FDA issues limited authorizations for pharmacists to prescribe Paxlovid

The Food and Drug Administration (FDA) on Wednesday issued a revision to its emergency use authorization (EUA) for Pfizer’s COVID-19 antiviral Paxlovid that will allow pharmacists to prescribe the treatment with certain limitations.

Under the original EUA from the FDA, only physicians, advanced practice registered nurses and physician assistants were permitted to prescribe Paxlovid to patients. The FDA said in its announcement that state-licensed pharmacists would now be able to prescribe Paxlovid, meaning many more pharmacy locations will now be able to provide coronavirus antivirals to patient sooner.

According to the FDA’s revised authorization, people who have tested positive for COVID-19 and are seeking antiviral treatment should bring pharmacists their “electronic or printed health records less than 12 months old,” “the most recent reports of laboratory blood work” and a list of current medications they are taking so pharmacists can be aware of possible drug interactions.

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

“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,” Cavazzoni said.

The FDA said pharmacists should refer patients for clinical evaluation if there is insufficient evidence to assess renal and hepatic function, potential drug interactions, the need for modification of other drugs or if Paxlovid is determined to not be an appropriate treatment due to potential drug interactions.

The initial exclusion of pharmacists from the providers able to prescribe the antiviral treatment was a point of contention in the White House’s “Test to Treat” initiative, with pharmacists arguing that leaving them out severely limited the initiative’s effectiveness.

While most, if not all, pharmacies have licensed pharmacists on staff, not all locations necessarily have health care providers like physicians and advanced practice registered nurses who can issue prescriptions, leading many patients to experience a delay in obtaining Paxlovid, which must be administered within five days of symptoms onset to be effective.

In many “medical deserts,” pharmacists may be the only health care providers easily accessible to rural residents.

Pharmacists’ organizations argued it was misstep by the Biden administration to exclude pharmacists, as they specialize in understanding drug interactions and risks. Pharmacists had also been included in previous EUAs for COVID-19 treatments, such as for monoclonal antibodies.

In March, around a dozen pharmacy organizations called on the White House to remove limits on prescribing the antiviral.