FDA Authorizes Pharmacists to Prescribe Paxlovid with Certain Limitations

Paxlovid is an oral antiviral drug that has been in the news as the latest, convenient treatment for mild-to-moderate COVID-19. It was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration in December 2021 to treat COVID-19. Until July 2022, Paxlovid needed to be prescribed by the patient’s health care provider. Now, in addition to a person’s regular health care provider, with the latest update of the EUA, the FDA authorizes pharmacists to prescribe Paxlovid (with certain limitations).

This is excellent news as this update in EUA of Paxlovid increases the treatment accessibility for patients all around the country. However, this development will undoubtedly affect our community pharmacies' workflow. To implement this change safely and effectively, big chain pharmacies will need to address staffing and scheduling issues as community pharmacists already have to manage heavy workloads.

Please continue reading to learn more about this latest coronavirus COVID-19 update.

What is Paxlovid?

Paxlovid is an antiviral medication that you can take by mouth at home. Based on data from the clinical trial conducted by Pfizer, Paxlovid has been shown to reduce the risk of severe illness and death by 89% in participants who received this medication compared to those who were given the placebo.

Paxlovid contains two medicines —nirmatrelvir and ritonavir. Paxlovid is available as a pre-packaged three-pill dose; each pack contains two (2) nirmatrelvir tablets and one (1) ritonavir tablet. The tablets in each pack are to be taken together two times a day for five days.

Nirmatrelvirblocks the key enzyme required for the coronavirus to multiply, thus, preventing COVID-19 from entering uninfected cells in the body. The other component of Paxlovid, ritonavir, acts as a booster for nirmatrelvir. Ritonavir slows the metabolism (breakdown) of nirmatrelvir in the liver and allows it to keep working for longer in the body.

The course of treatment of Paxlovid is 5 days. Each Paxlovid dose pack contains 3 tablets; these 3 tablets must be taken together twice daily for the entire 5 days.

Who should take Paxlovid?

The FDA has authorized Paxlovid treatment for adults and children 12 years or older who weigh at least 40 kilograms (about 88 pounds), have tested positive for COVID-19, and are at high risk of developing severe COVID-19 leading to hospitalization or even death. Examples of high-risk individuals include those over the age of 65 years and people with comorbid health conditions like diabetes, cancer, obesity, heart, kidney, or liver disease, and other conditions that weaken the immune system.

When should you take Paxlovid?

Like many antiviral drugs, timely treatment with Paxlovid is key. You should take this medicine within 5 days of your COVID-19 symptom onset. Once you have been sick for a week or longer, the drug can no longer undo the damage caused by the virus.

Do you need a COVID-19 test before Paxlovid?

Yes, Paxlovid is prescribed to people with mild to moderate COVID-19 who have positive results on direct SARS-COV-2 viral testing. This includes a positive result on a rapid antigen diagnostic test done at home or a positive PCR test result from a laboratory. People with a positive home rapid antigen test do not need to undergo a confirmatory PCR test for direct SARS-COV-2 viral testing. However, antibody tests are not considered direct SARS-COV-2 viral tests.

Is Paxlovid over the counter?

No, Paxlovid is not available over the counter. Up until July 2022, Paxlovid must be prescribed by a patient’s health care provider. Examples of a patient’s regular health care provider include a primary care physician or specialist, advanced practice registered nurse, or physician assistant licensed by law to prescribe drugs (human and veterinary drugs). With the recent EUA update, state-licensed pharmacists are authorized to prescribe Paxlovid to eligible patients.

Did the FDA authorize state-licensed pharmacists to prescribe Paxlovid?

Yes, in July 2022, the Food and Drug Administration revised the EUA, with the latest update authorizing state-licensed pharmacists to prescribe Paxlovid to eligible patients provided certain conditions are met.

The FDA recognizes the important role pharmacists have played in managing the pandemic. The ability of state-licensed pharmacists to prescribe Paxlovid is expected to expand access to this potentially life-saving medicine.

What conditions must a patient meet for a state-licensed pharmacist to prescribe Paxlovid?

Eligible patients who have tested positive for COVID-19 should seek care from their regular health care professional or test-to-treat site. If they are seeking care at community pharmacies where a state-licensed pharmacist can prescribe Paxlovid, they must provide the following information to the state-licensed pharmacist for appropriate patient assessment and drug evaluation:

Electronic or printed health records from the last 12 months for the state-licensed pharmacist to review renal and hepatic function (kidney or liver problems).
A list of current medications, including prescription drugs and over-the-counter medications, to rule out potentially serious interactions between Paxlovid and the patient’s other medications.

To ensure appropriate patient assessment, a state-licensed pharmacist must refer patients for clinical evaluation by a healthcare provider if:

There isn’t sufficient information available to assess the patient’s renal (kidney) and hepatic function.
There is a potential drug interaction between Paxlovid and another medicine that the patient is taking.
Potential drug interactions require modifications in the patient’s other medications.

Besides Paxlovid, what are some other oral antiviral medicines to treat COVID-19?

The U.S. Food and Drug Administration has also issued an EUA to another oral medication for COVID-19—molnupiravir (Lagevrio) made by Merck. However, this medication has only been found to reduce the risk of hospitalization and death from COVID-19 by 30%, based on data from different studies.

In contrast, based on the data from a clinical trial by Pfizer, Paxlovid (nirmatrelvir and ritonavir) has been shown to reduce the risk of severe illness and death from COVID-19 by 89% in the participants of the trial. While the recommendation is to take Paxlovid within 5 days of symptom onset, in the Pfizer clinical trial, these participants took Paxlovid within 3 days.

Another oral antiviral drug, Tamiflu, is used to reduce the duration of flu symptoms. It is similar to Paxlovid in that timely treatment is necessary for the drug to be effective. However, Tamiflu has not been studied for its ability to reduce the risk of severe illness or death from viral illnesses. It has only been studied to reduce the duration of flu symptoms.

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