FDA Revises EUA to Allow Pharmacists to Prescribe Pfizer’s Paxlovid
The FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the oral antiviral drug to COVID-19 patients.
“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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) in announcing the revised EUA yesterday.
Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients 12 years and older weighing at least 88 pounds 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.
The FDA said patients hoping to get Paxlovid from a pharmacist will need to show up with electronic or printed health records less than 12 months old, including blood work so pharmacists can look for kidney or liver problems. The agency said pharmacists may also get this information through a consult with the patient’s healthcare provider.
Patients will also need to list all medications they are taking so pharmacists can assess for a potential drug interaction.
Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test or a positive polymerase chain reaction (PCR) test to their provider are eligible for Paxlovid under the EUA.
Pfizer announced June 30 that it was seeking full FDA approval of Paxlovid, which would allow the company to sell the drug commercially (DID, July 1).
Thus far, about 1.7 million patients around the world have been prescribed Paxlovid, the more popular of the two oral COVID-19 drugs with EUAs. Merck and Ridgeback’s Lagevrio (molnupiravir) is the other.
As of the end of May 2022, Pfizer had shipped more than 12 million treatment courses of Paxlovid to nearly 40 countries, the company said. The U.S. has committed to purchasing 20 million courses. — Suz Redfearn