No end in sight for IV multivitamin shortage; patient lives are on the line
CDC, PEN society warn of danger to patients
The current shortage of IV multivitamins has led the American Society for Parenteral and Enteral Nutrition (ASPEN) in Silver Spring, MD, and the Centers for Disease Control and Prevention (CDC) in Atlanta to try to increase awareness of the shortage among care providers. It was nearly a year ago when Astra USA, of Westborough, MA, was left as the only domestic distributor of intravenous multivitamins for pediatric patients. Following its own problems, Astra’s distribution has fallen to less than 50% of last year’s production. Similar problems have hit the adult IV multivitamin supply market.
"The importance is tremendous, and there has been at least one fatality that we are aware of, so it’s life-threatening," says Ed Bernstein, the director of policy and research for ASPEN.
Alicia Mangram, MD, an epidemiologic fellow at the CDC, says the danger lies in the fact that many clinicians are unaware of the problem and, therefore, don’t take the proper steps to ensure patients are getting the appropriate nutrients.
"I don’t think enough people know there is a shortage," she says. "Every day, we think it’s going to end in two weeks, but it doesn’t seem like that ever happens, so I guess technically there is no sign as of now when this is going to end."
The fatality recently reported to ASPEN involved a patient on total parenteral nutrition (TPN) without multivitamins for six weeks. ASPEN says the death was probably related to thiamine deficiency.
"Lactic acidosis related to thiamine deficiency is one of the more severe life-threatening complications," says Mangram.
Several deaths related to vitamin shortage
ASPEN has received 23 reports of vitamin deficiency in patients on long-term TPN. The CDC reported in 1989 that three individuals died of lactic acidosis as a result of a similar IV multivitamin shortage, and the following three cases have been reported to the CDC this year and are associated with the shortage:
1. A 32-year old man underwent a total coloproctectomy with ileostomy as treatment for fulminant ulcerative colitis. TPN was initiated immediately, but no multivitamins were added to the solution because the hospital’s supply was exhausted. The patient’s condition deteriorated until 400 mg of thiamine was administered intravenously. A second dose of 400 mg was administered two hours later, after which the patient’s levels returned to normal.
2. An 11-year old girl with chronic idiopathic intestinal pseudo-obstruction syndrome, receiving home TPN, sought care following abdominal pain, vomiting, and decreased ostomy output. When outpatient treatment failed to yield results, the patient was hospitalized. Upon admission, the patient’s history revealed she had been started on oral multivitamins because TPN supplemented with multivitamins was not available. She discontinued her oral multivitamins without notifying her physician or home care provider. Treatment with parenteral thiamine and other Vitamin B supplementation improved her condition.
3. A 19-year old man began to receive home TPN for treatment of gastrointestinal dysmotility associated with antecedent chronic cholecystitis and complications of abdominal surgeries. He was later hospitalized because of non-bloody diarrhea and fever, among other symptoms. The central IV catheter was removed and cultured, and TPN was temporarily discontinued. Over the next five days the patient’s neurological status deteriorated. Symptoms included confusion, ophthalmoplegia, blurred vision, slurred speech, and evidence of cortical blindness. The home TPN provider reported that the patient did not receive intravenous multivitamins as a result of the national shortage. Within 24 hours of thiamine supplementation, the ophthalmoplegia and cortical blindness improved. Over the next several days, his mental status improved, and his serum lactate level became normal.
The complications are endless
Mangram is quick to point out, in light of the above incidents, that while lactic acidosis is the most life-threatening potential complication of TPN without IV multivitamins, it is just the tip of the iceberg regarding potential complications.
"Other vitamin deficiencies might not show up as so severe," she says. "The body may not have the full vitamin capacity or load that is needed, but it won’t show up as far as life-threatening complications."
Bernstein says pediatric patients may be at the highest risk because many health care providers have been using pediatric IV multivitamin stock for adults.
"It’s not dangerous for adults, but it’s very dangerous for pediatrics because that is where the most critical shortage is," he says.
While adults can be infused with pediatric multivitamins with no health risk, Bernstein notes that very small babies and those born premature must use the Astra product. As a result, ASPEN is recommending agencies stockpile any pediatric IV multivitamins they have.
"Our recommendation has always been that if you have any product for pediatrics, you save it for the really small babies, and then you adjust the dose of the adult product and you supplement it with Vitamin K for healthy babies up to 11 years old," says Bernstein.
But Mangram says it’s unsafe to categorize any population as more or less at risk.
"You can’t really group people; it’s just patients who are receiving TPN," she says. "If the physician is treating a patient with TPN and they are aware of the shortage, they will be able to make the appropriate adjustments. But it can be anybody from a neonate to a young adult to the elderly population." (See related story, at right.)
Several home infusion agencies have reported problems acquiring pediatric IV multivitamins to ASPEN. As a result, ASPEN has issued recommendations in dealing with pediatric patients.
Mangram says that through awareness, care providers and physicians can use readily available alternatives to offset the IV multivitamin shortage.
"There are other things that can be done to prevent a major vitamin deficiency," she says. "If the physician is not aware that the patient is not receiving the multivitamins as a package, they might not think to give the vitamins that are needed, which are available through other forms individually."
The U.S. Food and Drug Administration (FDA) and ASPEN have been working to bring other IV multivitamins to the United States from the following sources:
• Astra, (800) 225-6333, may have some MVI-12 and limited supplies of MVI-Pediatric.
• Fujisawa, (800) 727-7003, may have some supplies of MVC.
• Sabex, (800) 361-3062, has supplies of Multi-12 and has received approval from the FDA to bring its product to the United States.
• Baxter, (888) 229-0001, has begun limited supplies of Cernevit from France.
Some home care companies have reported difficulties purchasing Sabex’s Multi-12 product because the company will only sell to health care institutions that have received prior approval from the FDA. If you wish to receive prior approval from the FDA to purchase Multi-12, contact Jim Hamilton at the FDA by calling (301) 594-3150.
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