When Dr. James C. Salwitz scribbled a prescription for the chemotherapy drug methotrexate recently, he had a strange sensation. Spelling out the once-ubiquitous drug seemed strangely unfamiliar. The reason, he realized, was that it had been so long since he'd prescribed the drug.
"It's barely available, so we don't give any to adults any more, because we're saving it for the kids," said Salwitz, a physician at the Central Jersey Oncology Center, which has offices in Middlesex and Mercer counties.
That unfamiliar sensation is becoming more and more familiar. Drug shortages have been on a steady rise in the past five years, culminating with a record 267 shortages reported last year.
In response, President Barack Obama in October issued an executive order directing the Food and Drug Administration to shuffle and bolster its shortages staff, and to work with drugmakers to more quickly learn of potential supply disruptions. In May, the FDA said those efforts had prevented some 128 shortages.
But Salwitz, who also is a clinical professor at the Robert Wood Johnson Medical School, said the problem is far from over.
"There's been a partial fix," he said. "But it's still an issue."
The drugs in short supply change over time as problems are fixed and new disruptions arise. When a shortage occurs, doctors are forced to consider alternate treatment regimens or conserve drugs by prioritizing patients or delaying therapies.
Pharmacists can sometimes find alternate suppliers, though that can mean higher costs or quality concerns.
Evelyn Hermes-DeSantis, a clinical professor at the Ernest Mario School of Pharmacy at Rutgers University, said with drug shortages, there's no single culprit — or solution.
"I wish I had the magic answer, because I think if we had one reason, we could fix that reason," she said. "But I don't think there's just one reason."
Causes include product recalls, raw material shortages or natural disasters. Many of the shortages come down to simple economics, said Allen Vaida, executive vice president of the Pennsylvania-based Institute for Safe Medication Practices.
"There's been a consolidation of manufacturers in the marketplace, so pharmaceutical companies have consolidated, and some of them have gotten out of the business of producing drugs that may not have had a good return on investment," he said.
Shortages have been reported for brand-name and generic drugs alike. But the latter category of drugs typically comes with low prices and low profit margins, causing some companies to stop making them. If a given drug has only a few manufacturers, and one of those manufacturers quits, the others might not have the resources or regulatory approvals to fill the gap.
"All you need is either production or quality issues or whatever to close one of the plants or to have something go off line, and you have a major shortage," Vaida said.
Current law requires manufacturers only to report potential shortages if they're the sole manufacturer, and only if that drug is deemed "medically necessary" by the FDA. Since Obama's executive order, industry groups have been working with the FDA to construct more widespread reporting standards.
The Generic Pharmaceutical Association, for instance, has also instituted its own voluntary Accelerated Recovery Initiative, which includes hiring a third-party administrator to gather supply information from stakeholders and predict potential supply gaps of 90 days. Legislation also has been proposed in Washington requiring manufacturers to give six months' notice of shortages.
Daryl Schiller, president of the New Jersey Society of Health-System Pharmacists and the assistant director in charge of clinical pharmacy services at St. Barnabas Medical Center, said early warnings can only help so much.
"All that can really do in certain situations where you don't have an alternate (treatment) available is allow prescribers to cherry-pick who's going to get treated and who is not going to get treated," he said. "If there's nothing else to go to, an early warning is only putting off the inevitable."
Vaida said his group would like to see penalties for manufacturers that fail to warn the government about potential supply disruptions, and a requirement that manufacturers come up with contingency plans.
Schiller believes financial incentives may also be needed to help other manufacturers pick up the slack in cases of shortages.
"It's hard for a small startup company that might have one or two products to be able to cover supply," he said.
Angelo Cifaldi, a partner at the law firm Wilentz Goldman and Spitzer P.A., said incentives could be a "Band-Aid," but he said if Washington truly wants to solve the drug shortage problem, it should look in the mirror.
"The government is creating these problems by failing to properly fund the health care system in the United States," said Cifaldi, who also is an adjunct associate professor at Rutgers' Mario School.
Cifaldi said there is waste in the health care system — in the form of payments to "middle-men" like pharmaceutical benefits managers. But he said squeezing drug companies and pharmacies with regulations and shrinking reimbursements is a recipe for disaster.
"I just think it's frightening that, in the United States of America, we can't get the drugs we need to treat the patients," he said. "I think they (Washington politicians) need to look long and hard and think about what they're doing that's creating (the problem). Because it's them that's creating it."
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