Home Health Care: PN and EN Product Shortages
By Berri Burns, MEd, RD, LD, CNSC
Today’s Dietitian
Vol. 25 No. 7 P. 10

RDs can help mitigate the challenges to improve patient outcomes.

Health care is a fundamental human right, and having access to prescription drugs is vital for optimal medical care and patient outcomes.1 At some point, almost all sectors in every hospital— from rural clinics to urban health care systems—suffer from product supply shortages. The unanticipated arrival of COVID-19 in the United States in 2020 forced clinicians to face catastrophic shortages of medical supplies that rarely had been a concern beforehand. Innumerable medical equipment necessities—from the scarcity of ventilators to the minimal supply of tube feeding sets for enteral nutrition (EN) administration—became global causes for concern throughout the pandemic. And there was a baby formula shortage due to product recalls that jeopardized the health of millions of infants.

In this article, Today’s Dietitian focuses on the ongoing shortages of EN and parenteral nutrition (PN) products in the health care system and speaks with dietitians from the Cleveland Clinic about the impact these shortages have had on their daily work and patient care.

History of Shortages
When supply chains of PN and EN products are interrupted, health care providers face acute challenges to meet patients’ nutritional needs. These product shortages emerge due to interruptions in supply chain delivery, manufacturing issues, and regulatory concerns. The FDA states that drug product shortages occur “when the demand or projected demand for the drug within the United States exceeds the supply of the drug.”2 These periods of drug shortages often lead to serious consequences related to patient outcomes.3 Insufficient supplies of PN and EN formulas can delay nutrition therapy initiation in the hospital and home settings, interrupt nutrition therapy, or cause the administration of incorrect formulas. These issues can lead to malnutrition, overfeeding or underfeeding, fluid and electrolyte abnormalities, or EN intolerance.

Drug shortages of PN ingredients and additives have been on the rise for nearly 40 years.4 A shortage of any single parenteral element can be significant since formulas are composed of 20 or more individual sterile injectable components. Many ingredients can’t be substituted for alternative products without risking patient safety and causing harm.5

In 2011, the number of national drug shortages reached a record high of 267, of which 57% were sterile injection products. 3 As a result of the 2011 drug shortage crisis, the Food and Drug Administration Safety and Innovation Act of 2012 was enacted. This legislation created pathways for early identification and mitigation of potential drug shortages.4 Since nearly 40% of drugs and 80% of active drug ingredients are imported to the United States, this legislation expands the FDA’s authority to help protect the global drug supply chain and help patients maintain access to the medications they need.

Many events precipitated the 2011 crisis, including the closure of several compounding sites due to quality issues.6 However, challenges other than manufacturing quality issues are causing ongoing product shortages. “The primary causes of product shortages have shifted from those historically resulting from manufacturing compliance and quality issues to now unknown causes or issues related to an imbalance between supply and demand.”4

In 2017, Hurricane Maria destroyed a PN manufacturing facility in Puerto Rico. The destruction of this factory led to a wave of sterile injectable product shortages, especially amino acids. An interruption from a significant production source causes cascading failures in the product supply chain, thus exacerbating the need for other manufacturers to ramp up production.4 A single event such as Hurricane Maria can create long-lasting negative impacts on supply chain deliveries worldwide.

Data on EN product shortages are less definitive than data on PN product shortages due to inconsistent record keeping.4 According to Mulherin and colleagues, “Minimal documentation may be related to a lack of registered dietitians who are accustomed to reporting EN shortages coupled with less rigid federal oversight of medical foods compared with drugs.4 Medical foods aren’t drugs and, therefore, aren’t subject to regulatory requirements that are specific to drugs. The FDA requires all facilities involved in the manufacturing, processing, packing, or holding of medical foods for consumption in the United States to be registered with the agency. However, the FDA doesn’t retain a registry of medical foods.7

Product Shortage Crisis

Impacts of PN Shortages
Although product shortages in 2011 reached a record high, they represent only a fraction of what took place in 2023. In the first quarter of 2023 alone, 301 national drug shortages were recorded— of which 55% included sterile injectable ingredients.8

The fragility of specialty compounding pharmacies, coupled with supply chain distributions during the COVID-19 pandemic, contributed to the increase in shortages. “The lack of additives at compounding pharmacies seemed to fuel parenteral nutrition shortages,” says Elizabeth Galant, RD, LD, CNSC, home nutrition support clinician at the Cleveland Clinic. “Supply chain distribution issues lead to insufficient ingredients for compounding the sterile additives. During the pandemic, this worsened, and even if the additive could be made, the delayed logistics of getting the product to the hospital caused another layer of shortage.”

Kristin Izzo, MS, RD, LD, CNSC, a clinical nutrition manager at the Cleveland Clinic, says that some of the current challenges of PN shortages include logistical and supply chain disruptions as well as ongoing manufacturing and transportation staff limitations resulting from the pandemic. These delivery disruptions technically may not be considered product shortages since they were caused by supply chain limitations, but they impacted patients and caregivers just as much as standard product shortages. Despite these issues, Izzo believes a lack of compounding and administration materials poses the greatest risk to patient care during PN product shortages.

“There are many creative ways to combat component shortages for parenteral nutrition, but we have an extremely limited ability to provide adequate therapy when shortages impact the physical ability to compound and administer custom total parenteral nutrition,” Izzo continues.

“Fortunately, we have some great minds and resources in our home parenteral nutrition community. In recent years, we’ve had multiple IV lipid emulsions we’ve been able to learn more about and substitute in times of lipid shortages. When [possible], we have skilled clinicians that can determine if oral substitutes are an appropriate alternative for many components, such as magnesium, phosphorus, potassium, sodium bicarbonate, calcium, vitamins, and trace elements. We’ve also been able to work with our pharmacies to substitute different concentrations of sodium chloride during shortages. Recently, with our renal experts, we created a mathematical approach to replete bicarbonate deficits with oral rehydration solutions containing baking soda or other sodium bicarbonate oral medication replacements,” Izzo says.

Home PN is more challenging in the home setting, as it isn’t monitored as closely as it is in the hospital setting. Less monitoring for long-term PN patients increases the risk of nutrient deficiencies if there’s a shortage of PN components. For example, omission or inadequate provision of multivitamins poses the greatest risk to patients.4

Impacts of EN Shortages
Patients who require EN often are in a more dire situation than those needing PN due to the lack of monitoring and documentation of EN shortages.

The demand for EN products in hospitals exploded during the height of the COVID-19 pandemic. The surge in COVID-19 patients admitted to ICUs, who required tube feeding, placed a greater strain on EN inventory and exposed the potential for future shortages. Clinicians had to prioritize feeding administration pumps for patients with post pyloric feeding tubes.

Sarah McIntyre, RD, LD, an inpatient dietitian at the Cleveland Clinic, says that product shortages have made a significant impact on her practice. “Due to volume restrictions for many of my clinical patients, standard enteral formulas—in particular, shortages of calorie-dense products—have altered my practice. This scenario impacts hospital length of stay due to product demand and unavailable inventory and/or delayed delivery of products post discharge to home,” McIntyre says.

In 2022, the infant enteral formula crisis illustrated the long-lasting negative effects of a medical food shortage. On February 17, 2022, Abbott Nutrition announced a voluntary recall of powdered infant formula due to Cronobacter sakazakii contamination.9 Cronobacter sakazakii is a bacterium found naturally in very dry environments, including in dry foods such as powdered infant formula, powdered milk, herbal teas, and starches. Cronobacter illnesses are rare, but when infections occur in infancy, they can be fatal.9

Diana Schnee, MS, RD, CSP, LD, an outpatient pediatric nutrition support dietitian at the Cleveland Clinic, says that during the infant formula shortage, “Increased time was dedicated to helping patients find products, transition to appropriate alternatives, and deal with the side effects of changing formulas. Dietitians [offering a different] formula isn’t as simple as just giving an alternative product. Many of our kids are on specialized recipes, so they need recipes with new product alternatives. In addition, the creation and mixing of new recipes require substantial time above and beyond scheduled patient care.”

Andrea Adler, RD, CSP, CSPCC, LD, an inpatient pediatric nutrition support dietitian at the Cleveland Clinic, says, “[The] inpatient RD team worked with Patient Food Service to obtain comparable products [that weren’t] on the hospital enteral formulary.” For example, she says, “Some patients were required to transition to a free amino acid-based formula, since the semi-elemental infant formula available contained probiotics, which was contraindicated in the pediatric transplant population.” On the other hand, when it was closer to discharge, the inpatient RD team assessed what the Home Infusion Pharmacy’s inventory could provide if the hospital tube feeding prescription couldn’t be duplicated at home because of product shortages.

“Certain products aren’t yet available today. The [inpatient RD] team researched European infant formulas for alternative offerings. We were limited to infant formulas approved for import to the United States. Some of our patients transitioned from a 1 kcal/mL to a 1.2 kcal/mL product due to availability, but [they] didn’t necessarily [receive] an adjusted feed volume to account for the calorie difference.”

Strategies to Deal With Shortages
PN and EN product shortages can lead to many challenges for hospitals, patients, and caregivers both domestically and globally, but RDs who are part of interdisciplinary health care teams can help implement the following strategies to prepare and manage drug shortages to improve patient health outcomes.

• Use a decision tree. A decision tree is a treelike diagram that represents a series of decisions and their possible consequences or outcomes. It’s a flowchart that dietitians and other clinicians can use to decide how to prepare, monitor, and manage drug shortages. According to Schnee, a decision tree is centered on a root question or root problem and involves brainstorming a variety of ideas to help develop processes that can lead to making the best clinical decisions for improved patient outcomes. It serves as a starting point for clinicians to map out a plan to prepare for and manage drug product shortages.

• Standardize methods to report and manage shortages. Request a weekly email from the infusion pharmacy to update the status of the PN and EN formulary inventory and determine potential shortages. Next, collaborate with team members and leadership to develop contingencies if infusion pumps, tube feeding sets, or syringes are in short supply.

• Create a database of alternative PN and EN formulas patients can use if their current formula prescriptions are out of stock. The database will help clinicians choose alternatives when there are PN and EN formula restrictions and substitutions are necessary. Moreover, a database of currently available PN and EN formulas will encourage prescribing providers to order nonshortage items. When the shortage items are back in stock again, RDs can update the database to reflect the status change.

• Communicate with families and stakeholders. It’s important for RDs to discuss the status of product shortages with patients and caregivers and offer alternative formulas. Maintain open and consistent lines of communication with all supply chain personnel, manufacturers, RD teams, and those in leadership. All new prescriptions for alternative PN and EN formulas must be approved, formulated, and covered by insurance. In addition, these new prescription orders must be faxed or sent electronically to the infusion pharmacy.

Final Thoughts
Over the last few years, PN and EN product shortages have become more widespread. They’re unpredictable and affect many stakeholders, especially patients, their families, and consumers. The prevalence of product shortages creates growing challenges and hardships that can lead to severe health and economic consequences. Recently, temporary PN and EN product shortages have become the “new normal” in medicine, but making attempts to identify which shortages may be on the horizon and which ones could have the largest impact may be a step toward more timely mitigation. When communicating shortage updates and discussing potential solutions with all partners in the health care system, everyone will be better prepared to handle the shortages and improve patient care and health outcomes more seamlessly.

— Berri Burns, MEd, RD, LD, CNSC, is an advanced practice dietitian at Infusion Pharmacy at Home at Cleveland Clinic.


1. Hogerzeil HV. Essential medicines and human rights: what can they learn from each other? Bull World Health Organ. 2006;84(5):371-375.

2. Holcombe B, Mattox TW, Plogsted S. Drug shortages: effect on parenteral nutrition therapy. Nutr Clin Pract. 2018;33(1):53-61.

3. Badreldin HA, Atallah B. Global drug shortages due to COVID-19: impact on patient care and mitigation strategies. Res Social Adm Pharm. 2021;17(1):1946-1949.

4. Mulherin DW, Kumpf V, Shingleton K. Managing nutrition support product shortages: what have we learned? Nutr Clin Pract. 2023;38(1):27-45.

5. Food and Drug Administration Safety and Innovation Act (FDASIA). US Food and Drug Administration website. https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-safety-and-innovation-act-fdasia. Accessed June 4, 2023.

6. Caulder CR, Mehta B, Bookstaver PB, Sims LD, Stevenson B. Impact of drug shortages on health system pharmacies in the southeastern United States. Hosp Pharm. 2015;50(4):279-286.

7. Frequently asked questions about medical foods, third edition: guidance for industry. US Food and Drug Administration website. https://www.fda.gov/media/97726/download. Published March 2023. Accessed June 1, 2023.

8. Fox E. Drug shortages statistics. American Society of Health System Pharmacists website. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics. Accessed May 28, 2023.

9. Cronobacter and powdered infant formula investigation. Centers for Disease Control and Prevention website. https://www.cdc.gov/cronobacter/outbreaks/infant-formula.html. Updated May 24, 2022.