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COVID-19 Test to Treat Protocol

Chapa-De Test-To-Treat

Purpose

To provide timely access to safe and effective use of Paxlovid and molnupiravir for COVID-19.

Policy

  1. Positive on home antigen Covid-19 tests results are directed to Clinical
  2. Clinical Pharmacy screens to verify medication interactions and the patient’s symptoms have been persistent for less than 5 days.
  3. Paxlovid can be prescribed by medical
  4. Paxlovid can be prescribed by clinical pharmacist under the following conditions:
    1. There is sufficient access to health records less than 12 months old or consultation with health care provider in an established provider-patient relationship with the individual patient, to:
      1. Assess renal and hepatic function
      2. Obtain comprehensive list of medications
    2. All prescriptions will be adherent to components of Emergency Use Authorizations:
      1. Paxlovid Exit Disclaimer: You Are Leaving www.ihs.gov 
      2. Molnupiravir Exit Disclaimer: You Are Leaving www.ihs.gov 
    3. Paxlovid will be stored at Chapa-De Pharmacy in Auburn and Grass
    4. Chapa-De will comply with HHS and IHS policy related to Test to Treat

    Procedure For Evaluation and Prescribing

    1. Patient, who is positive for COVID-19, calls Chapa-De Medical Departments and results are forwarded to Clinical Pharmacist.
      1. Test results will be recorded in
    2. Clinical pharmacist screens patients to make sure the following is met:
      1. Patient falls into CDC criteria for high risk for covid19 complications Exit Disclaimer: You Are Leaving www.ihs.gov 
      2. Patient has had symptoms for less than 5 days
    3. If qualified, Clinical Pharmacist will
      1. Conduct medication reconciliation
      2. Evaluate
      3. Assess renal function
    4. If it has be determined that patient may benefit from and safely take Paxlovid therapy, clinical pharmacist can ePrescribe:
      1. eGFR >60ml/min/m3 : Paxlovid 150mg/100mg Take 3 capsules twice daily
        1. 1 Capsule ritonavir
        2. 2 Capsules nirmatrelvir
      2. eGFR 30-60ml/min/m3 : Paxlovid (renal pack) 150/100mg Take 2 capsules twice daily
        1. 1 Capsule ritonavir
        2. 1 Capsule nirmatrelvir
    5. If renal function from the last 12 months cannot be determined, clinical pharmacist will send TE to medical provider with recommendations on found drug Medical provider can, under their discretion, prescribe Paxlovid/molnupiravir or refer for monoclonal antibodies.
    6. If there are significant drug interactions or eGFR is <30ml/min/m3, Clinical Pharmacist will coordinate with PCP to get patient monoclonal antibodies in a timely manner.

    Procedure for Dispensing

    1. Clinical Pharmacist will document recommendation in Telephone Encounter and send telephone encounter to pharmacy.
      1. Documentation in Telephone Encounter
        1. “Paxlovid/molnupiravir has been evaluated for drug interactions and appropriateness of therapy, I recommend dispensing”
        2. “Paxlovid/molnupiravir has been evaluated for drug interactions and appropriateness of therapy, I DO NOT recommend dispensing:[REASONING]….”
    2. Chapa-De pharmacist, upon receipt of prescription for Paxlovid will check eClinicalWorks (eCW) Electronic Health Record to ensure that Clinical Pharmacist has completed Telephone Encounter.
    3. If there is no documented Telephone Encounter, pharmacy will contact Clinical
    4. Pharmacy will dispense Paxlovid/molnupiravir with EUA fact sheet and offer counseling as needed.
    5. Adverse Events related to Paxlovid or molnupiravir will be reported to MedWatch in accordance with EUA.

    Procurement and Distribution of Antivirals

    1. Paxlovid and molnupiravir will be purchased through Health Partner Order Portal (HPOP).
    2. Antivirals will only be distributed to established Chapa-De
    3. Current inventory will be communicated to Indian Health Services (IHS).
    Tier Risk group
    1
    • Immunocompromised individuals not expected to mount an adequate immune response to COVID-19 vaccination or SARS- CoV-2 infection due to their underlying conditions, regardless of vaccine status (see Immunocompromising Conditions below); or
    • Unvaccinated individuals at the highest risk of severe disease (anyone aged ?75 years or anyone aged ?65 years with additional risk factors).
    2
    • Unvaccinated individuals at risk of severe disease not included in Tier 1 (anyone aged ?65 years or anyone aged <65 years with clinical risk factors)
    3
    • Vaccinated individuals at high risk of severe disease (anyone aged ?75 years or anyone aged ?65 years with clinical risk factors)

    Note: Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; patients in this situation within this tier should be prioritized for treatment.

    4
    • Vaccinated individuals at risk of severe disease (anyone aged ?65 years or anyone aged <65 with clinical risk factors)

    Note: Vaccinated individuals who have not received a COVID-19 vaccine booster dose are likely at higher risk for severe disease; patients in this situation within this tier should be prioritized for treatment.