FDA expands Paxlovid prescription authority to pharmacists to combat COVID-19

State-licensed pharmacists are authorized to prescribe the anti-viral Paxlovid for eligible patients seeking treatment for COVID-19, according to the U.S. Food and Drug Administration (FDA).

On July 6, FDA announced a revision to the emergency use authorization (EUA) for Paxlovid (nirmatrelvir copackaged with ritonavir for oral use) for mild to moderate COVID-19 in adults and children at least 12 years old and weighing at least 40 kg, or about 88 pounds, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research said in a news release. “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.”

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, according to FDA. The federally supported Test-to-Treat sites were launched to give patients quick, free access to COVID-19 treatments, according to the program website. Community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer the service to patients.

FDA first approved the EUA for Paxlovid, made by Pfizer, in December 2021, as the first oral antiviral treatment for COVID-19. The drug combination “significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment.”

Patients who have tested positive for COVID-19 and are seeking Paxlovid must bring medical records so state-licensed pharmacists can 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 to examine for kidney or liver problems. State-licensed pharmacists could also receive this information through a consultation with the patient’s health care provider.
• A list of all medications they are taking, including over-the-counter medications, to screen for drugs with potentially serious interactions with Paxlovid.

According to FDA, state-licensed pharmacists 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:

• 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.

FDA said Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.