Dr. Williams: Welcome to our new podcast series, Q&A with FDA, from the FDA’s Division of Drug Information, or DDI. The division includes a team of pharmacists that answer thousands of FDA drug related inquiries from the public each year. In this new podcast series, we will be answering some of the most frequently asked questions that we’ve received. Perhaps you have had the same questions but never asked.
My name is Celia Williams. In today’s episode, we’ll be discussing Paxlovid, which is now widely available in community pharmacies. We know that though the number of COVID-19 hospitalizations has decreased dramatically since early 2022, some high-risk patients are still getting sick enough to require hospital admission, and early treatment with Paxlovid and other available authorized or approved therapeutics could make a difference. According to the National Institute of Health COVID Treatment Guidelines, Paxlovid is the preferred therapy for the management of non-hospitalized adults with COVID-19.
Today we are joined by Dr. John Farley, Director of the Office of Infectious Diseases, who will provide useful information to help health care providers in decision making regarding Paxlovid.
Hi Dr. Farley, how are you today?
Dr. Farley: Very well, thank you.
Dr. Williams: Lets jump right in for our listeners. Dr. Farley, we know that Paxlovid was authorized under emergency use authorization, or EUA, by FDA in December 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing who are also at high risk for progression to severe COVID-19, including hospitalization or death. How exactly should health care providers assess a patient for “high risk for progression to severe COVID-19”?
Dr. Farley: So patients in the authorized population with a risk factor for progression to severe COVID-19 are eligible for Paxlovid under the EUA even if they’re fully vaccinated. They do not have to have more than one risk factor to be considered “high risk”.
Information on conditions that place a patient with mild-to-moderate COVID-19 at increased risk for disease progression or death can be found on the CDC website. Health care providers should consider the benefit-risk for an individual patient.
Dr. Williams: We know that Paxlovid may be prescribed by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. And just recently, FDA expanded this to include state-licensed pharmacists.
Dr. Farley: That’s right, so FDA recognizes that the most appropriate health care provider to manage a patient with mild-moderate COVID-19 is the patient’s primary health care provider, and we recommend that patients should first consider seeking care from their regular health care provider. However, considering that Paxlovid must be taken within five days after symptoms begin, and that there are a considerable number of patients in the U.S. who do not have a primary health care provider, access has been a challenge for some patients. And the U.S. government has established a Test-to-Treat program through which people are able to get tested and – if they are positive and treatments are appropriate for them – receive a prescription from a health care provider licensed to prescribe drugs (either on site or through telehealth), and have their prescription filled all at one location. These “One-Stop Test-to-Treat” sites are available at thousands of locations nationwide. Pharmacists have played a very important role in combatting this epidemic, and authorizing state-licensed pharmacists to prescribe Paxlovid could broaden access even further, facilitating more efficient care in settings where pharmacists work as part of a multidisciplinary team, or facilitating access at community pharmacies that are not already participating as a Test-to-Treat site that decide they are able to offer this service to patients.
Dr. Williams: As a pharmacist myself, I agree that pharmacists have a really important role to play here. How should pharmacists assess whether a patient is eligible to receive Paxlovid?
Dr. Farley: Patients who’ve tested positive for COVID-19 should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:
- First, electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult or a call to the patient’s primary health care provider.
- Patients should also bring a list of all medications they are taking, including over-the-counter medications so the pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
State-licensed Pharmacist prescribers have the same requirements as all other prescribers to ensure that the EUA is being followed. Mild-to-moderate COVID-19 can be determined by patient self-report of symptoms. Since Paxlovid is not authorized for the treatment of severe COVID-19, patients reporting shortness of breath or difficulty breathing should be referred for immediate medical assessment to evaluate whether the illness has progressed to the severe stage and may require hospital care.
Dr. Williams: Do patients need a positive polymerase chain reaction (or PCR) test to be treated with Paxlovid?
Dr. Farley: Patients in the authorized population who report a positive home test result from a rapid antigen diagnostic test to their provider are eligible for Paxlovid under the EUA. A positive result on a PCR test also meets the requirement under the EUA to have a positive test result. However, confirmation of a positive home rapid antigen diagnostic test with additional direct SARS-CoV-2 viral testing, such as a PCR, is not required.
Dr. Williams: You mentioned limitations. Can you expand upon the limitations for state-licensed pharmacists to prescribe Paxlovid under the EUA?
Dr. Farley: Yes, Paxlovid may be prescribed for an individual patient by a state-licensed pharmacist only if sufficient information is available to assess renal and hepatic function, and sufficient information is available to assess for potential drug interactions.
If this information is not available, or if modification of other medications is needed due to a potential drug interaction, or if Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible, the pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs.
Dr. Williams: Do you have guidance on how pharmacists should assess renal and hepatic function?
Dr. Farley: State-licensed pharmacist prescribers must have access to sufficient information from health records to assess renal and hepatic function. Health records include access to an electronic health record system containing this information in progress notes or laboratory records, reviewing a printed health record such as a laboratory report provided by the patient, or reviewing information in electronic health records the patient may have access to through a phone app or other means. Health records within the past 12 months are generally acceptable, provided there is no patient self-report or other information suggestive of kidney or liver disease. State-licensed pharmacists may also consult with a health care provider in an established provider-patient relationship with the individual patient to obtain this information. If sufficient information is not available to assess renal and hepatic function, the pharmacist should refer the individual patient to a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs.
Dr. Williams: Will state-licensed pharmacists be able to prescribe both the regular and renal doses of Paxlovid?
Dr. Farley: Yes, provided the state-licensed pharmacist has adequate information to assess renal function and the patient otherwise meets the eligibility criteria for receiving Paxlovid under the EUA. Paxlovid is supplied in two different dose packs, one for standard dosing and one for moderate renal impairment dosing.
- In patients with moderate renal impairment (that’s a GFR between 30 and 60 milliliters/minute), the dosage of Paxlovid is 150 mg nirmatrelvir (that’s one 150 mg tablet) and 100 mg ritonavir (or one 100 mg tablet) twice daily for five days.
- Patients with mild renal impairment or normal renal function should receive the standard dose of 300 mg nirmatrelvir (that’s two 150 mg tablets) and 100 mg ritonavir (or one 100 mg tablet). Mild renal impairment includes anyone with an eGFR greater than 60. And all three of those tablets are taken together orally twice daily for five days.
Paxlovid is not recommended at this time in patients with severe renal impairment, which is a GFR less than 30 milliliters per minute.
Dr. Williams: You also mentioned drug interactions. Do you have guidance on how pharmacists should assess for potential drug interactions?
Dr. Farley: Pharmacists have always played and will continue to play a critical role in identifying potential drug interactions with Paxlovid. All prescribers, including pharmacists, are expected to utilize available health records or patient history to obtain a complete list of all medications (both prescribed and non-prescribed) that the patient is taking. State-licensed pharmacists may also consult with a health care provider in an established provider-patient relationship with the individual patient in order to obtain a comprehensive list of medications the patient is taking. Should an adjustment to another medication be needed due to a potential drug interaction, the state licensed pharmacist should refer the individual patient for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs.
Dr. Williams: Are there any tools available to help health care providers manage potential drug-drug interactions with Paxlovid?
Dr. Farley: Yes. FDA recently updated the Fact Sheet for Health Care Providers for Paxlovid to provide more specific recommendations for some drugs. We also developed a Prescriber Patient Eligibility Screening Checklist. That checklist is intended to support clinical decision making, and I believe it is a very helpful addition to any prescriber’s “toolbox.”
Paxlovid contains nirmatrelvir and ritonavir. Ritonavir is a strong inhibitor of cytochrome P450 3A. Potential drug interactions are an important consideration. However, several commonly used medications with potential interactions such as statins, oral contraceptives, and HIV medications can be easily managed under provider supervision. And these recommendations are provided in the Health Care Provider Fact Sheet and the Eligibility Screening Checklist Tool, which also contains an alphabetized list of drugs with potentially significant drug interactions.
There are also other resources regarding management of drugs with potentially significant drug interactions with Paxlovid, and these include the NIH COVID Treatment Guidelines, as well as the University of Liverpool COVID-19 Drug Interactions website.
Dr. Williams: These tools are all available on FDA’s EUA webpage at fda.gov/covideuatherapeutics, under Paxlovid. This webpage also contains a link to the COVID-19 Test-To-Treat locator, which lists community pharmacies that have Paxlovid in stock. That locator tool includes a search glass icon, and if you simply enter the patient’s zip code, the pharmacies with the drug in stock are actually listed by proximity to the patient.
Dr. Farley, this has been so helpful for healthcare professionals like myself, and for consumers. Do you have any final remarks you'd like to share with health care providers about Paxlovid?
Dr. Farley: Yes, Paxlovid reduces the risk of hospitalization and death for patients with mild-to-moderate COVID-19 at high risk of disease progression, and health care providers should consider treatment with Paxlovid or other approved or authorized therapeutics in accordance with the approved labeling or authorized Health Care Provider Fact Sheets. Patients who test positive for SARS-CoV-2 who have symptoms should discuss treatment options with their health care provider as soon as possible after testing positive. Health care providers and patients should refer to CDC recommendations regarding patient isolation. Patients should wear a mask and isolate if they have any symptoms regardless of whether or not they have been treated with an antiviral agent.
Dr. Williams: For more information about the EUA for Paxlovid, including possible risks of use, the Fact Sheet for Health Care Providers, Prescriber Patient Eligibility Checklist, frequently asked questions, and the COVID-19 Test to Treat Locator, please visit FDA’s EUA webpage at fda.gov/covideuatherapeutics.
Thanks for tuning in to “Q&A with FDA” podcast series. The full podcast and transcript of this recording is available at fda.gov/QAwithFDA.
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