The immunoglobulin shortage: A plea to hospital-based prescribers and pharmacists

By John G. Boyle, President & CEO

As the national patient organization for people living with primary immunodeficiency diseases (PI), the Immune Deficiency Foundation (IDF) continues to hear troubling reports about challenges patients are facing in accessing immunoglobulin (Ig) products. We are hearing these stories in alarming frequency both firsthand from patients, from government agencies, and in news reports from all around the U.S. 

Early on, many of the challenges seemed to be centered on subcutaneous Ig (SCIG) products and their availability through specialty pharmacies. For the last two months, though, IDF has been hearing more and more about intravenous Ig (IVIG) products and their availability within hospitals. This was not a surprise to many: if the SCIG market is tight, then the expectation is that new patients are more likely to be put on IVIG, thus putting more strain on that market. Many have compared this shifting of pressures to a balloon: squeeze one end and the other expands. Squeeze the other? The air then shifts to the opposite side.

But we seem to have reached an acceleration point. Last week alone we received over 100 e-mails and calls on this subject. Of particular concern are the reports where a hospital-wide communication is sent out indicating that their solution to the shortage is to reduce all Ig dosing by a fixed percentage.

IVIG and SCIG products each have several on-label indications, but those products have an even larger number of off-label uses. I’m not a physician, but considering the on-label, clinically proven uses of Ig, I’d say that this or any other one-size-fits-all approach to managing your Ig resources seems like a phenomenally bad idea. In fact, it sounds like bad medicine.

It’s time to talk about prioritization

Conversations about prioritization are never comfortable, but given that there is currently no light at the end of tunnel with this issue, they are necessary. As I wrote earlier this year, the issues with the plasma supply chain are global ones. Supply and demand levels for Ig are perilously close, and any wiggle room that used to exist within the market has now seemingly evaporated. As this is ultimately an issue of increasing demand, there are no quick or easy fixes. The issue is not going to resolve itself magically, so contingency plans need to be made and enacted.

The lives of people with PI who require Ig for antibody replacement truly depend on Ig, and they have no other viable options for maintaining their health. As uncomfortable as it may be to say, these individuals should be prioritized over others for whom Ig usage is not clinically proven to be as efficacious.

Questionable management of Ig by hospitals

Considering that previous Ig shortages, such as the ones in the late 1990s, had created similar predicaments, one would have expected hospitals and other centralized care systems to be thoughtful stewards of such a precious resource. At that time, many hospitals had their Pharmacy & Therapeutics Committees establish strategies to prioritize the IVIG available to hospital pharmacies. Some of the reports that we have received, however, paint a troubling picture of many hospitals seemingly being caught off guard by the issues within the Ig market.

Simply put, it’s unclear how hospitals are handling their on-label vs. off-label use of Ig. For off-label use of Ig, there are now biologic alternatives that should be considered. Are people with PI being told that they have to go without their Ig or have to accept a reduced dose because hospitals have managed their Ig resources poorly? It’s hard to say at this point. But when we hear about hospitals saying that they’re running low on Ig, we say—again—it’s time to prioritize, and consider alternatives for some patients with autoimmune/inflammatory disorders. The American Academy of Allergy, Asthma & Immunology (AAAAI) has published practice guidelines for Ig administration for a number of medical conditions, and is an excellent place to start the prioritization process using an evidence-based medicine approach for the administration of Ig products for off-label use.*

Cutting product availability to patients or reducing dosage by a set percentage is a dangerous proposition for people living with PI. Without proper dosing, we will get sick and require more extensive (and expensive) care. Knee-jerk reactions will not do, so we implore you to utilize evidence-based approaches to medicine. 
 

Let IDF and others help as a resource on Ig policy  

IDF is calling on hospitals to fully explore and take ownership of this emerging issue. As prescribers, pharmacists, and management teams educate themselves about Ig and review their current policies related to distribution of Ig products, we ask that you leverage existing resources to help you fully understand these problems and seek solutions that are evidence-based medicine.

The team at IDF and our Physician Advisory Committee are eager to share our knowledge and interact with hospitals that serve people with PI and that are struggling with these issues. While our resources and bandwidth are limited, we will do all that we can to assist.

In addition to working with IDF and professional organizations such as the AAAAI and Clinical Immunology Society (CIS), pharmacists and management teams should reach out to Ig product manufacturers as well to gain insight and information that will help them make informed decisions and create sound strategies about product management. Manufacturers need to hear from you to be informed directly from prescribers and hospitals about the particular circumstances you and your institutions are facing.

We need to work together 

For over a year, IDF has been engaged in this issue: trying to find answers and working toward solutions. Neither IDF, the FDA, the Plasma Protein Therapeutics Association (PPTA), nor anyone else engaged in this can do it alone. We need each other. Until we again reach a point when the supply of Ig and other plasma products allow everyone more breathing room—we need your attention, your understanding, and your collaboration so we can halt this troubling trend, and foster responsible stewardship of Ig as a vital therapeutic resource.

Those whose lives rely on Ig need your help. Please help us.

* Update on the use of immunoglobulin in human disease: A review of evidence. Perez EE, Orange JS, Bonilla F, Chinen J, Chinn IK, Dorsey M, El-Gamal Y, Harville TO, Hossny E, Mazer B, Nelson R, Secord E, Jordan SC, Stiehm ER, Vo AA, Ballow M. J Allergy Clin Immunol. 2017 Mar;139(3S):S1-S46. doi: 10.1016/j.jaci.2016.09.023. Epub 2016 Dec 29. Review.