This Wednesday, the U.S. Food and Drug Administration The FDA has authorized state-licensed pharmacists to prescribe Pfizer's COVID-19 drug Paxlovid to eligible patients.
“The FDA recognizes the important role that pharmacists have and continue to play in the fight against this pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
She added that since Paxlovid must be taken within five days of the onset of symptoms, “authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this medication for the treatment of COVID-19.”
Paxlovid, made by pharmaceutical giant Pfizer, is intended to treat mild or moderate cases of COVID-19 in people at high risk of severe illness, including hospitalization or death.
The drug, which has emergency use authorization, is approved for adults and children 12 years of age and older who weigh at least 40 kilograms or 88 pounds with positive results from direct SARS-CoV-2 viral tests.
Upon testing positive for COVID-19, patients should first consider seeking care from their regular healthcare provider or locating a drive-through testing site in their area.
While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations, community pharmacies that do not already participate as a trial-to-try site can decide whether and how to offer this service to patients.
Patients who have tested positive for COVID-19 and are seeking to determine their eligibility to receive Paxlovid where prescription is available from state-licensed pharmacists will be required to bring their electronic or paper health record that is less than 12 months old, including the most recent laboratory blood test reports, for the state-licensed pharmacist to review for kidney or liver problems.
Also, a list of all medications they are taking, including over-the-counter medications, so the state-licensed pharmacist can screen for medications with potentially serious interactions with Paxlovid.
It is important to note that individuals will be referred by the pharmacist for a clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe medications, if any of the following conditions apply:
- There is insufficient information to assess renal and hepatic function.
- There is insufficient information available to assess a possible drug interaction.
- Other medications may need to be modified due to potential drug interactions.
Patients in the eligible population who report a positive result from a rapid antigen home diagnostic test or a positive PCR test to their provider are eligible for Paxlovid.
What is Paxlovid?
Paxlovid is the brand name of the oral antiviral treatment developed by the pharmaceutical company Pfizer to treat COVID-19.
This consists of two sets of pills that must be taken together. The standard treatment includes two nirmatrelvir pills and one ritonavir pill twice a day for five days.
Paxlovid should be taken as soon as possible after a person becomes ill, and is not recommended for people who have been hospitalized for COVID-19.
The FDA approved Paxlovid in December 2021 for the treatment of mild to moderate COVID-19 in adults and pediatric patients ‒12 years of age and older who weigh at least 40 kg‒ who test positive for SARS-CoV-2.
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