Puerto Rico, which produces more pharmaceuticals
by dollar value
for the nation than any of the individual 50 states or any foreign country, has been key to the supply of these IV saline bags.
Since early November
, the US Food and Drug Administration has issued updates and guidance
to hospitals and medical facilities.
On Tuesday, Dr. Scott Gottlieb, the FDA commissioner, said in a statement
the agency continues "to expect that the shortage of IV fluids will improve in the coming weeks and months."
Measures taken by the FDA include working with manufacturers to import product into the US "from their foreign facilities," said Gottlieb.
The FDA has already approved IV saline products from Fresenius Kabi, a global healthcare company headquartered in Germany, and Laboratorios Grifols, a separate global health care company based in Spain. This "is expected to result in increasing product supply in U.S. market in the next several weeks," said Gottlieb. He added that the agency is looking at "additional potential import sites" as well.
The FDA is considering a way to extend existing supplies in hospitals. "If expiration dates can be safety extended, it would allow some near-expiry product that remains at the hospital level to be used," said Gottlieb.
"Despite these steps, it may still take more time for new product supply to diffuse across the marketplace and have a noticeable impact on product availability," he said.
In a previous statement on January 4
, Gottlieb noted that Baxter International Inc., "a leading producer of IV saline fluids," had reported their Puerto Rican facilities had returned "to the commercial power grid" on the island before the holidays.
A post on the company's website
noted that overall industry capacity, as well as "an aggressive flu season," had "diminished" the supply of small volume bags, which are manufactured in Puerto Rico and mainly used in pharmacies.
Bill Rader, a spokesman for Baxter, said the FDA had granted the company "special regulatory discretion" and allowed the company to import products normally made in Puerto Rico from its global facilities for the US market. Temporarily, then, Baxter has been shipping IV bags from Ireland, Australia, Canada, Mexico, England, Italy and Brazil to hundreds of US hospitals since late October.
Mexico's (and others') gain
Larger volume solution IV bags, including 500 ml and 1000 ml bags, are not manufactured in Puerto Rico, so the hurricane did not interrupt their production, noted Rader. "We continue making these and we're bringing additional units of large volume solutions courtesy of a permanent approval granted by FDA." This permanent agency approval will directly benefit one of Baxter's plants in Mexico, according to Rader.
Necessarily, the FDA also has been in "frequent communication" with hospitals, medical centers and other organizations with guidance about conservation efforts to mitigate the shortage, Gottlieb added. To that end, the FDA posted a fact sheet
compiled by American Society of Health-System Pharmacists and the University of Utah Drug Information Service that explained the situation and offered recommendations for care providers and pharmacies on the safety and conservation of the IV bags.
Other groups, including the American Hospital Association, believe addressing the shortage requires a more comprehensive strategy.
Hospitals feel the pain
In November, the association posted a letter on "the shortages of critical pharmaceuticals
," appealing to lawmakers who sit on the Oversight and Investigations Subcommittee of the House Energy and Commerce Committee.
"Recent natural disasters, most notably Hurricane Maria, have heavily compromised pharmaceutical manufacturing in Puerto Rico and now leave the US health care system on the brink of a significant public health crisis," wrote the association and others, including the American Society of Health-System Pharmacists.
Intermittent shortages of the IV bags, already a problem due to a limited number of suppliers and less than optimal manufacturing capacity, "are emerging as a serious problem for hospitals, health care systems, and ambulatory care infusion centers," the authors of the letter wrote. "Hospitals and other health care settings have reported that they are running critically low on product and are unclear as to when their supplies will be replenished."
Courtney Burke, Chief Operating Officer for the Healthcare Association of New York State, agrees with this assessment.