A drug derived from human blood plasma is in short supply, forcing hospitals to scramble to ensure the intravenously administered medication is available for patients with a rare condition who can’t live without it.
The product is intravenous immunoglobulin, abbreviated as IVIg, and administered to patients — many of them children — with hypogammaglobulinemia, a disorder that impairs the ability to fight infections. Regular infusions of IVIg provide the armies of antibodies needed to keep infections at bay.
Dr. Mark Jarrett, senior vice president and chief quality officer for the Northwell Health network, said IVIg is derived from plasma, the portion of blood that contains a plethora of vital proteins, which range from the factors that produce clotting to the antibodies needed to quash infections.
A major problem in recent months is not enough people are donating plasma in the quantities needed for a robust supply chain of IVIg, which is manufactured by specialty pharmaceutical companies. Immuno globulin G, or Ig, is the infection-fighting antibody isolated from plasma to produce the medication.
“Recently, there has been a very dramatic shortage, and it has gotten worse,” said Jarrett, noting that while a paucity of plasma donations may be one problem, the shortage has roots that are multidimensional.
“We are using the medication more than we did in the past. Uses for IVIg have expanded,” Jarrett said. “It is being used for autoimmune diseases and for transplant patients.
“Adults can develop acquired hypogammaglobulinemia where they lose the ability to make the immunoglobulins, and they need this medication as well,” he said.
Despite the shortage, Jarrett said the Northwell system has been able to provide IVIg to its patients without resorting to the desperate measures reported by medical centers elsewhere around the country.
“At this point in time, we haven’t had to ration it, but we are tracking the supply very closely,” Jarrett said. “We are working with all of our hospitals and all of our pharmacists.”
While Northwell provided information about its IVIg challenges, other centers were less candid about an array of issues, regarding everything from plasma donations to the availability of IVIg itself.
For example, Long Island Blood Services in Westbury, an affiliate of New York Blood Center in Manhattan, would not answer Newsday’s questions about plasma donations and referred inquiries to New York Blood Center. The center, in turn, referred questions to the trade organization America’s Blood Centersin Washington, D.C.
Stony Brook Hospital, a medical enterprise with a major children’s hospital on Long Island, said in an email there was no shortage of IVIg there. The spokeswoman did not elaborate.
John Boyle, president and chief executive of the Immune Deficiency Foundation in Towson, Maryland, said the shortage is worldwide and includes other plasma-derived proteins that are transformed into medications.
The paucity of plasma donations has put a spotlight on a difficult arithmetic problem, Boyle said, especially for patients with hypogammaglobulinemia and other primary immunodeficiency disorders.
“It takes about 120 donors, on average, to treat one patient with primary immunodeficiency. It’s not a one-to-one situation. You’re collecting and pooling together antibodies from multiple donors’ plasma,” Boyle said.
For people with hemophilia who require plasma-derived clotting factors to prevent excessive bleeding, the math is even more difficult.
“For a person with hemophilia, it’s closer to 1,000 donors that are needed to treat one patient. There are now more options for hemophiliacs because of the recombinant products,” Boyle said of genetically engineered clotting factors, which take some of the pressure off the plasma donation system.
Boyle said the IVIg shortage will not end soon, but he encouraged the public to consider donating blood plasma.
"Our community needs it for antibody replacement. There is no other mechanism for us,” said Boyle, who has an immunodeficiency disorder requiring infusions of IVIg.
Dr. Rita Reik, chief medical officer for America’s Blood Centers, the trade organization that represents the nation’s nonprofit blood centers, called the problem chronic, and explained there’s no way to solve it without first solving the plasma donation crisis.
“It’s a supply and demand problem,” Reik said. “This is a product that has a complex collection and manufacturing pathway.”
Like Jarrett, she thinks the increasing number of medical conditions that benefit from IVIg treatments have put pressure on the supply chain. Fifteen years ago, far fewer medical conditions were treated with the plasma-derived product, she said.