Washington, D.C.—State-licensed pharmacists are now able to prescribe the oral COVID-19 antiviral, Paxlovid (nirmatrelvir and ritonavir), with some limitations.
The FDA has revised the emergency use authorization (EUA) for Paxlovid to allow state-licensed pharmacists to prescribe the drug to eligible patients. The FDA mandates certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
"The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic," stated Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research. "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19."
The American Pharmacists Association (APhA) and other key pharmacy groups pushed hard for the change after the FDA specifically excluded pharmacists from prescribing the oral antiviral in the EUA.
Public health officials advise that patients who test positive for COVID-19 should first consider seeking care from their regular healthcare 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," according to a recent press release.
COVID-19-positive patients who are trying to determine eligibility for receiving Paxlovid from pharmacists must provide electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work, to the pharmacy. The FDA suggested that pharmacists could also receive this information through a consult with the patient's healthcare provider.
Also required is a list of all medications they are taking, including OTC medications, so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
The authorization has limitations, including that pharmacists 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.
• Sufficient information is not available 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.
Noting that more than 28,000 community pharmacies are located in federally recognized underserved communities, an APhA analysis pointed out recently that only 700 Test to Treat sites have been established in those communities to provide oral antivirals to COVID-19 patients.
The APhA argued that better utilizing pharmacies in those areas could increase access to treatments by about 3,900%.
The group recently released an analysis showing that underserved and vulnerable communities in the United States do not currently have equitable access to care. As of early May, when the analysis was conducted, slightly more than 2,300 Test to Treat sites were in existence and only 22% were in the most vulnerable areas in the country as defined by the Social Vulnerability Index. Additionally, only 30% of Test to Treat sites are in medically underserved areas of the U.S., according to the report.
"Although HHS has recognized the high level of training pharmacists receive by authorizing pharmacists to prescribe COVID-19 therapeutics, FDA's emergency use authorizations for oral COVID-19 antivirals specifically exclude pharmacists as prescribers," the APhA stated in a press release. "As a result, the majority of pharmacies cannot serve as Test to Treat sites. These medications are being underutilized and sitting on pharmacy shelves, which unnecessarily increases health care costs and puts lives at risk."
The APhA said it was calling on the federal government to include the nation's more than 70,000 community pharmacies as prescribers of oral COVID-19 antivirals. It said that would significantly increase equitable access to Test to Treat pharmacies "by opening the door to communities that need it the most."
The association advises that nearly 90% of the U.S. population lives within 5 miles of a pharmacy.
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