Questions-and-Answers-Treatment-Information-for-Providers-and-Facilities Questions and Answers: COVID-19 Treatment Information for Providers and Facilities

Questions and Answers: COVID-19 Treatment Information for Providers and Facilities

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​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Key points:​

  • Most adults and some children with symptomatic COVID-19 are eligible for treatments. 

  • Antiviral treatment saves lives and prevents hospitalizations. 

  • Given the broad range of people who can benefit from treatment, providers should have a low threshold for prescribing COVID-19 therapeutics. ​

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Intro​duction 

Frequently Asked Questions About Outpatient Treatments for SARS-CoV-2 

  1. Are available antivirals effective against new variants?

  2. Does a patient need a positive COVID-19 test in order to be prescribed nirmatrelvir/ritonavir (Paxlovid) or molnupiravir (Lagevrio)?

  3. What should providers consider when deciding whether to monitor patients for worsening symptoms or to prescribe?

  4. Can children be prescribed anti-SARS-CoV-2 outpatient treatments?

  5. Are anti-SARS-CoV-2 outpatient treatments safe for geriatric patients?

  6. ​​How can providers check drug-drug interactions with nirmatrelvir/ritonavir (Paxlovid) and other therapeutics?

  7. ​​​​Where can I find information on the contraindications for and side effects of available COVID-19 therapeutics? 

  8. Are renal and hepatic lab results required before a physician or advanced practice provider can prescribe nirmatrelvir/ritonavir (Paxlovid)?

  9. Do providers need to check patients’ creatinine levels to prescribe nirmatrelvir/ritonavir (Paxlovid)? Is the eGFR rele​vant?​

  10. ​​​What should a provider do when a patient has known or suspected kidney or liver disease?

  11. Are pharmacists limited in prescribing nirmatrelvir/ritonavir (Paxlovid), e.g., in cases where a patient’s kidney or liver functions are problematic, or a patient doesn’t have recent labs?

  12. Can I prescribe oral antivirals in ad​vance for patients who are traveling and concerned that they might develop COVID-19?

  13. Is it permissible to have a standing order for nirmatrelvir/ritonavir (Paxlovid) prescription and to have an RN conduct the assessment? 

  14. What does a clinician COVID-19 treatment workflow look like? 

  15. What are best practices for long-term care facilities?

  16. How can providers track whether patients take their COVID-19 therapeutics? 

  17. What is the best practice for following up with patients who have tested positive for COVID-19 (e.g., 2-3 days after positive test)? ​

Int​rod​uction​ 

Key points:
  • Most adults and some children with symptomatic COVID-19 are eligible for treatments. 
  • Antiviral treatment saves lives and prevents hospitalizations. 
  • Given the broad range of people who can benefit from treatment, providers should have a low threshold for prescribing COVID-19 therapeutics. 

For an overview of available outpatient treatments, please refer to the California Department of Public Health (CDPH) COVID-19 Treatment Resources for Healthcare Providers page. ​​​

​​COVID-19 treatments play an important role in preventing illness and helping people recover from COVID-19, with the goal of saving lives, reducing hospitalizations, and releasing pressure on stressed hospital systems. Treatments can be ordered for eligible patients based on exposure status, symptoms, and risk factors for severe disease progression. 

​CDPH recommends that providers prescribe nirmatrelvir/ritonavir (Paxlovid) to symptomatic patients who have tested positive for COVID-19, even if symptoms are mild. Nirmatrelvir/ritonavir (Paxlovid) can be prescribed to the majority of patients eligible for COVID-19 treatment. Remdesivir (Veklury) should be considered first when nirmatrelvir/ritonavir (Paxlovid) is clinically contraindicated, and molnupiravir (Lagevrio) may be considered if remdesivir is impractical. 

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Frequently Asked Questions about Outpatient Treatments for SARS-CoV-2 

​​1. Are available antivirals effective against new variants?

Yes.

Viruses ​continuously mutate as they circulate among the population, creating new variants. COVID-19 therapeutic products vary in their vulnerability to new variants depending on their mechanism of action. 

    • ​Nirmatrelvir/ritonavir (Paxlovid) inhibits protease, a necessary tool in the viral replication procedure.
    • Remdesivir (Veklury), inhibits RNA replication by incorporating itself into the viral RNA template and compromises the ability of the viral RNA synthesis.
    • Molnupiravir (Lagevrio) causes the viral RNA to mutate until it malfunctions. 

It is still possible that these oral antivirals may lose efficacy against future COVID variants, but their mechanisms of action may help extend the value of these drugs.​

Nirmatrelvir/ritonavir (Paxlovid) is FDA approved for adults and remains under an emergency use authorization (EUA) for patients age 12​17. Remd​esivir (Veklury) is an FDA approved antiviral for COVID-19 treatment. Molnupiravir (Lagevrio) is authorized for use under an EUA. 

​The National C​​enter got Advancing Translational Sciences maintains an OpenData Portal (NIH.gov) tracking COVID-19 therapeutics activity against SARS-CoV-2 variants. 

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2. Does a patient n​​eed a positive COVID-19 test in order to be prescribed nirmatrelvir/ritonavir (Paxlovid) or molnupiravir (Lagevrio)?

No.

On February 1, 2023, the Food and Drug Administration (FDA) revised the scope of emergency use authorizations (EUAs) for both nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio) to no longer require positive results of direct SARS-CoV-2 viral testing before prescribing. Patients must have a current diagnosis of symptomatic COVID-19. Clinical judgement regarding symptoms and exposure may be used when testing is not available.​

As of May 25, 2023, Paxlovid is approved by the FDA for adults, thus prescribing is up to clinical discretion.

3. What should providers consider when deciding whether to monitor patients for worsening symptoms or to prescribe? 

Antiviral treatments are indicated for mild to moderate illness with risk of progression to severe disease and have a 5- to 7-day window fo​r treatment. Please note that many common conditions and behaviors qualify individuals as “at risk of progression to severe disease,” including physical inactivity, obesity, depression, and more. Waiting for symptoms to worsen is not recommended.

If a patient is at risk for progression to severe disease and does not have any drug-drug interactions or contraindications to receiving nirmatrelvir/ritonavir (Paxlovid), they meet the treatment definition. If they do not qualify for treatme​​nt due to kidney or liver issues or drug-drug interactions, alternative treatments can be provided. 

The NIH provides up-to-date treatment guidelines on its website.  

4. Can children be prescribed anti-SARS-CoV-2 outpatient treatments? 

Nirmatrelvir/ritonavir (Paxlovid) is authorized for use in children 12 years and older and weighing at least 40kg.

Remdesivir (Veklury) is approved for use in mild to moderately ill adult and pediatric (28 days of age and older weighing at least 3 kilograms) outpatients who are at risk of disease progression. For pediatric dosing, see prescriber information (PDF).

Molnupiravir (Lagevrio) is only authorized for use in individuals 18 years and older due to its potential impact on bone and cartilage development.​

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5. Are anti-SARS-CoV-2 outpatient treatments safe for geriatric patients?

Multiple studies have shown that treatments are safe in the elderly without increased rates of adverse effects. Whenever possible, elderly patients should be encouraged to treat COVID-19 given the high-risk of progression to severe disease based on age alone.

According to the Centers for Disease Control (CDC): “Age remains the strongest risk factor for severe COVID-19 outcomes, with risk of severe outcomes increasing markedly with increasing age. 

Risk of severe outcomes is increased in people of all ages with certain underlying medical conditions and in people who are 50 years and older, with risk  increasing substantially at ages >65 years.

Residents of long-term care facilities are also at increased risk, making up less than 1% of the U.S. population but accounting for more than 35% of all COVID-19 deaths.” 

Underlying Medical Conditions Associated with Higher Risk for Severe COVID-19: Information for Healthcare Professionals | CDC

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6. How can providers check drug-drug interactions with nirmatrelvir/ritonavir (Paxlovid) and other therapeutics?

Use the consultative pharmacist or COVID-19 treatments team in your facility or health system, or use one of the resources below.

Drug-drug interaction resources include:   

7. Where can I find information on the contraindications for and side effects of available COVID-19 therapeutics?

Food and Drug Adminstration fact sheets for antiviral products include information on use criteria, preparation, contraindications, drug interactions, side effects and administration. 

While not a complete list of contraindications, the following should be noted:

  • Nirmatrelvir/ritonavir (Paxlovid) has significant and complex drug-drug interaction potential, primarily due to the ritonavir component of the combination. Review additional guidance from NIH on identifying and avoiding drug interactions.
  • Nirmatrelvir/ritonavir (Paxlovid) is not recommended for patients with severe hepatic or renal impairment and different dosing is required for moderate renal impairment. Given the presence of ritonavir, nirmatrelvir/ritonavir may also increase the risk of HIV-1 resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1.
  • Remdesivir (Veklury) is not recommended in pediatric patients (greater than 28 days old) with eGFR less than 30 mL/min or in full-term neonates (at least 7 days to less than or equal to 28 days old) with serum creatinine greater than or equal to 1 mg/dL.
  • Molnupiravir (Lagevrio) is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth. For more information on these precautions, please see the National Institutes for Health section on molnupiravir (NIH.gov) and the Molnupiravir Fact Sheet (PDF).

Product Fact Sheets

8. Are renal and hepatic lab results required before a physician or advanced practice provider can prescribe nirmatrelvir/ritonavir (Paxlovid)?

Assessment of renal and hepatic function is important when considering prescribing nirmatrelvir/ritonavir (Paxlovid).  

However, licensed physicians and advanced practice providers are not required to perform additional laboratory testing when prescribing nirmatrelvir/ritonavir (Paxlovid). Providers should use clinical judgement to determine if labs are necessary. 

Asking a patient if they have a history of kidney or liver problems is sufficient in most cases.  Patients often know if they have renal or liver problems, therefore, it is recommended that providers ask about patients’ status and check medication lists and lists of specialists that a patient has seen.   

For more information on clinical evaluation see:

9. Do providers need to check patients’ creatinine levels to prescribe nirmatrelvir/ritonavir (Paxlovid)? Is the eGFR relevant

Licensed physicians and advanced practice providers are not required to check creatinine levels in order to prescribe nirmatrelvir/ritonavir (Paxlovid).   

The eGFR is relevant if the patient has known kidney disease.  Without an eGFR in the past year, the provider should ask if the patient has had kidney issues. For patients with kidney issues, eGFR is relevant for Paxlovid dosing recommendations (NIH.gov). ​

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10. What should a provider do when a patient has known or suspected kidney or liver disease? 

Nirmatr​elvir/ritonavir (Paxlovid) dosing recommended in the Paxlovid Health Care Provider Fact Sheet (PDF): ​
    • eGFR ≥30 to 60 mJ/min: Niratrelvir 150 mg (one 150-mg tablet) with RTV 100 mg (one 100-mg tablet) twice daily for 5 days.
    • eGFR <30 mL/m​​in: Not recommended.  
    • Severe Hepatatic Impairment (Child-Pugh Class C):​ Not recommended.  ​
For patients not eligible for renal dosing, consider ordering remdesivir, or if remdesivir is unavailable, consider molnupiravir.  For patients with severe hepatic impairment, consider molnupiravir.​

For patients not eligible for renal dosing, consider ordering remdesivir, or if remdesivir is unavailable, consider molnupiravir.  For patients with severe hepatic impairment, consider molnupiravir.​

For hepatic issues, you can consult Drug Considerations for Medication Therapy in Cirrhosis ​(uspharmacist.com). ​

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11. Are pharmacists limited in prescribing nirmatrelvir/ritonavir (Paxlovid), e.g., in cases where a patient’s kidney or liver functions are problematic, or a patient doesn’t have recent labs?

​**The Department​​ of Consumer Affairs Order Waiving Restrictions on Pharmacists Independently Initiating and Furnishing Paxlovid to Individual Patients (PDF) expired on February 28, 2023. 

The State Board of Phar​​macy is encouraging interested persons to evaluate the federal Public Readiness and Emergency Preparedness Act (PREP Act) (phe.gov) with an attorney, if necessary, to determine eligibility for pharmacists to continue independently initiating and furnishing nirmatrelvir/ritonavir (Paxlovid) for individual patients. 

State-licensed pharmacists m​ust have access to a patient’s healthcare records within the past 12 months to assess for renal and hepatic function or contact with a provider who knows the patient’s status in order to prescribe nirmatrelvir/ritonavir (Paxlovid). 

Under the Paxlovid EUA (PDF) and​​ the 9th Amendment of the HHS PREP Act Declaration (phe.gov), if a pharmacist wishes to prescribe and renal and hepatic labs from the last 12 months are not available, the pharmacist may not prescribe and must refer to another healthcare professional (MD, PA, NP, DO) for treatment assessment. 

If labs are available, then phar​macists may prescribe according to the EUA guidance, using renal dosing when appropriate. See also the FDA Paxlovid Frequently Asked Questions (PDF). 

Test-to-treat refer​​ral information for patients who do not have a regular provider can be found at the HHS therapeutics locator website (arcgis.com). 

Please see additional information on the Board of Pharmacy’s website: COVID-19 Information 2/22/23 (ca.gov). 

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As of May 25, 2023, the FDA approved nirmatrelvir/ritonavir (Paxlovid)for mild to moderate COVID-19 in adults, thus prescribing this medication​​ for adults is up to clinical discretion.

For molnupiravir (Lagevrio) for adults and nirmatrelvir/ritonavir (Paxlovid) for patients ages 12​17, the practice of prescribing in advance goes ​​​against the conditions for prescribing under the emergency use authorization (EUA). While nirmatrelvir/ritonavir (Paxlovid) and molnupiravir (Lagevrio) remain under emergency use authorization (EUA), they may only be prescribed according to the terms of their EUAs, which require a current diagnosis of symptomatic COVID-19. When these medica​​tions are fully approved by the FDA, providers will have more leeway to use clinical judgement to determine when to prescribe. 

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Yes, an RN can assess the patient based on a standing workflow/order. Depending on the clinic workflow, the RN can sign and enter the provider's name or route the note to that provider to have them add a note that the case has been reviewed and the nirmatrelvir/ritonavir (Paxlovid) order has been approved. 

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Workflows should be customized to meet the needs of each org​​​anization.    ​

Sample workflows and best practices for clinics can be foun​​d on the Center for Care Innovations Therapeutics Resource Hub (careinnovations.org).

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According to the Centers for Disease Control (CDC), residents of long-term care facilities are “at increased ri​​​sk, making ​​up less than 1% of the U.S. population but accounting for more than 35% of all COVID-19 deaths.”  

Best practice​​s for long term care facilities are available below:

​Some electronic medical records allow ​​providers to see whether prescriptions are dispensed and filled.  Providers m​ust communicate with patients or caregivers to determine whether treatment was completed.  ​​

​Clinic​​s should do whatever possible to reduce barriers to prescribing and to measure treatment rates. 

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Follow-up for COVID-19 depen​​​ds on workforce (i.e., provider’s clinic availability) and other factors.   

It is recommended that a clinic perform a follow-up phone call in 2–3 days to assess a standard list of symptoms of worsening illness that can be carried out by a medical assistant and reviewed by a clinician. It is not recommende​​d that all patients be scheduled for follow-up visits as this would bring them out of isolation. ​​

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