FDA Expands EUA to Allow Pharmacists to Prescribe Paxlovid

Recently, the FDA expanded its emergency use authorization (EUA) for Paxlovid, an oral antiviral medication. This expansion permits pharmacists to prescribe this antiviral medication to patients experiencing mild or moderate symptoms.  

Paxlovid was initially authorized for emergency use on December 22, 2021. This drug is a combination of nirmatrelvir and ritonavir and has been successfully used for patients over 12 experiencing mild or moderate COVID-19 symptoms.  

Each chemical compound in Paxlovid serves a specific purpose. For example, the function of nirmatrelvir is to slow down or limit the virus’ replication in the body. Meanwhile, ritonavir slows the metabolism of nirmatrelvir, allowing it to persist and serve its function for an extended time.  

According to the original press release, Paxlovid was the first oral medication to manage and treat COVID-19. It is only used within the first five days of symptoms and is not recommended for asymptomatic patients.  

Studies on Paxlovid found that it yielded an 88% decrease in the risk of hospitalization or death for those infected with COVID-19.  

Due to the time-sensitivity regarding Paxlovid prescriptions, the EUA expansion may widen accessibility to the medication.  

“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, in the press release. “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.”  

Despite this expansion, the FDA advises pharmacists to reach out to additional medical professionals, including physicians, advanced practice registered nurses, or physician assistants in some instances, regarding renal and hepatic function, drug interactions, and medication modification.  

The original EUA highlights that understanding renal and hepatic risk is essential as Paxlovid dosage may change for patients with renal impairment. Previous studies have found that patients with severe kidney or liver issues should not take this antiviral medication.  

Furthermore, some aspects of Paxlovid, such as enzyme inhibition, can be dangerous and potentially fatal when interacting with patients’ other medications.  

While this EUA expansion may help remove a barrier to healthcare access, pharmacists and patients are urged to be vigilant in prescribing and using Paxlovid. A thorough understanding of patient history and monitoring of side effects is necessary for the safe use of the drug.