The FDA has given authorization, with some limitations. The American Medical Association says only doctors should be prescribing the drug used to treat COVID-19 patients.
Pharmacists can prescribe Paxlovid to COVID-19 patients, and advocates say it’s a good step to ensure fair access to the medication.
Physicians, meanwhile, insist only doctors should be prescribing the drug.
The Food and Drug Administration announced this week that pharmacists can provide Pfizer’s Paxlovid, a drug used to treat some of the most serious symptoms of COVID-19. The FDA did impose some limitations.
State-licensed pharmacists can prescribe the drug, but patients must provide a list of all medications they’re taking and electronic or printed health records less than a year old, including the most recent reports of laboratory blood work to review for kidney or liver problems.
David Pope, executive vice president of innovation and industry relations at OmniSYS, called it a big win for patients, because nine out of 10 Americans live within five miles of a pharmacy.
“It addresses equitable access for healthcare,” Pope said in an interview with Chief Healthcare Executive.
“There may not be a red light in every town, but there is a pharmacy in almost every town,” Pope said.
The American Pharmacists Association also welcomed the FDA’s announcement. Ilisa Bernstein, APhA interim executive vice president and CEO, said it’s time to recognize pharmacists as “critical providers of care for important COVID-19 treatments."
“Opening the door for pharmacists as prescribers will open the door to equitable access at pharmacies in communities across the country,” Bernstein said in a statement.
“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.
Doctors aren’t happy with the FDA’s decision. The American Medical Association criticized the FDA’s move.
Jack Resneck Jr., president of the AMA, said only physicians should be prescribing paxlovid.
“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.
“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.”
The AMA said it urges those who test positive to talk about treatment options with a physician, if they have one.
Pope and the pharmacists’ association both said that some people, particularly in rural areas, have to make a long trip to see a doctor.
In some cases, pharmacists will refer patients to a physician, but there are times when pharmacists are capable of prescribing Paxlovid, Pope said.
“Armed with the right information, I believe they’re up for the challenge,” Pope said. “While pharmacists are struggling under the weight of busy-ness, they’re absolutely excited about the opportunity.”
The FDA's announcement comes as the coronavirus BA.5 subvariant is now the dominant strain in the country, according to the U.S. Centers for Disease Control and Prevention. COVID-19 cases and hospitalizations have risen in the past two weeks.
The pharmacists’ association said one area that needs to be addressed is how the Center for Medicare and Medicaid Services and private insurers pay pharmacists.
“While we appreciate the opportunity to serve our patients in this capacity, this effort will only be successful and sustainable if CMS and other payers take immediate action to provide adequate and appropriate payment for pharmacist consultations and services,” Bernstein said.
If patients end up stuck paying more, Pope said that undercuts the goal of making it easier for people to get Paxlovid.
“I am concerned from a patient perspective,” Pope said. “If the visit is not covered by your insurance, you may elect not to go to your pharmacist. It flies in the face of equitable access."
“If your insurance doesn’t cover it, we’re placing an undue burden on the patient," he said.
Paxlovid is authorized for patients 12 and older with mild to moderate symptoms of COVID-19 and who face a risk of more serious complications.
The FDA’s move also could be a step toward giving pharmacists the ability to have a greater role in prescribing medications.
In Florida, pharmacists can test or treat patients for the flu, under a law that took effect in 2020.
Pharmacists have taken on greater roles in immunization and in tobacco cessation programs in recent years, Pope said. Now, they can help patients with COVID-19 obtain a prescription for a drug that can help them avoid more serious complications.
“This is a natural evolution,” Pope said.