there has to be a lesson to be learned from this – there has to be something we can hold on to for the future,” he said. “For me, it’s really about prioritizing health equity and thinking about health care delivery in a very different way than we used to.