Hurricane Helene’s flood-related damage to a key production facility last week in Marion, North Carolina (Baxter International North Cove plant) has serious potential to impact patient care nationally because it manufactures 60 percent of intravenous fluids (IV fluids) used by healthcare institutions throughout the U.S. According to the American Hospital Association (AHA), Baxter International’s North Cove plant produces 1.5 million bags of IV solutions daily.
IV fluids are an essential resource used in the emergency departments (EDs), operating rooms (ORs), intensive care units (ICUs), and are also an indispensable resource on ambulances, in infusion centers, and ambulatory surgical centers (ASCs). Simply put, IV fluids are a staple that medical facilities depend upon to take care of patients. It’s an essential aspect of routine, but more importantly emergency-related patient care.
“It will be impossible to treat patients without IV fluids”, said Peter Papadakos, M.D., Professor of Anesthesia, Surgery, Neurology, Neurosurgery and Director of Critical Care Medicine, University of Rochester Medical Center. “IV fluids have been a standard of care for over 100 years—it is the only way we have to administer life saving medications in ambulances, EDs, ORs and in the ICU.”
“The Baxter issue illustrates how one facility in a rural area that manufactures the majority of IV solutions nationally can cause a collapse of the entire supply chain when affected by a weather issue and loss of power; you would think placing a key resource in a rural area with no infrastructure is a bad business plan,” added Papadakos.
The Critical Need for IV fluids
Not just for simple hydration, IV fluids are necessary for treating patients with sepsis, but also for prehospital resuscitation (in ambulances) for patients before low titer O positive whole blood (LTOWB) or packed red blood cells (PRBCs) can be initiated in ambulances for patients who have ongoing blood loss as a result of blunt or penetrating trauma, nosebleeds, tonsillar bleeding or even obstetric or gynecologic-related hemorrhage.
Rationing of intravenous fluids will be an important and essential aspect of approaching any shortage encountered in the coming weeks to months. Oral hydration (as well as beverages with glucose and electrolytes), where appropriate, may help to offset shortages in some cases.
“Baxter has paused all shipments at this time and then will be implementing allocations later this week, but we do not yet know what those allocations will represent relative to our baseline utilization, said Michael J. Apostolakos, MD, FCCP, Chief Medical Officer and Vice President at the University of Rochester Medical Center.
“The IV fluid market is one with very limited excess capacity and the other two large manufacturers [B. Braun and ICU Medical] typically will take care of their existing customers with very limited ability to pick up additional customers. We are exploring all opportunities with alternative suppliers, but historically that has not been very successful,” added Apostolakos.
“The AHA is involved and we hope to work with the government to allow shipments form other countries to help ameliorate the problem. We were notified by Baxter that we will receive 40% allotment of what we have historically received moving forward. We are beginning conservation strategies and have roughly about four weeks supply in the current distribution network aside from the 40% allocation; no effects yet on clinical care and we hope to avoid such but will likely need suppliers outside the US,” explained Apostolakos.
Many healthcare systems, depending on their specific vendors and supply chain may only keep two weeks to a month of additional intravenous fluids available through a third party distributor or in an internal warehouse. Other systems may keep larger stockpiles of inventory—up to 3-6 months—based on their consumption and supply chain distribution networks. As a result, any disruption is sure to have ripple effects on optimal patient care. As Dr. Apostolakos explained, having to reach out to foreign suppliers is a distinct possibility, particularly with limited options for readily accessible sources of IV fluids.
Other large established healthcare systems have already made extensive preparations for such shortages or disruptions in their supply chain related to natural disasters—or simply manufacturing delays or supply chain issues.
“Mass General Brigham has activated an Incident Management Team (IMT) to monitor and manage the shortage of IV and other fluids that is arising from damage to the Baxter manufacturing facility in North Carolina,” said Paul Biddinger, M.D. Chief Preparedness and Continuity Officer at Mass General Brigham (MGB) and the Chief of the Division of Emergency Preparedness in the Department of Emergency Medicine at MGB, and the Director of the Center for Disaster Medicine at Massachusetts General Hospital (MGH).
“We are currently delivering all clinical services as normal, but are proactively emphasizing conservation of our fluid supply where possible to avoid waste. We have a team of our medical, supply chain, emergency preparedness and other leaders working as a part of this IMT to identify areas of our hospitals that may be disproportionately affected by the shortage and to mitigate any potential impacts. We are trying to work with other suppliers to procure additional replacement products as well,” explained Biddinger.
“We have experienced many supply chain interruptions in the last several years, including a major disruption to IV fluid supplies in 2017 following Hurricane Maria in 2017, and we have a specific playbook and protocol for how we approach these kinds of events that is based on our experience and best practice. We expect this to be a dynamic situation and cannot say how long this situation may last, or how it may evolve,”added Biddinger.
The Federal Response to a Potential IV Fluid Shortage Event
Other Federal agencies, including the FDA and the Administration for Strategic Preparedness and Response (ASPR) are expected to play an important role in managing the ongoing supply chain crisis. The goal of these agencies will be to speed up reviews of alternative drug applications while also working with manufacturers to boost capacity for IV fluid production, including bringing other manufacturers with sterile production facilities online.
“In the Department of Health and Human Services (HHS), the Administration for Strategic Preparedness and Response (ASPR), has produced guidance for the management of prior shortages,” said James Augustine, M.D., Clinical Professor of Emergency Medicine in the Department of Emergency Medicine at Wright State University in Dayton, Ohio, and a Fire EMS medical director in Southwest Florida and Ohio.
“The process was first used in 2014, when a shortage of normal saline was managed by temporary distribution of fluids produced in Norway. Guidance was provided again in 2017, the second crisis, which followed the destruction of IV fluid preparation capability in Puerto Rico by Hurricane Maria,” added Augustine who also serves as Medical Director for the International Association of Fire Chiefs (IAFC), and a member of the EMS Eagles Global Alliance of Fire EMS Medical Directors led Paul Pepe, M.D., a highly regarded expert in EMS and resuscitation.
Augustine explained that ASPR’s document on Partnering with the Healthcare Supply chain During Disasters published in August, 2024 “provides an overview of the emergency planning and response considerations of healthcare supply chain owners, operators, and end users, with insights for healthcare coalitions and supply chain partners on preparedness, response, and recovery. It offers insights into response during serious or catastrophic events, compared to normal supply chain operations.”
ASPR’s TRACIE (Technical Resources, Assistance Center, and Information Exchange), offers a wide variety of information resources, including those on drug shortages. Additional references through TRACIE to guide healthcare systems related to shortages of drugs, injectable medications or other key solutions can be crucial for management’s decision making in times of supply chain disruptions.
EMS Leadership During a Potential IV Fluid Shortage Event
Augustine described that “EMS leaders will need to develop strategies to address the shortage of IV fluids, and on an ongoing basis, the shortage of medicines that are unavailable. He believes that it would be “wise to have emergency leaders meet and prepare a regional Incident Action Plan (IAP), facilitated by convening a regional group of Emergency Department leaders, EMS chiefs, and hospital pharmacists to discuss ongoing management strategies.”
In the event of shortages of fluids and medications, “strategies must be implemented to improve logistics and ensure timely and effective safety notifications to the emergency care providers. This includes active inventory management, medical protocol flexibility, provider education, and a Quality Improvement initiative that focuses on timely educational materials to update the EMS staff, and advise at the point of use about correct dosing, compatibility issues, and side effects. Some EMS systems are printing safety cards for providers to give an immediate visual prompts.” added Augustine.
Some EMS agencies have developed IAPs and IMTs. Many plans allow for phased activation, as shortages worsen. The phased approach creates the flexibility to react based on the dynamics of shortages, and ensures that EMS agencies and hospitals act cooperatively with local, regional and state response strategies.
To deal with potential shortgaes of normal saline (NS) IV fluids, “clinical leaders must find ways to reduce the usual use of bags of IV fluids and substitute items like IV saline locks for the patients who have need by medical protocol for IV access, but do not immediately need IV fluid,” offered Augustine.
For special clinical situations that healthcare providers use normal saline for convenience—such as wound irrigation for contaminated wounds, or eye flushes for various chemical exposures—substitution of clean or sterile water is adequate and safe according to Augustine. For any ongoing needs for fluid therapy, agencies must consider the use of alternate IV fluids such as PlasmaLyte if available.
Implementing Solutions to IV Fluid Shortages
Ongoing shortages of IV fluids have been noted since 2014, and are multifactorial in nature. Stemming from production and manufacturer issues and delays related to plant shutdowns for inspections leading up to 2104, along with a “worse than average” flu season in 2014 putting a strain on already limited supplies, hospitals saw a major jump in prices of bags of IV saline (nearly five to six times the price prior to the shortage).
While the FDA enacted legislation in 2012 to help the agency respond to drug shortages—requiring manufacturers to report discontinuations or disruptions of drugs including IV fluids, a series of IV fluid product discontinuations related to contamination and unplanned production shutdowns from major manufacturers on the heels of the devastation by Hurricane Maria in 2017 of the key facility producing the majority of IV saline shipped throughout the U.S. resulted in a seismic disruption in the supply chain.
A major acquisition by the company, ICU Medical, in February of 2017 of Hospira Infusion Systems from Pfizer led to the establishment of it as a leader in infusion therapy. But in July of 2017, ICU medical announced a voluntary recall of one lot of IV fluid (normal saline) related to findings of particulate matter (stainless steel) distributed between 2016-2017 to Hospira customers. In March of 2017, B. Braun another, major producer of of IV fluids issued a press release announcing production interruptions resulting in lower supply of product to meet customer needs, along with announcement of a plant shutdown to perform critical maintenance, further leading to supply chain issues. Hurricane Maria then hit Puerto Rico in September 2017, shutting down Baxter’s production of IV normal saline along with other critical injectable medications.
While the U.S. can certainly reach out to foreign manufacturers as a stopgap measure to meet demand for IV fluids, the need to create incentives to diversify and regionalize production initiatives in an effort to bring more U.S-based manufacturers online is imperative. In this way, if a large manufacturer goes offline, (Baxter, in this case) other manufacturers can step up to assist with production.
Importantly, as climate change accelerates, we must remain vigilant where manufacturing plants are built. Appalachia remains an under-recognized region that is at risk for massive inland flooding. Collapsed bridges and roads that were washed away remain a limiting factor in accessibility for reaching the Baxter manufacturing plant in North Carolina. Infrastructure that supports ideal terrain and geographic factors related to flooding and surrounding bodies of water must be considered in planning future locations for manufacturing plants for sterile IV fluids and injectable medications.
Another recent natural disaster (July, 2023), when winds from an EF-3 tornado destroyed a North Carolina Pfizer plant which manufactured close to 25% of the drugmaker’s sterile injectables utilized by U.S hospitals, also illustrated the fallout from lack of regionalization for production facilities for critical sterile injectables and other vital IV therapeutics. The Pfizer plant, (1.4 million square feet), was one of the largest sterile injectable plants globally, manufacturing close to 400 million products including many critical products used daily by anesthesiologists such as medications to alleviate pain, treat infections (antibiotics), and neuromuscular blockers to relax muscles prior to placement of a breathing tube in the OR or in ASCs.
Regionalization, as Papadakos emphasized, must be considered in future planning of production facilities to mitigate the effects of one production plant dominating the landscape for national production of IV fluids, injectable medications and dialysis solutions, and potentially going offline in the event of a natural or manmade disaster
Just as economic incentives (tax breaks) may lure companies to certain regions, and at the same time provide much needed jobs, the importance of regionalization (by placement of additional production facilities in more secure locations that are at lower risk of impact for natural disasters) must be an equally important consideration.
And, while medical manufacturers such as Baxter Healthcare Corporation have received millions in tax incentives from state and local governments linked to expansions of its facilities, subsequent layoffs when long term deals expire upend employees’ lives, becoming victims of well intentioned deals favoring state and local communities as well as large corporations.
We must do better when it comes to planning and foresight for availability of critical medical supplies affecting the survival of people living in the U.S. Lessons learned from prior natural disasters, including floods, hurricanes, tornados and ultimately Covid-19, should serve as a wake-up call.
