The closure of Baxter’s plant in Marion, N.C. damaged by Hurricane Helene has caused an IV solution shortage. This facility is a critical supplier of intravenous and peritoneal dialysis solutions, producing approximately 60% — or 1.5 million bags — of the IV solutions used every day in the U.S. and nearly 85% of the solutions used in Ohio.

Baxter is actively working on remediation efforts and exploring alternative production sites to mitigate the impact of the plant closure. Baxter announced Oct. 8 that it will be changing allocation for some IV solution supplies from 40% to 60% effective Oct. 9. In addition, Baxter expects to be at 70% by the end of October and 90% to 100% by the end of the year.

Zone Management System

OHA has engaged the zone emergency management system, which divides the state into three bands with the clinical leadership of an OHA member hospital coordinating the activities within each area:

• Zone 1 (Regions 1, 2, 5) — Scott Steele, MD, Cleveland Clinic
• Zone 2 (Regions 4, 7, 8) — Andrew Thomas, MD, The Ohio State University Wexner Medical Center
• Zone 3 (Regions 3, 6) — Evaline Alessandrini, MD, Cincinnati Children’s Hospital Medical Center

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Immediate Ohio Steps

OHA, working with the Ohio Department of Health, has implemented the following steps to serve all hospitals across the state:

• All hospitals must report their IV solution inventories daily through the ODH EMResource portal so a thorough assessment can be completed of Ohio’s needs. Each Ohio hospital has an EMResource contact. If you need help identifying your organization’s contact, Ryan Everett.
• All hospitals should assess and begin conservations methods.
• The Ohio Department of Health summarized the state’s strategies in a letter to providers.
• A statewide group of perioperative experts convened to develop principles which procedures should or should not be postponed if the initial rounds of conservation do not preserve enough supply or if the shortages continue for a longer period than expected.
• OHA will share via our social media channels the steps hospitals and the state are taking so the general public is aware of the issue.

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Ohio Board of Pharmacy Resolutions

The Board of Pharmacy on Oct. 11 issued the following resolutions to help mitigate the impact of the Baxter plant disruption:

• Purchase of IV and Peritoneal Dialysis Solutions from Non-Ohio Licensed Out-of-State Facilities
• Non-Patient Specific Drug Compounding by In-State Pharmacies for Hospitals and EMS Extension of IV Fluid Hang Times
• Inside an ISO Class 5 PEC

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OHA Member-Only Resources

OHA member hospital leaders may log in using the link above to access recordings and materials from leadership briefings located at the bottom of this page.

Help Accessing Your myOHA Account        Help Creating a myOHA Account

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Report Price Gouging

The Department of Justice, Federal Trade Commission and the Consumer Financial Protection Bureau warned that law enforcement would use every tool available to stop price gouging, price fixing and other illegal scams. They encourage people to report violations at www.justice.gov/DisasterComplaintForm or www.reportfraud.ftc.gov/.

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Federal Response

The American Hospital Association, in a letter to President Joe Biden, asked the Administration for a series of actions to support hospitals while the overall hurricane recovery efforts continue in the Southeast part of the country:

1. Direct the Food and Drug Administration (FDA) to:

• Declare a shortage of sterile IV solutions, which will permit the use of certain flexibilities not otherwise available to health care providers.
• Provide flexibilities to allow hospitals and health systems to prepare sterile IV solutions in their own pharmacies and waive the 1-mile rule so that hospitals and health systems can distribute these products among their facilities without a patient specific order.
• Identify international manufacturers capable of producing sterile IV solutions and their appropriate containers.
• Extend the shelf-life of all sterile IV and peritoneal dialysis solutions that are beyond or nearing their expiration date.

2. Declare a national emergency under the National Emergencies Act and/or the Stafford Act and request that Department of Health and Human Services Secretary Xavier Becerra declare a national Public Health Emergency to create the circumstances that will allow for waivers of Medicare/Medicaid rules and regulations.

3. Invoke the Defense Production Act to:

• Require appropriate manufacturers to prioritize and accept contracts for materials and services necessary to produce sterile IV solutions and their containers.
• Incentivize appropriate manufacturers to expand the production and supply of the critical materials and goods needed to produce sterile IV solutions and their containers.

4. Direct the Department of Defense to make transportation available for emergency supplies from other international sources identified by the FDA.

5. Remove any barriers to the importation of sterile IV and peritoneal dialysis solutions from abroad that are approved by the European Union.

6. Secure transport to domestic distribution centers for such supplies to be allocated to hospitals and other health care providers in need.

7. Direct the Federal Trade Commission and the Department of Justice to be on alert for and intervene in matters related to price gouging.

8. Appoint a person within the Administration to serve as the point of contact for matters related to the IV solution shortage.

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Extended Use Dates

The FDA on Oct. 28 announced extended use dates for certain parenteral drug products following a stability review of data submitted by Baxter International. Providers and patients with the specified lot numbers can continue using these products through the updated dates, assisting in current supply challenges.

The extended use dates apply to specific lot numbers listed in an FDA-provided table. View the table here.