ANTIVIRAL PILLS
Biden’s Test to Treat program for new COVID antiviral pills will require people to get a doctor’s prescription to get the drug, which can reduce hospitalization and death if a person is positive.
Pharmacies were key to rolling out vaccines to millions of Americans quickly, and under a new pandemic response plan promoted by President Joe Biden, drugstores will be deployed once again to deliver a powerful tool against COVID-19 — an antiviral pill that can reduce the chances of hospitalization and death by 88%.
But the new initiative, called Test to Treat, will not work as easily as Biden made it sound during the
State of the Union address last week, when the president described pharmacies as one-stop shops where, “People can get tested ... and if they’re positive, receive antiviral pills on the spot at no cost.”
Unlike the vaccines, antiviral pills require a doctor’s prescription. That means only pharmacies with an on-site clinic and doctor can test and treat patients as envisioned in the White House plan, which also proposes using community health centers, long-term care facilities and Department of Veterans Affairs centers for Test to Treat.
The federal initiative will face other limitations, including a scarce supply of antivirals, inadequate testing and a significant number of uninsured Americans who do not have a regular doctor.
Biden said in his address to the nation that the federal government has “ordered more of these pills than anyone in the world,” and that the drug manufacturer, Pfizer, is working on delivering 1 million pills in March and 2 million in April — two to four times more than the 500,000 that have been distributed to all states to date.
In Florida, there were 9,300 doses of Paxlovid at 220 locations and 74,000 doses of Molnupiravir at 1,032 locations as of March 8, according to the U.S. Department of Health and Human Services.
But without giving pharmacists the authority to prescribe antivirals to COVID-positive patients, the White House will not be able to deliver on the promise of faster, easier access to potentially lifesaving treatments, said Michael Jackson, CEO of the Florida Pharmacy Association, an industry advocacy and lobbying group.
“We’ve literally put millions and millions of vaccines into the arms of patients,” he said. “That distribution
system made a huge difference and we can make a difference here.”
WHICH PHARMACIES WILL PARTICIPATE?
While Test to Treat is less than a week old and regulators and eligible providers are already registering to participate and order antiviral drugs directly, Biden administration officials said the government will launch a website in mid-March where patients can find locations participating in the program, along with information on where they can get free masks, tests and vaccines.
Walgreens and CVS Health issued statements when asked about plans for participating in Test to Treat, and neither pharmacy company would say exactly how many or which of their stores will offer testing and treatment for COVID-19 on site.
A CVS Health spokesman said the company’s pharmacies with walk-in clinics, known as MinuteClinic, are “uniquely positioned to help support the Government’s Test to Treat initiative.” A Walgreens spokeswoman said the company’s pharmacies “stand ready to further support in the timely and accessible delivery of COVID-19 treatments to patients” and added that details on the rollout in stores were forthcoming.
But doctors, Florida’s health department and the manufacturers of the new COVID-19 antiviral pills, which received the Food and Drug Administration’s emergency use authorization in December, said they pose a greater safety risk for patients than the vaccines.
One pill, called
Paxlovid and manufactured by Pfizer, has significant risk of adverse effects due to interactions with other drugs, including analgesics, anti-HIV medications, and even St. John’s Wort, an herbal product. A second pill, called Molnupiravir, is not authorized for patients who are younger than 18 or pregnant or breastfeeding. Both drugs must be taken within the first five days of symptom onset.
DOCTORS’ PERSPECTIVE
Annie Luetkemeyer, an infectious disease physician specialist with the University of California San Francisco, said she was glad to see the president address COVID-19 medication access in the State of the Union. She just worries that people will take away the wrong message from the president’s address and think that antivirals are easy to access at the corner drugstore.
Luetkemeyer said the biggest barrier for providers in San Francisco is that there are many testing sites in the community that have done a good job of setting up in lowincome neighborhoods and other areas of need. The problem is that once a patient tests positive at a community site, she said, there’s no easy way to connect them to treatment.
“We don’t have providers on site, no medications on site,” she said.
Even for patients who have health insurance and a regular doctor, Luetkemeyer said, there’s no guarantee their doctor will get back to them in a couple of days with a prescription or that their general practitioner will be familiar with the available options for therapeutics.
“It’s a lot to ask our system to do,” she said. “We need a solution for people who are going to a testing site and getting tested.”
The American Medical Association, the largest group representing physicians in the United States, issued a statement soon after the White House unveiled its Test to Treat initiative last week warning against allowing pharmacists to prescribe antivirals.
“The pharmacy-based clinic component of the test-to-treat plan flauts patient safety and risks significant negative health outcomes,” Gerald E. Harmon, a physician and AMA president, said in a prepared statement.
Harmon said that while the initiative improves access to testing and treatment for patients without a regular doctor, the plan “oversimplifies” the prescribing decisions that physicians make, which are based on a patient’s medical history, the complexity of drug interactions and possible adverse effects.
‘PHARMACISTS ARE TRUSTED’
Yet pharmacists are not only one of the most accessible healthcare providers, they’re also one of the most knowledgeable about drug interactions and their potential adverse effects on patients, said Dr. Timothy Loftus, a physician and attorney who leads the University of Miami’s Health Disparities Project, an initiative to address the pandemic’s disproportionate impact and ongoing toll on low-income and minority communities.
“I can’t think of anybody better to watch out for drug interactions than a pharmacist,” he said. “People trust their pharmacist.”
Loftus said he foresees other problems that could hinder the White House’s plan, such as inadequate testing and the relatively short supply of antivirals.
“We still have a testing problem in this country,” he said. “Later this summer or fall, could we see a new variant and a resurgence, and we’re back in a testing crisis, and people want to get this pill but the pharmacies are not stocked on tests? If we have another surge, will we have enough pills in pharmacies to handle it?”
According to estimates from the Department of Health and Human Services, which distributes COVID-19 therapeutics, about 500,000 doses of Paxlovid and 1.8 million doses of Molnupiravir have been distributed to states and U.S. territories as of March 6.
Requiring a doctor’s prescription could also exclude the millions of Americans who are uninsured and do not have a regular doctor. In Florida, about 19.5% of residents aged 18 to 64 years old (or 4.2 million people) were uninsured in 2020, significantly higher than the national average of 14%, according to national health statistics reported by the Centers for Disease Control and Prevention.
PHARMACISTS WANT POWER TO PRESCRIBE
Florida or the federal government could authorize pharmacists to prescribe COVID-19 antiviral medications through a standing order from the State Surgeon General, similar to the order issued in August 2021 for Regeneron monoclonal antibodies; by amending a Florida law that allows pharmacists to test and treat for specific conditions, including influenza and strep throat; or through a declaration by the federal government using the Public Readiness and Emergency Preparedness or PREP
Act, which was invoked in March 2020 for COVID-19 tests, vaccines and other drugs and preempts state requirements on who can prescribe, dispense or administer therapeutics.
Jackson, the CEO of the Florida Pharmacy Association, said he wants state officials to authorize pharmacists to prescribe COVID-19 antivirals through administrative actions or an executive order from the governor.
“The state surgeon general, in my opinion, can issue a standing order and define what’s in that order and the terms and conditions under which a pharmacist can provide these medications,” he said. “We are trained to recognize patients who are eligible and recognize patients who are not eligible, and refer patients to a primary care provider if they have one, and refer one to a community health center if they don’t.”
Jackson said that people with COVID are already visiting pharmacies for help, and that pharmacists are often familiar with those individuals and their needs, even if they don’t have a traditional physician-patient relationship.
“We see the issues that they’re running into,” he said. “In many cases, as a pharmacist ... I see a patient who can benefit from some of these medications. I can point to a medication on my shelf, if I have it, and say, ‘This is what you need. But I can’t give it to you because I don’t have any authority to give it to you.’ ”
‘GO WITH THE SCIENCE’
But Florida’s surgeon general is not currently considering a standing order to authorize pharmacists to prescribe the pills.
Jeremy Redfern, press secretary for the Florida Department of Health, said the standing order for monoclonal antibodies is based on “the riskbenefit profile” of the treatment.
“Monoclonals are relatively benign, especially when compared to antiviral medications,” Redfern said in an email. “Monoclonals have a risk for an allergic reaction, which is something that can be handled within the settings for which they are being administered.
“The antiviral medications are very different. ... There are quite a few side effects and possible contraindications,” he said. “These medications need to be prescribed by a provider that is licensed to do so, as the treatment needs to be individualized.”
Though the COVID-19 antivirals are authorized only for emergency use during the pandemic, and drug manufacturers are still learning about the potential risks, UM’s Loftus said health officials know enough about the drugs to authorize pharmacists to prescribe them to specific groups of individuals with the highest chance of severe disease or death.
“You have to go with what the science says,” Loftus said.
He said the drugs carry warnings for providers about drug interactions and what groups of people should not receive them. For instance, Molnupiravir is not indicated for people who are pregnant or thinking of getting pregnant, and for people younger than 18 because it may affect bone and cartilage growth.
“But that’s not really the target,” he said. “The target is mostly going to be older people beyond their child-bearing years, who are at high risk, who could walk in with their symptoms, get a positive test and if it’s positive receive the drug.
“For those people,” he said, “it’s hard for me, from almost any angle I want to come at it, to see why that should be an issue.”