The Food and Drug Administration announced that pharmacists can start screening patients to see if they are eligible for Paxlovid and then prescribe the medication, which has been shown to restrain the worst effects of COVID-19. Hitherto just physicians could prescribe an antiviral drug.
The statement arrives as COVID-19 cases, hospitalizations and deaths are increasing again, though they stay near their lowest levels since the coronavirus outbreak started in 2020.
Biden administration officials have shown frustration that many hundred Americans continue to die of COVID-19 daily, despite the availability of vaccines and treatments.
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Administration officials have been working for months to improve access to Paxlovid, opening thousands of sites where patients who test positive can fill a prescription for Paxlovid. The FDA change will make thousands more pharmacies qualified to quickly prescribe and administer the pill, which has to be used early to be effective.
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“Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment," announced FDA drug center director Patrizia Cavazzoni.
Nonetheless, use could be limited by paperwork requirements. Patients are expected to bring their recent health records— including blood tests — and a list of their current medications so pharmacists can check that Paxlovid won't negatively interact with different drugs. As an alternative, pharmacists can consult with the patient's doctor.
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Paxlovid is meant for people with COVID-19 who are more likely to become seriously ill. That includes older people and those with other health matters like heart disease, obesity, cancer or diabetes that make them more vulnerable.
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The FDA authorized Paxlovid last December based on results reveling it reduced hospitalizations and deaths by almost 90% among unvaccinated patients most likely to get the severe disease. The drug has demonstrated less impressive results in patients who already have vaccine protection and some physicians have reported cases of COVID-19 symptoms returning after treatment with the drug.
Expanding the test-and-treat program to include pharmacists could add thousands of further options for patients. The two largest U.S. drugstore chains — CVS Health and Walgreens — run roughly 19,000 locations combined.
CVS Health already provides COVID-19 care at 1,100 clinic locations inside drugstores.
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There likewise are almost 19,400 independent pharmacies not tied to a big chain, according to the National Community Pharmacists Association.
Pharmacist Michele Belcher said ahead of the announcement that she hoped to be able to test customers for COVID-19 and offer the pill because there is a lack of primary care doctors in her community, the small, southwestern Oregon city of Grants Pass.
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Belcher explained she worries that some people may have difficulty acquiring a doctor’s appointment for a prescription throughout the narrow window to start the pill.
Belcher, owner of the independent Grants Pass Pharmacy, stated she used to test and treat for COVID-19 using injectable drugs that are no longer as effective. Her pharmacy routinely checks for potentially harmful interactions with other drugs a patient may be taking, she announced.
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“Pharmacists are the drug experts,” she stated. “That’s something we do every day, all day, make sure there are no interactions with any medications.”
However, the latest reports have been suggesting side effects among humans and has health safety concerns. In this video, Dr. Sanjhit Saseedharan, Head of Critical Care, SL Raheja Hospital talks about MOLNUPIRAVIR side effects, caution, eligibility and other details.
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Since Paxlovid is cleared by the kidneys, dose adjustments may be required for patients with mild-to-moderate kidney disease, explains Dr. Topal. “For patients with severe kidney disease—or who are on dialysis—or those with severe liver disease, Paxlovid is not recommended; the levels of the drug can become too high and could cause increased side effects,” he states.
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