By now, nearly every anesthesiologist or their group has been impacted by the shutdown of a Baxter manufacturing plant in North Carolina that produced I.V. fluids and other solutions. In late September, flooding caused by Hurricane Helene infiltrated the building, washed away local bridges, and disrupted the lives of the 2,500 employees at the North Cove plant. Almost immediately, anesthesiologists, hospital pharmacies, and others were scrambling not just to procure additional product from back-up suppliers but to establish local I.V. fluid conservation strategies.
The Baxter manufacturing facility shutdown had and continues to have a significant impact on the health care supply chain. The facility manufactured about 60% of the U.S. supply of I.V. solutions, producing approximately 1.5 million bags per day. Immediately after the Baxter situation was announced, ASA staff were in contact with Baxter, the U.S. Food and Drug Administration, the American Hospital Association, and other stakeholders. ASA physicians and staff shared strategies across health care, offering our recommendations on how Baxter and others could best mitigate the shortage.
Unfortunately, anesthesiologists have been managing various drug shortages for many years. At a late-breaking session on the I.V. fluid shortages at ANESTHESIOLOGY® 2024, ASA members reported daily challenges in delivering quality care and protecting patient safety within the confines of available drugs at their facilities. Responding to the I.V. fluid shortage appeared to reflect continued frustration with the supply chain, but anesthesiologists remained resolved in their commitment to find and implement local solutions.
For those anesthesiologists working in large hospitals or facilities with pharmacies, the burden of identifying back-up suppliers and procuring additional product is shared between multiple stakeholders and hospital administrators. For those working in smaller hospitals, ambulatory surgery centers, or in places with limited or no pharmacy support, including solo anesthesiologists, finding additional supply has been difficult. The Baxter allotment of 50% and then 60% often could not meet patient needs, even with local conservation protocols in place. Even if a hospital could reduce its I.V. fluid use by 30%, that facility would still lose ground each week the shortage dragged on.
We also received reports of medical centers and hospitals cancelling or delaying surgeries until I.V. fluid supplies could be restocked. For those groups, Baxter appeared to be a primary source of I.V. fluids, and those hospitals were struggling to find suppliers to fill the gap. In those cases, we learned that anesthesiologists were leading on a number of fronts – from communicating with surgeons and pharmacies on surgical schedules and expected fluid requirements, to protecting I.V. fluid needs for emergency and urgent procedures.
Although there was a significant degree of coordination and communication between Baxter, federal authorities, and medical and health care-related societies, it may have seemed to ASA members that each individual society was publishing conservation strategies. The American Society of Health-System Pharmacists (ASHP) issued lengthy guidance for conservation. The American Hospital Association hosted several podcasts. At ASA, we collected policies and procedures from multiple facilities and provided general guidance that most anesthesiologists were likely already implementing. The suggestions served as guideposts for anesthesiologists to consider and implement accordingly based upon local need, patient populations, and surgical procedures. In several conversations at ANESTHESIOLOGY 2024, anesthesiologists described their leadership in coordinating and implementing conservation efforts with surgeons, pharmacists, postanesthesia care unit nurses, and other local stakeholders.
ASA staff coordinated our society’s response to the supply chain issues with a standing physician drug shortage workgroup involving members of the Committee on Quality Management & Departmental Administration, the Committee on Patient Safety and Education, and the Committee on Pain Medicine. During the course of the governance year, the workgroup reviews proposed regulations, participates in cross-specialty drug shortage coalition meetings, and advocates for ASA’s positions before federal regulators. In addition to developing guidance, workgroup members have participated in calls with Baxter and the FDA on this shortage. Members of this workgroup also led the above-mentioned session during the 2024 ASA annual meeting, describing their local challenges and conservation efforts. The session emphasized implementing ASA guidelines around preoperative fasting, more closely assessing patient needs, and the limitations to tracking outcomes related to how an I.V. shortage may affect quality of care or patient safety.
The Baxter I.V. fluid shortage will affect anesthesiologists not just in their day-to-day planning but also in establishing long-term change. ASA’s primary suggested action is to encourage all appropriate preoperative and preprocedural patients to consume clear liquids until two hours before the anesthesia or sedation start time in accordance with the ASA Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration. Anesthesiologists at the annual meeting described flipping the script for patients from “You may drink clear liquids” to “We want you to drink clear liquids” up to two hours before the procedure. Anesthesiologists also noted progress in working with postanesthesia nurses and staff to not switch out the patient’s I.V. bag on arrival in the postanesthesia care unit until after the fluid has been completely used. Changing the culture on both of these actions appears to be a primary objective for many anesthesiologists. Our actions also encourage prioritization of oral hydration after surgery as appropriate to lower reliance on I.V. fluids.
Baxter and federal authorities have worked to import I.V. fluids from international Baxter plants as a way to stabilize and maintain their allocations. Anesthesiologists cannot control the amount of product brought into the country, and they have limited knowledge in knowing whether their next allotment will arrive on time and in sufficient quantities. However, in understanding what they do control, anesthesiologists are making difficult yet meaningful decisions to prioritize and preserve patient safety by implementing equitable access to care as much as possible and leading in ways that positively influence clinical practice, despite the challenges of this particular shortage.