The U.S. Food and Drug Administration said on Wednesday it had authorized state-licensed pharmacists to prescribe Pfizer Inc’s (PFE.N) COVID-19 pill to eligible patients to help improve access to the treatment.
The antiviral drug, Paxlovid, has been cleared for use and available for free in the United States since December, but fewer than half of the nearly 4 million courses distributed to pharmacies by the government so far have been administered.
Use of the pill, authorized to treat newly infected, at-risk people to prevent severe illness, has, however, jumped in recent weeks as infections rise.
“Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients,” Patrizia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research, said in a statement.
The agency said patients who tested positive for COVID-19 should bring their health records for the pharmacists to review for kidney and liver problems.
The American Medical Association (AMA) said in a statement prescribing decisions should be made by a doctor wherever possible.
“It (Paxlovid) is not for everyone and prescribing it requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving,” said AMA President Jack Resneck.
The FDA said pharmacists should refer the patients to a healthcare professional licensed to prescribe drugs if there is not sufficient information to assess kidney or liver function, or if modifications are needed due to a potential drug reaction.
Patients with reduced kidney function may need a lower dose of the treatment, the agency has said.
People in socially and economically disadvantaged regions are about half as likely to receive antiviral COVID-19 pills like Paxlovid than those in wealthier zip codes, a study by the U.S. Centers for Disease Control and Prevention showed. read more
SOURCE: Reuters – Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, NJ; Editing by Shinjini Ganguli and Deepa Babington