When Hurricane Helene roared through North Carolina in September, the damage it caused went well beyond local homes and businesses. The North Cove-based manufacturing plant of Baxter International -- the largest supplier of intravenous (IV) and peritoneal dialysis solutions in the United States -- was "significantly impacted" in an unprecedented way by the rain and storm surge that caused flooding in the facility and damage to bridges leading to the facility. This has resulted in supply change disruption throughout the country.
The reduction in available IV fluids is "having a significant impact on hospitals because IV fluids are absolutely essential for the treatment of many types of patients," Nancy Foster, vice president for Quality and Patient Safety Policy, American Hospital Association (AHA), told Medscape Medical News.
Robert D. Glatter, MD, attending physician in the Department of Emergency Medicine, Lenox Hill Hospital, New York City, and assistant professor of emergency medicine at Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, noted that IV fluids are indispensable "not just for simple hydration but for treating patients with sepsis, resuscitation of patients before whole blood or red blood cells are available, for patients with ongoing blood loss from blunt or penetrating trauma, on board ambulances, in infusion centers, intensive care units, and routine medical floors." These fluids also are essential before childbirth and surgery and in treating prematurely born infants.
An October 9 statement issued by Baxter indicated the company is working to "fully restore" their North Cove manufacturing operations and increasing manufacturing capacity at its other sites, including those outside the United States. It's increasing the current US allocation levels of the highest demand IV fluids from 40% to 60% for direct customers and from 10% to 60% for distributors. In addition, it's increasing high-concentration dextrose and sterile water for injection allocations, with additional increases anticipated by early November, and prioritizing allocations for IV solutions and nutrition products to 100% for children's hospitals.
"Our goal continues to be to restore customers to 100% allocation levels as soon as possible" and to restart North Cove production "in phases," returning to 90%-100% allocation of certain IV solution product codes by the end of 2024," according to the statement.
"We will spare no resource -- human or financial -- to restart operations and help ensure patients and providers have the products they need," stated Baxter CEO Joe Almeida.
On October 7, the AHA wrote a letter to President Biden urging the administration to "take immediate actions to increase the supply of IV solutions for the nation's hospitals, health systems, and other healthcare providers that are already struggling to provide care." The letter made a series of requests, including a formal declaration of shortage in sterile IV solutions; making transportation available for emergency supplies from international sources identified by the US Food and Drug Administration (FDA); securing transportation to domestic distribution centers of needed supplies; and extending the shelf life of all sterile IV and peritoneal dialysis solutions that are beyond or nearing their expiration date.
On October 11, the Biden-Harris Administration announced it was continuing to take action to support access to IV fluids, which includes "ensuring restoration of key production sites, protecting products, and opening imports, in partnership with manufacturers, distributors, hospitals, and other stakeholders." As a result of these steps, hospitals now have 50% more products available to them, compared with the previous week.
The statement echoed and expanded on an earlier October 9 letter to healthcare leaders and stakeholders sent by Secretary Xavier Becerra from the US Department of Health and Human Services (HHS), stating that HHS is "coordinating a USG-wide response to address supply chain disruptions."
Becerra's letter noted that recovery and infrastructure repair efforts are underway at the Baxter facility, driven by the Administration for Strategic Preparedness and Response (ASPR) and the Federal Emergency Management Agency, and much of the inventory at the Baxter's North Carolina plant has been saved.
In addition, the HHS is working with manufacturers, nationally and globally, to increase production capacity. The FDA is "expediting regulatory reviews" as well as consideration of any shelf-life extension requests that manufacturers may submit for short-dated products, and ASPR is "providing technical assistance."
On October 12, the Centers for Disease Control and Prevention issued a health advisory directed toward healthcare providers; pharmacists; healthcare facility administrators; and state, tribal, local, and territorial health departments, urging them to "immediately assess their supply and develop plans and mitigation strategies to reduce the impact on patient care."
On October 11, the FDA formally declared shortages of three new parenteral drug products produced at the North Carolina Baxter plan (Dextrose 70% IV Solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution). In the meantime, the FDA released immediately-in-effect guidance entitled "Temporary Policies for Compounding Certain Parenteral Drug Products."
Foster said conservation strategies should be undertaken "to protect what we have." These AHA-recommended strategies are drawn from a more extensive list of conservation recommendations issued by the American Society of Health-System Pharmacists, updated on October 4.
Individual medical associations, such as the American Thoracic Society, the American Society of Pediatric Nephrology, and the American Society of Anesthesiologists, have issued recommendations relevant to their specific specialties regarding the IV fluid shortage. Healthcare providers are encouraged to turn to their society for further guidance.
The supply disruption has far-reaching implications that both predate and transcend the current crisis.
"The root cause of ongoing shortages of IV fluids is ultimately related to a string of natural disasters and other market forces, which have prevented a significant rebound, since the shortage of intravenous fluids began around 2014," Glatter stated. "The need to bring more manufacturers on board is quite clear, so that if a large producer goes offline -- Baxter, in this case -- others can step up to assist with production."
He emphasized that "as climate change progresses, we must remain vigilant about where manufacturing plants are built." For example, Appalachia "remains an under-recognized region that is at risk for massive inland flooding," he said. And because collapsed bridges limited accessibility to the Baxter manufacturing plant in North Carolina, "infrastructure that supports ideal locations must be considered in planning future locations for manufacturing plants."
Peter J. Papadakos, MD, director of critical care medicine and professor of anesthesiology, surgery, neurology, and neurosurgery, University of Rochester, New York, agreed this is not the first time a crisis of this nature has happened. In 2017, for example, Hurricane Maria damaged the manufacturing plant of Baxter International in Puerto Rico, leading to disruptions in the IV fluid supply chain. "We need to learn from history that maybe we need more satellite manufacturing hubs to make medical supplies critical in diverse areas of the country," Papadakos said.
He suggested that these hubs "could be interconnected via technology to pick up the slack in times of emergencies. Companies need to have several factories making critical medical supplies that are located in different geographical areas of the US."
By being interconnected, the company could know what's in stock at any given facility and pick up production at other plants to make up for the deficits caused by weather or other issues. "Thus, the supply wouldn't be affected as it is now."
Foster suggested steps providers can take, such as "thinking about alternative ways to treat the patient in front of them -- for example, you may or may not need to give IV fluids to every patient who comes into the emergency department. Maybe they can be treated in a different way, or maybe a smaller IV bag can be used to conserve fluids, and the patient can be reassessed every few hours to determine if they still need to be on IV fluids or whether that can be discontinued."
Postponing elective surgeries might also help. "As we learned from COVID, elective surgeries should be done fairly promptly but can be postponed for a short period until the situation is better," she said.
She agreed that when one organization is responsible for a substantial part of the market, that creates a "single point of failure, to borrow a term from the engineering field. This means that if this 'point' is taken out, one has to scramble to meet the need."
The crippling of the Baxter plant as a result of the hurricane shows how dependent our nation is on that plant in providing the IV fluids necessary for daily care in the hospital, and that single point of failure can have a "crippling effect on the entire system."
Foster suggested that we need to "think about options for diversifying, such that if a single plant goes out or a cyberattack occurs and a single source goes down, how can we be more resilient across the entire health field?" Looking at "single points of failure in the system and shoring them up has to be part of our national strategy going forward."
Glatter, Papadakos, and Foster declared no relevant financial relationships.