VERIFY – YOU’VE GOT QUESTIONS, WE’LL FIND ANSWERS
A 9NEWS project to make sure what you’ve heard is true, accurate, verified. Want us to verify something for you? Email firstname.lastname@example.org
Viewers have reached out to 9NEWS asking about an IV fluid shortage due to the devastation hurricanes caused in Puerto Rico.
“Many of our nations IV fluids were made in Puerto Rico,” a hospital employee said in a news tip. “IV fluids can be vital in saving lives for people who are suffering from cancers, surgery, and traumas.”
A patient with an autoimmune disorder said in an email she has regular infusions and only received half the fluids she typically does after being notified there is a nationwide saline shortage.
“Any chance you could get the real story?” she asked.
The 9NEWS Verify team reached out to the Food and Drug Administration, local hospitals and the manufacturer itself to determine if there is a saline shortage affecting our area hospitals.
THE SALINE SHORTAGE
There is a temporary shortage of small saline bags, but the reduction in manufacturing after Hurricane Maria’s destruction in Puerto Rico compounded an already existing problem.
Baxter is the largest maker for the U.S. of small saline bags, also known as “mini bags,” which come from its Puerto Rico facilities.
These IV bags are used in hospitals across the country to provide patients fluids and medicines.
“While these products have been in shortage industry wide since 2014 and other manufacturers exist, the agency and Baxter recognized that further shortage of this product could potentially put U.S. healthcare at risk,” according to a FDA Commissioner statement on Oct. 13.
The FDA is working to assist Baxter to limit any shortages and allowed the company to temporarily import products from its facilities in Ireland and Australia, Canada, Mexico and England.
In an email Bill Rader with Baxter Corporate Communications said, the first products from these special imports were shipped in late October.
“While these actions will help mitigate some of the projected shortfall in supply, they unfortunately will not fully bridge the gap to meet our customers’ needs in the near term,” Rader said. “Baxter will continue in its commitment to ramp up production in Puerto Rico, and elsewhere around the globe, to help address product demand in the U.S.”
The commissioner also testified on Oct. 24 about the hurricane response and said drug shortages are addressed through importation of alternative supplies “in rare cases.”
“We have had to do this for one manufacturer, so far, as a result of circumstances related to Hurricane Maria,” according to the testimony, which was referring to the IV solution Baxter makes.
RESPONSE TO THE SHORTAGE
Rader said the company is working on potential substitutes for certain products currently manufactured in Puerto Rico, and Baxter continues to manufacture large volume solutions at capacity.
“Contrary to some prior media reports, we do not make large volume sterile solutions, such as 500 mL and 1 liter solutions, in Puerto Rico,” Rader said in the email. “Production of our large volume sterile solutions was therefore not impacted by the hurricanes.”
In Puerto Rico, the company makes 50 mL and 100 mL mini-bags.
Rader said recently the FDA permanently approved IVs produced in one of its America plants, and the additional supply is expected to help the market in early 2018.
According to an FDA statement emailed to our Verify team, in addition to supporting temporary importation of IV saline, the FDA is working with U.S. companies to increase supply to meet the growing demand and is expediting its review of new product applications that would help with the shortage.
Baxter’s three manufacturing sites had minimal structural damage from Hurricane Maria, and limited production has resumed, according to Rader.
He said the damage to Puerto Rico’s electrical, communications, and transportation systems still presents challenges, but the company has diesel generation backup has restored communication at all its facilities and is using smaller transport vehicles for efficiency.
LOCAL HOSPITAL RESPONSE
UCHealth spokesperson Dan Weaver said in an email that hospitals across the nation experienced supply chain delays and decreased supplies for some devices and pharmaceuticals because of the hurricane damage in Puerto Rico.
“We are primarily seeing decreased supplies and delays of the 50ml and 100ml bags,” Weaver said. “We are often able to use a different size saline bag or administer a drug in a way that does not need the use of saline.”
He added there are still supplies of these bags, which are being used anytime a patient’s care requires.
“Our supply chain and pharmacy departments have been monitoring the situation closely and have made a few changes to make sure we will continue having the supplies we need for patients,” Weaver said.
The supply chain and pharmacy departments are working to conserve supplies, get them from different manufacturers, and save them for patients who have the biggest need, according to Weaver.
He said procedures have not been postponed because of the shortages, and patient care has not been impacted.
“We are not out of stock for these supplies, but we don’t know when the supply chain delays and shortages will be alleviated,” Weaver said.
He added hospitals have experienced shortages or shipping delays of saline for years, which is partly because there are few manufacturers.
Denver Health Medical Center said its patients are not experiencing any affects from the saline shortages.
The saline shortage that has been around since 2014 was exacerbated by the reduction in manufacturing after Puerto Rico experienced extensive hurricane damage.
The FDA, Baxter and local hospitals are keeping a close eye on the situation and taking extra measures to ensure the decreased supplies have no, or minimal, impacts on patients.