FDA decision prompts praise from pharmacists for expanding treatment and equity around nation.
Expanding access to Paxlovid is good for COVID-19 patients, but physicians should be leading health care plans for those dealing with the virus, two medical groups said.
On July 6, FDA announced a revision to the emergency use authorization (EUA) for Paxlovid (nirmatrelvir copackaged with ritonavir for oral use), allowing state-licensed pharmacists to prescribe the drug for mild to moderate COVID-19 in adults and children at least 12 years old and weighing at least 40 kg, or about 88 pounds, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
The American Pharmacists Association (APhA) praised the move as a way to expand access to COVID-19 treatment in underserved communities, and at least one expert said the change is critical for pharmacists to advance as health care providers.
The American Medical Association (AMA) and the American College of Physicians (ACP) called for greater access to Paxlovid to treat COVID-19 and agreed pharmacists are key members of treatment teams for patients.
But granting greater prescription authority could have unintended effects on patients, according to the physician groups.
Use of Paxlovid “can be complicated by the patient’s health status and existing treatment regimen,” so prescribing it should be up to the patient’s regular physician to ensure the drugs are the most appropriate treatment for the patient, ACP President Ryan D. Mire, MD, FACP, said in a news release. FDA recommended patients gather and present their own medical records to pharmacists – a “less than optimal” approach, especially when patients are dealing with acute illness, Mire said.
“The new FDA policy could compromise the provision of the most-appropriate, evidence-based care for patients,” Mire said. “Pharmacists are an important part of the clinical care team, however ACP opposes independent pharmacist prescriptive privileges and initiation of drug therapy outside of a collective practice agreement, physician standing order or supervision, or similar arrangement. The policy laid out by the FDA could remove the physician from the care process, preventing them from tracking potential adverse interactions. ACP underscores the importance of encouraging patients to consult their regular physician after testing positive for COVID-19 since the physician has a comprehensive awareness of the patient’s medical history.”
FDA should look for other ways to increase access to Paxlovid and additional care for COVID-19, Mire said.
AMA President Jack Resneck Jr. agreed on the importance of Paxlovid as a “critical tool in the fight against COVID-19.” But analyzing a patient’s medical history goes beyond a pharmacist’s scope and training, he said in a news release.
“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.”
In March, the U.S. Department of Health and Human Services (HHS) launched the Test to Treat initiative to get free treatments for COVID-19. The program, created through the HHS Offices of the Assistant Secretary for Preparedness and Response, is intended to make one-stop centers for tests and, if needed, treatments from local pharmacy-based clinics.
A program goal – and something APhA advocated for – was to improve equitable distribution of Paxlovid around the country. APhA argued the COVID-19 oral antiviral drugs were not being dispensed fairly and backed the claim with their own study and one by the federal Centers for Disease Control and Prevention.
The pharmacist group thanked FDA for the authorization.
“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,” APhA Interim Executive Vice President Ilisa BG Bernstein, PharmD, JD, FAPhA, said in a news release. “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.”