Drug shortages are becoming a national issue

The Kansas City StarSeptember 28, 2011 

Bryan Schearer had great odds for a quick recovery when he was diagnosed with Hodgkin’s lymphoma in November. After six months of chemotherapy with a four-drug cocktail, he’d have as much as a 90 percent chance of a cure.

But after the 20-year-old Kansas City man started treatment, one of his chemotherapy drugs, bleomycin, vanished from pharmacy shelves and joined the nation’s growing drug shortage list.

Schearer’s chemotherapy failed. Now he’s going through a grueling — and riskier — stem-cell transplant to rid his body of cancer.

“If it wasn’t for that bleomycin, (the treatment) would all be over now,” Schearer said. “It’s not really fair. From what I heard, it had to do with money. Companies would rather make Cialis or Viagra instead of a drug thousands of patients need.”

Yes, blame manufacturers that switch to drugs with higher profit margins — but also blame short supplies of raw materials, factory breakdowns and quality problems that slow production lines.

They’re all factors contributing to what’s become a daily, nail-biting crisis for doctors, pharmacists and patients as more and more drugs become hard to find. Supplies were short for 110 drugs at some point during 2008, according to the Food and Drug Administration. By last year, the number had grown to 178, and so far this year, more than 200 drugs have made the shortage list.

Drug shortages were the subject of a congressional hearing last week, and the FDA monitors them constantly.

Most of the drugs in short supply are injectables, often the ones that flow through the intravenous lines of hospital patients. Many, like bleomycin, are important to cancer treatment.

“My patients’ lives are being put at risk by these shortages,” said Joseph McGuirk of the University of Kansas Cancer Center. “Sometimes, patients are truly missing their chemotherapy. Other times, we get them in the nick of time.”

That happened just this week: A woman was hospitalized with an acute form of leukemia that demanded immediate treatment, but KU Hospital didn’t have enough of the drug she needed.

Other patients who take the drug every three months had their own supplies on hand. So hospital staff started calling them to see whether any would lend some to the woman with the promise they would have the drug later when they needed it. Meanwhile, staffers searched the area until they found a HyVee pharmacy that had the drug.

Those backup plans were shelved when the hospital’s shipment arrived Tuesday morning.

“It’s a circus act,” McGuirk said. “But for our patients, it’s life and death.”

One study pegged the annual labor costs of dealing with drug shortages at $216 million nationally.

Michelle Rockey, coordinator of the KU Cancer Center pharmacy, said she spends up to five hours a day managing drug shortages, contacting manufacturers and wholesale distributors.

“It’s hard to predict what we can get,” Rockey said. “At what point do you let doctors know about a shortage to avoid running out, but not panic everyone?”

Drugs recently in short supply include paclitaxel, which is used most notably to treat breast cancer but also is effective against ovarian, lung and gastric cancers; the anti-nausea drug prochlorperazine; electrolytes used by patients fed intravenously; and Doxil, a breast and ovarian cancer drug with such tight supplies that many patients are on waiting lists.

Manufacturers contend with a variety of supply and production problems that lead to shortages:

• Manufacturing and shipping delays caused by natural disasters such as the earthquake in Japan and last year’s volcano in Iceland.

• Poor-quality raw materials outsourced to overseas suppliers, such as the contaminated heparin ingredients from China that caused patient deaths in 2008.

• Quality and regulatory issues at factories ranging from labeling errors to particles of glass or metal in drug vials.

Generic drugs with expired patents account for many of the shortages. Production is concentrated among a small number of companies

A relatively poor return on generic injectable drugs can be a reason for discontinuing production in favor of other medications, said Jack Fincham, a professor at the University of Missouri-Kansas City School of Pharmacy.

“For generic manufacturers, making the injectable drugs is a more lengthy and costly process than making tablets,” Fincham said. “It may be more profitable to make oral forms than injectables.”

One group profiting from the shortages is speculators who buy up supplies of essential drugs and then resell them for exorbitant prices when they are in short supply.

Mark-ups by these “gray market” dealers average 650 percent above normal retail prices but can top 4,500 percent for some drugs, according to Premier, a purchasing network of hospitals and other healthcare organizations.

“We probably get phone calls from gray-market distributors daily,” said Mark Woods, clinical coordinator of the pharmacy department at St. Luke’s Hospital.

Typically, faxes for a drug will arrive as soon as a shortage appears: “We have plenty in supply. Call today,” they will say, according to Woods.

St. Luke’s hasn’t resorted to gray-market drugs — the hospitals within its system share supplies — but other hospitals do.

“Many fine, reputable hospitals across the United States have been forced to deal with them. Many of these people aren’t regulated,” said Fincham of UMKC.

Gray-market drugs may be close to expiration, he said. They may have been stored improperly. They may even be counterfeit.

The FDA has been trying to deal with shortages by helping companies bring problem factories into compliance while encouraging other companies to ramp up production during a shortage. The agency also has speeded regulatory review of new manufacturing sites and suppliers. In some cases, the FDA has allowed temporary importation of shortage drugs from unapproved sources.

But the agency’s authority is limited. Although manufacturers report many disruptions in production voluntarily, they aren’t required to.

And except in some cases where they are the only source of a product, companies aren’t required to notify the FDA when they discontinue production.

A bill now in Congress would require drugmakers to report potential shortages.

To read more, visit www.kansascity.com.

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