On July 6, 2022, the Food and Drug Administration (FDA) revised the Emergency Use Authorization for COVID-19 treatment Paxlovid. Under the new authorization, state-licensed pharmacists can now prescribe Paxlovid to eligible patients, amending the previous authorization that required an examination and a prescription from a licensed physician before pharmacists could dispense the treatment.
From the FDA press release:
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research. “Since Paxlovid must be taken within five 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.”
There are still limitations, however. If sufficient information isn’t available to assess a patient’s renal and hepatic function, or if the pharmacist cannot determine if there could be a potential drug interaction, that patient will still need to be seen by a licensed physician to obtain a prescription for Paxlovid.
“This latest FDA authorization significantly expands access to crucial and timely COVID-19 therapy for those at high risk for disease progression,” said Jason Ausili, Pharm.D., chief clinical officer for EnlivenHealth. “Community pharmacists, the nation’s most accessible healthcare providers, are uniquely positioned to fill this important gap in care across the U.S., especially in medically underserved areas and medical deserts. This is an exciting step forward for the profession and for those throughout the country that currently lack convenient access to this potentially life-saving therapy.”
The Next Step: Make the Authorization Permanent
The FDA has empowered pharmacists to prescribe Paxlovid to eligible patients, that authorization isn’t permanent, which continues to worry some in the industry. “Pharmacists are highly-skilled at evaluating the safety and efficacy of medications and are distinctly qualified for ‘Test to Treat’ programs for conditions like COVID-19, Flu, and Strep,” said Ausili. “Their education, skills, experience, and genuine patient and provider relationships drive confidence in their ability to meet the conditions set forth by the FDA. The most notable shortcoming highlighted by the FDA’s letter of authorization is that it will only make a temporary impact without the action of lawmakers.”
While the authorization activates the privileges pharmacists gained through the 9th Amendment to the Public Readiness and Emergency Preparedness (PREP) Act, the public health emergency (PHE) is set to expire on July 15, 2022. While it is likely to be extended another 90 days (the federal government gives at least 60 days notice if they don’t intend to extend the PHE beyond its current expiration date), the idea that these privileges are still temporary is enough to cause alarm within the industry.
Lawmakers need to take immediate action to adopt legislation that ensures long-term public access to these services and equitable reimbursement for pharmacists. For example, the Equitable Community Access to Pharmacists Services (ECAPS) Act, still awaiting a vote in Congress, expands Medicare coverage to permanently include pandemic-related services provided by a pharmacist.
The FDA authorizing pharmacists to prescribe Paxlovid to eligible patients is an exciting and important step forward — but it is far from the final step needed.