FDA Revises EUA for Paxlovid; Allows State-Licensed Pharmacists to Prescribe

Today, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. State-licensed pharmacists may prescribe Paxlovid to patients who have tested positive for COVID-19 if the pharmacist has sufficient information to evaluate the patient's renal and hepatic function and has access to a comprehensive medication list to assess for potential drug interactions.

Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation 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.
• 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.

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients 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.

ASHP has led multiple discussions with the administration, including calling on the FDA and the White House to grant pharmacist prescribing authority for oral antivirals. Thank you to the ASHP members, pharmacy professionals, and health systems who joined us in asking FDA to take this action.