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“Children Are Dying”
Comments () | Published May 22, 2013

It’s perhaps little wonder that manufacturers are tight-lipped regarding shortages. They view the specifics of their operations as proprietary and don’t want to frighten off shareholders. But hospitals’ decision to hide the issue from patients, parents, and the press is more baffling.

A Virginia Hospital Center spokesman refused to let NICU nutritionists speak for this article. But a pharmacist at the hospital said they were short of “everything under the sun,” completely out of selenium, and rationing products such as lipids and sodium phosphate. “Oh, God, it’s frustrating,” the pharmacist said. “I would think this place would have something as simple as salt and electrolytes available for patients. It doesn’t make sense and it’s very dangerous, especially for the babies.”

Three-year-old Paige Colmer has been on IV nutrition since birth. "These shortages are terrifying us," her mother, Kristina, says. "Our reality every day is we never know when the last day may be." Photograph courtesy of Kristina Colmer.

Pharmacists from two other local hospitals claim that nutrient and trace-element shortages have been resolved, but NICU employees at those hospitals say otherwise.

“We never got to a point where we ran out of anything other than zinc,” one hospital administrator, flanked by a PR executive, told me. Another hospital employee, unchaperoned, later called the administrator’s statement “bullshit” and said, “She flat-out lied.”

A NICU dietitian at a DC hospital says that once she alerted her hospital’s administration to the nutrient shortage, after one meeting with the risk-management and legal teams, she and her colleagues were shut out of further meetings: “The impression I got was ‘Don’t go to the media.’ ”

Some NICU staff members contacted for this article said they were afraid to speak on the record because their bosses would blame them for reporting news that could reflect poorly on the hospital.

Even when asked as simple a question as “What PN components is your hospital short on?” a George Washington University Hospital NICU dietitian said softly, “There needs to be attention drawn to this issue. My hands are tied.” Another employee revealed that GW is out of calcium chloride and short on zinc chloride, magnesium sulfate, selenium, and other items and is sequestering nutrients for the neonates.

Keli Hawthorne, the dietitian at the USDA/ARS Children’s Nutrition Research Center in Houston, says she’s not surprised that hospitals are muzzling their dietitians because they don’t want to scare people or attract blame. “There’s concern people would think we’re not appropriately caring for their infant,” she says. “And the fact is we’re doing the best that we can.”

But by remaining silent, hospitals end up doing a greater disservice to the patients they’re worried about scaring: If people don’t know about the problem, they won’t push lawmakers to fix it. And patients will continue to suffer.

Some people already know about the shortages, though. Tens of thousands of patients rely on IV nutrition at home, where home-health-care companies send them supplies. Many of these patients, or their parents, know exactly what belongs in their PN, so they know exactly what’s missing.

Parents are desperately checking the FDA’s drug-shortage site to learn when their babies might finally get the nutrients they need—but the posted availability dates keep slipping ever farther away.

“You just kind of have to pray,” says Kristina Colmer, a mother in Midland, Maryland, whose three-year-old daughter, Paige, has been on PN since birth. “PN is what keeps her alive, so these shortages are terrifying us.” The family’s home-health-care company hasn’t been able to get zinc, phosphorous, or calcium, and Paige hasn’t received IV pediatric multivitamins in more than a year. She has been taking adult multivitamins instead, but now those are becoming difficult to get, too. She’s getting lipids only because she’s enrolled in a clinical study.

The girl’s phosphorous levels have been so low that she was almost hospitalized. Colmer fears that her daughter will go into renal failure because of her lack of phosphorous. “She’s the light of our lives, a complete joy,” she says. “I don’t know what we would do without her. But our reality every day is we never know when the last day may be.”

Another reason hospitals may be keeping the issue out of the press is that there’s no equitable system of drug distribution. “It’s first come, first served,” Abrams says. “There isn’t a good national or even local system for saying, ‘X hospital has a critical shortage of this component, Y hospital has extra—can we shift it over?’ ”

Some hospitals with extra supplies hoard them to protect their patients. “We’ve started to stockpile, which we didn’t do before,” says the Virginia Hospital Center pharmacist. “You have to do it. You try to buy more than you would normally need, and that is adding to the problem.”

Hospitals are afraid to share their supplies because they don’t want to reduce the buffer for their own patients. Some have refused even Children’s National, the highest-level NICU in the Washington region and the referral center for the sickest kids. “They’d say, ‘We have one vial—we can’t give you our one vial,’ ” says director of pharmacy Ursula Tachie-Menson.

Because many adverse effects aren’t getting reported, the full scope of the crisis isn’t known, says Bona Benjamin of the American Society of Health-System Pharmacists: “If it’s being reported routinely, I’m not seeing that. I’ve been encouraging the pharmacists I talk to to keep track and consider doing articles in the biomedical literature on the impact of shortages on their patient population, but truthfully, they have their hands full just managing shortages. The fact that it’s a public-health crisis would escalate priority.”

• • •

The FDA can’t force a manufacturer to produce drugs. But baby Atticus, Emily Greene, and Kristina Colmer need a central oversight entity either to have that authority or to find the means to secure them elsewhere—immediately.

In October 2011, President Obama signed an executive order charging the FDA to work harder to address drug shortages. His speech at the time mentioned cancer drugs but not nutrients or trace elements. Obama said, “Even though the FDA has successfully prevented an actual crisis, this is one of those slow-rolling problems that could end up resulting in disaster for patients and health-care facilities all across the country.”

Nineteen months later, health advocates—and even the FDA’s Valerie Jensen—say the crisis is here. Two congressional bills went nowhere, and although in July 2012 Obama signed the Food and Drug Administration Safety and Innovation Act, experts say it won’t create more drugs, just provide earlier warning of shortages.

The law says manufacturers must give FDA six months’ notice of an anticipated shortage (or inform the FDA as soon as practicable). But an April 23, 2013, e-mail the FDA sent in response to a patient inquiry includes a cookie-cutter paragraph that says firms are not required to provide notice of discontinuations (except for sole-source, medically necessary products), “nor is there a penalty for firms that do not report discontinuations to FDA.”

Both the FDA and manufacturers say that they’re cooperating with the law, however, and that early notifications have helped prevent shortages. They won’t say which drugs have been saved—that’s proprietary information—but Jensen says nutrients were among them.

There are lights on the horizon. Manufacturers are building extra capacity; Hospira has invested hundreds of millions of dollars in improving its plants. Experts hope smaller manufacturers can be enticed to enter the market to break up the larger manufacturers’ stranglehold. Eventually, someone may overhaul the system. Several doctors say their hospitals would pay a markup of 50 percent or higher if they could be confident in a stable supply of IV nutrition.

A fix isn’t that simple, however. The existing manufacturers are at capacity, and bringing new ones online takes at least two years. “In 20 years of economics, this is the most complicated market I have ever dealt with,” says Sherry Glied, a health-policy-and-management professor at Columbia University. Once manufacturers finish building additional capacity, she says, theoretically plants will stop running 24/7, there will be slack in the system, “and you can deal with a shortage because people can run their lines an extra couple hours and it’s fine. You won’t have this weird phenomenon of cascading shortages where one drug goes on shortage, then that one gets fixed, then another one goes on shortage because there’s very tight capacity.”


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Posted at 10:30 AM/ET, 05/22/2013 RSS | Print | Permalink | Comments () | Articles