WASHINGTON (AP) — Pharmacists can prescribe an advanced COVID-19 pill directly to patients under a new U.S. policy announced Wednesday that aims to expand the use of Pfizer’s drug Paxlovid.
The Food and Drug Administration said pharmacists can begin screening patients to see if they qualify for Paxlovid and then prescribe the drug, which has been shown to curb the worst effects of COVID-19. Previously, only a doctor could prescribe an antiviral drug.
The announcement comes as COVID-19 cases, hospitalizations and deaths are rising again, although they remain near their lowest levels since the outbreak began in 2020.
Biden administration officials have expressed frustration that several hundred Americans are dying from COVID-19 every day despite the availability of vaccines and treatments.
Administration officials have been working for months to expand access to Paxlovid, opening thousands of sites where patients who test positive can get a prescription for Paxlovid. The FDA’s change will allow thousands more pharmacies to quickly prescribe and dispense pills that must be used earlier to be effective.
“Because Paxlovid must be taken within five days of the onset of symptoms, allowing state-licensed pharmacists to prescribe Paxlovid could increase access to timely treatment,” FDA Drug Center Director Patricia Cavazzoni said in a statement.
However, use may be limited by documentation requirements. Patients are expected to bring recent medical records, including blood tests, and a list of medications they are taking so that pharmacists can check for medical conditions and medications that may interact negatively with Paxlovid. Alternatively, pharmacists may consult with the patient’s physician.
Paxlovid is for people with COVID-19 who are more likely to be seriously ill. This includes the elderly and people with other health problems such as heart disease, obesity, cancer or diabetes that make them more vulnerable. It is not recommended for patients with serious kidney and liver diseases. The course of treatment is three tablets twice a day for five days.
Last December, the FDA approved Paxlovid for use in ages 12 and older based on results that showed it reduced hospitalizations and deaths by nearly 90 percent among unvaccinated patients, who are most likely to develop severe disease. The drug has shown less impressive results in patients who already have it vaccine protection and some doctors have reported cases of COVID-19 symptoms returning after treatment with the drug.
Expanding the testing program to treat pharmacists could add thousands of additional options for patients. The two largest US drugstore chains — CVS Health and Walgreens — together operate about 19,000 locations.
CVS Health is already providing COVID-19 treatment at 1,100 pharmacy clinics.
According to the National Pharmacists Association, there are nearly 19,400 independent pharmacies not affiliated with a large chain.
Pharmacist Michelle Belcher said before the announcement that she hopes to be able to test customers for COVID-19 and offer pills because her community, the small town of Grants Pass in southwestern Oregon, lacks primary care doctors.
Belcher said she worries that some people may find it difficult to get a doctor’s appointment for a prescription during the lean period to start taking the pills.
Belcher, owner of the independent Grants Pass Pharmacy, said she used to test for and treat COVID-19 with injectable drugs that are no longer as effective.
Her pharmacy routinely checks for potentially harmful interactions with other medications a patient may be taking, she said.
“Pharmacists are drug experts,” she said. “That’s what we do every day, all day, to make sure there’s no interaction with any medications.”
Murphy reported from Indianapolis.
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