- The FDA today published a revision of the Emergency Use Authorization (EUA) for the COVID-19 drug composed of the drugs nirmatrelvir and ritonavir (trade name Paxlovid).
- The drug may be prescribed “in eligible patients, with certain limitations to ensure adequate evaluation” of the person.
- The entity recommended that, “upon testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a test site to treat in their area.
Today the US Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patientswith certain limitations to ensure proper patient evaluation and Paxlovid prescription.
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Patients should first consider seeking care from their health care provider
Testing positive for COVID-19patients should first consider seeking care from their health care provider medical care routine or locate a test site to treat in your area.
Yes ok this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations, as described below, community pharmacies not yet participating as a trial-to-treat site can decide if and how they will offer this service to patients.
CONDITIONS
The patients who tested positive for COVID-19 and seek to determine their eligibility to receive Paxlovid in places where prescription is available from pharmacists State-licensed pharmacists should bring the following information to make sure the state-licensed pharmacist has enough information to determine your eligibility to receive Paxlovid:
Electronic or paper health records less than 12 months old, including the most recent laboratory blood test reports to be checked for kidney or liver problems by your state-licensed pharmacist. State-licensed pharmacists may also receive this information through consultation with the patient’s health care provider.
A list of all medications they are takingincluding over-the-counter drugs, so your state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
The state-licensed pharmacist must refer patients for a clinical evaluation with a physician
Subject to the limitations described in the authorization, the pharmacist licensed by the state must refer patients for a clinical evaluation with a physician, a advanced practice registered nurse or a physician assistant licensed or authorized under state law to prescribe medications, if any of the following apply:
- Insufficient information is available to assess renal and hepatic function.
- Insufficient information is available to evaluate a possible drug interaction.
- Modification of other medications is necessary due to possible drug interaction.
ABOUT PAXLOVID
Paxlovid is licensed for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive direct viral test results for SARS-CoV-2, who are at high risk of progression to severe COVID-19, including hospitalization or death.
Patients in the licensed population who report a positive rapid antigen home test result or a positive PCR test result to their provider are eligible for Paxlovid under the EUA.. Confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral tests, such as PCR, is not required.
Antibody tests are not considered direct viral tests for SARS-CoV-2.
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