FDA on Wednesday issued a revision to its emergency use authorization (EUA) for Paxlovid that will allow pharmacists to prescribe the drug under certain conditions, a move meant to address what was a point of contention in the Biden administration's "Test to Treat" initiative.
Under FDA's initial EUA for Paxlovid, only physicians, advanced practice RNs, and physician assistants were allowed to prescribe Paxlovid. The Biden administration's "Test to Treat" program intended to expand access to the drug by allowing patients who test positive for Covid-19 pharmacies to also receive free antiviral pills on site. But those clinics required an in-house nurse practitioner or physician assistant to be present.
Under the newly revised EUA, state-licensed pharmacists will be able to prescribe Paxlovid provided patients who have tested positive for Covid-19 bring "electronic or printed health records less than 12 months old" as well as "the most recent reports of laboratory blood work" and a list of medications they're taking to the pharmacist.
If there's not enough evidence for a pharmacist to determine a patient's renal and hepatic function, potential interactions of Paxlovid with other medications, a need to modify other drugs, or whether Paxlovid isn't the right treatment for the patient, patients should be referred for clinical evaluation, FDA said.
"The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic," Patrizia Cavazzoni, director of FDA's Center for Drug Evaluation and Research, said.
"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," Cavazzoni added.
The American Medical Association (AMA) has argued against allowing pharmacists to prescribe the drug, saying that allowing pharmacists to prescribe Paxlovid "flaunts patient safety and risks significant negative health outcomes."
Allowing pharmacists to prescribe Paxlovid is well intentioned, AMA said, but it "oversimplifies challenging prescribing decisions" including the many drug interactions that come with Paxlovid.
"Patients will get the best, most comprehensive care from physician-led teams—teams that include pharmacists," said AMA President Jack Resneck Jr. "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."
However, pharmacists argue that many pharmacies do not have in-house NPs or PAs on staff, meaning patients could be delayed in receiving Paxlovid, which has to be administered within five days of a patient experiencing symptoms.
Susan Davis, a pharmacy professor at Wayne State University and former president of the Society of Infectious Disease Pharmacists, in March said, "We have been managing drug interactions and dose adjustments routinely for decades. We could handle this."
Michele Belcher, a pharmacist in Grants Pass, Oregon, said she has wanted to be able to prescribe Paxlovid to patients because there's a shortage of primary care doctors in her small town. Belcher said her pharmacy always checks for potentially harmful drug interactions with any prescription.
"Pharmacists are the drug experts," she said. "That's something we do every day, all day, make sure there are no interactions with any medications." (Choi, The Hill, 7/6; Gonzalez, Axios, 7/6; Perrone/Murphy, Associated Press, 7/6; Robbins, New York Times, 7/6; Ingram, MedPage Today, 7/6)
Create your free account to access 2 resources each month, including the latest research and webinars.
You have 2 free members-only resources remaining this month remaining this month.
Never miss out on the latest innovative health care content tailored to you.