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Originally published Saturday, January 21, 2012 at 6:01 AM

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FDA: Prescription-drug shortages getting worse

The shortages are raising safety concerns for patients, delaying treatment, and causing higher costs, pharmacy groups say.

Detroit Free Press

Some drugs that arehard to find

The federal Food and Drug Administration lists drugs with shortages, provides answers to common questions and invites consumers to alert the agency about issues.

Here are some examples of drugs in short supply, and the reasons cited on the FDA site.

Adderall, for attention deficit/hyperactivity disorder. Reason: Supply issues and uneven product distribution patterns.

Mitomycin, for bladder cancer. Reason: Increase in demand and manufacturing delays.

Morphine sulfate injection, for pain relief. Reason: Manufacturing delay.

Ondansetron injection, to prevent nausea and vomiting caused by cancer chemotherapy and surgery. Reason: Increased demand and temporary suspension of manufacturing by one manufacturer of the drug.

Avalide, to treat high blood pressure. Reason: Manufacturing delays.

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DETROIT — Theresa Hart has encountered major problems filling her prescription for Adderall, the hyperactivity medicine she has taken for 10 years.

She, her pharmacist at Kroger in Lake Orion and her doctor spent months repeatedly calling around in search of the medicine. Finally, Hart decided to try a similar drug, Vyvanse, but she doesn't think it gives her the same focusing power as Adderall.

"I just don't feel it's as sharp," she said.

Dr. Joel Young, Hart's Rochester Hills psychiatrist and a hyperactivity-disorder specialist, said some of his patients call five or six pharmacies to get their medication.

"It's been terrible in the last quarter," Young said.

Prescription-drug shortages — a national issue for the past few years — are getting worse, raising safety concerns for patients, delaying treatment plans and even surgeries, and causing higher out-of-pocket costs and rising prices in health care, pharmacy groups say.

The most common causes are manufacturing violations, production delays, shipping problems or ingredient shortages. The problem — called a national health crisis by federal regulators and leading industry groups — has worsened because of complex legal, regulatory, economic and other factors, according to a 2011 report from the federal Food and Drug Administration (FDA).

Shortages grow as generic manufacturers have consolidated and fewer plants are left making certain drugs, the FDA and others say.

Pharmacists at the University of Michigan, the Detroit Medical Center, St. John Providence Health System, Henry Ford Hospital, the Barbara Ann Karmanos Cancer Institute and Priority Health all report increased problems finding medicines recently. The issue consumes at least 40 hours a week — double what was spent a few years ago to manage drugs in short supply, said Ed Szandzik, director of pharmacy services at Henry Ford Hospital, Detroit.

Pharmacists feel "like day traders who are on the computer constantly all day" for supplies, sometimes to replenish stocks of those drugs that could get tight, said Gary Blake, director of pharmacy at St. John Hospital & Medical Center, Detroit.

"If we don't buy it, somebody else will," he said.

More drugs on list

The number of drugs in short supply more than tripled from 61 in 2005 to more than 200 this year, according to industry groups and the FDA, which lists drugs with shortages on its website — www.fda.gov.

The most critical shortages involve cancer, antibiotic, nutrition and electrolyte-imbalance medicines, according to a fall report from the FDA.

Those used for neuromuscular conditions, anesthesia in surgery, pain and antiviral conditions also have had bad shortages, the report said. Some hospitals have postponed surgery because they didn't have the right anesthesia drug, pharmacy groups say.

A University of Michigan study found three drugs are hardest to get: succinylcholine injections, a muscle relaxant used in surgery; dextrose 50 percent syringe medicine, to restore blood glucose levels, and epinephrine injections, used in cardiac surgery.

Labor costs associated with managing the shortages contribute an estimated $216 million in extra spending a year, according to research published by U-M pharmacist Burgunda Sweet in the October issue of the American Journal of Health-System Pharmacy. The 353 pharmacy directors surveyed overwhelmingly agreed that drug shortages increased costs.

The worries are prompting alerts about what people need to know about searching for replacement drugs.

The health-system pharmacy group, for example, has consumer resources at www.safemedication.com that raise questions about the safety of medicines purchased online or through gray-market sources — nontraditional or alternative distributors and brokers.

Drugs bought those ways may be much more expensive and may not be properly monitored for minimum production standards, the group says.

Consumers also need to alert their pharmacists and health-care providers about other medicines they take so they know about any possible adverse interactions between medicines that can cause complications or not be suitable for people with other chronic medical problems.

"Safety becomes a big issue," said Stephen Smith, pharmacy director at the Karmanos Institute.

"Physicians, pharmacists and nurses are used to certain regimens (to treat cancer)," he said. "We use the gold standard. If you throw in drugs they are not as familiar with, you may have to remind them that these drugs work a little differently."

Price gouging reported

Shortages also have raised concerns about higher prices and gouging by wholesale drug companies that obtain supplies of hard-to-get drugs and jack up the costs.

On a typical day earlier this month, Szandzik said he got a half-dozen unsolicited inquiries from companies charging four to 10 times the cost of a drug.

Bob Lytle, who owns Lytle Pharmacy in Rochester, said the price of Adderall more than tripled over the past three months, from $30 for 100 pills to more than $100.

Shire, the Philadelphia company that initially made Adderall, and Teva Pharmaceuticals, one of the firms now making and distributing it, did not return several calls or emails for comment. Teva and a second manufacturer are suing Shire, accusing it of hoarding the product and refusing to supply them with enough medicines to fill their contracts.

Part of the problem is that the FDA doesn't have authority to order manufacturers to report shortages — though many do voluntarily.

President Obama has asked some manufacturers of drugs with no generic equivalent to do more to report product interruptions to the FDA. He's also expanding a five-person staff at the FDA that has investigated shortages.

Last month, the Generic Pharmaceutical Association — the trade group for the generics industry, which accounts for more than 75 percent of drug prescriptions in the U.S. — suggested other possible solutions. Those include creating a high-level team within the FDA to respond to shortages and hiring an independent third party to study drugs identified as having or likely to have shortages soon.

Expected to continue

Pharmacists expect the problem will persist. They say people should work with their medical teams and pharmacist to understand drug options and other issues, particularly if problems continue beyond three months. Internet sources of drugs may not be safe or reliable, so don't look for options there, Szandzik and others said.

Hart continues to call around monthly to see whether her Adderall is back in stock and said pharmacists in her area tell her the shortage may continue early this year.

"It's just another big inconvenience and another problem I have to solve every month," she said.

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