The American Medical Association (AMA) was quick to slam 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 allowed pharmacists 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 no has insufficient information to assess renal and hepatic function; if there is insufficient information to assess potential drug interactions; if changing other medications is necessary due to a potential drug interaction; or if Paxlovid is not an appropriate treatment option for the patient, based on the current FDA Fact Sheet2 or due to potential drug interactions when recommended monitoring would not be possible.
Additionally, to receive Paxlovid from a state-licensed pharmacist, patients must provide pharmacists with their electronic or printed health records that are less than 12 months old, including the most recent lab reports for blood work. and a list of all medications taken, including over-the-counter medications.
“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research. “Given that Paxlovid must be taken within 5 days of symptom onset, allowing state-licensed pharmacists to prescribe Paxlovid could expand access to prompt treatment for some patients eligible to receive this drug for the treatment of COVID-19.”
However, AMA President Jack Resneck, Jr., MD, criticized the FDA’s decision to allow pharmacists to prescribe the drug.
“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 symptoms. follow-up care to determine if a patient is improving — requirements well beyond the scope and training of a pharmacist,” 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 receive the best and most comprehensive care from teams led by physicians – teams including pharmacists,” he added. . “But, whenever possible, prescribing decisions should be made by a physician who knows the patient’s medical history and is able 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 doctor, if they have one.
However, the APhA and NCPA leaders rejected the AMA’s position on the matter.
“Pharmacists are drug experts and are highly skilled and educated in identifying appropriate use, drug interactions and side effects,” said Ilisa BG Bernstein, PharmD, APhA Acting Executive Vice President and CEO. , in a statement provided to Drug Topics®. “In this case, the government has strongly recognized the value and access that pharmacists can provide to COVID-19 treatment options, such as Paxlovid.”
“Fortunately, the AMA’s view is not shared by the majority of physicians who work daily alongside pharmacists across our nation to provide essential health services to patients and communities, many of them in underserved areas. serviced nationwide,” 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 delivers optimal patient outcomes and consumers have voted with their feet and rolled up their sleeves more than 250 million times during the pandemic that they want their local pharmacist to be part of Team Consumer, providing vaccinations, monoclonal antibody therapies, point-of-care testing and other preventative health care services.
Additionally, there are more than 28,000 community pharmacies located in federally recognized underserved communities, but only 838 Test to Treat sites have been established in those communities, the APhA said. “Operating pharmacies in these areas could increase access to treatment by around 3,200% and provide one-stop points of care for those who need it most.
The FDA change follows a new analysis from the CDC,4 which confirmed the APhA’s earlier findings5 inequitable distribution of COVID-19 oral antivirals, the organization said in a press release.6
“Removing barriers to pharmacists prescribing oral antivirals has the potential to be a game-changer to address health equity and provide timely access to these lifesaving treatments in pockets of the country where pharmacists can be the only health care provider for miles – just as has been the case with the administration of COVID-19 vaccines,” Bernstein said.
“Pharmacists are educated, trained and able to assess patients according to 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 life-saving medicine. Our members are ready to get to work,” added Bernstein.
“FDA’s action is an extremely important review for patient access and equity in the use of COVID-19 antivirals,” said NACDS President and CEO Steven C. Anderson. , in a press release.6
“Having a pharmacy within 5 miles of 90% of Americans has led to remarkable effectiveness on behalf of the American people in the COVID-19 vaccination effort. This action on COVID-19 antivirals is a critical step forward, and one that NACDS has advocated for in the best interests of patients across the country,” Anderson added. “Now, to make greater public access a reality, we encourage the federal government to take the next steps necessary to support pharmacy assessments that guide the use of this life-saving therapy.
The NACDS calls for “outstanding reimbursement challenges to be immediately resolved to help effectively support pharmacist prescribing of COVID-19 antivirals to improve public access and promote equity,” the NACDS said. ‘organization. “NACDS encourages legislators, the Centers for Medicare & Medicaid Services, and commercial payers to immediately support coverage of pharmacy assessments that inform appropriate prescribing of this lifesaving therapy.”
1. Coronavirus (COVID-19) Update: FDA allows pharmacists to prescribe Paxlovid with certain restrictions. Press 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. Health Care Provider Information Sheet: Emergency Use Authorization for Paxlovid. Pfizer. Accessed July 6, 2022. https://www.fda.gov/media/155050/download
3. WADA Statement on Prescribing Paxlovid. Press release. WADA. July 6, 2022. Accessed July 19, 2022. https://www.ama-assn.org/press-center/press-releases/ama-statement-paxlovid-prescribe.
4. Gold J, Kelleher J, Magid J, et al. Distribution of oral antiviral drugs for the treatment of COVID-19 by zip code – Level of 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. Unequal access to COVID-19 testing to treat – Pharmacists can help if allowed. 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. Break: FDA allows pharmacists to prescribe Paxlovid to treat COVID-19. APhA. Press 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 Action on Pharmacist-Prescribed COVID-19 Antivirals; Urges legislators, CMSs and commercial payers to take the next steps to make improved access a reality. NACDS. Press release. July 6, 2022. Accessed July 19, 2022. https://www.nacds.org/news/nacds-welcomes-fdas-action-on-pharmacist-prepressed-covid-19-antivirals-urges-next-steps-for- cms-legislators-and-commercial-payers-to-make-better-access-a-reality/