On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker and easier access for patients.
Pfizer’s Paxlovid was first granted an EUA in December 2021, meaning that the FDA authorized the product for emergency use, even though it has not been approved for any purpose by the FDA. Paxlovid is used to treat patients 12 years or older who test positive for COVID-19 and who are at high risk that the disease will progress and become severe, leading to hospitalization or death. The drug has been shown to significantly reduce the risk of hospitalization or death. Paxlovid must be taken within five days after the onset of symptoms, so timely access is key.
Pharmacists are typically prohibited from performing certain clinical activities, such as assessing patients or independently prescribing medications. These limitations have temporarily been lifted during the COVID-19 pandemic, as the Public Readiness and Preparedness Act (PREP Act) authorized pharmacists to take actions like administering COVID-19 tests and vaccines, and order and administer certain COVID-19 treatments.
Despite the general authorizations in the PREP Act, the initial EUA for Paxlovid did not allow pharmacists to prescribe Paxlovid. The initial authorization limited prescribers to doctors, advanced practice registered nurses, and physician assistants, which made it difficult for some patients to obtain the drug during the five-day window.
The July 6 updated authorization allows state-licensed pharmacists to prescribe Paxlovid in certain circumstances. There must be “sufficient information” available to the pharmacist, either through the patient’s medical records or by speaking with another health care provider, to assess kidney and liver function. The pharmacist must also be able to obtain a complete list of medications, both over-the-counter and prescription, that the patient is currently taking in order to evaluate potential drug interactions. If these conditions are met, the pharmacist may choose to prescribe Paxlovid to the patient.
Paxlovid is an important piece of the White House’s COVID-19 response plan going forward. The government purchased 20 million courses of Paxlovid, and has worked to set up test-to-treat sites where patients can receive a COVID-19 test and get an immediate Paxlovid prescription if their test is positive. With the new authorization, pharmacies can become additional test-to-treat sites across the country.
Although timely prescribing of Paxlovid is important, among the factors to considered before prescribing Paxlovid under the updated EUA are the following.