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U.S. expanding covid-pill access

Spike revs antiviral demand by Compiled Democrat-Gazette Staff From Wire Reports | April 27, 2022 at 6:57 a.m.
This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2. Also known as 2019-nCoV, the virus causes covid-19. - Photo by NIAID-RML via AP

The Biden administration announced plans Tuesday to nearly double the number of pharmacies that carry antiviral pills to combat covid-19 as many consumers report difficulty finding a doctor to prescribe the medication, or a pharmacy that carries it, when they get sick.

The administration is also taking other steps to boost availability of the drug, a pill from Pfizer called Paxlovid, including an effort to stand up more "test-to-treat" programs in pharmacies and clinics, where many people will be able to get a five-day regimen of pills after testing positive for the coronavirus.

The drug has been in increased demand in recent weeks as coronavirus cases once again rise, driven by the highly transmissible omicron subvariant BA.2. The seven-day average of new coronavirus cases was about 50,000 on Tuesday, up from about 38,000 one week earlier, even as many new infections go unreported as more people rely on home test kits.

"Paxlovid is a really important step in our ability to fight this pandemic," Ashish Jha, the White House coronavirus response coordinator, said at a briefing Tuesday. "Our job is to make sure those doses are getting out there and into the hands of patients that would benefit."

The actions are designed to surmount hurdles that have emerged as people try to get Paxlovid, which studies have shown can reduce the risk of hospitalization or death by about 90% when taken within three to five days of the start of symptoms.

Some experts commended the steps the administration is taking but said those measures will not ameliorate some of the issues that have made it difficult for many people to access Paxlovid, leaving much of the national supply unused.

More than 600,000 courses of the drug remain available, and states have not ordered the full supply made available by the federal government. The United States has committed to buying 20 million treatment courses.

[RELATED: In Arkansas, covid pills struggle to catch on despite effectiveness » arkansasonline.com/427pills/]

"It really speaks to this huge problem of implementation and all the hurdles of bringing in something new to our very messy health-care system," said Abraar Karan, an infectious-disease physician at Stanford University. "It has to be orchestrated quite well, and we're seeing in real-time rollout all the things that can go wrong with this. There are so many parts that need to be improved for this to have the kind of effect we're looking for."

Other experts welcomed the administration's efforts, especially as cases rise, but said simply boosting the supply wasn't enough, noting that inequities persist in who has access to Paxlovid. People without health insurance and those who live far away from medical providers or pharmacies are among those at highest risk from covid and face some of the highest hurdles to receiving effective treatment, said Julie Morita, executive vice president of the Robert Wood Johnson Foundation.

"It is essential that we collect and report data on who is receiving Paxlovid and other antiviral medications to swiftly pinpoint and address any disparities that emerge," Morita said.

The medication is available in about 20,000 locations across the country, including pharmacies, hospitals, community health clinics and urgent-care centers. In some areas, however, residents may live hundreds of miles from the nearest pharmacy or provider that carries the drug.

The administration said it expects Paxlovid to soon be available in about 30,000 locations, with a goal of 40,000 in coming weeks. It will also allow certain pharmacies to order the antivirals directly from the government free of charge.

On Monday, the Centers for Disease Control and Prevention put out a national health advisory to physicians, instructing them to not use certain treatments, including antibiotics, in patients with covid.

And in an acknowledgment of the information gap that has made it difficult for many Americans to know about Paxlovid and how to access it, administration officials said they would work to boost public awareness. They also said they wanted to ensure that people knew that the drug must be taken within five days of the onset of symptoms.

In Arkansas, the pills have been slow to catch on for medical providers and covid-19 patients.

Despite marketing efforts by the Arkansas Department of Health, many Arkansans still aren't aware the pills exist, let alone their benefits, the Arkansas Pharmacists Association's Nicki Hilliard said, and pharmacists around the state say they have pills on the shelves not being used.

Finding the medication can also be difficult for some doctors and patients with only 100 pharmacies -- out of more than 750 in the state -- distributing the antiviral pills. As of April 15, the Health Department had received 9,180 Paxlovid pills and 16,912 molnupiravir pills since they first became available.

The department had distributed 5,800 Paxlovid and 12,728 molnupiravir pills to pharmacies around the state. Pharmacists also cannot prescribe the pills, unlike the monoclonal antibody infusion treatments, meaning a doctor's visit is necessary.

Adding to the low usage rates in the state is the fact that fewer covid-19 tests are being performed. The pills must be taken within five days of the onset of symptoms, so early testing at the first sign of the virus is important.

QUEST FOR PAXLOVID

In recent weeks, some patients have reported calling multiple pharmacies and visiting numerous health clinics and emergency rooms in sometimes unsuccessful efforts to get Paxlovid. Even doctors have shared stories of herculean efforts to get the drug for their older, high-risk relatives after they became infected.

One of those obstacles, Jha said, is differing interpretations of the eligibility guidelines. Some health departments and doctors might go by the Centers for Disease Control and Prevention's definition of people at high risk for becoming severely ill or dying from covid, which includes not only people 65 and older and those with chronic medical conditions but also people who are at increased risk based on "where they live or work, or because they can't get health care."

"In other cases they say, 'Because of a shortage, we're limiting it to extremely high-risk patients,'" said Dr. Walid Gellad, a pharmaceutical and drug safety expert at the University of Pittsburgh, citing recent screening guidance for pharmacists in Los Angeles County.

Addressing the confusion among prescribers, Jha said, "The word on the street was these things are not widely available, you should restrict it to the highest-risk patients. ... What we need to do is help American physicians and nurse practitioners understand that we now have plenty available," Jha said.

The administration said it would aim to provide clearer guidance for doctors about a host of covid treatments, including their benefits, interactions with other drugs, side effects and underlying medical conditions that may restrict their use, according to a White House fact sheet. Those efforts should help put doctors "in a position to quickly prescribe one of these treatments where appropriate," the fact sheet states, particularly because Paxlovid must be prescribed within five days of symptoms beginning.

Giving pharmacists prescribing power could dramatically expand the speed and ease with which people get the treatment, public health experts say. But regulators at the FDA and other federal health officials believe there is reason to not allow pharmacists to prescribe Paxlovid themselves, even though some Canadian pharmacists can do so.

The treatment can interfere with certain medications and should be prescribed at a lower dose for people with kidney impairment, which is measured with a blood test.

Pharmacists say they are highly trained and well equipped to conduct such screening themselves. Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, said pharmacists could get Paxlovid to patients faster if they could prescribe it, "without having to call a physician's office and wait for a call back, and hope it happens within five-day period."

'TEST TO TREAT'

A new federal program that Biden announced earlier this year, called "test to treat," is supposed to let people visit hundreds of facilities across the country to get tested for the coronavirus and, if positive, receive Paxlovid on the spot. But almost two months later, it is still limited in its reach and has not dramatically sped up access to the drug beyond what its sites were already equipped to do, experts said.

Of the more than 2,000 test-to-treat sites, about half are CVS MinuteClinics with in-house nurse practitioners and physician assistants who can prescribe the drug. Many of the other sites are Walgreens, Kroger and other chain pharmacies, as well as federally funded health centers.

Public health experts and patients who have tried navigating the program say that appointments can still be difficult to find, and can require long drives. Much of rural America lacks easy access to the program.

Many of the large-scale testing sites have closed in Arkansas and federal funding to cover the cost of covid-19 testing for the uninsured dried up in March.

Unless Congress approves a $10 billion deal for more covid aid, which has been stalled for weeks, the government would not be able to develop and distribute next-generation vaccines if needed or purchase new, more effective treatments that may emerge, Jha said. The government would also be inhibited from purchasing additional treatment courses of existing drugs, including Paxlovid, when the current supply runs out.

"So far, Congress has not stepped up to provide the funds that are needed for our most urgent needs," Jha said.

Information for this article was contributed by Yasmeen Abutaleb of The Washington Post, Noah Weiland of The New York Times and by Jeannie Roberts of The Arkansas Democrat-Gazette.

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