Covid-19: FDA authorises pharmacists to prescribe Paxlovid

The US Food and Drug Administration (FDA) has authorised licensed pharmacists to prescribe Pfizer’s oral antiviral drug Paxlovid (nirmatrelvir and ritonavir) to eligible patients who have tested positive for covid-19, subject to some limitations.1

The FDA’s action on 6 July, a revision of the emergency use authorisation, will make the drug more widely available to people with covid-19, particularly in rural and poor areas. About 90% of the US population lives within five miles of a pharmacy, according to the American Pharmacists Association.2 Until now, only doctors, nurses, and physician assistants could prescribe Paxlovid.

The drug is approved for treatment of mild to moderate covid-19 in adults and children aged 12 or older who weigh at least 40 kg and are at high risk for progression to severe covid-19, including hospital admission or death. Those who report a positive home test on either a rapid antigen diagnostic test or a polymerase chain reaction test are eligible for Paxlovid without further testing.

Patrizia Cavazzoni, director of FDA’s Center for Drug Evaluation and Research, said, “The FDA recognises the important role pharmacists have played and continue to play in this pandemic. Since Paxlovid must be taken within five days after symptoms begin, authorising state licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for treatment of covid-19.”

The American Medical Association expressed caution. President Jack Resneck Jr said, “While most 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 follow-up care to determine whether a patient is improving—requirements far beyond the pharmacist’s scope and training.” Covid-19 patients are best treated by a physician led team that includes pharmacists, he said.3

There are about 300 000 pharmacists in the US. They are licensed by individual states and each state regulates what pharmacists can prescribe and administer in that state. They can usually administer some or all vaccines, including childhood and adult vaccines. In some states they may be able to administer additional treatments.

The FDA advised patients who tested positive to first seek care from their regular health care provider or locate a Test to Treat site. Many of these sites are at “minute clinics” at chain drug stores. At these sites people can be tested for covid-19 and if they are positive they can receive a prescription from a healthcare provider (either on site or through telehealth), and have their prescription filled all at one location. Thousands of these one stop sites are available throughout the country, at pharmacy based clinics, federally funded health centres, long term care facilities, and community based sites. The programme was expanded in May.

The FDA advised that if people seek care directly from a pharmacist when they test positive, they should bring printed or electronic health records that are less than a year old and include the most recent reports of laboratory blood work for the pharmacist to review for kidney or liver problems. They should also bring a list of all medications they are taking—including over the counter drugs—so the pharmacist can screen for potentially serious drug interactions, the FDA added. If the patient does not bring sufficient information the pharmacist is advised to refer the person to a physician, advanced practice nurse, or physician assistant who is licensed to prescribe drugs.