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Remdesivir HHS EUA Inventory Use Policy

Issue: The purpose of this policy is to establish a procedure for the appropriate use of remdesivir inventory supplied by the US Department of Health and Human Services (HHS) via the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA).  

Background:  

Kettering Health Network (KHN) may access IV remdesivir via three modalities: 

  1. Gilead Expanded Access Clinical Trial  
  1. Enrollment of patients via Innovation Center 
  1. Limited to KMC only 
  1. Compassionate Use in pregnant women and individuals <18 years of age 
  1. Case-by-case assessment by Gilead  
  1. All KHN facilities eligible to request assessment via Gilead 
  1. US Department of Health and Human Services (HHS) via Emergency Use Authorization (EUA) 
  1. Distributed to KHN via HHS based on COVID-19 volumes 
  1. Supply is finite with future availability unknown 
  1. All KHN facilities eligible to use 

KHN will obtain the bulk of remdesivir supply from the US HHS via EUA (#3). The EUA permits the emergency use of the unapproved product remdesivir for treatment of coronavirus disease 2019 (COVID-19) in adults hospitalized with severe disease. The FDA’s EUA mandates certain conditions must be met for any healthcare facility administering the authorized remdesivir. 

The below policy and procedure establish a mechanism to ensure safe and compliant administration of remdesivir to COVID-19 patients at KHN. 

Policy 

The appropriateness of remdesivir orders is reviewed by a Pharmacy and Therapeutics (P&T) appointed physician specialized in Infectious Disease or Pulmonology/Critical Care via chart-review. Decisions will be based on the following criteria for use: 

Inclusion Criteria: 

  1. Age >18 years of age 
  1. Hospitalized with Laboratory-confirmed SARS-CoV-2 (within the last 7 days) 
  1. Weight > 40 kg 
  1. Initiated on mechanical ventilation within the last 72 hours or Pulmonary/Critical Care opinion that respiratory failure is progressing and need for intubation is likely 

Exclusion Criteria: 

  1. AST or ALT > 5x ULN 
  1. Renal failure defined as CrCl < 30 ml/min using Cockgroft-Gault formula or dialysis 
  1. Eligible for enrollment into the Gilead Expanded Access Trial or Compassionate Use  

Initial treatment courses will be limited to 5 days. Re-evaluation for possible extension to 10-day course will occur on Day 5 of therapy.  

In the event the number of patients meeting inclusion criteria exceeds drug supply on hand, an ethics committee will guide decision-making 

Procedure 

  1. Prescribing physician enters a non-formulary request for remdesivir 
  1. Prescribing physician communicates evaluation request to P&T-appointed reviewer 
  1. Reviewer’s contact information is provided in Epic order 
  1. Prescribing physician provides “Fact Sheet for Patients And Parent/Caregivers Emergency Use Authorization (EUA) Of Remdesivir For Coronavirus Disease 2019 (COVID-19)” to patient or caregiver 
  1. Hyperlink to Fact Sheet is embedded in Epic order 
  1. Prescribing physician documents in the patient’s medical record that the patient/caregiver has been: 
  1. Given the Fact Sheet for Patients and Parents/Caregivers 
  1.  Informed of alternatives to receiving remdesivir, and 
  1. Informed that remdesivir is an unapproved drug that is authorized for use under EUA 
  1. P&T-appointed reviewer notifies prescribing physician and Inpatient Pharmacy of approval decision 
  1. Pharmacist enters remdesivir order under prescribing physician’s name if request approved 
  1. Prescribing physician reports all medication errors and serious adverse events through the FDA’s MedWatch Adverse Event Reporting program  
May 20, 2020