Nationwide Shortage of Immunoglobulin Forces Patients to Find Alternatives

As far back as December 2018, pharmacists began noticing that their orders for intravenous immunoglobin (IVIg) therapy weren’t being filled, and the shortage has continued to manifest nationwide. Patients with a variety of immune disorders depend on the therapy for treatment of symptoms that affect quality of life and mobility, and for others it can be lifesaving.

At any given time, a link in the plasma and immunoglobulin supply or delivery chain that involves manufacturers, distributors, specialty pharmacies, and various sites of care can be disrupted. Usually, these disruptions only one region and supplies can be obtained from elsewhere.

Now, though, the plasma supply is tight in the U.S. and globally. The need for plasma and plasma-derived products increases each year, but the complex nature of Ig products as biologics means that it takes time to increase the supply.

“If you had 100 patients, we could only provide treatment for 70 of them [due to shortages]” explained Jon Horton, a pharmacy director in Virginia. To meet demands, pharmacists, doctors, and patients are working to find alternative treatments depending on the specific disorder, he added, such as steroids, rituximab, and plasmapheresis to alleviate symptom burden in those with auto-immune conditions.  However, for patients with hypogammaglobulinemia, there is no substitute for IVIg.

Sources: WTKR, June 18, 2019; Immune Deficiency Foundation, January 15, 2019.

ASH members are increasingly concerned about the national shortage of intravenous immunoglobin (IVIG). The Society has contacted the U.S. Food and Drug Administration’s (FDA’s) Drug Shortage Office and Office of Compliance and Biologics Quality regarding the critical nature of this shortage. The FDA is directing all questions to individual manufacturers to resolve the shortage; Manufacturers’ contact information can be found online.

ASH continues to monitor this shortage, and ASH members who are dealing with a critical case that requires this therapy and are encountering access issues should contact the Society (kstark@hematology.org) or visit the ASH Drug Shortage page for additional resources.

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