Continued manufacturing issues at both American Regent and Hospira have caused the US FDA to begin allowing foreign imports as early as next week to combat a shortage of critical drugs for infants, the agency told us.
“Three of the components of total parenteral nutrition (TPN) are in critical shortage – zinc (which dates to 2011), trace elements and sodium phosphate,” FDA spokeswoman Lisa Kubaska, PharmD, told Outsourcing-Pharma.com. “Children’s hospitals rely on these lifesaving drugs to treat premature infants and other patients who are unable to eat/drink by mouth or are experiencing zinc or other deficiencies.”
The shortages “are largely caused by the decision of American Regent/Luitpold [Pharmaceuticals], a large manufacturer of these products, to shut down at the end of 2012. While the FDA did not want American Regent to shut down, and in fact, encouraged them not to because of the medically necessary products they manufacture, the company felt that in order to address their quality issues which have included issues involving particulate matter in their injectable products they had to temporarily cease operation,” Kubaska said.
American Regent noted, in a letter to healthcare professionals in April , the particulate matter was found in sodium phosphate injections. And the American Society of Health-System Pharmacists said both American Regent and Hospira supplies of the injection were on back order, though Hospira estimates some product will be released in June.
“We’ve encouraged them not to automatically destroy product that contains particulate matter; rather, to evaluate the product to see if there’s a way to use it after taking steps to make it safer,” Kubaska said. “We’re also working with American Regent to help them figure out how best to prioritize which products they should bring back to market first, given the severity of need.”
Visible particles also caused American Regent to issue a letter in March about its calcium gluconate injections .
Paul Kurdman, product manager at American Regent, told us that the company is ramping up production of the drugs but there is not a set timeline for when product will be available.
The FDA’s decision to allow foreign imports comes after careful consideration of their manufacturing sites, though Kubaska declined to name the companies involved.
“In these instances, FDA evaluates the foreign drug to ensure that it is of adequate quality and that the drug does not pose undue risks for US patients. However, this process to find a foreign manufacture that is willing and able to import drugs to the United States can take time,” Kubaska said. “This is why the FDA is focusing on pharmaceutical quality initiatives. Many times, manufacturing quality issues are the source of drug shortages.”
She added that the import of these injectable nutrition drugs, will not only “bolster the current supply,” but create “a backup to avert future shortages of these critical drugs.”
Hospira Taking Drastic Measures
Another manufacturer for a number of these products, Hospira, also has had issues meeting demand as remediation efforts at its Rocky Mount, North Carolina, facility continue.
Dan Rosenberg, a Hospira spokesman, told Outsourcing-Pharma.com that the company has gone so far as to fly product “on the day of release to an institution when there was a life-threatening patient need.”
But still he said the company has had a hard time “ramping up production to cover for the unanticipated loss of production from” American Regent.
To further address the critical shortages, Rosenberg said Hospira has adopted multiple strategies:
- Dedicated teams were formed to shorten the time for product release;
- Increased commodities are being ordered with vendors, expediting deliveries;
- Hospira has managed inventory through a direct order process that reduces the ability of users to hoard product.
“The FDA has asked American Regent and Hospira, the two firms that supply zinc injection to the United States, to prioritize this drug. American Regent recently released their zinc injection and FDA is encouraging both firms to produce this drug at levels needed to supply all patient needs. Hospira plans upcoming releases in June,” Kubaska added.
US Senators Prompted Action
Prior to this announcement today by the FDA, 13 senators from both sides of the aisle sent a letter earlier this week to FDA Commissioner Margaret Hamburg. Sen. Al Franken (D-Minn.), whose office released the letter , noted the “deeply concerning” shortages of the TPN components, as well as potassium phosphate, calcium gluconate and calcium chloride.
Sen. Franken wrote that at “one hospital in the Midwest, providers have been forced to reduce doses of electrolytes in children greater than 1500g in order to protect doses for neonates.
“At other hospitals, rationing of intravenous phosphate has forced neonates in the Cardiac Intensive Care Unit to go without this critical product, and some of these seriously ill infants are also beginning to show signs of phosphorous deficiency. Several hospitals have reported that they are within one or two weeks of running out of these products completely,” he wrote.