FDA Authorizes Paxlovid Prescribing by Pharmacists, with Limitations

The US Food and Drug and Drug Administration (FDA) on Wednesday revised the Emergency Use Authorization (EUA) for nirmatrelvir and ritonavir (Paxlovid) to authorize prescribing of the oral COVID-19 antiviral to state-licensed pharmacists, according to an agency news release.

The revision comes with several limitations, according to the FDA, to ensure patients are assessed appropriately and the drug prescribed correctly.

For example, so that the pharmacist has adequate information to determine whether or not a patient is eligible to receive Paxlovid, a patient must provide:

• Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work to allow assessment for kidney or liver problems. The information should also be provided via consult with the patient’s health care provider.
• A list of all medications they are taking, including over-the-counter medications to allow screening for potential drug-drug interactions.

Further, if any of the following apply to the situation, the pharmacist is bound by the limitations of the authorization to refer a patient to their primary health care provider for clinical evaluation:

• Insufficient information to assess renal and hepatic function or assess for potential drug interactions.
• Modification of a patient’s current medications is needed to avoid a potential drug interaction.
• Paxlovid is not an appropriate therapeutic option for the patient based on the current Paxlovid Fact Sheet for Healthcare Providers or because there is a potential for drug interactions for which recommended monitoring would not be feasible.

The FDA also advises that patients who test positive for COVID-19 first consider consulting their regular health care provider or locating a Test-to-Treat site nearby.

“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research in the release. “Since Paxlovid must be taken within 5 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.”

APhA supports move

“Removing barriers to pharmacist prescribing of oral antivirals has the potential to be a game-changer for addressing health equity and providing timely access to these life-saving treatments in pockets of the country where pharmacists may be the only health care provider for miles—just as it has been for the administration of COVID-19 vaccines,” commented Ilisa BG Bernstein, PharmD, JD, American Pharmacists Association (APhA) interim executive vice president and CEO in a APhA statement.

“Pharmacists are educated, trained, and able to assess patients in accordance with clinical guidelines for appropriate use of these more convenient COVID-19 treatment options. We look forward to working with our colleagues to improve access to this lifesaving medication.”

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and children aged ≥12 years weighing at least 40 kg who have tested positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19, including hospitalization or death.