Infusion Cancelled - Shortage

Understanding Supply 

There’s a lot out there about a shortage of immunoglobulin (Ig) therapy. While yes, there are products that are in shortage, there is also supply out there of most products, even the ones who have an FDA-declared shortage. It is kind of like going to Wal-Mart and they are out of stock, but the Target down the street has the same product. So, I want to talk a little bit about the steps you can take to maintain access to your product of choice and what we, as a community, can do to push ensure sure shortages like this don’t happen again. It is important to understand the varying aspects of how this happens to ensure we reduce the level of panic, and increase the level of action! 

First, let’s talk about the industry and how supply works for Ig therapy. You’ll notice that many of the people experiencing the most dire consequences of shortage are those who are infusing in hospital settings and infusion suites. Why is that? Because those settings order product on an as-needed basis, with 30 or so days in reserve, some hospitals are reporting as little as 3-5 days’ supply for critical emergencies. Hospitals and infusion suites do not invest in maintaining the same levels of inventory as a specialty pharmacy due to space constraints, the constantly changing patient mixes, cost, etc. There are tons of reasons why hospitals don’t just keep months’ worth of several different products for patients. Often, they carry a single product or two, and only carry limited stock so that they can ensure they don’t unnecessarily use resources. Makes sense, right? 

Specialty Pharmacies, on the other hand, keep a lot more stock. The math is simple. Every week, they are sending a month or more of product out to many patients, whereas the hospitals are infusing maybe 25 patients a month. It makes sense for the SPs to have deep stock of products, because they know they will use it before it expires and that they will have demand to support constant supply of a variety of products. To learn more, visit our previous post on a Behind the Scenes look at your SP.  

With all that in mind, it makes sense that the SPs have been largely insulated from a lot of the issues that patients in hospital settings are experiencing, especially given the fact that they can see these shortages coming and order up to compensate. Hospitals and infusion suites are often caught flatfooted and it’s hard for them to come by product sometimes, and now is one of those times. Remember, it can take 9-12 months for plasma to be collected, manufactured, and make it to your home. More on that later.  

What can we do? What should we do? 

Well, if you’re being told your setting can’t get your product or they’re trying to change your dose or frequency, the first words out of your mouth should be whywhen should I expect my infusion as prescribed by my physician, have you notified my physician, and what are my options. Take notes and make sure to add the date, time, and who you spoke with on the call. 

Next, there are 3 phone calls I’d recommend making. 

1.    The first is to call your doctor and let them know what’s happening. If you have a patient portal, send a message through there. Ask the doctor what your options are for your next infusion. Is it appropriate to switch to a specialty pharmacy and get the infusion at home? Can you tolerate other products? All questions to ask. 

2.    Call the manufacturer of your product and let them know. 

3.    The last (and potentially most important) call or email is to the FDA’s Center for Biologics Evaluation and Research(CBER) to let them know that you’re being told you can’t get your infusion as prescribed by your doctor. 

I see a lot of people suggesting going to the media. It’s up to your discretion, but I wouldn’t do that as a first step. Here’s why: call the people who can create accountability and find you product, rather than just creating an echo chamber. If people aren’t reporting the issues, FDA won’t take action. Manufacturers can’t adjust their supply chain. It’s hard to know where the problems are if you aren’t willing to take action and let them know what’s going on. Media is looking for a story to get viewers, there is not guarantee that it changes your ability to get your next infusion. If you find no one from the above calls help you, then call the local station. 

So, we can talk more about what we would like to see going forward to prevent these kinds of issues in the future, but I wanted to have a conversation to help you better understand the process and that the shortage isn’t as dire as it might seem. Yes, being told your next infusion is not going on as scheduled is scary, but you have options. Advocate for yourself and be annoyingly persistent! 

NEED Help

Let us know what you’re experiencing – are you having problems getting your product as prescribed? Send me an email:  lisa@immunecompetence.org or leave a comment below!