FDA Gives Pharmacists Thumbs Up for Paxlovid Prescribing

Licensed pharmacists can now prescribe nirmatrelvir-ritonavir (Paxlovid) for COVID-19 patients at high risk of progressing to severe disease (though with some limitations), the FDA announced on Wednesday.

“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,” Patrizia Cavazzoni, MD, director of the agency’s Center for Drug Evaluation and Research, said in a statement.

FDA noted that patients should still aim to talk to their regular healthcare provider first, or locate an authorized test-to-treat site. But if those options are unavailable, state-licensed pharmacists can now prescribe the highly effective antiviral as well.

Limitations outlined in the revised emergency use authorization (EUA) state that pharmacists should refer patients to a primary care provider for evaluation if insufficient information is available for assessing kidney function, liver function, or for potential drug interactions, and also if potential drug interactions might require medication changes.

The agency is advising patients to bring in their medical records from the past year, including recent blood work, so pharmacists can evaluate potential kidney or liver problems, as well as a list of the medications they currently take, so pharmacists can screen for possibly serious drug interactions with nirmatrelvir-ritonavir.

The scope of the revised EUA appears aimed at allaying concerns from the American Medical Association (AMA), among others, following the launch of the Biden administration’s test-to-treat initiative. When the program was launched in March, the AMA warned against the pharmacist component of the plan, in particular saying in a statement that it “flaunts patient safety and risks significant negative health outcomes.”

Though well intentioned, the AMA noted at the time that it “oversimplifies challenging prescribing decisions,” not least of which include the drug’s multiple pages of drug interactions that may call for reducing, pausing, or changing any number of medications.

Nirmatrelvir-ritonavir is authorized for adults and kids ages 12 and up who test positive for SARS-CoV-2 (on rapid at-home antigen tests or on a PCR test) and are at high risk for progression to severe illness.

In clinical trials, the drug was shown to reduce the risk of hospitalization or death from COVID-19 by 89% in these patients. It has failed to show significant benefit in trials involving standard-risk patients, including those vaccinated against COVID-19.