FDA revises EUA for Paxlovid, allowing pharmacists to prescribe it

The FDA announced that state-licensed pharmacists can now prescribe the COVID-19 treatment Paxlovid with some limitations.

Paxlovid (nirmatrelvir/ritonavir; Pfizer) received emergency use authorization (EUA) from the FDA in December, becoming the first oral antiviral treatment for COVID-19.

In March, President Joe Biden announced a test-to-treat initiative that allowed select pharmacies to provide antiviral treatment to patients who test positive for COVID-19 on the spot at no cost. However, the American Society of Health-System Pharmacists (ASHP) noted that, because of the specific language in the EUA for Paxlovid, pharmacists could not order the antiviral, limiting use of the test-to-treat initiative to pharmacies with walk-in clinics where a nurse practitioner or physician assistant can order antivirals.

Now, the FDA has revised the EUA to allow pharmacists to prescribe Paxlovid under certain circumstances, with “limitations to ensure appropriate patient assessment and prescribing of Paxlovid,” the agency said.

“This is a significant step in improving patient access to Paxlovid,” Michael Ganio, PharmD, MS, BCPS, FASHP, senior director of pharmacy practice and quality at ASHP, told Healio. “A recent CDC report found underutilization in highly vulnerable zip codes despite having a large number of dispensing sites. The report suggests that access to a prescriber is a limiting factor in patient access to the COVID oral antiviral. The FDA’s actions will improve the number of available prescribers.”

According to the FDA, people who test positive for COVID-19 and want to know if they are eligible to receive Paxlovid at pharmacies where it is available should bring a list of all medications they are taking and health records that are less than 1 year old for the state-licensed pharmacist to review. The pharmacist could also consult with the patient’s health care provider about the patient’s eligibility, the FDA said.

The prescribing limitations outlined in the EUA also state that pharmacists should refer patients for clinical evaluation with a physician, an advanced practice registered nurse or a physician assistant who is licensed or authorized to prescribe drugs if:

• the pharmacist does not have sufficient information to assess potential drug interactions and renal and hepatic function;

• other medications need to be modified due to potential drug interactions; or

• the pharmacist finds that 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,” the release said.

Although Ganio applauded the FDA’s actions, he also noted that barriers remain because not all pharmacies will have the staff resources needed to take on the additional responsibilities.

“To address this, pharmacist evaluation of patients for appropriate treatment with Paxlovid must be a recognized service by Medicare and private payers so that pharmacies can adequately staff locations to expand patient access to Paxlovid prescribers,” Ganio said.

Jack Resneck Jr., MD, president of the AMA, said in a statement that Paxlovid is a “critical tool in the fight against COVID-19” but warned the drug “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 said. “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.”

References:

• AMA statement on Paxlovid prescribing. https://www.ama-assn.org/press-center/press-releases/ama-statement-paxlovid-prescribing. Published July 6, 2022. Accessed July 7, 2022.
• Coronavirus (COVID-19) update: FDA authorizes pharmacists to prescribe Paxlovid with certain limitations. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations. Published July 6, 2022. Accessed July 7, 2022.
• Fact sheet for healthcare providers: Emergency use authorization for Paxlovid. https://www.fda.gov/media/155050/download?utm_medium=email&utm_source=govdelivery. Published July 6, 2022. Accessed July 7, 2022.