The nation is facing an IVig shortage, having to ration current supply.
Hospitals in Oakland County, Michigan, are facing a gross shortage of immune globulin – with antibodies harvested from plasma – that is used to combat autoimmune disorders and other conditions. The problem is so severe that hospitals are currently rationing what supplies they have.
“It’s a big problem,” said Annette Karageanes, director of pharmacy, system operations for Beaumont Health System. “It impacts a lot of patients in many ways.”
Intraveneous immune globulin (IVig) contains an antibody that can improve the disposition of patients who have weak immune systems due to underlying diseases. Some conditions it’s used for include HIV/AIDS, lupus, and cancer, according to Karageanes. And, the shortage is a result of increased illness and demand in recent years.
“Hospitals and other medical systems have taken steps to monitor and prioritize distribution and use,” according to the Food and Drug Administration (FDA). “Increasingly, the product is targeted for patients who need it to stay alive and is rationed, suspended or withheld from patients with non-life-threatening conditions.”
“We are aware of the nationwide shortage and have put a variety of measures into place to minimize impact to patient care,” Henry Ford Health System also stated.
Beaumont’s response is to have two dozen staff members meet each week to set priorities for distribution. “It’s a tedious process and we have to micromanage our supplies to meet patient needs,” Karageanes said. “It’s a process that requires a lot of communication and touches the health system throughout Southeast Michigan.”
Dr. Teena Chopra, professor of infectious diseases at the Wayne State School of Medicine, said immune globulin (also known as IVig) “has been a lifesaver” in many ways. “For [conditions such as myasthenia gravis] and other disorders, IVig is essential,” said Chopra. In fact, there are no alternative treatments on the market.
It can take up to a year to produce and supply immune globulin from plasma donations. The nation has responded by increasing the number of available donation facilities and has seen an uptake in use. However, currently, nearly half of all donated plasma is shipped outside of the United States. In order to meet current demand, these numbers would need to increase much more significantly.
“The bottom line is that we do need more plasma,” Schmidt said.
The FDA is working with companies to approve new center applicants as quickly as possible. The agency’s site states, the “FDA does not have legal authority to require a manufacturer to begin producing, continue producing, or increase their production of drugs. However, FDA does work with manufacturers whenever possible to help mitigate shortages when we learn of them. The agency is working very closely with the applicants/manufacturers…to help mitigate the supply situation for IG products as best as possible. It is also working with industry in exploring ways to improve the manufacturing yield of IG products.”
The FDA recommends protocol in times of shortage, which Michigan’s hospitals are already implementing. The agency states: “When IG supplies are limited, health care providers, hospitals, and medical systems may be required to decide which patients will receive priority treatment. We encourage such health care providers, hospitals, and medical systems to prospectively devise an evidence‑based approach to such decisions. Hospitals and other medical systems with only one IG product contract may wish to consider a second IG product contract to improve resilience during and after this time of shortage.”