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December 31, 2011

'Gray market' combats drug shortages in Mass.

By Beverly Ford
The Berkshire Eagle

A shortage of lifesaving drugs used on ambulances and in emergency rooms across Massachusetts is endangering patient lives and forcing some hospitals to turn to a thriving "gray market" of pharmaceutical re-sellers to obtain the scarce medications, sometimes at prices more than 1,000 percent above their original cost, The New England Center for Investigative Reporting has learned.

"This is not a pretty situation. It's a frightening situation," said William Churchill, chief of pharmacy services at Brigham & Women's Hospital in Boston, one of many Massachusetts hospitals, including Berkshire Medical Center, now grappling with the drug shortage crisis.

Churchill may be right.

This year, 213 drugs have been listed in short supply, surpassing last year's total of 211 to become the worst year ever for drug shortages in the United States, according to figures supplied by the University of Utah Drug Information Service, which racks those numbers. Most of those drugs are older, sterile injectables that are now manufactured as generic brands.

While drug shortages date back decades, it wasn't until the last two years that the situation reached epic proportions, spurred by production shutdowns caused by product contamination, material shortages, regulatory issues and other manufacturing problems, said Valerie Jensen, a pharmacist and expert on drug shortages with the U.S. Food and Drug Administration. Corporate mergers and cutbacks by generic drug makers seeking better profit margins made the situation even worse.

"It's a perfect storm of conditions with a rapidly consolidating marketplace, a health care system that is trying to control costs, an issue with raw materials and a marketplace that doesn't have a good redundancy system in place to handle things when a plant shuts down," said Allen Vaida, executive vice president of the Institute for Safe Medication Practices. "No question about it. It's a national crisis."

From hospital emergency rooms to ambulance lock boxes all across the state, when it comes to certain lifesaving drugs, the cupboard is growing bare, those on the frontline of medicine say.

"It's pretty much the worst we've ever seen it," said Joseph M. Hill, director of federal legislative affairs for the American Society of Health System Pharmacists, of the shrinking supply of drugs now on hand.

Berkshire Medical Center, too, has seen shortages of emergency-care drugs, which have sometimes led the hospital to use alternative medications of the same class, according to spokesman Michael Leary. The situation, however, has not been so problematic that BMC has had to ration or change patient protocols, he said.

"To date we have not had an instance where we have not been able to care for a patient as a result of low supply," Leary told The Eagle.

Dan LaPlante, manager of Adams Ambulance, said his organization and other ambulance services he communicates with have not experienced problems with keeping drugs in stock.

"We do hear about it from the state on updates on different drugs that could have shortages," he said, "but so far we haven't run into the situation where we could not get what we needed."

Among the drugs found to be in short supply during 2011 were injectable versions of calcium gluconate, used by first responders to regulate heart rhythm in patients suffering cardiac arrest; succinylcholine, a muscle relaxer used to intubate patients; naloxone hydrochloride, which reverses drug overdoses; and propofol, an anesthetic used in emergency surgery better known for causing the death of singer Michael Jackson. Most of those medications are older generic injectables that are widely used in emergency situations. Some of those shortages, among them propofol and succinylcholine, have since been resolved but others continually crop up, creating a gap in emergency drug stockpiles.

"It's really a serious situation," added Hill. " Unfortunately, we don't have a silver bullet to deal with it."

Silver bullet aside, managing the shortage of emergency medicines has taken a toll on providers who now must deal with the task of not only finding scarce drugs but also buying substitute pharmaceuticals in case meager supplies run out. Rationing scarce medications is now common practice at three out of four hospitals nationwide, a survey by the American Hospital Association found.

"We're all clearly affected by it," Churchill said of the shortage, noting that hospital pharmacists, once accustomed to seeing one shortage a month, now face multiple shortages sometimes on a weekly basis.

Health officials say the impact of the shortages is felt nationwide with rural areas and smaller hospitals, many with less buying power than their big-city counterparts, suffering the most.

At Massachusetts General Hospital in Boston, Dr. Paul Biddinger, director of operations for the Department of Emergency Medicine, termed the nationwide situation "a crisis," saying in an interview with the New England Center for Investigative Reporting that frequent drug shortages, once relegated to cancer drugs, have now "hit the mainstream medications used in emergency rooms." Ambulances, many of which get their drug supplies through hospitals, are also facing a critical shortage.

Health care providers are so concerned, in fact, that Bay State hospitals, including Mass General, have begun rationing certain drugs, delaying non-emergency treatments and using substitute drugs in place of the original. Still, the pharmaceutical market is thriving.

Health care providers are so concerned, in fact, that Bay State hospitals, including Mass General, have begun rationing certain drugs, delaying non-emergency treatments and using substitute drugs in place of the original. Still, the pharmaceutical market is thriving.

"Gray market" suppliers, usually small wholesalers or individuals who closely monitor and react to pharmaceutical trends, are scooping up medications as soon as a shortage becomes apparent then selling back the products to drug distributors, other wholesalers or hospitals at inflated prices that can sometimes top more than 1,000 percent of a drug's original cost.

A 2011 study by Premier Inc., which collects and analyzes clinical and financial data for the health care industry, found that propofol, used for critical care sedation, was selling on the "gray market" at 3,170 percent above its original cost. The cardiology drug, Labetalol, topped Premier's "gray market" price list at 4,533 percent above cost. That's nearly 4,000 percent above the 650 percent average the study says most "gray market" drugs sold for.

While such inflated prices may sound like gouging, prosecuting "gray market" wholesalers has proved to be a difficult task since many operate in southern states where laws are lax. Several "gray market" vendors identified by hospitals and contacted by the New England Center for Investigative Reporting either did not return phone calls or declined to comment on the price-gouging issue.

"The ability of the authorities to prevent people from selling at this rate (of inflated cost), particularly during a shortage, is limited," said Andrew Seger, president of the Massachusetts Society of Health-System Pharmacists, an advocacy and education group. "I have seen no state take action against it."

Madeleine Biondolillo, director of the Massachusetts Department of Public Health's Health Care Safety and Quality Bureau, says DPH has not had any reports of adverse incidents as a result of the drug shortage but is monitoring the situation closely.

"We're not getting any complaints regarding any infringement on care because of the shortages," she said. "That doesn't guarantee it isn't happening, but we usually see that fairly quickly when there seems to be an uptick in problems. What I surmise is that providers are doing what they are supposed to do under the circumstances."

So far, 15 deaths attributed to the drug shortage have occurred nationwide, an Associated Press study found. None of those deaths occurred in Massachusetts, federal and state health officials said.

To mitigate human error and reduce drug overdoses and underdoses, medical personnel must be re-trained each time a new drug is substituted for an old, hospital officials said. At Brigham & Women's Hospital, that means training 2,500 nurses and about 1,500 doctors at a cost that can take a substantial cut from the hospital's bottom line, says Churchill. Other hospitals are following suit.

The complexity and costliness of scheduling training and seeking out adequate drug supplies has taken its toll on first responders and emergency room staff throughout the Bay State.

"It's become a huge problem for everyone" said Roy Guharoy, chief pharmacy officer with the University of Massachusetts Memorial Medical Center in Worcester, who expects even more drug shortages in the future. "Unless we deal with the issues now," he added, "they're only going to continue."

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