Home Infusion Pharmacy Closures and Nutrition Product Shortages

Home Infusion Pharmacy Closures and Nutrition Product Shortages

Vanessa J. Kumpf, PharmD, BCNSP, FASPEN

Note: Some parts of this article are focused on HPN and home infusion pharmacies because of the closures in 2022 and ongoing shortages of HPN components, but as this article was going to press, backorders of enteral formula were being reported. Many of the tips offered here apply to home tube feeding and DME or home care companies, as well as infusion pharmacies.

Some of you may have been impacted by or read about the recent closures and consolidation of select home infusion pharmacies. Last year, many consumers of home parenteral nutrition (HPN) and home IV fluid therapy were told by their infusion pharmacy that they would no longer be able to provide the service. It was a scary time of uncertainty for many and has caused some to worry if other infusion pharmacies will also stop servicing consumers of HPN or of home enteral nutrition (HEN or tube feeding). In addition, product shortages related to parenteral and enteral nutrition continue to wreak havoc on a global basis.

Both topics have recently been in the news and warrant a focused informative and constructive discussion within the Oley community. It is the intent of this article to educate you, as a consumer or caregiver, on measures you can take to receive the product and services you need to stay safe.

Home Infusion Pharmacy Closures: What Happened?

In June 2022, many consumers serviced by Coram/ CVS specialty infusion services and Optum Infusion were informed that they would need to transition to another agency to receive HPN and home IV fluid services. Select pharmacy branches were closing, staff positions were being eliminated, and services were being consolidated. In the case of Coram, a transition team was formed to assist consumers in transitioning to another infusion pharmacy.

This transition occurred over a rapid four- to six-week period, which didn’t allow much time for consumers to evaluate their options. Consumers who were impacted may have tried contacting their home nutrition therapy prescriber for assistance in making this transition, but not all prescribers had the resources available to handle this issue. Social media was another tool used by some to help navigate the transition, with varying degrees of success.

The reason for closures and elimination of services was not provided, but many speculate it was related to increased costs associated with products and labor in servicing consumers of HPN and home IV fluid therapy without a corresponding increase in insurance reimbursement. Many individual PN components have increased in cost over the past several years for various reasons. Product shortages have often necessitated use of alternative agents that are more expensive. In addition, an FDA initiative that encouraged manufacturers to seek formal approval of previously “unapproved” PN components has resulted in higher cost.

Changes in labor force resulting from the COVID pandemic is another potential factor. It is important to recognize that people receiving HPN often have complex medical needs and an advanced level of knowledge and expertise is required to properly manage their care. This creates additional challenges for infusion pharmacies to maintain the proper workforce when servicing these people.

Finding a New Home Infusion Provider

The reality is that at some point, every home nutrition support consumer may be placed in a position where they need to change their home infusion pharmacy or DME company. It may be due to termination of service, but it may also be due to other factors, such as a move out of state, a change in health insurance, or even a concern over quality of service. The question becomes, how do you find an alternate provider that best meets your needs?

Ask for recommendations of other agencies from people you know, such as the doctor or team that prescribes your HPN or tube feeding, or other consumers requiring the therapy. Check with your health insurance provider to ask for a list of available agencies within network, if applicable.

Here are some questions you can ask prospective agencies to help assess their level of quality and clinical expertise:

• What clinicians are employed by the agency and what is their level of education and training? Will you as a consumer or caregiver have access to dietitians and nurses in addition to pharmacists? What is their level of experience? Specialty certification in nutrition support is available for pharmacists, nurses, and dietitians and demonstrates at least a minimum level of knowledge in clinical nutrition. This certification includes BCNSP (Board Certified Nutrition Support Pharmacist) and CNSC (Certified Nutrition Support Clinician). Do any of the clinicians have one of these certifications?

• Does the agency serve the geographical area where you live? How will you receive deliveries? What happens if you need an urgent delivery?

• What happens if an urgent issue arises after business hours? Is there a clinician available twenty-four hours a day, seven days a week to address these issues?

• What kind of equipment and supplies will the agency provide? Are there limitations to the number and types of infusion pumps and supplies available? For example, if you require HPN every night, you may benefit from a back-up infusion pump in the event of pump malfunction in the middle of the night and your company cannot replace the pump in a timely manner.

• Is the agency experiencing any product shortages related to the therapies you require? If so, do they have a plan in place to manage these shortages? While product shortages are often unavoidable, there should be a reasonable alternative plan in place. If the answer is “I don’t know” or there is no alternative plan in place, this should raise a significant quality concern.

• Does the agency have experience managing other HPN consumers? How many people who are on the same therapy that you require do they currently service? You really don’t want to be the only one!

• How does the agency accommodate travel away from home, especially when the travel is for an extended period or out of state?

While it may not be realistic to find a perfect home infusion provider or DME company that checks all the boxes, you as a consumer must determine what criteria are most important to you. Focus on that as you tailor what questions to ask and as you consider your best option. Don’t be afraid to speak up and ask for what you need. You need to advocate for your right to receive the products and services you need to keep you alive and safe!

Nutrition Support Product Shortages: Why is it happening?

Product shortages related to PN therapy are not new, but the problem had historically been intermittent and short-lived. Almost every PN component has been in short supply at some point in time, but the frequency seems to have increased, and the problem has expanded to include shortages of products related to EN therapy as well. The impact of the COVID-19 pandemic on supply chain issues and workforce demand has certainly played a role in creating product shortages.

Several factors contribute to making PN ingredients particularly susceptible to shortages. The sterile injectable components of PN are produced by only a few manufacturers and the geographic diversity of manufacturing sites is limited. In addition, there are limited sources of the active ingredients and the raw materials needed to produce the active ingredients.

We have experienced closure of production sites due to natural disasters, such as with Hurricane Marie in 2017. Some manufacturers have had to temporarily halt production due to quality issues requiring corrective action, such as what occurred with infant formula manufactured by Abbott Nutrition. When one company is unable to manufacture a PN component or EN formula, it increases demand on another company, and it takes long lead times to meet this demand. In some cases, there is only a single manufacturer available, and no one is there to pick up the unmet need for supply.

What You Can Do to Manage Nutrition Product Shortages

For consumers of HPN, it may be necessary to reduce the dose of a specific nutrient in your PN to conserve supply. It may also be necessary to remove the nutrient entirely if supply is unavailable. In addition, certain products used to administer your PN or EN may be in limited supply at times. For example, this may include supply of pumps, tubing sets, and flushes. You may be asked to switch to a different pump or supply item.

Here are things you can do to stay informed, educated, and safe during periods of product shortages:

•Ask your doctor or team that prescribes your home nutrition therapy and your home infusion provider to keep you updated of any product shortages affecting your therapy.

•If you are on PN, adhere to any oral supplement regimen you are asked to take when the dose of that nutrient that you would normally receive by IV is reduced or removed.

◊ Ask your infusion pharmacy to provide the necessary supplement to help ensure you are taking the proper dosage form and dose.

◊ If you are asked to purchase the over-the-counter supplement on your own, make sure it is the correct one.

◊ Notify your doctor or team that prescribes your PN if you do not tolerate the oral nutrient supplement.

•If you are on PN, review your label to look for changes or omission of a nutrient.

◊ Notify your doctor or team that prescribes your PN and your infusion pharmacy if you think something is missing.

•If you are on PN or EN, ask your infusion pharm-macy or DME company to keep you updated regarding return of supply. You should resume normal dosing as soon as product is available.

•If you are on PN or EN, ask your infusion pharmacy or DME company if you have any questions regarding a product change.

Invited Commentary

From Vanessa, author of the article:

The ability of home nutrition support consumers to receive the care they need has been significantly impacted by both service closures and product shortages. The problems are likely not going away anytime soon. While news accounts of these events have tended to play up the victim side of the story, it is just as important to discuss constructive ways that we as an Oley community can best manage existing barriers and minimize risk of future harm.

While it is imperative that we as a country maintain an adequate number of home infusion pharmacies to meet the needs of all HPN consumers, it may not be a therapy that all infusion pharmacies should even attempt to provide. It is a specialized therapy that requires an advanced level of training and experience in order to maintain safe practice. Instead of promoting the provision of HPN services within all home infusion pharmacies, it may in fact be better to focus the therapy with those infusion pharmacies equipped with a competent staff and necessary resources in place to manage HPN. As a consumer of HPN, you have a right to demand competence from all your providers and should feel empowered to seek it out and change providers whenever that care is thought to be inadequate.

From Andrea, a prior home infusion dietitian:

I agree with this, however with Coram and Optum decreasing their footprint, it unfortunately decreases the options of home infusion providers and if a patient is too picky, they may find themselves without an option. Also, changing providers frequently may be seen as a “red flag.” Patients should weigh all options and go with the provider who meets the most of their criteria; they may find their current provider is their best option. Unfortunately, switching providers often can’t help in situations where there are national shortages or problems at the manufacturer level.

From Maisy, a home parenteral (IV) nutrition consumer:

As a consumer I think the vitamin shortage was the first time I really acknowledged how serious these things are. I’m grateful I can take some things PO (by mouth) and I really started reevaluating my diet, trying to be really intentional and get the most out of what I eat, which I’ve almost never thought about. Ultimately I don’t know if that would make a difference, but it felt like something I could control. It’s scary.

From Michael, a home enteral nutrition (tube feeding) consumer:

In November 2022, my DME provider informed me that my formulas, Jevity 1.0 and Ensure Plus, were out of stock and on backorder. I always try to build up a reserve supply, so I wasn’t too worried, but then it happened again, and again, and again, and it keeps happening, so now I have no confidence that my life-sustaining feeding supplies will be available when I need them. At first, I thought that this was my provider’s fault, so I started looking around for a new supplier but quickly realized that other providers were having similar issues. It turns out that the problem is with Abbott Labs, the manufacturer of Jevity and Ensure—and baby formula. We all heard so much about the baby formula crisis, but not a word about this shortage in the press or on TV.

As a temporary solution, my provider suggested that I switch to Nutren 1.0 with Fiber and Boost Plus, both Nestlé products, but guess what? Because of the huge demand for these substitutes, these formulas are also on backorder—the whole supply chain is clogged up. I had been asking, through Abbott’s customer service hotline, what was going on. Finally, in late February, Abbott sent out a letter to the DME providers listing all of its products that are unavailable and listing ETAs, but in the case of Jevity 1.0, there still is no ETA.

What is going on, and what can we do about it?

From Roger, a home enteral nutrition (tube feeding) consumer:

I contacted the Oley Foundation on February 22 about my concerns relating to the lack of availability of Jevity1.5 in my area. As I ventured out to find Jevity (for which I pay out of pocket), I was met with disappointment and confusion. My pharmacy reported that would be going the product in a week or two as the order was backordered. I have yet to receive any product and I didn’t contact Oley until three weeks had passed. I started contacting as many suppliers as I could about Jevity and the answer was the same—no product. I called Abbott laboratories and was assured that product would be available “soon.”

I spoke with a dietitian who had no idea what I could do as a substitute for the Jevity other than to try Boost. I explained I couldn’t handle Boost as it caused me severe diarrhea. I changed tactics and purchased “meal replacement” products and added the needed fiber and drank them slowly and as safely as I could. Not a wise decision, on my part, as I choked frequently and, further, caused myself some serious constipation.

Good friends found some Jevity and ordered it. The prices varied from $48.00 to $65.00 per case, and shipping fees were all over the board. These orders came from Ebay as well as a few private sources. Some of the Jevity I did receive was out of date. One case arrived with an open container and the remainder of that case was coagulated. One case I received cost me $55.00 in shipping fees. I am still uncertain as to what the current situation is, but I have enough now to get through three more weeks

IF I CUT MY CURRENT NEEDS IN HALF DAILY.

There are positives about this situation for sure. I am totally responsible for my own welfare and I am certain that I will make a plan for backup supplies in the future.

One last note: I am not aware of the size of our numbers in the world, but surely we deserve a heads up about our needs and the availability of life-saving formulas.

ACTION ITEM: Tell us, the Oley Foundation, about your experiences with shortages and or switching home infusion providers. We can only advocate for you when we know and understand your concerns. Email us at oleyfoundation@gmail.com.

List of Essential Vitamins

•vitamin A

•vitamin C (ascorbic acid)

•vitamin D

•vitamin E

•vitamin K

•thiamine (vitamin B1)

•riboflavin (vitamin B2)

•niacin

•pyridoxine (vitamin B6)

•folic acid

•vitamin B12 (cyanocobalamin)

•biotin

•pantothenic acid

Managing the IV Multivitamin Shortage

The supply of IV multivitamins has experienced intermittent periods of shortage for the past several decades. We are now facing another period of product shortage. The manufacturer recently announced the unavailability of a component that is critically needed to supply the product, and the timeline to resolve the issue is uncertain. This will impact the availability of both adult and pediatric IV multivitamins for weeks to several months. There are no alternative IV multivitamins available in the U.S. market. This creates a challenging situation since multivitamins are a critical component of PN.

Here is what you can do to advocate for yourself:

•Discuss the issue with your HPN clinician and your home infusion pharmacist and ask if there is a plan in place to ensure you are getting what you need until the shortage is resolved.

•You may be asked to reduce the frequency of IV multivitamin to three days per week. If this is the case, you should also be supplementing with an oral multivitamin daily.

•Ask your home infusion pharmacy to provide an appropriate oral multivitamin supplement until the IV multivitamin shortage is resolved. If this is not possible, you will need to purchase a supply.

•Make sure you are taking an oral multivitamin that is complete with thirteen vitamins (see above). Avoid the use of oral multivitamins in the gummy form. They lack many of the necessary B-vitamins.

•Notify your HPN clinician if you are unable to tolerate an oral multivitamin.

•The American Society for Parenteral and Enteral Nutrition (ASPEN) has developed recommendations to help clinicians manage patients receiving PN when an IV multivitamin shortage occurs. It is a great resource that you can share and discuss with the doctor that prescribes your HPN and with your home infusion provider. The document can be accessed at nutritioncare.org.

On Your Behalf

In January, the Oley Foundation, as well as two coalitions Oley is part of, the Digestive Disease National Coalition (DDNC) and Patients and Providers for Medical Nutrition Equity (PPMNE), submitted comments to the Centers for Medicare and Medicaid Services (CMS) asking that medically necessary foods—such as IV nutrition and tube feeding—be considered an Essential Health Benefit. The request for information for CMS was in relation to insurance coverage. Importantly, this was also an opportunity to highlight that IV nutrition and tube feeding are life-sustaining and critical.

You can read more about the CMS request for comments at federalregister.gov/ documents/2022/12/02/2022-26282/request-forinformation-essential-health-benefits and find links to the letters submitted by Oley, DDNC, and PPMNE at oley.org/Legislation.