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July 6, 2022July 6, 2022 – The U.S. FDA has revised emergency use authorization (EAU) for Pfizer’s PaxlovidTM (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to eligible patients, within certain limitations.
- The FDA recommends that patients first consider obtaining care from their regular healthcare provider or a Test-to-Treat site in their area.
- If a patient has tested positive for COVID-19 and wishes to obtain a Paxlovid prescription from a pharmacist, the FDA advises them to bring the following information to determine their eligibility to receive the medication:
- Electronic or printed health records less than 12 months old. These should include the most recent reports of laboratory blood work for the pharmacist to review for kidney or liver problems. A pharmacist can also obtain this information through consultation with the patient’s healthcare provider.
- A list of all medications the patient is taking, including over the counter (OTC) products, so the pharmacist can screen for potentially serious drug-to-drug interactions.
- The pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function or to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
- Paxlovid is authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (at least 12 years old and weighing at least 40kg, or 88 pounds) who are at high risk for progression to severe COVID-19 and have positive results of direct SARS-CoV-2 viral testing (including OTC at- home tests).