FDA allows temporary compounding of dexamethasone sodium phosphate due to shortages during COVID-19 pandemic

July 29, 2020 · Clinical Connection team

The U.S. Food and Drug Administration (FDA) recently added dexamethasone sodium phosphate to their approved list of medications that may be temporarily compounded during the COVID-19 pandemic.

In recent weeks, some medications, such as dexamethasone sodium phosphate injection, have been in short supply due to an increased demand for use with COVID-19 patients. To remedy this, the FDA created a list of medications that can be temporarily compounded by outsourcing facilities and pharmacy compounders during the pandemic. On July 14, 2020, the FDA added dexamethasone sodium phosphate to this approved list.

To date, there are no medications approved by the FDA to treat the virus itself. However,
short-term use of low-dose dexamethasone can be used for severely ill hospitalized COVID-19 patients who require supplemental oxygen or mechanical ventilation, according to the Infectious Diseases Society of America and the World Health Organization. As more information and treatment options are identified to effectively treat COVID-19, we will provide updates as necessary.

Potential impact on workers’ compensation and auto no-fault

If a claimant requires treatment with medications to manage symptoms related to COVID-19, corticosteroids, such as dexamethasone, are allowed on our COVID-19 supplemental formulary.

With this announcement from the FDA, if a severely ill claimant requires hospitalization, and a hospital is unable to obtain commercially available FDA-approved dexamethasone, the hospital may consider contacting an outsourcing facility to obtain compounded dexamethasone, in accordance with the FDA’s guidance.

For updated information on FDA Drug Shortages, click here.

For more information from the Centers for Disease Control and Prevention (CDC) on what to do when someone is sick with COVID-19, click here.

If you have any questions, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

Sources:

1. U.S. Food and Drug Administration (FDA). FDA News Release. Coronavirus (COVID-19) Update: Daily Roundup July 14, 2020. Dexamethasone Sodium Phosphate Added to the Lists of Drugs for Temporary Compounding by Outsourcing Facilities and Pharmacy Compounders. Available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-july-14-2020.

2. Key US Medical Group Adds Steroids to COVID-19 Treatment Guidelines - Medscape - Jun 26, 2020.

3. Steroid Should Be Kept for Serious Coronavirus Cases, WHO Says - Medscape - Jun 17, 2020.