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December 19, 2011

Shortage of lifesaving drugs 'is endangering patient lives'

By Beverly Ford
The Lowell Sun

BOSTON —A shortage of lifesaving drugs used on ambulances and in emergency rooms is endangering patient lives and forcing some hospitals to turn to a thriving "gray market" of pharmaceutical resellers 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 grappling with the drug-shortage crisis.

Churchill may be right.

So far 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 tracks those numbers.

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

"It's pretty much the worst we've ever seen it," Joseph Hill, director of federal legislative affairs for the American Society of Health System Pharmacists, said of the shrinking supply of drugs now on hand. The organization's vice president termed the shortage "a serious public health threat" in testimony before a congressional committee on health care in November.

Scott Meagher, a member of the Southeastern Massachusetts Emergency Medical Services Committee, one of five regional EMS committees in the state, grapples with the shortage every day as a Rehoboth paramedic.

"This isn't something just happening in small pockets. It's a national problem," said Meagher, "We're all very much aware of it."

Locally, hospitals say they are working to prevent any shortages, which ensures that patients have access to medication when they need it.

"Lowell General Hospital is certainly not immune from the challenges the drug shortages have presented across the nation," said Robert Ritchie, director of pharmacy at LGH. "We continue to work proactively with our medication suppliers to ensure that we are anticipating any potential shortages and procuring medications appropriately in advance."

Timothy Regan, chief of emergency medical services at Saints Medical Center, said there are no drug supply shortages affecting Saints' emergency services.

"While all health-care providers must constantly manage fluctuations in the supply of pharmaceuticals to various hospital departments, Saints works with a wide range of primary and secondary sources to ensure there are no shortages," he said. "We are not experiencing any supply problems that would impact our emergency services, nor do we purchase any medicines on the so-called gray market."

Jeffrey Stewart, director of Clinical Services and Education for Trinity Emergency Medical Services, which provides ambulance services to 13 communities in Greater Lowell and New Hampshire, said there is a shortage of Valium and Ativan, anti-seizure medications.

"It happens periodically that the manufacturers of these medications have an issue in their production line, or problem in packaging line that inhibits their supply chain. As a result, we're short of medications for a period of time," he said.

He said the problem is concerning and there should be a priority on awareness of the problem, but he said he wouldn't call it a "crisis."

"But I guess it depends on your definition of 'crisis,' " he added.

"A perfect storm"
Among the drugs 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.

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."

"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. During one recent month, between 50 and 60 pharmaceuticals were unavailable from manufacturers, he noted.

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." Frequent drug shortages, once relegated to cancer drugs, have now "hit the mainstream medications used in emergency rooms," he said. Ambulances, many of which get their drug supplies through hospitals, are also facing a critical shortage.

"We estimate we could be at the point within a month where some supplies might not last the length of the shortage," Biddinger said. "We're certainly very concerned."

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."

Almost all states require pharmaceutical wholesalers to be licensed but only three states, Maine, Kentucky and Texas, have price-gouging laws that specifically address pharmaceuticals, according to the National Conference of State Legislatures. There is no federal law that addresses the issue either. In Massachusetts, the state's price-gouging law only targets gasoline and petroleum products.

Yet despite legal loopholes that allow gray-market vendors to push prices sky high, hospitals desperate to find the right drug for patients continue to seek out these shadowy sellers, though few admit it publicly.

"Some hospitals will buy from this gray market if they are backed against the wall and can't get alternatives," said Dr. Ahmed Elmogy, an emergency physician with Holyoke Medical Center in Holyoke who, like others interviewed, said his hospital doesn't purchase drugs from gray-market vendors.

Some hospitals look to other medical facilities for help in obtaining critical need drugs rather than resort to paying the inflated prices that "gray market" sellers demand, says Buddinger. That informal exchange system allows larger hospitals with more buying power to help smaller hospitals get the drugs they need to treat emergency patients.

"Everybody is doing the best they can with the resources they have," said Patricia Noga, vice president for clinical affairs at the Massachusetts Hospital Association, which is working with public-health officials and legislators to mitigate the effects of drug shortages.

The group's parent organization, the American Hospital Association, which surveyed 820 hospitals nationwide earlier this year, found that 99 percent of all hospitals had experienced a shortage of one or more drugs. Half of those hospitals reported a shortage of 21 or more drugs and 82 percent said the drug crisis caused them to delay patient treatment. A total of 91 percent experienced a shortage of drugs in their emergency care unit within the last six months, the survey found.

Madeline Biondolillo, director of the Massachusetts Department of Public Health's Health Care Safety and Quality Bureau, said 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."

"Very risky business"
Still, it's not just the shortage of critical medicine or the rising price of "gray market" drugs that has first responders and hospital emergency-room personnel concerned. It's how to provide the best patient care while at the same time preventing medical mixups when administering drug substitutes, many of which have different potencies than their more commonly used counterparts. Fentanyl, for example, which is used as a substitute for morphine, is 10 times stronger than the opiate. A wrong dose, hospital officials worry, could cause death.

"It's very risky business," said Churchill. "Nobody wants to get into a situation where you are asking your clinical staff to use drugs they're not familiar with so you have to do a really good job educating them."

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

Vaida, however, says it may be difficult to prove if any emergency patients died as a result of the drug shortage because often they're injured so badly, it would be tough to tell whether a death is due to physical trauma, the reaction to a substituted drug, or human error.

"In our mind, that's just the tip of the iceberg," Vaida said of the 15 deaths. "No one may be attributing a death because they really aren't aware that a drug actually caused the death. If someone is not aware of the potency of one medication and gives too much so that the patient goes into respiratory arrest and dies, they may attribute it to the fact that the patient came into the hospital with respiratory problems."

To mitigate human error and reduce drug overdoses and underdoses, medical personnel must be retrained 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, said 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."

Yet the FDA, which regulates new drugs, has little authority to change things. Unable to order pharmaceutical makers to step up production when a shortage occurs, and with no federal law on the books regulating price gouging of drugs, the FDA is virtually powerless to change current conditions, critics say. In fact, drug firms aren't even required to tell the FDA when they stop producing a drug. That may soon change, however. Agency officials say they are working closely with drug manufacturers to prepare for shortages before they occur. That effort has helped avoid 101 drug shortages this year alone, said Jensen.

The real test will come soon, however. The FDA hopes to make pharmaceutical firms more responsive through legislation that will require the creation of an early warning system to report pending drug shortages as soon as they are known.

Copyright 2011 MediaNews Group, Inc.

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