FDA Allows Pharmacists To Prescribe Pfizer Paxlovid COVID-19 Pills, AMA Reminds Medical History To Monitoring Side Effects

JAKARTA - The United States Food and Drug Administration (FDA) announced that it has authorized state-licensed pharmacists to prescribe Pfizer Inc.'s COVID-19 pills to eligible patients to help improve access to treatment.

The antiviral drug Paxlovid has been authorized for use and is available free in the United States since December, but less than half of the nearly 4 million distributed to pharmacies by the government so far have been dispensed.

Use of the pill, which is permitted to treat people who are newly infected and at risk to prevent severe illness, has spiked in recent weeks as infections rise.

"Because Paxlovid must be taken within five days of symptoms starting, allowing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients," Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement, cited from Reuters, July 7.

The agency said patients who test positive for COVID-19 should bring their health records for review by pharmacists for kidney and liver problems.

Meanwhile, the American Medical Association (AMA) said in a statement, prescribing decisions should be made by doctors wherever possible.

"It (Paxlovid) is not for everyone and prescribing it requires knowledge of the patient's medical history, as well as clinical monitoring for side effects and follow-up treatment to determine if the patient is improving," said AMA President Jack Resneck.

The FDA says pharmacists should refer patients to a licensed healthcare professional to prescribe medication, if there isn't enough information to assess kidney or liver function, or if modification is needed because of a potential drug reaction.

Patients with decreased kidney function may require lower doses of the medication, the agency said.

People in socially and economically disadvantaged areas are about half as likely to receive a COVID-19 antiviral pill as Paxlovid than those in wealthier postal codes, a study by the US Centers for Disease Control and Prevention (CDC) shows.