Be Prepared for Audits on Pharmacist-Prescribed Paxlovid

The FDA released a statement on July 6, 2022, which expanded the Emergency Use Authorization (EUA) of PaxlovidTM (nirmatrelvir and ritonavir) “to authorize state-licensed pharmacists to prescribe PaxlovidTM to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of PaxlovidTM.” As pharmacies across the country are gaining access to this anti-viral COVID-19 therapeutic agent, it is important to understand the specifications of the EUA and verify your pharmacy has a process in place to capture and maintain documentation supporting the validity of the claim, in the event these claims are audited. Think to yourself, would an auditor have irrefutable evidence that this patient qualified for treatment and that the pharmacist-prescribed PaxlovidTM was provided pursuant to EUA guidelines?

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Patient Qualifications EUA Limitations for Pharmacists to Prescribe PaxlovidTM Additional Documentation to Maintain
Must meet ALL:
·         ≥ 12 years old
·         ≥ 88 pounds (40 kg)
·         Positive SARS-CoV-2 viral testing
·         Symptom onset was within ≤ 5 days
·         Mild-to-moderate coronavirus disease
·         At high risk for progression to severe COVID-19, including hospitalization or death
Must meet ALL:
·         Sufficient medical records < 12 months old or consultation with health care provider to assess renal (kidney) function
·         Sufficient medical records < 12 months old or consultation with health care provider to assess hepatic (liver) function
·         Sufficient information is available (via access to health records, patient reporting of medical history, or consultation with health care provider) to obtain a medication list to check for potential drug interactions
PAAS National® analysts suggest ALL of the following:
·         Patient-specific placeholder hardcopy referencing the pharmacist’s authority to prescribe (e.g., EUA and PREP Act, standing order, or collaborative agreement, etc.) and details of the prescription
·         Proof patient met all qualifications
·         Proof pharmacist verified kidney function, liver function, and had sufficient information to assess potential drug interactions
·         Vaccine administration record
·         Date/version of the Fact Sheet for Patients, Parents, and Caregivers EUA of PaxlovidTM for COVID-19 that was given

PAAS Tips:

  • Limitations on authorized use of PaxlovidTM:
    • Not authorized for the treatment of patients requiring hospitalization due to severe COVID-19
    • Not authorized for pre-exposure or post-exposure prophylaxis to prevent COVID-19
    • Not authorized for use longer than five consecutive days
  • Kidney and liver function, as well as the patient’s current list of medications, must be assessed to determine if PaxlovidTM is an appropriate therapy for the patient and if the dose needs to be reduced
  • For additional details refer to the:
    • July 6, 2022, Emergency Use Authorization for Paxlovid
    • Fact Sheet for Healthcare Providers: EUA for PaxlovidTM
    • Fact Sheet for Patients, Parents, and Caregivers: EUA of PAXLOVIDTM for COVID-19
    • List of medical conditions and factors associated with increased risk for progression to severe COVID-19 as per the CDC
Sara Hathaway, PharmD