Advisory 24-10-09 Baxter IV Solution Supply Disruption Oct 9 Written By Jill White The Department of Public Health issued the following advisory today: “The Department is actively monitoring the disruption at Baxter International’s North Cove plant in North Carolina following the rain and storm surge from Hurricane Helene. This plant manufactures approximately 60% of the domestic supply of IV solutions, producing 1.5 million bags per day across several product lines.As of Wednesday, 09 OCT 2024, Baxter has reported that it continues to scale production across its global locations and is working closely with FDA on temporary importation of products to increase available inventory. Baxter’s goal is to restart North Cove production in phases and return to 90% to 100% allocation of certain IV solution product codes by the end of 2024. Baxter stated that they are increasing the current U.S. allocation levels of their highest-demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective today. They have resumed shipments to hospitals and dialysis patients based on allocations. Information on products currently in shortage can be found here: https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolinaAdditionally, Hurricane Milton has intensified to a Category 4 storm in the Gulf of Mexico, with anticipated landfall on Florida’s Gulf Coast in the early morning hours of Thursday 10 Oct 2024. Of particular concern is B. Braun’s manufacturing facility in Daytona Beach, Florida. B. Braun holds approximately 23% market share in the IV fluids industry and has been working to increase capacity in the wake of Baxter’s impacts.Action Steps: While the level of impact is still dynamic, these supply chain disruptions may be impactful for ambulance services. It is critical to manage and identify conservation strategies - which should include: • Completing a thorough assessment and maintaining inventory of all types of IV fluids, • Evaluating clinical needs to forecast how long these levels will last, • Work with additional vendors/suppliers to identify alternate sources and be aware of any delays/allocation, and • Messaging this situation and need for conservation strategies to your field staff. In addition to being prudent in the management of internal inventories, the Department recommends ambulance services prioritize the use of IV fluids utilizing these guidelines: 1. Be thoughtful and judicious in the use of IV fluids. a. For example, do not preemptively spike and hang bags at the beginning of a shift or before assessing if a patient needs intravenous fluid. 2. Consult medical control if you are unsure if a patient requires IV fluids.Sharing Critical Shortages: As our health care system continues to navigate this developing situation, it is important to maintain communication and situational awareness. We would ask that critical shortages and no ability to resupply, which may interrupt the ability to deliver patient care, be shared with your Health and Medical Coordinating Coalition (HMCC), who will also be the pathway to critical resource requests. The HMCCs are Department contracted to support cross-disciplinary planning and response including coordination of urgent and emergent resource requests – these groups will not replace your current vendors and supplies but will work across the health care continuum in a region to identify if other entities have any resources to share during times of emergencies. You can use the following resource to find out which HMCC covers your agency: https://www.mass.gov/info-details/learn-about-the-health-and-medical-coordinatingcoalitions.The Department is maintaining communication with federal partners and the HMCCs. We will provide updates as more information becomes available. In the meantime, please ensure that your EMS agencies are communicating with supply officers and distributors to confirm the availability of IV fluids and explore alternative suppliers if necessary. Thank you for taking proactive and prudent steps and being strong partners as we work through the situation.” — ADVISORY 24-10-09 TO: Massachusetts Licensed Ambulance Services FROM: Susan Lewis, NRP, Director, Office of Emergency Medical Services Kerin Milesky, Director, Office of Preparedness and Emergency Management DATE: October 09, 2024 RE: Baxter Advisory: IV Solution Disruption Jill White
Advisory 24-10-09 Baxter IV Solution Supply Disruption Oct 9 Written By Jill White The Department of Public Health issued the following advisory today: “The Department is actively monitoring the disruption at Baxter International’s North Cove plant in North Carolina following the rain and storm surge from Hurricane Helene. This plant manufactures approximately 60% of the domestic supply of IV solutions, producing 1.5 million bags per day across several product lines.As of Wednesday, 09 OCT 2024, Baxter has reported that it continues to scale production across its global locations and is working closely with FDA on temporary importation of products to increase available inventory. Baxter’s goal is to restart North Cove production in phases and return to 90% to 100% allocation of certain IV solution product codes by the end of 2024. Baxter stated that they are increasing the current U.S. allocation levels of their highest-demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective today. They have resumed shipments to hospitals and dialysis patients based on allocations. Information on products currently in shortage can be found here: https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolinaAdditionally, Hurricane Milton has intensified to a Category 4 storm in the Gulf of Mexico, with anticipated landfall on Florida’s Gulf Coast in the early morning hours of Thursday 10 Oct 2024. Of particular concern is B. Braun’s manufacturing facility in Daytona Beach, Florida. B. Braun holds approximately 23% market share in the IV fluids industry and has been working to increase capacity in the wake of Baxter’s impacts.Action Steps: While the level of impact is still dynamic, these supply chain disruptions may be impactful for ambulance services. It is critical to manage and identify conservation strategies - which should include: • Completing a thorough assessment and maintaining inventory of all types of IV fluids, • Evaluating clinical needs to forecast how long these levels will last, • Work with additional vendors/suppliers to identify alternate sources and be aware of any delays/allocation, and • Messaging this situation and need for conservation strategies to your field staff. In addition to being prudent in the management of internal inventories, the Department recommends ambulance services prioritize the use of IV fluids utilizing these guidelines: 1. Be thoughtful and judicious in the use of IV fluids. a. For example, do not preemptively spike and hang bags at the beginning of a shift or before assessing if a patient needs intravenous fluid. 2. Consult medical control if you are unsure if a patient requires IV fluids.Sharing Critical Shortages: As our health care system continues to navigate this developing situation, it is important to maintain communication and situational awareness. We would ask that critical shortages and no ability to resupply, which may interrupt the ability to deliver patient care, be shared with your Health and Medical Coordinating Coalition (HMCC), who will also be the pathway to critical resource requests. The HMCCs are Department contracted to support cross-disciplinary planning and response including coordination of urgent and emergent resource requests – these groups will not replace your current vendors and supplies but will work across the health care continuum in a region to identify if other entities have any resources to share during times of emergencies. You can use the following resource to find out which HMCC covers your agency: https://www.mass.gov/info-details/learn-about-the-health-and-medical-coordinatingcoalitions.The Department is maintaining communication with federal partners and the HMCCs. We will provide updates as more information becomes available. In the meantime, please ensure that your EMS agencies are communicating with supply officers and distributors to confirm the availability of IV fluids and explore alternative suppliers if necessary. Thank you for taking proactive and prudent steps and being strong partners as we work through the situation.” — ADVISORY 24-10-09 TO: Massachusetts Licensed Ambulance Services FROM: Susan Lewis, NRP, Director, Office of Emergency Medical Services Kerin Milesky, Director, Office of Preparedness and Emergency Management DATE: October 09, 2024 RE: Baxter Advisory: IV Solution Disruption Jill White