FDA Revises Paxlovid EUA to Allow State-Licensed Pharmacists to Prescribe Drug Under Certain Conditions
Paxlovid treats COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (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.
The FDA has revised the emergency use authorization previously issued to nirmatrelvir and ritonavir (Paxlovid; Pfizer) to allow state-licensed pharmacists to prescribe Paxlovid to eligible patients with COVID-19, with certain limitations that ensure appropriate patient assessment and prescribing of the drug. The EUA was granted in December 2021 for use in high-risk patients with COVID-19.
“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 Center for Drug Evaluation and Research, in a press release. “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.”
The investigational medication treats COVID-19 in adults and children [12 years of age and older weighing at least 88 pounds (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.
Under the revised EUA, after testing positive for COVID-19, patients should initially consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area. Although the revised EUA allows state-licensed pharmacists to prescribe Paxlovid with certain limitations, community pharmacies not currently participating as a Test-to-Treat site can decide whether or how they will offer this service to patients, according to the FDA.
To determine eligibility for administration of pharmacist-prescribed Paxlovid where prescribing by state-licensed pharmacists is available, those who tested positive for COVID-19 should bring the following to allow the pharmacist to determine eligibility Paxlovid:
- Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
- A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
Under the limitations in the EUA, state-licensed pharmacists should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
Under the EUA, patients in the authorized population with a positive home test result from a rapid antigen diagnostic test or a positive PCR test to their provider are eligible for Paxlovid. Confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral testing, such as a PCR, is not required and antibody tests are not considered to be direct SARS-CoV-2 viral tests, according to the FDA.
Paxlovid consists of 2 oral antiviral drugs, nirmatrelvir and ritonavir, that must be taken together. It is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at an increased risk of progression to severe disease.Nirmatrelvir is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro; also known as 3C-like protease or nsp5 protease). Inhibition of Mpro subsequently results in inhibiting viral replication by preventing the processing of polyprotein precursors. Ritonavir is a pharmacokinetic enhancer with no activity against SARS-CoV-2 Mpro. Ritonavir inhibits CYP3A-mediated metabolism of nirmatrelvir, resulting in increased nirmatrelvir plasma concentrations.
In a phase 2/3, randomized, double-blind, placebo-controlled study in non-hospitalized symptomatic adult subjects with a laboratory confirmed diagnosis of SARS-CoV-2 infection, subjects were randomized in a 1:1 ratio to receive Paxlovid or placebo orally every 12 hours for 5 days.
The researchers evaluated COVID-19-related hospitalization or death from any cause through day 28, viral load, and safety. The trial found that treatment of symptomatic COVID-19 with nirmatrelvir plus ritonavir resulted in a risk of progression to severe COVID-19 that was 89% lower than the risk with placebo, without evident safety concerns.
In a statement, the American Society of Health-Systems Pharmacists (ASHP) praised the FDA action in recognizing the important role that pharmacists have played in the pandemic.
“ASHP is pleased to see the FDA remove this barrier to patients’ access to this critical treatment,” said Tom Kraus, ASHP vice president of government relations. “Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication.”
Coronavirus (COVID-19) Update: FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations. FDA. News release. July 6, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations