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When Hurricane Maria crippled the Caribbean and Puerto Rico, knocking out services and power, it also dealt a devastating blow to the daily supply of intravenous fluid bags, which are manufactured in Puerto Rico and stockpiled in hospitals across the United States.
The Baxter company is a leading supplier of IVs to the U.S. The company announced that all three of its Puerto Rico facilities are back up and running and in a statement (below), the company said it expects to return to more normal supply levels for its products in the upcoming weeks.
But hospitals, medical providers, and patients that were accustomed to a ready supply of IVs are finding they need to change procedures to make up for the loss. Deborah Pasko, director of medication safety and quality at the American Society of Health System Pharmacists, explains.
Below is the full statement from Baxter
Restoring reliable product supply for our patients and customers remains our priority, and we are making progress on the road to a full recovery of our operations.
Manufacturing Operations in Puerto Rico
All three of Baxter’s manufacturing facilities in Puerto Rico are connected to the electric grid and all lines are running. The last facility was connected in late December. Prior to grid connection facilities were on backup diesel generation. Reliable and stable electric power is key to our ongoing efforts to restoring sustainable manufacturing operations. All facilities will continue to have backup diesel generation in case of power interruptions, which still occur intermittently.
Supporting Product Supply
Clarifying what we make in Puerto Rico: In Puerto Rico, Baxter manufactures MINI-BAG (small volume parenterals, or SVPs) and MINI-BAG Plus 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.
To help support product supply for the U.S. market of the products we make it Puerto Rico, 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, noted above, from Baxter facilities in Ireland, Australia, Canada, Mexico, England and Italy.
Millions of units of these special imported products have been shipped from these sites and have entered the U.S. supply chain, with the earliest of these beginning in October. These incremental products have been received by hospitals across the U.S., from smaller community hospitals to larger hospital systems. While these products have helped to support supply they do not fully address the gap in demand and, based on the quantity available, not all U.S. hospital customers have received these products. We also continue to work with the FDA to explore opportunities to leverage other Baxter manufacturing facilities to help address product demand.
We are making progress in supply efforts. We have increased the amount of small volume parenterals available to customers thanks to increased production in Puerto Rico and the special importation products. Overall, we expect to return to more normal supply levels for products made in Puerto Rico in the coming weeks.
All of our product inventory is being managed proactively to optimize supply and distribution, and we’re doing all we can to get products to customers as quickly and efficiently as possible in compliance with regulatory requirements. We’ve worked with customers to expedite shipping to meet critical demands and, during this time, we have also supported product demand for the crisis situations associated with the Las Vegas shooting and California wildfires.
Large Volume Solutions
As it relates to large volume solutions (LVPs, often referred to as “saline”), we do not manufacture these products in Puerto Rico, and we continue to manufacture these products at capacity. Large volume solutions, such as 500 mL and 1000 mL are those typically used as hydration bags. These are the products referenced on the website, which are not made in Puerto Rico. We are also bringing additional units of LVPs to the U.S. market through a recent permanent approval from the FDA for IVs produced in one of our North American manufacturing plants. We expect to see this incremental supply benefitting current customers and providing us the opportunity to service other customers in the beginning of 2018.
Supporting Employees and Communities in Puerto Rico
Responding to the needs of our employees and communities has also been a priority. We mobilized quickly in the aftermath of the storm through a combination of product donations, financial assistance, on-the-ground support and employees going above-and-beyond to help maintain patient access to our life-sustaining products and therapies. This work continues. Immediately after the storm passed, Baxter began helping our more than 2,000 employees in Puerto Rico procure necessities such as gasoline, food, water and toiletries. We coordinated multiple daily flights to transport approximately 25,000 pounds of needed supplies for employees. We distributed gas-powered generators and propane cooktops, and installed laundry stations at our manufacturing facilities to support employees’ personal needs. We also continue to provide the communities around our manufacturing facilities with access to potable water.