FDA Allows Pharmacists to Prescribe COVID Drug Paxlovid | Health

THURSDAY, July 7, 2022 (HealthDay News) — Patients who test positive for COVID-19 can now obtain the antiviral pill Paxlovid directly from their pharmacist, the U.S. Food and Drug Administration announced Wednesday.

The action removes limits that limited prescribing power to health care providers and Test-to-Treat sites.

“The FDA recognizes the important role that pharmacists have played and continue to play in combating this pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release announcing the change. “Given that Paxlovid must be taken within five days of symptom onset, allowing state-licensed pharmacists to prescribe Paxlovid could expand access to prompt treatment for some patients eligible to receive this drug for the treatment of COVID-19.”

Paxlovid, made by Pfizer Inc., is intended to treat mild to moderate cases of COVID in people at high risk for severe COVID. It is approved for adults and children 12 years and older who weigh at least 88 pounds.

Patients who test positive for COVID-19 should always consider contacting their regular healthcare provider for Paxlovid first, the FDA noted.

Community pharmacies not already participating as a Test-to-Treat site can decide if or how they will offer this service to patients, the FDA added.

The American Medical Association (AMA) has expressed reservations about expanding prescribing power.

“Paxlovid is an important treatment and an essential tool in the fight against COVID-19,” WADA President Dr. Jack Resneck said in a statement released Wednesday. “While the majority of COVID-19 positive patients will benefit from Paxlovid, it is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and symptoms. follow-up care to determine if a patient is improving – requirements well beyond the scope and training of a pharmacist.

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will receive the best and most comprehensive care from teams led by doctors – teams that include pharmacists,” Resneck added. “But, whenever possible, prescribing decisions should be made by a physician who knows the patient’s medical history and is able to follow up. To ensure the best possible care for COVID-19 patients, we urge people whose test positive discuss treatment options with their doctor, if they have one.

Under the new authorization, patients are considered eligible for the drug if they are part of the population eligible to obtain the drug and have a positive rapid home antigen test or a positive PCR test. There is no need to confirm a positive test at home with a PCR test, the agency added.

Despite the decision to expand the use of Paxlovid, the paperwork required to obtain it is still significant.

This includes electronic or printed health records that are less than 12 months old, including the most recent reports of lab blood tests for the state-licensed pharmacist to investigate for kidney or liver problems, the FDA said. .

Instead, the pharmacist might receive this information through a consultation with the patient’s health care provider.

Patients should also provide a list of their current medications, including over-the-counter medications they are taking, so that the pharmacist can screen for potentially harmful drug interactions.

The pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed to prescribe medications if there is insufficient information for the pharmacist to assess the safety of the drug. patient. This includes if there is not enough information to assess the patient’s kidney and liver function. Paxlovid is not recommended for patients with severe kidney or liver problems.

More information

The US Centers for Disease Control and Prevention has more on COVID-19 treatments.

SOURCE: US Food and Drug Administration, press release, July 6, 2022

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