The granting of the EUA comes with certain limitations, as the prescribing pharmacist must refer patients for clinical assessment with a physician.
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The U.S. Food and Drug Administration is authorizing state-licensed pharmacists to prescribe Pfizer‘s Paxlovid (nirmatrelvir and ritonavir) to treat COVID-19.
The granting of the emergency use authorization (EUA) comes with certain limitations, however, as the prescribing pharmacist must refer patients for clinical assessment with a physician, advanced practice registered nurse or licensed physician assistant. They cannot prescribe Paxlovid if there is not enough information to evaluate renal and hepatic function or potential drug interaction, if modifications are needed because of possible drug interactions and if it is not deemed to be the right therapeutic option based on the fact sheet for healthcare providers or where monitoring will not be feasible.
Paxlovid has the FDA’s authorization to treat mild-to-moderate COVID-19 in pediatric patients ages 12 years and up and weighing at least 40 kgs and adults who have tested positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19.
Patients in the said populations who test positive using home rapid antigen diagnostic tests (PCR tests) are also eligible to receive the drug, with no need to conduct additional direct SARS-CoV-2 viral testing. Positive antibody tests are not classified as direct SARS-CoV-2 tests.
The FDA also noted that those who test positive for COVID-19 should first locate a Test-to-Treat site in their area or a regular healthcare provider. Only state-licensed pharmacists are allowed to prescribe the drug, and community pharmacists who are not part of a Test-to-Treat site should figure out how to provide the service outside of this location.
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research said.
“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 added.
To get Paxlovid through a state-licensed pharmacist, patients should bring electronic or printed health records not older than 12 months, including the latest blood work data, so that the pharmacist can evaluate for liver or kidney issues. Patients should also bring a list of all the medications they are currently taking to enable pharmacists to spot potential drug interactions.
The EUA is in effect for as long as the FDA deems it fit.
“This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act,” the FDA wrote in its announcement.
