- 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.
Index hide1 “The FDA recognizes the important role that pharmacists have played and continue to play in fighting this pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “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 COVID treatment. -19”.
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.
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.
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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