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Updates on IV Fluids Shortages
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               To say the shortages of IV fluids is a multifaceted problem is an understatement. To understand it on even a basic level (which is what we’re hoping to present here), you need to know: the terms “large volume parenterals” and “small volume parenterals” (LVP and SVP for short); that part of any given shortage could be a problem with the bags or containers that hold the LVPs and SVPs, in addition to shortages of the various things that go into those bags; and that a shortage of SVPs has an impact on the supply of LVPs, as health care providers may substitute LVPs for SVPs if SVPs are in short supply.

 

               LVP saline bags are typically used to hydrate patients and SVP saline bags (generally in 50 and 100 ml sizes) are often used to deliver other IV medicines. FDA and manufacturers had taken steps to address a shortage of LVPs before Hurricane Maria hit. FDA had approved Baxter’s importation of LVPs from its manufacturing facility in Mexico, for example. Hurricane Maria, however, affected the production of SVPs, which has put added pressure on the supply of LVPs.

 

               To understand what has been done to address the shortages and where things stand now, we looked to the FDA, and to Baxter, whose manufacturing facilities in Puerto Rico were affected by Hurricane Maria this past fall.

 

FDA Responses

From January 16 and February 1, 2018, FDA press releases

               The FDA has:

  • Worked with manufacturers to ensure that their Puerto Rico facilities can operate at full capacity.
  • Worked with manufacturers such as Baxter and B. Braun to import product into the U.S. from their foreign facilities.
  • Approved importation of IV saline products from additional companies, specifically Fresenius Kabi and Laboratorios Grifols.
  • Extended the expiration dates of certain products, including some 500 ml saline bags (after examining company data to ensure it meets FDA quality and safety standards).
  • Continued to identify supply gaps and work with manufacturers who may be able to fill these gaps.

Baxter’s Global Response to Hurricane Maria

William Rader, Global Director, Corporate Communications, Baxter International Inc.

               Hurricane Maria hit Puerto Rico with devastating effects on September 20, 2017, and complex recovery efforts continue across the island. Baxter activated a global response to Hurricane Maria—to support the needs of patients and healthcare providers in the U.S. and to support our employees on the island—and we continue to make progress on the road to a full recovery of our operations.

 

               All of Baxter’s manufacturing facilities are now connected to the electric grid and are operating at pre-hurricane levels. Reliable and stable electric power is key to our ongoing efforts to restore sustainable manufacturing operations. Baxter has maintained backup diesel generators in all of our Puerto Rico facilities in case of power interruptions, which still occur intermittently.

 

Addressing Current Product Supply Demands

               In Puerto Rico, Baxter manufactures MINI-BAG and MINI-BAG Plus (small volume parenterals, or SVPs) Container Systems, which are primarily used in the pharmacy to compound or admix a medication or to aid in the delivery of a medication, as well as amino acids and certain pre-mixed products. Restoring reliable supply of these products remains our priority.

 

               To help support product supply for the U.S. market, Baxter activated targeted recovery strategies across our global manufacturing network, including working with the FDA to secure regulatory discretion for the temporary special importation of certain products (including nutrition products) from Baxter facilities in Ireland, Australia, Canada, Mexico, England, Italy, and Brazil. Millions of new units of special importation products have been shipped to hundreds of U.S. hospitals since late October and product continues to enter the supply pipeline. We also continue to work with the FDA to explore opportunities to leverage additional Baxter manufacturing facilities to help address product demand in the U.S.

 

               Overall, progress is being made on product supply thanks to the improving production in Puerto Rico and the special importation products. To that end, we expect to return to more normal supply levels for products made in Puerto Rico in the coming weeks.

 

Supporting Baxter Employees and Communities

               Baxter mobilized quickly in the aftermath of the storm to get our facilities back on line, and to help our local employees and their communities. Baxter’s local work force not only faced daily challenges getting to and from work as transportation and services were damaged or destroyed, but all of our 2,000 Puerto Rico team members had to deal with the urgent basic needs of their own families and neighbors. Baxter provided a combination of product donations, financial assistance, and on-the-ground support to our employees in Puerto Rico to help maintain patient access to our life-sustaining products and therapies.

 

LifelineLetter, January/February 2018

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
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