1st COVID-19 Pill Can Now Be Prescribed By Florida Pharmacies

FLORIDA — Following Wednesday's authorization by the U.S. Food and Drug Administration, the Florida Department of Health has issued a notice allowing Florida pharmacists to prescribe the first oral antiviral, Paxlovid, for high-risk patients.

The U.S. Food and Drug Administration revised the Emergency Use Authorization for Paxlovid, manufactured by Pfizer, authorizing state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations.

"The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "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."

Originally granted an Emergency Use Authorization in December, the pill contains two inhibitors — nirmatrelvir and ritonavir — for early treatment of COVID-19. It was originally approved for adults ages 18 and older with acute COVID-19 with a risk factor for progression to severe disease or for those ages 60 or older, regardless of chronic medical conditions.

According to researchers at Florida Atlantic University, among 2,085 randomized people, there was an 88 percent reduction in deaths for Paxlovid users.

Click here for a list of providers in Florida that have the pill.

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 pounds) 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.

Patients 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.

Confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral testing, such as a PCR, is not required. Antibody tests are not considered to be direct SARS-CoV-2 viral tests.

To enhance access, the U.S. government already has purchased 10 million courses of treatment from Pfizer for $5 billion.

When testing positive for COVID-19, the FDA advises patients to first consider seeking care from their regular health care providers or locating a Test-to-Treat site in their area.

While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations, community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients.

Patients who have tested positive for COVID-19 and are trying to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:

• Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient's health care provider.
• A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.

Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:

• Sufficient information is not available to assess renal and hepatic function.
• Sufficient information is not available to assess for a potential drug interaction.
• Modification of other medications is needed due to a potential drug interaction.