All the patients who test positive for an infectious disease Coronavirus caused by the SARS-CoV-2 virus can now get the antiviral pill named Paxlovid (nirmatrelvir and ritonavir) directly from their authorized pharmacists, the U.S. Food and Drug Administration announced on July 06, 2022.
The action eliminates the limits that had restricted prescribing authority to health care specialists and Test-to-Treat sites.
While announcing the change, Patrizia Cavazzoni, director for the Food and Drug Administration’s Center for Drug Evaluation and Research, said, “The FDA recognizes the important role pharmacists have played and continue to play in combating COVID. Since Paxlovid (nirmatrelvir & ritonavir) must be taken within 5-days after symptoms begin, authorizing pharmacists to prescribe this antiviral could expand access to timely treatment for some patients who are eligible to receive this medicine for the treatment of Coronavirus Disease.”
Paxlovid (nirmatrelvir and ritonavir), made by Pfizer Inc., aimed to treat mild-to-moderate cases of Coronavirus Disease in individuals who are at increased risk for severe COVID. This antiviral medicinal product is approved for adults and for children ages 12 and up who weigh at least 88 pounds.
Patients who test positive for this infectious disease (COVID) should still consider reaching out to their regular healthcare professionals for Paxlovid: an oral antiviral medicine first, the Food and Drug Administration noted.
Community pharmacies not already participating as a Test-to-Treat site can determine if or how they will offer this service to patients, the Food and Drug Administration added.
According to AMA President Dr. Jack Resneck, “Paxlovid (nirmatrelvir pills; ritonavir pills) is a vital treatment and essential tool against Coronavirus Disease. While the majority of Coronavirus positive patients will benefit from this oral antiviral therapy, it is not for all and prescribing it typically needs knowledge of a patient’s medical history, as well as clinical monitoring for adverse reactions and follow-up care to specify whether a patient is improving – requirements far beyond a pharmacist’s scope and training.”
Under the recent authorization, patients are considered eligible for the medicine if they are in the population authorized to get the medicine and have a positive at-home rapid antigen test or a positive PCR test. It is not needed to confirm a positive at-home test with a PCR test, the agency added.
Regardless of the intent to expand the use of Paxlovid (nirmatrelvir ritonavir), the paperwork required to get it is still significant.
This includes electronic or printed health findings that are less than 12 months old, including the most recent findings of laboratory blood work for the pharmacist to review for renal or liver complications, the FDA said.
In lieu of this, the pharmacist could receive this detail through a consultation with the patient’s health care provider.
Respective patients should also provide the list of their current medicines, including over-the-counter drugs they take, so that the pharmacist can screen for potentially hazardous drug interactions.
Pharmacists should refer patients for a clinical evaluation with a physician, authorized nurse or physician assistant licensed to prescribe medicines if there is not sufficient details for the pharmacist to assess patient safety. This includes if there is not sufficient information to assess the patient’s renal and liver function. Paxlovid (nirmatrelvir; ritonavir) isn’t recommended for patients with severe renal or liver complications.