What Healthcare Providers Need to Know About Paxlovid’s New Prescribing Requirements
Key takeaways:
Paxlovid (nirmatrelvir/ritonavir) is an oral medication that’s FDA approved to treat mild to moderate COVID-19 in certain people who are at a high risk of becoming severely ill. It was initially only available via emergency use authorization (EUA).
In July 2022, pharmacists gained the authority to prescribe Paxlovid through an update to the medication’s EUA. Paxlovid’s EUA is still active and valid.
All prescribers should confirm Paxlovid is appropriate for their patients, with particular attention to medication interactions and recent renal and hepatic function.
Paxlovid (nirmatrelvir/ritonavir) is an oral medication that’s no stranger to headlines. It was first authorized by the FDA in December 2021 to treat mild to moderate COVID-19. In mid-2022, prescribing authority for Paxlovid was expanded to pharmacists to help people with COVID receive treatment faster and to make the medication more accessible. Fast forward to May 2023, Paxlovid was fully FDA approved for use. It’s the first oral antiviral pill to be approved for COVID.
How did Paxlovid’s updated emergency use authorization expand prescribing?
On July 6, 2022, the FDA revised the emergency use authorization (EUA) for Paxlovid to allow pharmacists to prescribe it to eligible patients. While this is not the first time pharmacists have been authorized to prescribe a medication, it is a milestone that the American Pharmacists Association strongly pushed for.
Before the FDA can issue an EUA for any unapproved medical product or device, the Secretary of the Department of Health and Human Services (HHS) must rule that it’s appropriate. Part of that process involves the HHS Secretary ensuring that the situation meets certain criteria, including that there are no other adequate, available, and approved alternatives. Because of this, it is unlikely that we will see a rapid expansion in pharmacist’s prescribing authority for other medications, unless changes are made to either state or federal legislation.
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The revised EUA does not remove prescribing authority for Paxlovid from other licensed providers. This includes physicians, physician assistants, nurse practitioners, and others with prescribing authority in their state, whether or not they’re participating in the Test to Treat program.
What’s more, even though Paxlovid is now fully approved for use, that doesn’t change who can prescribe it. Pharmacists, physicians, and other licensed providers can all still prescribe it for eligible people.
When can a pharmacist prescribe Paxlovid?
Pharmacists must meet additional requirements to prescribe Paxlovid. Pharmacists may only dispense Paxlovid to patients that meet certain eligibility guidelines and they must ensure the following conditions are met:
Sufficient information is available to assess renal and hepatic function. Pharmacists must have access to health records less than 12 months old or speak with a healthcare provider who has an established relationship with the patient.
Sufficient information is available about the patient’s comprehensive medication history. Pharmacists must collect a comprehensive medication history by speaking with a patient or their healthcare provider and/or looking at their health records.
In some cases, pharmacists may be unable to meet these conditions or may determine that Paxlovid is not appropriate because of a medication interaction or other issue. In these cases, pharmacists are required to refer patients to their regular provider.
When is a patient eligible for Paxlovid?
Eligible patients are those who are at least 12 years old, weigh at least 40 kg (88 lbs), and have mild to moderate COVID. Patients should begin taking Paxlovid within 5 days of the start of their symptoms.
To be eligible, a patient must also be at a high risk of progressing to severe COVID that could potentially lead to hospitalization or death. While Paxlovid’s labeling does not specifically define “high risk,” the CDC considers high-risk individuals to be those who:
Have certain health conditions, such as cancer, chronic kidney disease, or chronic lung disease
Have multiple chronic health conditions
Have a weakened immune system
Have disabilities
Are over the age of 65
Previously, a positive COVID test was also required in order to dispense Paxlovid. However, on February 1, 2023, the FDA removed this requirement. Now, it’s only a recommendation. This opens the door to treatment for people who test negative for COVID but have symptoms and are at high risk for severe illness.
When should Paxlovid not be prescribed?
Paxlovid should not be prescribed:
To patients who need to be hospitalized because of severe COVID
For either pre-exposure or post-exposure prophylaxis
For longer than a 5-day duration
To patients with severe renal impairment, or an estimated glomerular filtration rate (eGFR) of less than 30 mL/min
To patients with severe hepatic impairment, or Child-Pugh class C or greater
To patients taking certain interacting medications
Paxlovid is metabolized by CYP3A, which represents a possible interaction with other medications, including but not limited to:
Amiodarone (Pacerone)
Rivaroxaban (Xarelto)
Dabigatran (Pradaxa)
Colchicine (Colcrys, Mitigare)
Finally, the effects of Paxlovid on patients who are pregnant or breastfeeding are not fully known. But the FDA has noted that, while published observational studies on Paxlovid do not currently indicate any increase in the risk of birth defects, there are known risks associated with untreated COVID during pregnancy.
The recommendations of the American College of Obstetrics and Gynecology state that clinicians can consider prescribing Paxlovid to patients who are pregnant. The organization’s recommendations also note that breastfeeding is not a contraindication.
The bottom line
Pharmacists are the latest addition to the list of providers authorized to prescribe Paxlovid. All prescribers should ensure the medication is only written for patients who are eligible to receive it. However, pharmacists must also ensure they have access to adequate information to assess a patient’s renal and hepatic function, as well as obtain a thorough medication history.
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