The US Food and Drug Administration (FDA) has revised the Emergency Use Authorisation (EUA) for Paxlovid (nirmatrelvir and ritonavir), authorising pharmacists to prescribe the drug to eligible patients.
Under the revision, state-licensed pharmacists will be able to prescribe the drug to patients testing positive for COVID-19, on the condition that they can provide recent health records and a list of current medicines they are taking.
As outlined in the authorisation, the health records must be less than 12 months old and include the most recent reports of laboratory blood work to check for kidney or liver problems.
Patients are encouraged to first seek care from their doctor or use a mobile test-to-treat site in their area. Community pharmacies not already participating as a test-to-treat site can also decide if or how they will offer the treatment to patients.
Under the limitations in the authorisation, the pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant, if sufficient information is not available in certain cases.
Paxlovid is an orally administered drug that should be given at the first sign of infection for the treatment of patients with mild-to-moderate COVID-19 who are at a high risk of developing severe disease. The drug is currently approved or authorised for conditional or emergency use in more than 65 countries.
Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said: “The FDA recognises the important role pharmacists have played and continue to play in combating this pandemic.
“Since Paxlovid must be taken within five days after symptoms begin, authorising 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.”
In June, Pfizer announced the submission of a New Drug Application (NDA) to the FDA for the approval of Paxlovid for both vaccinated and unvaccinated patients who are at high risk of severe illness from COVID-19, consistent with current emergency use authorisation.
The NDA submission follows positive results from a phase 2/3 EPIC-HR study which demonstrated that, compared to placebo, treatment with Paxlovid reduced the risk of hospitalisation in non-hospitalised, high-risk adult patients treated within five days of symptom onset or death from any cause by 88%.