FDA allows licensed pharmacists to prescribe Pfizer’s Paxlovid under certain conditions
(CNN) — The U.S. Food and Drug Administration revised the emergency use authorization for Pfizer’s COVID-19 antiviral treatment, Paxlovid, on Wednesday to allow state-licensed pharmacists to prescribe the treatment to people who are eligible.
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Dr. Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”
People who test positive for COVID-19 should first consider seeing their regular health care provider or finding a local test-to-treat site, where they can get a prescription from a provider, the FDA said.
Those who want to get Paxlovid from a pharmacist need to have with them electronic or printed health records that are less than 12 months old and that include blood work to review for kidney or liver problems, as well as a list of all medications being taken, both over-the-counter and prescription, to screen for drug interactions. The health records could also be obtained through a consult between the pharmacist and a person’s health care provider.
There are some limitations to the revised EUA to ensure appropriate assessment and prescribing, the FDA said. Pharmacists should refer people to medical providers such as doctors if there is not enough evidence to check kidney function, liver function or potential drug interactions, if modification of other medications is needed or if Paxlovid is not an appropriate treatment.
The American Pharmacists Association said its research found that “increasing access to authorized prescribers, including pharmacists, will increase availability and provide more opportunities for socially vulnerable and medically underserved communities to access these lifesaving medications.”
“Opening the door for pharmacists as prescribers will open the door to equitable access at pharmacies in communities across the country,” association interim Executive Vice President and CEO Ilisa BG Bernstein said in a statement.
But the American Medical Association was critical of the FDA’s move.
“While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving — requirements far beyond a pharmacist’s scope and training,” AMA President Dr. Jack Resneck Jr. said in a statement.
“Patients will get the best, most comprehensive care from physician-led teams — teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up.”
Paxlovid is authorized for the treatment of mild to moderate COVID-19 in those over the age of 12 who have had a positive COVID-19 test and are at high risk for severe COVID.
The antiviral was granted emergency use authorization in December. In May, Pfizer announced that it had submitted an application for full FDA approval of Paxlovid.
About a third of the US population lives in a county with a “high COVID-19 community level,” where the US Centers for Disease Control and Prevention recommends universal indoor masking and warns that the health care system is at risk of extra burden. Data from the US Department of Health and Human Services shows that COVID-19 hospitalizations are also rising slowly nationwide.