Paxlovid, made by Pfizer Inc., is meant to treat mild-to-moderate cases of COVID-19 in people who are at high risk for severe COVID-19. Photo by Kches16414/Wikimedia Commons
Patients who test positive for COVID-19 can now get the antiviral pill Paxlovid directly from their pharmacists, the U.S. Food and Drug Administration announced Wednesday.
The action removes limits that had restricted prescribing authority to healthcare providers and Test-to-Treat sites.
"The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic," Dr. Patrizia Cavazzoni, director for the FDA's Center for Drug Evaluation and Research, said in a news release announcing the change. "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."
Paxlovid, made by Pfizer Inc., is meant to treat mild-to-moderate cases of COVID-19 in people who are at high risk for severe COVID-19. It is approved for adults and for children ages 12 and up who weigh at least 88 pounds.
Patients who test positive for COVID-19 should still consider reaching out to their regular healthcare provider for Paxlovid first, the FDA noted.
Community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients, the FDA added.
The American Medical Association (AMA) expressed reservations about the broader prescribing authority.
"Paxlovid is an important treatment and critical tool in the fight against COVID-19," AMA President Dr. Jack Resneck said in a statement issued Wednesday. "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."
"In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams - teams that include pharmacists," Resneck added. "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. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one."
Under the new authorization, patients are considered eligible for the medication if they are in the population authorized to get the medication and have a positive at-home rapid antigen test or a positive PCR test. It is not required to confirm a positive at-home test with a PCR test, the agency added.
Despite the move to expand the use of Paxlovid, the paperwork required to get it is still significant.
This includes electronic or printed health records that are 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, the FDA said.
In lieu of this, the pharmacist could receive this information through a consult with the patient's healthcare provider.
Patients should also provide a list of their current medications, including over-the-counter drugs they take, so that that pharmacist can screen for potentially harmful drug interactions.
The pharmacist should refer patients for a clinical evaluation with a physician, advanced practice registered nurse or physician assistant licensed to prescribe drugs if there is not sufficient information for the pharmacist to assess patient safety. This includes if there is not enough information to assess the patient's kidney and liver function. Paxlovid isn't recommended for patients with severe kidney or liver problems.
The U.S. Centers for Disease Control and Prevention has more on COVID-19 treatments.
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