Today, the American Society of Health-System Pharmacists (ASHP) sent a letter to Vice President Mike Pence to urge the transparent and orderly allocation of remdesivir among hospitals
Today, the American Society of Health-System Pharmacists (ASHP) sent a letter to Vice President Mike Pence to urge the transparent and orderly allocation of remdesivir among hospitals.1
On May 1, the FDA issued Emergency Use Authorization (EUA) of the antiviral agent for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 (COVID-19) in hospitalized patients. However, ASHP's letter indicates that hospitals are unsure about the steps needed to access the drug and how drug allocations will be determined by the federal government.
According to the letter, remdesivir’s very limited initial supply suggests that many patients with COVID-19 will be unable to receive it, and therefore transparency regarding the timeline for future commercial availability and distribution of remdesivir is needed.1
“Because the current supply is so limited, many of these hospitals will likely have to wait to purchase remdesivir until Gilead has commercial supply available,” said Paul W. Abramowitz, PharmD, ScD (Hon), FASHP, chief executive officer of ASHP.1 “To allow hospitals to plan, it is imperative that the allocation process for the drug be transparent and well communicated to our nation’s hospitals, and their chief pharmacy officers and directors of pharmacy.”
Abramowitz also requested that the Trump Administration coordinate with the FDA and Department of Health & Human Services to provide flexibility to hospitals to reallocate the product to meet changing needs, for example if another hospital in the state experiences a spike in severe cases.1
“Hospitals should have the ability to send remdesivir doses where they are most needed,” Abramowitz wrote.1
Remdesivir received EUA for hospitalized patients with severe COVID-19, defined as patients with an oxygen saturation ≤94% on room air or requiring supplemental oxygen or requiring mechanical ventilation or requiring extracorporeal membrane oxygenation.
ASHP also sent a letter last month to request that the Administration initiate significant increases in manufacturing of supportive medications critical to ventilating and treating patients with severe COVID-19.
1. Re: Ensuring Transparency of Remdesivir Allocations. ASHP; May 7, 2020. Accessed May 7, 2020. https://www.ashp.org/-/media/assets/advocacy-issues/docs/GRD-Pence-Letter-Remdesivir-Allocation?utm_source=SM050720&utm_medium=TW&utm_campaign=remletter