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Drug shortages pose danger

By Michael J. Alkire
Special to the Observer

For more than two years, the U.S. health care system has experienced a record number of drug shortages. Nationwide, 250 drugs were in shortage in 2012; that number has increased to approximately 300 drugs in 2013.

The Charlotte-area has not proven immune to this condition.

In a recent NPR interview about shortages, local hospital representatives painted a troubling picture.

“We’ve never seen anything like this,” said one. “It’s “the new normal,” said another. And according to a third, “We’re all living in fear that if the other shoe drops tomorrow, what are we going to do to take care of these patients?” That’s the most troubling part: Drug shortages can delay medical procedures that are necessary for a patient’s survival. Substitution of similar medications, if available, may lead to errors and adverse events, especially if prescribers are unfamiliar with the alternative products’ dosing and interactions with other drugs.

Although the reasons for shortages are multi-faceted, part of the problem stems from the manufacturing process. Most drugs are made thousands of miles and several time zones away. And in many cases, they are coming from a single nation – China.

China makes 90 percent of all U.S. vitamins, enzymes and amino acids. They supply 70 percent of the world’s penicillin, 50 percent of its aspirin and 35 percent of all acetaminophen. And U.S. drug companies purchase 40 percent of all pharmaceutical ingredients from nations like China – with some estimating this may reach 80 percent within 15 years.

This overdependence has put our health care system a heartbeat away from a severe crippling.

Just one example proves the point.

Pharmaceutical grade barite is used to produce barium milkshakes used to see into the gastrointestinal tract. China, which mines half the world’s barite, recently implemented mining safety regulations after a series of accidents and deaths. As a result, China’s production of barite contracted to less than a quarter of what it once was.

Although efforts to improve safety are admirable, they also created a widespread drug shortage once supply dried up. The problem is particularly acute because there isn’t a substitute for barite to x-ray the GI tract, which means exams that could diagnose stomach cancers, ulcers and digestive disorders can’t be ordered.

This could happen at any time, with almost any supply, imported from any nation. Even western countries can involve risk. This was the case recently when European manufacturers of propofol, a popular sedation drug, threatened to cease shipments to the U.S. if the drug was used to carry out death penalty sentences. Had this occurred, another shortage would have been unavoidable.

No easy solution exists. But we can start by sourcing materials from multiple geographies. Even better would be domestic manufacturing using advanced technologies that would decrease our dependence on foreign nations altogether.

Equally important, buyers need to consider the reliability of supply before they make a purchase. My company, Premier, Inc., develops purchasing contracts for 100,000 health care providers nationwide. We examined our supply contracts, and discovered we had too many imports. We took steps to diversify to several regions of the globe, adding domestic manufacturers to our portfolio at an affordable price. If more buyers followed this example, we could dynamically shift demand and avoid shortages before they affect patients.

Last, we need more competition in the market. Heritage Pharmaceuticals, for instance, is a new entrant with Cidofovir, a generic drug used to treat viruses in AIDS patients, and Ondansetron to prevent nausea and vomiting caused by cancer therapy. These two drugs, once in limited production and susceptible to shortages, now have guaranteed volume through hospital buying contracts, creating an incentive for greater production. For companies like Heritage Pharmaceuticals, shortages present a low-risk opportunity to break into the pharmaceutical market and compete with new products.

Drug shortages are a major safety issue, and drug makers have a moral imperative to ensure a ready supply. It’s time to realize the threats of our overdependence on foreign countries, and be strategic about which supplies we import, and in what quantities. With patient lives on the line, we can’t afford a shortage of concern.

Michael J. Alkire is chief operating officer for Charlotte-based Premier, Inc.

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