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Pharmacists can now prescribe nirmatrelvir-ritonavir (Paxlovid) with certain limitations under a revised Emergency Use Authorization (EUA) for the COVID-19 antiviral treatment.
The pills must be taken within 5 days of symptom onset, so enabling patients to obtain a prescription from pharmacists could expand access to timely treatment, Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, noted in a statement.
Allowing pharmacists to prescribe the treatment will improve access in communities with fewer physicians and advanced practice clinicians, the president of the Infectious Diseases Society of America pointed out in a statement. “[R]ecent data show people who may be most in need of antiviral treatment for COVID-19, including Paxlovid, may not be receiving it because of where they live,” Daniel McQuillen, MD, said. “Barriers to treatment are particularly steep for many people of color and individuals with lower incomes who have been disproportionately impacted by COVID-19 and who live in underserved communities with fewer health care providers.”
But the president of the American College of Physicians (ACP) expressed concern about the FDA’s decision. The ACP “believes that more needs to be done to improve access to Paxlovid for treating COVID-19 infections in the outpatient setting,” Ryan Mire, MD, acknowledged in a statement. “[H]owever we believe that relaxing prescribing standards could jeopardize patient safety and undermine collaborative care.”
“The policy laid out by the FDA could remove the physician from the care process, preventing them from tracking potential adverse interactions,” Mire continued.
Nirmatrelvir-ritonavir is authorized to treat mild to moderate COVID-19 in nonhospitalized patients aged 12 years or older who are at high risk of progression to severe disease due to age, obesity, cancer, or chronic diseases such as type 1 or type 2 diabetes. (High-risk patients who have mild to moderate COVID-19 but are hospitalized for other reasons are also eligible.)
If people test positive for COVID-19, they should first consider seeking care from the health care professional who regularly provides it or at a test-to-treat site, the FDA recommends. Under the revised nirmatrelvir-ritonavir EUA, patients who test positive for COVID-19 and decide to seek a prescription from a pharmacist should provide electronic or printed health records less than a year old, including laboratory blood work, so the pharmacist can review them for liver or kidney problems. Patients also need a list of all medications they are taking so pharmacists can screen for drugs with potentially serious interactions with nirmatrelvir-ritonavir.
Créditos: Comité científico Covid