Is Paxlovid authorized under emergency use for treatment of mild to moderate COVID-19 disease in certain individuals?
Yes. Paxlovid (nirmatrelvir/ritonavir) is authorized under emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 disease in adults and pediatric patients (12 years and older weighing ≥ 40 kg) who are at high risk for progression to severe COVID-19 disease.
Why is it important for patients to have access to Paxlovid?
Paxlovid is authorized for individuals who are at risk of progression to severe COVID-19 disease, including hospitalization or death. This medication must be initiated in eligible, high-risk individuals within 5 days of mild to moderate COVID-19 symptom onset. In a study conducted by Pfizer, Paxlovid significantly reduced the risk of death and hospitalizations by 89% compared to placebo in nonhospitalized and high-risk adult patients who were treated within the initial 3 days of symptoms onset. Despite the emergence COVID-19 variants, Paxlovid still serves as a valuable therapy option for eligible patients. Therefore, increasing timely access to Paxlovid is critical.
If my patient is eligible but their symptoms are mild, is Paxlovid recommended?
Paxlovid is authorized to treat mild to moderate COVID-19 symptoms in patients who are at risk of progression to severe illness, including hospitalization or death. Therefore, it is important to assess patients with a diagnosis of mild to moderate COVID-19 disease to determine whether they are eligible to receive Paxlovid and initiate therapy, if appropriate. Patients who are eligible to receive Paxlovid are at risk of progressing to severe COVID-19 disease and should not wait for their symptoms to worsen before beginning therapy. For more information about eligibility please see the FDA fact sheet for health care providers.
What is COVID-19 rebound, and is it related to Paxlovid?
Some patients with COVID-19 experience a recurrence of symptoms or a new positive viral test after having previously tested negative. The phenomenon, called “COVID-19 rebound,” occurs independently and regardless of Paxlovid treatment or vaccination status. This brief recurrence of symptoms may be part of the natural progression of SARS-CoV-2 in some patients.
Recent case reports document that some patients who have completed a course of Paxlovid and have recovered can experience recurrent illness and/or subsequently test positive 2 to 8 days later, including patients who were up-to-date with COVID-19 vaccination. Both the recurrence of illness and positive test results improved or resolved without additional treatment. The CDC issued an advisory to update health care providers on the potential for COVID-19 rebound.
If a patient experiences COVID-19 rebound after taking Paxlovid, should a second course of Paxlovid be prescribed?
No, a second course of Paxlovid should not be prescribed. Currently, there is no evidence that additional COVID-19 treatment is required in patients experiencing COVID-19 rebound. Patient monitoring continues to be the most appropriate management for patients experiencing a recurrence of symptoms after completion of a treatment course of Paxlovid. Patients are advised to reisolate for at least 5 days per CDC guidance. Health care providers are recommended to report cases of COVID-19 rebound after Paxlovid treatment to Pfizer and FDA MedWatch.
What should pharmacists know about their authority to provide Paxlovid?
On September 9, 2021, HHS released the ninth amendment to the Public Readiness and Emergency Preparedness (PREP) Act. This amendment gives eligible pharmacists the federal authority to order and administer COVID-19 therapeutics that FDA has approved, authorized, cleared, or licensed.
When FDA authorized Paxlovid for emergency use as a COVID-19 therapeutic, the agency outlined a list of authorized prescribers, which initially excluded pharmacists. On July 6, 2022, FDA revised the EUA for Paxlovid to include pharmacists in the list of authorized prescribers, under certain conditions.
What conditions must pharmacists meet to prescribe Paxlovid as outlined in the EUA?
FDA’s EUA change permits Paxlovid to also be prescribed for an individual patient by a state-licensed pharmacist if both of the following conditions are met:
- Sufficient information is available, such as through access to health records less than 12 months old or consultation with a health care provider in an established provider-patient relationship with the individual patient, to assess renal and hepatic function.
- Sufficient information is available—such as through access to health records, patient’s reporting of medical history, or consultation with a health care provider in an established provider-patient relationship with the individual patient—to obtain a comprehensive list of medications (i.e., prescribed and nonprescribed) that the patient is taking to assess for potential drug–drug interaction.
The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug–drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the authorized fact sheet for health care providers or due to potential drug–drug interactions for which recommended monitoring would not be feasible.”
What liability protections exist?
During the public health emergency, pharmacists are protected under the PREP Act.
What if my state’s scope of practice does not allow me to order and/or administer COVID-19 therapeutics?
During the public health emergency, the federal authority to order and/or administer COVID-19 therapeutics applies even when state law otherwise prohibits a qualified person from ordering, dispensing, or administering covered COVID-19 therapeutics.
What if my state’s scope of practice is more permissive than this federal authority?
When state scope of practice allows pharmacists, pharmacy technicians, or pharmacy interns greater authority to order and/or administer therapeutics, this more permissive state authority would remain. Individuals practicing in such states should continue to follow their state scope of practice.
What steps can pharmacists take to ensure they have adequate supplies of Paxlovid in their pharmacies?
Distribution of Paxlovid is managed through the Health Partner Ordering Portal (HPOP). Pharmacies are considered providers and will be onboarded and managed by a central partner to begin submitting orders for Paxlovid. Central partners include jurisdictions (e.g., state health departments), Federal Retail Pharmacy Therapeutics Partners (FRPTPs) (e.g., CVS, Walgreens, Publix, Albertsons), and federal entities (e.g., Department of Defense, Indian Health Service).
If your pharmacy is not part of the FRPTP program, reach out to your state health department to register with HPOP as a provider.
ASPR’s Test to Treat Site Locator is designed for providers and displays locations that have received shipments of COVID-19 therapeutics.
What is the average amount of time needed to complete the patient assessment?
Based on preliminary feedback APhA has collected, pharmacists are completing patient assessments within 15–30 minutes on average and up to 45–60 minutes for more complex patient assessments. There are several associated clinical services required to prescribe Paxlovid, such as consultation to determine patient eligibility, assessing renal and hepatic function, obtaining a comprehensive list of medications (prescribed and nonprescribed), and assessing for potential drug–drug interactions.
Does a COVID-19 test need to be administered by the pharmacy before Paxlovid can be prescribed?
No. Patients who are symptomatic and report a positive test result from an FDA-authorized rapid antigen diagnostic test or a PCR test to the prescriber are eligible for Paxlovid if they meet other eligibility criteria when assessed. Individuals who report a recent known exposure to COVID-19 as well as signs and symptoms consistent with mild to moderate COVID-19 may be prescribed Paxlovid by their pharmacist even if they have a negative direct SARS-CoV-2 viral test result if they meet the remaining eligibility criteria. FDA continues to recommend the use COVID-19 testing when assessing whether a patient is eligible to receive COVID-19 oral antivirals.
Does the pharmacist need proof of a positive COVID-19 test?
No. Proof of a positive COVID-19 test is not required, and a patient’s report of a positive COVID-19 test is considered sufficient.
What resources will be needed to provide patient assessments?
There are several approaches pharmacists can take to safely assess and dispense Paxlovid to patients with an active COVID-19 infection. The right approach will differ depending on the resources available to the pharmacy. Pharmacists are encouraged to follow The Pharmacists’ Patient Care Process to deliver consistent and complete patient care. Some resources to consider include
- Dedicated spaces: Offering curbside and/or telehealth services for assessments and dispensing of Paxlovid may help reduce the potential for the infected individual to expose others. Some pharmacies may be able to create separate private spaces for COVID-19–positive patients to access these services. Temporary spaces such as trailers, tents, or areas of the pharmacy where a separate entrance exists can also be useful approaches.
- Staffing: Pharmacists will need to have dedicated time to provide the associated clinical services required to prescribe Paxlovid, such as performing consultation to determine patient eligibility, assessing renal and hepatic function, obtaining a comprehensive list of medications (prescribed and nonprescribed), and assessing for potential drug–drug interactions. Each assessment can take 15–30 minutes on average, and some may last as long as 45–60 minutes. It is critical to consider staffing resources before implementing prescribing services for Paxlovid.
- PPE: Personal protective equipment (PPE) must be used along with other strategies to reduce transmission from patients who are COVID-19–positive and being assessed for Paxlovid eligibility. Pharmacies may be able to order PPE through their local and state public health departments.
- Technology: Pharmacists will need a clinical documentation system to document the clinical assessment for Paxlovid eligibility. Other software programs for patient appointment scheduling and prescreening for Paxlovid eligibility can provide efficiencies in the assessment process.
Can a patient assessment be conducted via telehealth?
Yes. To reduce the potential for COVID-19 transmission, pharmacists may conduct patient assessments via telehealth and issue a prescription to patients for whom Paxlovid is indicated. The pharmacist must comply with telehealth requirements when providing this service.
Can a pharmacist call in a prescription for Paxlovid to another pharmacy?
Yes. As long as the pharmacist meets the conditions outlined in Paxlovid’s EUA for prescribing and has conducted a patient assessment, the prescribing pharmacist can call in the Paxlovid prescription to the patient’s desired pharmacy for dispensing.
When should a pharmacist refer a patient to another provider for further assessment?
The EUA lists several scenarios in which the pharmacist should refer a patient for clinical evaluation (e.g., telehealth, in-person visit) with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs. This includes the following scenarios:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug–drug interaction.
- Modification of other medications is needed due to a potential drug–drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug–drug interactions for which recommended monitoring would not be feasible.
Patients exhibiting shortness of breath and difficulty breathing may be progressing to severe COVID-19 disease and should be referred immediately for further clinical evaluation.
Is reimbursement available for the clinical services required for pharmacists to prescribe Paxlovid or for the dispensing the product?
At this time, there is no federal coverage and limited state coverage for the associated clinical services required for pharmacist prescribing of Paxlovid. Pharmacists providing patient assessment and prescribing Paxlovid are currently requiring patients self-pay for the service.
While payment for the patient assessment is limited, reimbursement should be in place for dispensing Paxlovid; however, reports indicate that reimbursement for dispensing Paxlovid and the enhanced dispensing activities required is very low. APhA continues to call for fair reimbursement to pharmacists who provide this clinical service, and we hope you’ll take action too.
As reimbursement pathways are established, it is important to separate payment for the clinical services for pharmacists provide to assess the patient and prescribe Paxlovid (if eligible) from the dispensing fees for these medications. There are 3 scenarios that can result from each patient encounter:
- Assessment and dispensing: The pharmacist conducts an assessment, determines that Paxlovid is indicated for the patient, and prescribes Paxlovid. The patient chooses to fill their prescription for Paxlovid at the pharmacy or the pharmacy of their choice; in either case, a pharmacist dispenses the medication.
- Assessment only: The pharmacist conducts an assessment and determines that the Paxlovid is not indicated for the patient. The pharmacist may refer the patient for further clinical evaluation as indicated.
- Dispensing only: Paxlovid is prescribed by a provider other than the pharmacist and the pharmacist dispenses Paxlovid. This may require modifications to the packaging in order to make renal dose adjustments and other enhanced dispensing requirements to ensure patient safety.