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FDA allows remdesivir under emergency clause

13 Sep 2020

Potential benefits outweigh known risks



By: Jasmin Chaudhary, MD, medical director for infection prevention and antibiotic stewardship; and Danielle Britt, PharmD, antibiotic stewardship

The FDA recently authorized Veklury (remdesivir) for the treatment of hospitalized adult and pediatric patients with COVID-19 regardless of severity of disease under an emergency use aurorization). The agency’s review also concluded that the “known and potential benefits of remdesivir outweigh the known and potential risks for these uses.”

In light of this decision, the ability to order remdesivir for our hospitalized COVID-19 patients will be expanded to our adult hospitalist groups and pulmonology.

Certain administrative and legal documentation/information is required of providers using remdesivir under the EUA that must be completed to maintain regulatory compliance.

Requirements:

  1. Disclosure that remdesivir is an unapproved drug authorized by the FDA under an EUA.
  2. A copy of the FDA Fact Sheet for Patients and Parent/Caregivers-EUA of Remdesivir For Coronavirus Disease 2019 (Covid-19) (https://www.fda.gov/media/137565/download must be supplied to the patient or power of attorney in the patient’s or POA’s primary language. Alternative languages can be found on the Salem Health intranet. Providing the fact sheet can be deferred in an emergent situation. http://sphome.phhservices.org/Pharmacy/Pages/COVID%20Resources%20and%20Information.aspx
  3. Provide the patient or POA all of the information necessary to make an informed decision including risks, benefits, and alternatives.
  4. Documentation in the chart that verbal consent was obtained from the patient or POA after review of benefits and risks and that discussion of treatment was held. Signed informed consent is not required. Prior to order entry, providers must document discussion of treatment in the medical record.

We will focus on educating our house staff regarding the regulatory requirements associated with the remdesivir and convalescent plasma ordering processes.

For more information, please contact: Danielle Britt, PharmD; Martin Johnson, MD; Sierra Schneider, RN; or Jasmin Chaudhary, MD.