This Wednesday, the U.S. Food and Drug Administration. The FDA authorized state-licensed pharmacists to prescribe Pfizer's COVIID-19 drug Paxlovid to eligible patients.
"FDA recognizes the important role that pharmacists have and continue to play in the fight against this pandemic," said Patrizia Cavazzoni, director of FDA's Center for Drug Evaluation and Research.
He added that because Paxlovid must be taken within five days of symptom onset, "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."
Paxlovid, manufactured by pharmaceutical giant Pfizer, is intended to treat mild to moderate cases of COVID-19 in people at high risk of severe disease, including hospitalization or death.
The emergency use authorization drug is approved for adults and for children 12 years of age and older weighing at least 40 kilograms or 88 pounds with positive direct SARS-CoV-2 viral test results.
Upon testing positive for COVID-19, patients should first consider seeking care from their usual healthcare provider or locating a testing site to treat 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 test-to-treat site can decide whether and how they will offer this service to patients.
Patients who tested positive for COVID-19 and seek to determine their eligibility to receive Paxlovid where prescribing by state-licensed pharmacists is available should bring with them their electronic or paper health record 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 that the state-licensed pharmacist can detect medications with potentially serious interactions with Paxlovid.
It should be noted 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:
- Insufficient information is available to assess renal and hepatic function.
- There is insufficient information available to evaluate a possible pharmacological interaction.
- It is necessary to modify other medications due to a possible drug interaction.
Patients in the authorized population who report a positive rapid antigen home diagnostic home test result or a positive PCR test to their provider are eligible for Paxlovid.
What is Paxlovid?
Paxlovid is the trade name of the oral antiviral treatment developed by Pfizer Pharmaceuticals to treat COVID-19.
This consists of two sets of pills to be taken together. The standard treatment includes two tablets of nirmatrelvir and one tablet of ritonavir twice a day for five days.
Paxlovid should be taken as soon as possible after the person becomes ill, and is not recommended for people who have been hospitalized for COVID-19.
The FDA cleared Paxlovid in December 2021 for the treatment of mild to moderate COVID-19 in adults and pediatric patients ?12 years of age and older weighing at least 40 kg? with positive SARS-CoV-2 results.
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