According to the agency, this new authority may improve access to patients at high risk for severe COVID-19.
The FDA has revised the previous emergency use authorization (EUA) for nirmatrelvir and ritonavir (Paxlovid), with state-licensed pharmacists now authorized to prescribe the drug to eligible patients.1
However, there are some limitations in place to ensure “appropriate patient assessment and prescribing.”
Per these limitations, pharmacists should 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.
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.”
Paxlovid is authorized for the treatment of mild to moderate COVID-19 in adults and children 12 years of age and older weighing at least 40 kg who have tested positive for SARS-CoV-2 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Check back tomorrow for an additional update on the latest FDA Paxlovid announcement, including responses from national pharmacy organizations and the American Medical Association.