The Food and Drug Administration (FDA) said Wednesday that it revised the emergency use authorization for Paxlovid, allowing authorized state-licensed pharmacists to prescribe the Pfizer antiviral medication to eligible patients.
“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,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
There were “certain limitations” that would ensure patients were properly assessed and prescribed the drug.
State-licensed pharmacists should refer patients for clinical evaluation if sufficient information is not available to assess renal and hepatic function or to assess a potential drug interaction, the FDA said.
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The agency added that community pharmacies not already participating as test-to-treat sites can decide how or if they will offer this service.
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 infection in adults and pediatric patients 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.
It has been cleared for use and available for free in the US since December.
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Fewer than half of the nearly 4 million courses distributed to pharmacies by the government have been administered.
Those authorized who report a positive home test result from a rapid antigen diagnostic test or a positive PCR test, to their provider are eligible for the pill.
Patients who test positive should bring health records for pharmacists to review for kidney and liver problems.
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Patients with reduced kidney function may need a lower dose of the treatment.
Reuters contributed to this report.