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q have captured the attention of lawmakers and the FDA
Shortages of parenteral nutrition products have captured the attention of lawmakers as well as the Food and Drug Administration.
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Hungry for a solution

Shortages of IV nutrition products challenge providers and regulators

By Jaimy Lee
Posted: June 8, 2013 - 12:01 am ET

Tim Weaver, an 18-year-old college student who lives in Naperville, Ill., is one of the estimated 30,000 people in the U.S. who rely on intravenous nutrition products to keep them alive.

Weaver was diagnosed with short bowel syndrome within days of his birth. To ensure he's getting the right fluids and the right nutrients, which keep him healthy and out of the hospital, he has been on total parenteral nutrition every week for the past six years.

However, the constant shortages of IV nutrition products during the past three or so years have sent him, his family and his healthcare providers scrambling to find alternatives that might not be as effective or can carry additional risks.

“These things are an essential part of my life, and without them I wouldn't be here today,” Weaver says.

During a hospitalization in 2010, Weaver says calcium was in short supply. As a result, he had to use an alternative product that required infusions that took several hours longer. He also had to wear a heart monitor as a precaution against side effects.

Years of shortages have left Weaver with deficits in vitamin D, fats and soluble vitamins.

The shortages aren't limited to patients like Weaver. Hospitals struggle to find enough zinc for premature babies in the neonatal intensive-care units and the right amount of calcium to adequately supply emergency crash carts and cardiac surgeries.

Another 367,000 patient discharges reported the use of parenteral nutrition in 2010, the most recently available data from the Agency for Healthcare Research and Quality. Some patients could have been hospitalized more than once.

“All I know is something needs to be done,” Weaver says. “I don't know what it is, and I don't know how it's going to work.”

Healthcare providers agree on the need for action. “It's very, very frustrating,” says Erin Fox, director of the University of Utah Hospitals and Clinics' drug information service. “It's very upsetting to the clinicians not being able to provide a product that you know your patient needs. It's very upsetting to have to ration out product and perhaps deprive a patient who needs therapy for another patient who needs it more.”

As the U.S. grapples with drug shortages, lawmakers, regulators, healthcare providers and numerous other stakeholders are also trying to find a solution.

The shortages are not limited to the electrolyte and mineral injections used for total parenteral nutrition, but include cancer therapies and anesthesia drugs. Officials have blamed everything from the market structure and reimbursement of generic drugs to the role of group purchasing organizations in driving down prices and whether increased oversight from the Food and Drug Administration has led to the shutdowns of more manufacturing plants.

Despite new legislation and some action from the Obama administration, progress to stem or solve the shortages has been slow, and clinicians are being forced to ration some of the most basic IV nutrition product drugs used in their hospitals.

Although the number of new shortages has dropped, there were still 300 active drug shortages as of April 30, according to the University of Utah Drug Information Service. Thirty-two of those scarce products are electrolytes or nutritional items, such as phosphate, magnesium and dextrose.

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The IV nutrition market highlights many of the regulatory and corporate shortfalls that have contributed to the drug-shortage crisis in the U.S.

Most of the products are generic and inexpensive, a cost equation that has provided few incentives for drug manufacturers to continue making the medically necessary products. The products are provided daily to some patients with gastrointestinal disorders, as well as to hospital patients undergoing chemotherapy, receiving treatment for burns or staying in the intensive-care unit.

“We're going to do as much as possible,” says Peggi Guenter, senior director of clinical practice, advocacy, and research affairs for the American Society for Parenteral and Enteral Nutrition. “Pharmacists and hospitals are stuck in the middle of this whole mess.”

Most IV nutrition products are manufactured by a small number of drug companies. In many cases, one of the companies is the sole manufacturer of a specific product.

American Regent, a generic manufacturer and sole-source provider of several nutrition products, temporarily shut down for the first time in 2011. The closure occurred after years of scrutiny from the FDA over the company's manufacturing processes. A company spokesman did not respond to requests for comment.

Because the Luitpold Pharmaceuticals subsidiary is a sole-source manufacturer, the FDA used its regulatory discretion to allow the company to continue distributing some products such as injections of potassium phosphates and calcium gluconate that have visible particles.

Pharmacists are expected to use a filter to draw out the particles before they are given to patients.

“We don't have very much resiliency in our supply chain,” Fox says, “and this is a great example where we have one company that basically makes all of these highly critical, highly essential products, and when they have a problem with their factory, there's no one to take up the slack.”

“It's less than ideal to have particles in your solutions,” Fox adds. “You wonder what they are. What if someone forgets to filter out those particles? You wonder if those particles are undissolved drug.”

Baxter, B. Braun Medical and Hospira also manufacture IV nutrition products in the U.S. Those companies have also reported drugs in short supply in recent years, which has prompted the FDA to look outside the U.S. for new sources of some of these products.

The agency in May announced it was granting regulatory approval allowing Fresenius Kabi USA to import trace elements and phosphate injections from its plants in Norway to help ease some shortages.

“The question is: When will the U.S. supply be able to fully meet patient need?” says Valerie Jensen, associate director of the FDA's drug shortages program. “At this point, that's unknown.”

The agency has also received prompting from lawmakers to take additional steps. Sen. Al Franken (D-Minn.) and 13 other senators sent a letter in May to FDA Commissioner Dr. Margaret Hamburg over concerns that nutrition shortages were harming critically ill infants.

“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,” the lawmakers said in the May 6 letter.

“Several hospitals have reported that they are within one or two weeks of running out of these products completely.”

In some cases, hospitals have turned to compounding pharmacies to obtain IV nutrition products. The safety of drugs mixed by compounders, long part of the healthcare supply chain, is now in question.

The compounding market has come under intense scrutiny in the months since contaminated steroid injections distributed last year by the New England Compounding Center sickened hundreds and led to 55 deaths.

“Hospitals have run out,” Jensen says. “And they don't have a source to go to, especially for some of the sole-source products. So they've had to turn to compounders. … Again, that's why FDA is doing everything we can do to get an overseas source that can be used as a backup, and we're doing everything we can to resolve the shortage.”

But physicians say regulators aren't moving fast enough. Hospitals are being forced to ration products, based on patient need; some hospitals are stockpiling medications, which can negatively affect neighboring providers; and there are ongoing concerns that alternative products or temporary drug protocols will lead to adverse events.

Physicians and pharmacists say the newly developed protocols for how providers should use alternatives or rationed products in patient care are often challenging given the fluidity of the shortages.

The NICU is usually the last part of the hospital to have its nutrition products rationed. In many cases, rationing will first occur in other areas such as the ICU.

“We are having untold difficulties managing all of these children,” said Dr. Praveen Goday, nutrition program director at 296-bed Children's Hospital of Wisconsin in Milwaukee. “If the NICU is being rationed, that means we are in dire straits.”

Unlike other shortages, during which hospitals and providers have reported price-gouging, the costs of IV nutrition products have not been an issue. However, the low price of these products may have contributed to a lack of interest from manufacturers to remain in the market or begin making them.

“Hospitals would absolutely pay a little bit more to have product,” ASPEN's Guenter says.

“Hospitals are spending so much time and energy trying to get product. It would be way more cost effective to pay $1 or more to get a product.”

Follow Jaimy Lee on Twitter: @MHjlee

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