Pharmacists can prescribe the lead COVID-19 pill directly to patients under a new U.S. policy announced Wednesday that aims to increase use of Pfizer’s drug Paxlovid.
The Food and Drug Administration said pharmacists could start screening patients to see if they are suitable for Paxlovid and then prescribe a drug that has been shown to curb the worst effects of COVID-19. Previously, only doctors could prescribe antiviral drugs.
The announcement comes as the number of COVID-19 cases, hospitalizations and deaths are rising again, although they remain at their lowest levels since the coronavirus outbreak began in 2020.
Biden administration officials have expressed disappointment that several hundred Americans continue to die daily from COVID-19 despite the availability of vaccines and treatments.
Administration officials have been working for several months to expand access to Paxlovid, opening thousands of sites where patients who test positive can write a prescription for Paxlovid. The FDA change will give thousands more pharmacies the ability to quickly prescribe and dispense pills that must be used early to be effective.
“Because Paxlovid must be taken within five days of symptom onset, allowing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment,” FDA drug center director Patricia Cavazzoni said in a statement.
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However, use may be limited by paperwork requirements. Patients are expected to bring their latest medical records, including blood tests, and a list of their current medications so that pharmacists can check for health 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 become 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. Not recommended for patients with severe kidney or liver disease. The course of treatment is three tablets twice a day for five days.
The FDA approved Paxlovid in December last year for children aged 12 years and older based on results showing it reduces hospitalizations and deaths by nearly 90% among unvaccinated patients who are most likely to develop severe illness. The drug has shown less impressive results in patients who already have vaccine protection, and some doctors have reported cases of COVID-19 symptoms returning after treatment with the drug.
Expanding the test-treatment program to include pharmacists could add thousands of additional options for patients. The two largest US pharmacy chains – CVS Health and Walgreens – unite about 19,000 points.
CVS Health is already providing COVID-19 care in 1,100 pharmacy clinics.
There are also about 19,400 independent pharmacies that are not affiliated with a major chain, according to the National Association of Pharmacists.
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Pharmacist Michelle Belcher said ahead of the announcement that she hopes to be able to test customers for COVID-19 and offer pills because her area, the small southwestern Oregon town of Grants Pass, lacks primary care doctors.
Belcher said she worries that it may be difficult for some people to make an appointment with a doctor for a prescription at a time when there is limited time to start taking the pills.
Belcher, owner of independent pharmacy Grants Pass, said she used to test and treat COVID-19 with injectables 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. “It’s something we do every day, all day, to make sure there’s no interaction with any medications.”