Pharmacy Groups Respond to AMA Criticism on Pharmacists Prescribing Paxlovid

Groups responded quickly in defense of pharmacists’ ability to prescribe Paxlovid through Test to Treat programs.

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.”

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