Sunday, November 27, 2022

FDA authorizes pharmacies to sell Paxlovid pill against covid-19

FDA decision, who wants Accelerate access to medicine for those who need itRemoves limitations restricting health care providers’ ability to prescribe Paxlovid.

“The FDA recognizes the important role that pharmacists have played and continues to play in fighting this pandemic,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a news release announcing the change. “Since Paxlovid Must be taken within five days of onset of symptomsAuthorization for State-Licensed Pharmacists to Prescribe Paxlovid Expand access to timely treatment Certain patients who are eligible to receive this medicine.

Paxlovid, manufactured by pharmaceutical giant Pfizer, aims to Treat mild or moderate cases of COVID in people at high risk Serious infection, including hospitalization or death. It is approved for adults and children 12 years of age and older who weigh at least 88 pounds,

Patients who test positive for COVID-19 should continue to consider the possibility Visit your regular healthcare provider first for a Paxlovid prescriptionFDA noted.

The FDA said community pharmacies that do not yet participate as treatment trial centers can decide whether they will provide this service to patients.

Paxlovid. medical community reservation against increased access to

“PaxLovid is an important treatment and an important tool in the fight against COVID,” AMA President Jack Resnek said in a statement. “Although most patients who have tested positive will benefit from Paxlovid, it is not for everyone and Its prescription requires knowledge of the patient’s medical historysimultaneously clinical monitoring of side effects And this follow-up care To determine whether a patient is improving, requirements that go far beyond the scope and training of a pharmacist.”

The AMA’s president reminded that whenever possible, prescription decisions should be made by a doctor who is aware of the patient’s medical history.

Under the new authorization, patients deemed eligible to receive the drug if they belong to a population authorized to receive it and have a positive rapid antigen test at home or a positive PCR test. The agency said it is not necessary to confirm a positive home test with a PCR test.

Despite the widespread use of Paxlovid, the paperwork required to obtain it remains extensive.

essential Submit medical history not less than 12 months old in electronic or printed format, Including the latest laboratory blood test reports for state licensed pharmacists to review kidney or liver problemsAccording to the FDA.

If the pharmacist has insufficient information to assess patient safety, refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed to prescribe medication to the pharmacist needed.
Paxlovid is not recommended for patients with severe kidney or liver problems.

Paxlovid is the brand name of Pfizer’s oral antiviral treatment for Covid-19. It is made up of two sets of pills that are taken together. Standard treatment with Paxlovid consists of two nirmatrelvir tablets and one ritonavir tablet twice a day for five days, for a total of 30 tablets.

As an antiviral, Paxlovid should be taken as soon as possible after a person becomes ill, and is not recommended for people who have been hospitalized for COVID-19.

And pfizer clinical trial released last year, carried out on about 2,250 people who were not vaccinated against SARS-CoV-2 with at least one risk factor (obesity, high blood pressure or diabetes), indicating that the drug is effective in this type of disease. Reduces hospitalization and deaths by 88%. At the time it was also reported to be effective against the Omicron variant.

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