The U.S. Food and Drug Administration has authorized state-licensed pharmacists to prescribe COVID-19 pill Paxlovid (nirmatrelvir and ritonavir) by drug major Pfizer Inc. to eligible patients, with certain limitations.
The agency has revised the Emergency Use Authorization or EUA for Paxlovid for the authorization, which could improve access for some patients at high risk for severe covid-19. The limitations are set to ensure appropriate patient assessment and prescribing of Paxlovid.
Pfizer in late June had submitted a New Drug Application or NDA to the FDA for approval of Paxlovid for both vaccinated and unvaccinated patients who are at high risk for progression to severe illness from COVID-19.
The FDA now said that when testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area. This will allow state-licensed pharmacists to prescribe Paxlovid with certain limitations. Further, community pharmacies not already participating as a Test-to-Treat site can also decide if or how they will offer this service to patients.
For determining eligibility to receive Paxlovid from state-licensed pharmacists, COVID-19 patients should bring health records less than 12 months old, as well as a list of all medications they are taking, including over-the-counter medications.
Under the limitations in the authorization, the pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant, if sufficient information is not available in certain cases.
Patrizia Cavazzoni, director for the FDA's Center for Drug Evaluation and Research, said, "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19."
Paxlovid is currently authorized for emergency use to treat mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death.
Under the EUA, patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test, or a positive PCR test, to their provider are eligible for Paxlovid.
Paxlovid is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness.
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