FDA backs pharmacist prescribing of Paxlovid for COVID

by Stephen Riddle

Some patients with COVID-19 will be able to get easier access to Pfizer’s oral antiviral therapy Paxlovid, after the FDA ruled that pharmacists would be able to prescribe the drug.

The regulator has revised the emergency use authorisation (EUA) for Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to patients, providing they can provide recent health records and a list of current medicines they are taking.

Specifically, the pharmacist will need to see records that are less than 12 months old and include blood test results that can be used to check for kidney or liver problems, or be able to consult with the patient’s healthcare provider.

If those criteria cannot be met, the pharmacist will have to refer the patient to a doctor, advanced practice registered nurse, or physician assistant able to prescribed the drug.

Patients should try to talk to their doctor first, or use a mobile test-to-treat site which are located outside pharmacies in some areas, with community pharmacists now a backup option if those are unavailable.

Ahead of the changes, the American Medical Association (AMA) had warned that the pharmacy-based clinic component of the test-to-treat scheme “flaunts patient safety and risks significant negative health outcomes,” not least because Paxlovid “has six pages of drug interactions.”

The restrictions on pharmacy prescribing outlined by the FDA seem to be in response to those concerns, but a new statement issued by the AMA after the announcement suggests it has not been wholly successful.

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—requirements far beyond a pharmacist’s scope and training,” said the organisation’s president Jack Resneck.

Nevertheless, the move will expand access to Paxlovid, which is authorised for the treatment of mild-to-moderate COVID-19 in patients who have a positive test result and are considered to be at high risk of developing severe disease.

It’s good news for Pfizer, which has maintained its prediction that sales of Paxlovid will reach $22 billion this year, despite slower-than-anticipated demand since the antiviral was authorised last December. It made $1.5 billion from the drug in the first quarter of the year.

“The FDA recognises the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, director of the FDA’s Centre for Drug Evaluation and Research (CDER).

“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,” she added.

The FDA’s amendment to the EUA comes as Pfizer has just filed for full approval of Paxlovid.

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