State-licensed pharmacists in the United States are now authorized to prescribe Pfizer’s COVID-19 pill Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment, the U.S. Food and Drug Administration (FDA)said.
According to the American Pharmacists Association, the FDA recognized pharmacists’ expertise by revising the Emergency Use Authorization (EUA) for Paxlovid “to include pharmacists among other health care professionals permitted to prescribe this therapeutic medication.”
Previously, only doctors, nurses, or physician assistants were allowed to prescribe the two-drug treatment (nirmatrelvir and ritonavir) in line with its EUA “for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.”
FDA’s authorization comes in light of Paxlovid’s increased use in recent weeks to treat newly infected, at-risk people to prevent severe illness. Pfizer’s clinical trial results showed that Paxlovid cut the risk of hospitalization or death by 88% in non-hospitalized, high-risk adult patients who were taking the treatment for five days shortly after the onset of COVID-19 symptoms.
Patrizia Cavazzoni, Director of the FDA’s Center for Drug Evaluation and Research, emphasized in a statement that “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.”
According to FDA’s instructions, patients who have tested positive for COVID and want a prescription for the pills should bring “the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems” and a list of the all other medications they take, “so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.”
If case of lacking or insufficient information or if modifications are needed due to potential drug interaction, pharmacists should refer patients to other prescribers.
