The Sterile Intravenous (IV) Fluid Shortage Crisis Update

Baxter International’s manufacturing facility in North Carolina was closed on September 29, 2024 due to heavy rains and flooding from Hurricane Helene. Roads and bridges near the plant were also part of the destruction. Baxter’s facilities supply 60% of the nation’s intravenous (IV) fluids.¹ Healthcare facilities are experiencing significant supply disruptions, forcing providers to conserve sterile solutions, delay procedures and seek alternatives.^1,2 Unfortunately, sterile IV fluid shortages due to natural disasters are not a new phenomenon.

Premier, Inc., a group purchasing organization (GPO), conducted a survey between October 7-8, 2024 and found that more than 86% of healthcare providers are experiencing shortages of IV fluids due to Hurricane Helene. The extent of the shortages was consistent throughout the U.S. and across all provider types. Eighty-eight percent of survey respondents reported that less than half of their orders for IV fluid were being filled. Fifty-four percent of respondents also noted that they have 10 or less days on hand of IV fluids in stock, decreasing from a prior average of 15 to 22 days. Facilities with 25 or less beds were more likely to report receiving zero percent of what was ordered.³

Although having 15-22 days of sterile solutions on hand may be the norm, a new report shows medication shortages (from multiple causes) can last 3 years.⁴ For pharmacy to stock enough medications/supplies to meet the demands for this length of time is not likely. Managing pharmacy inventory involves determining when products need to be purchased. For example, some medications have higher usage at different times of the year. Pharmacies need to consider how much of each product to order (current patient needs and monthly usage data) and how much to keep on hand (monthly usage data, expiration dates & return policy dating). Typically, medication inventory practices of having adequate stock on shelves for a set number of days is common. However, it is also important to minimize excessive stock to prevent waste and products from expiring on the shelf.^5,6

Many hospital pharmacies will use a version of a Just-in-Time process for some medications.^5,6 In this situation, wholesalers deliver supplies daily or even twice a day, and orders can be placed the day before and received the next day. Funds are not tied up with large inventory for lengthy periods and this reduces the cost related to medication purchasing. The process is best used when supplies are available, and needs can be predicted, which is the opposite of when drug shortages occur.^5,6 Some pharmacy directors are considering buffering the inventory (predetermined level of additional stock) of select medications/solutions that would typically cause patient delays or significant problems such as oncology treatments, surgeries, procedures and critical care needs. Discussions with wholesalers to use similar strategies for select medications can be part of the hospital’s purchasing plan.⁷

Many government agencies, organizations, safety groups, and manufacturers have developed plans, guidance, and efforts to assist with the burden that hospitals and other facilities are facing in caring for patients. With the Food and Drug Administration (FDA) approval, Baxter International facilities airlifted IV sterile products from different international manufacturing plants into the United States. The shipments contained tens of millions of individual units of the needed fluids. The temporary importation is from Baxter plants in Thailand and Singapore with other plants that are assisting from Canada, Ireland, the U.K., Mexico, Spain and China. The FDA also approved extensions for the shelf life for greater than 50 intravenous and irrigation products.^1,2,8,9,10

Additionally, the FDA published guidance on compounding of certain parenteral drug products by outsourcing facilities and by state-licensed pharmacies and federal facilities that are not registered with the FDA as outsourcing facilities. The FDA has expedited any needed regulatory action and conducted regulatory assessments to get the plant back online. Department of Health and Human Services has invoked the Defense Production Act for Baxter to obtain needed materials. Other organizations have offered safety information, suggested practices and appropriate documents. B. Braun Medical, another IV fluid manufacturer, is helping to replenish the shrinking hospital inventory of solutions. B. Braun is the second largest supplier of IV fluids. Two of their plants, located in Daytona Beach, Florida, temporarily closed to safeguard the supply of finished IV solution products before Hurricane Milton. The company moved more than 60 truckloads of IV solutions from the Daytona Beach distribution center.^1,2,8,9,10

Multiple societies, organizations, groups, suppliers and government agencies, have developed strategies and/or recommendations on managing the current sterile solutions shortage. Below is a condensed and modified list of strategies from the American Society of Health Systems Pharmacists “Small-and Large-Volume Fluid Shortages – Suggestions for Management and Conservation.”¹¹

Conservation – Large Volume Products

• Evaluate the clinical need to continue intravenous fluid replacement at every shift change and bag change.
• Assess the need to initiate “keep vein open” (KVO) orders and the need to continue those orders at every shift change.
• Review the organization’s standard KVO rates and consider reducing to the lowest reasonable rate.
• Consider catheter locks with flushes for eligible patients.
• Use oral electrolyte and hydration whenever possible.
• Discontinue infusions as soon as appropriate.
• Avoid discontinuing and restarting intravenous fluids during transitions of care (such as between the emergency department and other nursing units) unless clinically necessary.
• Consider policies that allow completion of a currently hanging infusion bag before switching to a different infusion product unless clinically contraindicated.
• Evaluate total fluid requirements for surgeries and transition to oral fluids within 24 hours after surgery.
• Develop policies for substitution of intravenous solutions based on product availability in the organization.
• Use smaller volume bags for low infusion rates
• Consider reserving some products for specific clinical situations
• Avoid opening and “pre-spiking” bags in anticipation of use for surgery.
• Use other large volume electrolyte replacement solutions where appropriate.
• Consider extending hang times for intravenous solutions (if spiked immediately prior to administration). (See ASHP website for references on specific suggestions)

Good news from Baxter was reported in a news release on October 31. Customers were informed that the North Carolina site is restarting their highest throughput IV solution manufacturing line at its North Carolina facility. The company plans to begin distribution of new products by mid- to late November.

Patricia A. Meyer, PharmD, M.S., FASHP, FTSHP, Adjunct Professor Anesthesiology, Texas A&M College of Medicine

Russell K. McAllister, MD, Professor of Anesthesiology Baylor College of Medicine-Temple, Chair of Anesthesiology, Baylor Scott & White Health-Central Texas

Patricia Meyer is a speaker for Eagle Pharmaceutical and has consulted for Heron.

Dr. McAllister has no conflicts of interest.

REFERENCES

1. Baxter. Hurricane Helene Updates. [Press Release]. 11/07/2024. Accessed 11/10/2024 at https://www.baxter.com/baxter-newsroom/hurricane-helene-updates
2. U.S. Department of Health and Human Services. HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene. Fact Sheet. [Press Release]. 10/18/2024 Accessed on 11/01/24. https://www.hhs.gov/about/news/2024/10/18/fact-sheet-hhs-continues-action-increase-access-supply-iv-fluids-hurricane-helene.html
3. Premier, Inc. Data: More Than 86 Percent of Providers Experiencing Shortages of IV Fluids in Aftermath of October Hurricanes. [News Release]. 10/10/24 Accessed on 10/25/24 https://premierinc.com/newsroom/blog/premier-inc-data-more-than-86-percent-of-providers-experiencing-shortages-of-iv-fluids-in-aftermath-of-october-hurricanes
4. US Pharmacopeia. USP Annual Drug Shortages Report: Economic factors underpin 2023 shortages. USP. June 2024. Accessed on 11/2/24. https://www.usp.org/news/us-drug-shortages-reach-decade-high-and-last-longer
5. OctariusRx. How much inventory to keep on hand. Client Newsletter. Accessed on 11/02/2024. https://octariusrx.com/how-much-inventory-should-you-keep-on-hand/
6. CAERT, Inc Stocking and Restocking. E-unit. Accessed on 11/2/24 https://www.isbe.net/CTEDocuments/HST-690028.pdf
7. Fox E, Chou J, Fauel C, Jensen V. Drug Shortages: Current Trends and Management Strategies. Presented as an ASHP Webinar. 07/20/23. ACPE# 0204-0000-23-569-H04-P/T. ASHP. Bethesda, MD
8. CDC. Disruption in Availability of Peritoneal Dialysis and Intravenous Solutions from Baxter International Facilities in North Carolina. CDC Health Alert Network. CDCHAN-00518. 10/12/2024. Accessed on 11/01/2024. https://emergency.cdc.gov/han/2024/han00518.asp
9. B. Braun. B. Braun takes steps to secure the supply of critical IV fluids in the U.S. [News Release] 10/18/2024. Accessed on 10/25/2024. https://www.bbraunusa.com/en/about-us/media/company-news/2024/b–braun-takes-steps-to-secure-the-supply-of-critical-iv-fluids-.html
10. FDA. Hurricane Helen: Baxter manufacturing recovery in North Carolina. Update 2024. 11/02/2024. Accessed on 11/03/2024. https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina
11. Small and Large Volume Fluid Shortage Suggestions for Management and Conservation. Drug Shortages/Shortage Resources/Publications. ASHP. 10/25/2024. Accessed on 11/01/2024 https://www.ashp.org/drug-shortages/shortage-resources/publications/fluid-shortages-suggestions-for-management-and-conservation