Updated May 27, 2020
Remdesivir Distribution Process for Hospitals and Health-Systems
The information below was provided by the Tennessee Department of Health (TDH) and Tennessee Hospital Association (THA) on May 21:——As you know, in mid-May, the Tennessee Department of Health (TDH), acting on a recommendation from the Tennessee Hospital Association (THA), approved a distribution process for the federal allotment of remdesivir received by the state.
Treatment courses are distributed on a patient-specific, first come, first served basis using the approved criteria, with oversight by a panel of Vanderbilt University Medical Center (VUMC) physician experts. For greater efficiency and monitoring, VUMC is updating the request process for remdesivir using the online RedCap system instead of a paper request form, beginning immediately.
If a hospital has a patient for whom they think remdesivir may be appropriate, they should submit a request to RedCap or email COVIDRX@vumc.org, if they have difficulties with the RedCap link. Please note that any email requests sent to Mark Sullivan’s email address will be forwarded directly to COVIDRX@vumc.org.
Additional detail is provided in the Guidance Document on the clinical guidelines for both adult and pediatric patients and on logistics for requesting medication.
- There is limited clinical data on potential adverse effects for remdesivir at this time. As Tennessee health system pharmacists continue to use the drug per the FDA Emergency Use Authorization (EUA), we need to remain vigilant for potential serious adverse drug events (SAEs). MedWatch is in receipt of at least two reports to date from Tennessee; one acute kidney injury (AKI), and one thrombotic stroke. Pharmacists are urged to ensure that monitoring for both of these events is in place.
- Based on literature, the standard baseline and daily laboratory monitoring requirements include CMP, CBC, and INR. Pharmacists may see elevations in transaminases, which is mentioned in the FDA EUA Fact Sheet. It is unclear if this is related to COVID-19 or the drug. The FDA EUA requires daily chemistries, heme (CBC), transaminase, bilirubin, alkaline phosphatase, creatinine and creatinine clearance monitoring. These are the minimum mandatory tests for patients on remdesivir.
- Given the increased risk for thrombosis and other complications in this patient population, all COVID-19 confirmed patients should also receive baseline D-dimer quant, ferritin level, CRP, ESR, PT/INR, PTT, fibrinogen, LDH, and procalcitonin. If baseline D-dimer quant is elevated or other signs of DIC (low fibrinogen, abnormal PT/INR or PTT) are present, then daily D-dimer quant, PT/INR, PTT, fibrinogen, and CRP monitoring is recommended in addition to the testing required by EUA. For normal baseline D-dimer quant, repeating D-dimer quant, PT/INR, PTT, fibrinogen, and CRP is recommended every other day. In some cases, treatment for PE with enoxaparin has been started empirically in patients with a high index of suspicion for PE before diagnostic confirmation, given the very high rates and high mortality in this population.
To request reimbursement for the transport cost of Remdesivir, hospitals should follow these steps:
- Email an official hospital invoice to John Webb (John.Webb@tn.gov) and Valerie Oliver (Valerie.Oliver@tn.gov), and include the name of a hospital contact.
- Include a copy of the shipping invoice or a cost report of in-house courier services to serve as supporting documentation of the hospital invoice.
- State in the email that the invoice is for the transport of Remdesivir.
Payments will be made through TDH’s Edison system with a 15-day turnaround. For questions, contact John Webb, Deputy of Operations, at John.Webb@tn.gov.