FDA allows pharmacists to prescribe Paxlovid with certain restrictions
New prescribing authority could improve access for some patients at high risk of severe COVID-19
SILVER SPRING, MD., July 6, 2022 /PRNewswire/ — Today, the United States 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 proper patient assessment and prescription of Paxlovid.
“The FDA recognizes the important role that pharmacists have played and continue to play in the fight against this pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Given that Paxlovid must be taken within five days of symptom onset, allowing state-licensed pharmacists to prescribe Paxlovid could expand access to prompt treatment for some patients eligible to receive this drug for the treatment of COVID-19.”
When testing positive for COVID-19, patients should first consider seeking care from their usual healthcare provider or finding a Test site to treat in their field. While this action allows state-licensed pharmacists to prescribe Paxlovid with certain limitations outlined below, community pharmacies that do not already participate 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 to receive Paxlovid in locations where prescription by state-licensed pharmacists is available should bring the following information to ensure that the licensed pharmacist by the state has enough information to determine their eligibility to receive Paxlovid:
- Electronic or printed health records that are less than 12 months old, including the most recent lab blood test reports that the state-licensed pharmacist needs to review for kidney or liver problems. State-licensed pharmacists could also receive this information through consultation with the patient’s healthcare provider.
- A list of all medications they take, including over-the-counter medications, so the state-licensed pharmacist can screen for medications with potentially serious interactions with Paxlovid.
Within the limits described in the authorization, the state-licensed pharmacist must refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or licensed under the law of the State to prescribe drugs, if any of the following conditions apply:
- There is insufficient information to assess renal and hepatic function.
- Sufficient information is not available to assess a potential drug interaction.
- Changing other medications is necessary due to a potential drug interaction.
- Paxlovid is not an appropriate treatment option based on the Fact Sheet for Health Care Providers or due to potential drug interactions for which the recommended monitoring would not be possible.
Paxlovid is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients (aged 12 years and older weighing at least 40 kilograms or approximately 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 eligible population who report a positive home test result of a rapid antigen diagnostic test or a positive PCR test to their provider are eligible for Paxlovid under EUA. Confirmation of a positive rapid home antigen diagnostic test with an additional direct viral test for SARS-CoV-2, such as PCR, is not required. Antibody tests are not considered direct viral tests for SARS-CoV-2.
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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.
SOURCE US Food and Drug Administration