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Federal changes coming to distribution of this COVID treatment
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Registered Nurse Jill Fontana prepares to give a COVID-19 antibody infusion to a patient Wednesday, Jan. 27, 2021, inside the Northeast Georgia Medical Center. The monoclonal antibody infusion is for the treatment of people with mild COVID-19 who are at high risk for progressing to severe COVID-19. - photo by Scott Rogers

Health care providers may have their supply of monoclonal antibodies disrupted as the federal government has changed the way the highly effective COVID-19 treatment will be distributed across the country. 

The decision, announced Monday, Sept. 13, by the U.S. Department of Health and Human Services, was caused by a high increase in demand for treatments, according to a statement Wednesday, Sept. 15, from the Georgia Department of Public Health. Health care providers will no longer be able to order treatments directly from drug vendors. 

Monoclonal antibody treatment, frequently referred to by the brand name Regeneron, involves administering to patients — either by IV or by injection — laboratory manufactured antibodies to fight off infection of COVID-19. Northeast Georgia Health System officials have said the treatment is highly effective at reducing risk of hospitalization of patients when administered within seven days of a person experiencing COVID-19 symptoms. 

The treatment has been used much more often recently, especially as providers have been able to administer it much more quickly using injections rather than an IV infusion. 

The Department of Health and Human Services will determine each state’s weekly allocation of antibody treatment products based on use and the local number of COVID-19 cases, according to the statement. Then, Georgia’s DPH will choose which sites in the state will receive the product and how much each site gets. 

Health care providers must record their administration of the products in order to be eligible to receive additional shipments, according to the statement.

“Ultimately, this should improve our ability to communicate our need for monoclonal antibody treatment medications,” Melissa Frank, director of pharmacy services at Northeast Georgia Medical Center, wrote in a statement Wednesday, Sept. 15.

But the change has already disrupted supply for some providers, including Longstreet Clinic, which has locations in Gainesville, Oakwood and Braselton. The clinic tried to submit an order for the treatment through a drug vendor last week before they were informed of the distribution change, said Chief Operating Officer Loren Funk. The clinic does not currently administer monoclonal antibody treatment, he said. 

“We were making our plans to do so and that change from how they’re distributing has slowed that process,” Funk said. “I’m in the process of figuring out how and if we can go through the proper channels to be able to get the Regeneron to administer.”

Funk said he was told the change would be temporary, but there is not a timeline on when distribution methods may go back to normal. The clinic currently works with NGHS to get the right COVID-19 care for its patients when there is something it cannot provide, such as monoclonal antibodies, Funk said. 

DPH officials stressed that monoclonal antibodies are not a substitute for getting vaccinated. Those who receive the treatment may get vaccinated 90 days afterwards.

You can find a provider near you who administers monoclonal antibodies here.

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