Tuesday
August, 16

FDA Authorizes Prescription Of Paxlovid For COVID-19 Patients

The antiviral medication Paxlovid is now available from pharmacists for patients who test positive for COVID-19, the U.S. The Food and Drug Administration stated on Wednesday.

The action lifts restrictions that limited the use of prescription drugs to healthcare professionals and Test-to-Treat locations.

In a news release announcing the change, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic.” Since Paxlovid must be taken within five days of the onset of symptoms, allowing state-licensed pharmacists to prescribe it could increase the number of patients who have timely access to treatment and are eligible for Paxlovid for the treatment of COVID-19.

The Pfizer Inc. drug Paxlovid is used to treat mild-to-moderate COVID in patients who are at high risk of developing severe COVID. Adults and kids over the age of 12 who weigh at least 88 pounds are both permitted to use it.

According to the FDA, patients who test positive for COVID-19 should still think about seeing their regular doctor first before taking Paxlovid.

The FDA said that community pharmacies that are not currently taking part as Test-to-Treat sites may choose whether or how to provide this service to patients.

Concerning the expanded prescribing authority, the American Medical Association (AMA) voiced its concerns.

According to a statement released on Wednesday by AMA President Dr. Jack Resneck, “Paxlovid is an important therapeutic and critical weapon in the fight against COVID-19.” While the majority of COVID-19-positive patients will benefit from Paxlovid, it is not appropriate for everyone, and prescribing it necessitates a medical knowledge of the patient, clinical monitoring for side effects, and follow-up care to see if the patient is improving—requirements that are well outside the purview of a pharmacist’s expertise.

Patients will receive the best, most comprehensive care from physician-led teams, teams that include pharmacists, nurses, and other healthcare professionals, in the fight against a virus that has killed more than a million people in the United States and is still highly present and contagious “Resneck threw in. “But, whenever possible, the choice to prescribe should be made by a doctor who has access to the patient’s medical records and the capacity to monitor the patient. We encourage persons who test positive to discuss treatment options with their doctor, if they have one, to ensure that COVID-19 patients receive the best care possible.

According to the new authorization, individuals are deemed qualified for the drug if they fall within the group of people who are allowed to obtain it and have positive results from either a PCR test or an at-home quick antigen test. The agency also stated that a PCR test is not necessary to follow up on a positive at-home test result.

The documentation needed to obtain Paxlovid is still substantial despite efforts to increase its scope of use.

The FDA stated that this includes digital or paper health records that are less than a year old, as well as the most recent laboratory blood work reports for the state-licensed pharmacist to check for kidney or liver issues.

Instead of doing this, the pharmacist could speak with the patient’s doctor to get this information.

For the pharmacist to check for potentially hazardous drug interactions, patients should also submit a list of their current prescriptions, including any over-the-counter medicines they use.

If there is insufficient information for the pharmacist to evaluate patient safety, they should send patients for a clinical examination with a doctor, advanced practice registered nurse, or physician assistant who is authorized to dispense medication. This also applies if there is insufficient data to evaluate the patient’s liver and renal function. Patients with severe liver or kidney issues shouldn’t use paxlovid.

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The antiviral medication Paxlovid is now available from pharmacists for patients who test positive for COVID-19, the U.S. The Food and Drug Administration stated on Wednesday.

The action lifts restrictions that limited the use of prescription drugs to healthcare professionals and Test-to-Treat locations.

In a news release announcing the change, Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said, “The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic.” Since Paxlovid must be taken within five days of the onset of symptoms, allowing state-licensed pharmacists to prescribe it could increase the number of patients who have timely access to treatment and are eligible for Paxlovid for the treatment of COVID-19.

The Pfizer Inc. drug Paxlovid is used to treat mild-to-moderate COVID in patients who are at high risk of developing severe COVID. Adults and kids over the age of 12 who weigh at least 88 pounds are both permitted to use it.

According to the FDA, patients who test positive for COVID-19 should still think about seeing their regular doctor first before taking Paxlovid.

The FDA said that community pharmacies that are not currently taking part as Test-to-Treat sites may choose whether or how to provide this service to patients.

Concerning the expanded prescribing authority, the American Medical Association (AMA) voiced its concerns.

According to a statement released on Wednesday by AMA President Dr. Jack Resneck, “Paxlovid is an important therapeutic and critical weapon in the fight against COVID-19.” While the majority of COVID-19-positive patients will benefit from Paxlovid, it is not appropriate for everyone, and prescribing it necessitates a medical knowledge of the patient, clinical monitoring for side effects, and follow-up care to see if the patient is improving—requirements that are well outside the purview of a pharmacist’s expertise.

Patients will receive the best, most comprehensive care from physician-led teams, teams that include pharmacists, nurses, and other healthcare professionals, in the fight against a virus that has killed more than a million people in the United States and is still highly present and contagious “Resneck threw in. “But, whenever possible, the choice to prescribe should be made by a doctor who has access to the patient’s medical records and the capacity to monitor the patient. We encourage persons who test positive to discuss treatment options with their doctor, if they have one, to ensure that COVID-19 patients receive the best care possible.

According to the new authorization, individuals are deemed qualified for the drug if they fall within the group of people who are allowed to obtain it and have positive results from either a PCR test or an at-home quick antigen test. The agency also stated that a PCR test is not necessary to follow up on a positive at-home test result.

The documentation needed to obtain Paxlovid is still substantial despite efforts to increase its scope of use.

The FDA stated that this includes digital or paper health records that are less than a year old, as well as the most recent laboratory blood work reports for the state-licensed pharmacist to check for kidney or liver issues.

Instead of doing this, the pharmacist could speak with the patient’s doctor to get this information.

For the pharmacist to check for potentially hazardous drug interactions, patients should also submit a list of their current prescriptions, including any over-the-counter medicines they use.

If there is insufficient information for the pharmacist to evaluate patient safety, they should send patients for a clinical examination with a doctor, advanced practice registered nurse, or physician assistant who is authorized to dispense medication. This also applies if there is insufficient data to evaluate the patient’s liver and renal function. Patients with severe liver or kidney issues shouldn’t use paxlovid.

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