A Simple Solution Would Make COVID Antivirals More Accessible, Pharmacists Say

People in the U.S. who suspect they have COVID may now be able to get tested and treated much more quickly, thanks to a new federal program announced by President Joe Biden in his March 1 State of the Union address. The initiative, known as Test to Treat, allows people to take a COVID test at certain pharmacies and other sites—or send in the results of an at-home test—and receive a prescription for antiviral pills from medical providers at the same location

Early this month participating pharmacies  began distributing two antiviral medications: Pfizer’s Paxlovid and Merck’s molnupiravir, which are respectively 88 and 30 percent effective at preventing hospitalization and death from COVID when given within five days of symptom onset.

Both medications are most effective when administered soon after a person becomes infected with the SARS-CoV-2, the virus that causes COVID, so the ability to start treatment without visiting a doctor’s office could be game-changing for many patients. “Any efforts that go toward improving that efficiency are very welcome,” says Julie Ann Justo, an infectious disease clinical pharmacist at the University of South Carolina.

But Justo and others worry that the Test to Treat program’s impact will be limited because it does not allow pharmacists to prescribe the drugs. Although more than 41,000 pharmacies in the U.S. participated in a federal partnership program to administer COVID vaccines, far fewer have an attached clinic where a physician, nurse practitioner or physician’s assistant can prescribe the antivirals, as required by the U.S. Dept of Health and Human Services (HHS)—and the department currently describes only hundreds of pharmacy sites taking part in Test to Treat.

Justo and others say that is a missed opportunity: In September 2021 HHS amended its policies to allow licensed pharmacists to prescribe COVID therapeutics. Many states already allow pharmacists to prescribe particular medications, including birth control and the opioid overdose drug naloxone. And several allow pharmacists to adjust the dosage of medications for conditions after consulting with a physician.

A positive COVID test could eliminate the need for a physician’s diagnosis. Nevertheless, the Food and Drug Administration’s current emergency use authorizations for Paxlovid and molnupiravir only permit health care providers to prescribe the drugs. The HHS did not respond to requests for comment.

Many pharmacists say that hurdle could be easily overcome. A March 8 letter to Biden signed by 14 professional pharmacy organizations advocated that Test to Treat should give pharmacists prescribing authority for COVID antivirals. “Pharmacists are clinically trained medication experts and are the primary healthcare professionals responsible for ensuring safe medication use…,” it said. “Unfortunately, rural and underserved communities are less likely to benefit from your test to treat approach because of this limitation.”

But medical organizations have opposed the idea. A March 4 statement from the American Medical Association, attributed to its president Gerald Harmon, said that “the pharmacy-based clinic component of the test-to-treat plan flaunts patient safety and risks significant negative health outcomes.”

Harmon added that, despite the antivirals’ effectiveness, Paxlovid can interact with numerous other drugs that a patient might be taking, and molnupiravir may affect bone growth in young people. “Leaving prescribing decisions this complex in the hands of people without knowledge of a patient’s medical history is dangerous in practice and precedent,” the AMA statement said.

The statement enraged pharmacists and patient advocates. Matthew Cortland, who works on health care and disability issues at the think tank Data for Progress, says that the AMA’s position “seems to me to be much more about physician ego” than serving disabled, chronically ill, immunocompromised or older Americans. “The notion that somehow pharmacists are ill-equipped to navigate [drug] interactions when that’s literally what their doctorate is in is laughable and absurd.”

Jacinda Abdul-Mutakabbir, an infectious disease pharmacist at Loma Linda University, who works on health care equity issues, is among those disappointed by the Test to Treat program’s limited scope. People of color, particularly Black, Hispanic and Native American individuals, are more likely to be hospitalized and die from COVID than white individuals but are less likely to receive novel therapeutics or to have a health care provider. Allowing patients to receive prescriptions at a local pharmacist, she says, would be a good way to overcome the inequitable distribution of treatment. “This was something that may have allowed for some type of equity, some type of parity, and now we’re once again in that exact same spot,” she says.

Another problem is the drug supply. The U.S. has ordered a total of 20 million Paxlovid courses from Pfizer. Earlier this month, the White House asserted that four million of them were available, with an additional one million coming in March and 2.5 million in April. But the federal spending bill passed on March 15 does not include money for further purchases. In a press briefing that day, a White House official said the administration will not be able to buy more pills without additional funding.

Even if pharmacists are given prescribing authority under Test to Treat, pharmacies will need to work out some kinks, such as providing places for patients to isolate while receiving their test and prescription to avoid spreading COVID and ensuring that pharmacists have access to patients’ full medical records. “This is a country that put human beings on the moon,” Cortland says. “You cannot convince me we are incapable of safely running a test-to-treat program nationwide.”

Still, Justo is hopeful that HHS will eventually move to allow pharmacists to prescribe the drugs. “It’s not whether physicians or pharmacists should be the ones prescribing,” she says. “I think we need all hands on deck. We need as many opportunities as possible for patients to receive health care.”