The U.S. 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 patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
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When testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area.
While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations as described below, community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients.
Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:
• Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
• A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
Paxlovid is authorized 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 results of direct SARS-CoV-2 viral testing, who are at high risk for progression to severe COVID-19, including hospitalization or death.
Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test, or a positive PCR test, 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 testing, such as a PCR, is not required.
Antibody tests are not considered to be direct SARS-CoV-2 viral tests. ■