By William K. Alcorn
A nationwide shortage of components for nutrients fed intravenously to premature babies has not affected local hospitals, but it has occasionally been a close call.
Intravenous nutrients, a subset of injectable drugs, are used to feed premature babies with undeveloped gastrointestinal tracts and older surgical patients who can’t accept food orally or via their gastrointestinal track.
With this mode of nutrition, the usual suck-and-swallow method of nutrition can be bypassed, said Mary Petrea Cober, clinical pharmacy coordinator for Akron Children’s Hospital’s neonatal intensive-care unit.
The NICU specializes in the care of ill or premature newborn infants.
There have been shortages of components for injectable drugs and intravenous nutrients on and off for a couple years, primarily because the number of U.S. suppliers dropped from five to two, Cober said.
She said, however, “We’ve always been able to stay ahead of [the shortage]. We’ve never run out of anything dire, but it did get very scary on occasion when we were down to a two-week supply of components.”
There are no substitutes for the components. Injectable drugs are fairly new, with the products being developed in the 1960s and 1970s.
“Everything we put in the IV bag — currently the biggest are phosphate products, trace elements, zinc and copper and sodium — you either have them or you don’t,” Cober added.
Cober and Barry Shick, chief pharmacy officer for Humility of Mary Health Partners, say their health systems have so far weathered the shortages through careful planning, monitoring of supplies in-house and in the marketplace, and use of alternative treatments.
HMHP orders IV-nutrient components and medications through national drug wholesalers.
“When we can’t get what we need, we order directly from the manufacturers,” Shick said.
He agrees with Cober that part of the problem is the shortage of component manufacturers.
The number of manufacturers has decreased, Shick believes, because they are in business to make a profit, and when something is not as profitable, they discontinue it.
Also, Shick said, the U.S. Federal Drug Administration has stepped up standards, and sometimes the raw ingredients are in short supply.
At HMHP, he said arrangements have been established with drug wholesalers that will try to obtain quantities on HMHP’s behalf if there are possible shortages.
“Internally, we have fantastic inventory control people who stay up on this religiously,” Shick said. We know what average usage is and we try to secure product to that level. We have a fantastic team overseen by doctors and nurses.”
The nutritional committee meets routinely, but may have ad hoc meetings if supply becomes acute, he said.
The other option is using alternatives, not so much for IV nutritional, but for other applications, and tube feeding directly into the stomach when possible.
To address the shortages of injectable-drug products, the FDA recently approved the importing of IV-nutrition components from Europe.
U.S. Sen. Sherrod Brown, D-Avon, said he applauds the FDA decision, which he said came on the heels of a letter signed by him and 14 other senators urging the regulatory agency to do everything in its power to get the products back on the market.
Cober said Akron Children’s is exploring the options of using products made in Norway. But, she said, no one here has ever worked with them and it will take some time getting used to them.
“It is not something we could order today and use tomorrow,” she said.
The bigger issue, she said, is making sure the intravenous product is sterile, which has to happen at the manufacturing level.
“I make sterile IVs from sterile products. From what I have been told and read, these plants in Norway are FDA inspected,” she said.
Domestic suppliers are trying to increase production, but recently the availability of multivitamin products seems to have gotten worse, Cober said.
“It is an ever-changing problem that never seems to completely go away,” she said.