Pharmacy Groups Respond to AMA Criticism on Pharmacists Prescribing Paxlovid

The American Medical Association (AMA) was swift in its criticism of pharmacists immediately after the FDA revised its previous emergency use authorization (EUA) for nirmatrelvir and ritonavir (Paxlovid), allowing state-licensed pharmacists to prescribe the COVID-19 drug to eligible patients.¹

On July 6, the FDA authorized pharamcists to prescribe the drug, but included several limitations, such as requiring pharmacists to refer patients to their health care provider for clinical evaluation if there is insufficient information to assess renal and hepatic function; if there is insufficient information to assess potential drug-drug interactions; if modification of other medications is needed due to a potential drug-drug interaction; or if Paxlovid is not an appropriate therapeutic option for the patient, based on the current FDA Fact Sheet² or due to potential drug-drug interactions where recommended monitoring would not be feasible.

Additionally, to receive Paxlovid from a state-licensed pharmacist, patients must provide pharmacists with their electronic or printed health records less than 12 months old, including most recent lab reports for blood work and a list of all medications being taken, including OTC medications.

“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research. “Since Paxlovid must be taken within 5 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.”

However, AMA president Jack Resneck, Jr., MD, criticized FDA’s decision to allow pharmacists to prescribe the medication.

“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,” Resneck said in a statement.³

“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,” he 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.”

However, APhA and NCPA executives rejected AMA’s stance on the issue.

“Pharmacists are medication experts and are highly trained and educated in identifying appropriate use, drug interactions, and side effects,” Ilisa BG Bernstein, PharmD, interim executive vice president and CEO of APhA, said in a statement provided to Drug Topics®. “In this case, the government has firmly recognized the value and access that pharmacists can provide for COVID-19 treatment options, such as Paxlovid.”

“Fortunately, AMA’s viewpoint is not shared by the majority of physicians who work alongside our nation’s pharmacists everyday in delivering critical healthcare services to patients and communities, many in underserved parts of the country,” Bernstein added.

The AMA “continues to be out of step with the American public in its objection to pharmacists providing COVID treatments,” echoed NCPA CEO Douglas Hoey, R.Ph., in a statement provided to Drug Topics®. “Team-based care provides optimal outcomes for patients and consumers have voted with their feet and rolled up sleeves over 250 million times during the pandemic that they want their local pharmacist on Team Consumer, providing vaccinations, monoclonal antibody therapies, point-of-care testing, and other preventive health care services.”

Additionally, there are more than 28,000 community pharmacies located in federally recognized underserved communities, yet only 838 Test to Treat sites have been established in those communities, APhA said. "Tapping the pharmacies in these areas could increase access to treatments by about 3,200% and provide one-stop points of care to those who need it most.

FDA’s change comes following a new analysis by CDC,⁴ which confirmed APhA’s earlier findings⁵ of inequitable dispensing of COVID-19 oral antivirals, the organization said in a news release.⁶

“Removing barriers to pharmacist prescribing of oral antivirals has the potential to be a game-changer for addressing health equity and providing timely access to these life-saving treatments in pockets of the country where pharmacists may be the only health care provider for miles—just as it has been for the administration of COVID-19 vaccines,” Bernstein said.

“Pharmacists are educated, trained, and able to assess patients in accordance with clinical guidelines for appropriate use of these more convenient COVID-19 treatment options. We look forward to working with our colleagues to improve access to this lifesaving medication. Our members are ready to get to work,” Bernstein added.

“The FDA’s action is an extremely important revision for patient access and for equity in the use of COVID-19 antivirals,” said NACDS President & CEO Steven C. Anderson, in a news release.⁶

“The fact that there is a pharmacy within 5 miles of 90 percent of Americans led to remarkable effectiveness on behalf of the American people in the COVID-19 vaccination effort. This action on COVID-19 antivirals is a crucial step forward, and one for which NACDS has advocated in the best interest of patients throughout the nation,” Anderson added. “Now, to make better access for the public a reality, we encourage the federal government to take the necessary next steps to support pharmacy-based assessments that guide the use of this lifesaving therapy.”

NACDS is asking that “outstanding reimbursement challenges be immediately addressed to help effectively support pharmacist prescribing of COVID-19 antivirals to enhance public access and foster equity,” the organization said. “NACDS is encouraging lawmakers, the Centers for Medicare & Medicaid Services, and commercial payers, to immediately support coverage for the pharmacy-based assessments that inform the appropriate prescribing of this lifesaving therapy.”

References

1. Coronavirus (COVID-19) update: FDA authorizes pharmacists to prescribe Paxlovid with certain limitations. News release. FDA. July 6, 2022. Accessed July 19, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations

2. Paxlovid. Fact Sheet for Healthcare Providers: Emergency Use Authorization for Paxlovid. Pfizer. Accessed July 6, 2022. https://www.fda.gov/media/155050/download

3. AMA statement on Paxlovid prescribing. News release. AMA. July 6, 2022. Accessed July 19, 2022. https://www.ama-assn.org/press-center/press-releases/ama-statement-paxlovid-prescribing.

4. Gold J, Kelleher J, Magid J, et al. Dispensing of oral antiviral drugs for treatment of COVID-19 by zip code–Level Social Vulnerability — United States, December 23, 2021–May 21, 2022. Morb Mortal Wkly Rep. 2022;71(25):825-829. Doi:10.15585/mmwr.mm7125e1

5. Inequity to COVID-19 Test to Treat access — Pharmacists can help if permitted. APhA. Accessed July 7, 2022. https://www.pharmacist.com/Advocacy/Issues/Inequity-to-COVID-19-Test-to-Treat-Access-Pharmacists-can-help-if-permitted.

6. Breaking: FDA permits pharmacists to prescribe Paxlovid to treat COVID-19. APhA. News release. July 6, 2022. Accessed July 19, 2022. https://www.pharmacist.com/APhA-Press-Releases/breaking-fda-permits-pharmacists-to-prescribe-paxlovid-to-treat-covid-19

7. NACDS welcomes FDA’s action on pharmacist-prescribed COVID-19 antivirals; Urges next steps for lawmakers, CMS and commercial payers to make better access a reality. NACDS. News release. July 6, 2022. Accessed July 19, 2022. https://www.nacds.org/news/nacds-welcomes-fdas-action-on-pharmacist-prescribed-covid-19-antivirals-urges-next-steps-for-lawmakers-cms-and-commercial-payers-to-make-better-access-a-reality/