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Breaking News: Short-Term Ideas Failing to Mitigate Drug Shortages

SoRelle, Ruth MPH

doi: 10.1097/01.EEM.0000415449.65015.96
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James Augustine, MD, does not mince words when he describes the country's drug shortages, particularly those that affect emergency medicine.

“It has really blossomed recently,” he said. “We are in the middle of what I think is unprecedented in terms of emergency care.”

He pointed to two lists of backordered drugs as examples of the escalating problem. The one from a year ago is half a page, but this year's list is almost four pages. While shortages of cancer and attention-deficit drugs have taken center stage in the national media, emergency medicine and emergency medical services have been hit hard, and it is difficult to pinpoint the reason.

“In my opinion, I think this may be a bigger battle between drug companies and the regulatory agencies that is causing the stoppages of drug production,” said Dr. Augustine, the director of clinical operations at EMP in Canton, OH, and the medical director for a variety of fire emergency medical services. “We are juggling drugs in the emergency department in a way that has not happened before.”

The problem is much studied, but the data are equivocal. One problem is that the U.S. Food and Drug Administration can encourage companies to report shortages, but they can only compel reporting when drugs considered life-supporting or life-sustaining are discontinued by a manufacturer. The American Society of Health-System Pharmacists (ASHP) in partnership with the University of Utah Drug Information Service is also attempting to monitor shortages, providing the most current and correct information.

A November 2011 report from the U.S. Government Accountability Office noted that drug shortages have skyrocketed since 2006, many of which are generic injectables. (See FastLinks.) Some 1,190 drug shortages were reported between January 2001 and June 2010, with a record number of 196 reported in 2010. Shortages continued to mount in 2011, eventually reaching more than 200. Which drugs are in short supply depends in part on the agency doing the counting.

“We've always had drug shortages,” said Bona Benjamin, RPh, who coordinates the ASHP's Drug Shortages Web Resource Center, though she agreed that the issue has become more critical in recent years. While shortages of cancer drugs have garnered the most attention, she noted “a real risk in the emergency department.”

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Shortages of injectable generic drugs are the most acute in the emergency department, and Ms. Benjamin said all the ED's “fundamental” drugs are on the list, including anesthetics, opiates, calcium, potassium, cardiac medications, and metered dose inhalers. “You have an emergency department and no succinylcholine, no injectable antipsychotic drugs, no antiseizure drugs or diuretics. It's like sending someone out to fix a structure without tools. The real risk in the emergency department is the speed at which you must move,” she said. “You have to know where everything is, and it's standardized. You have to know what you are picking up, and what you have used. You don't have a lot of time to read labels and think about dosages. Now, you are seeing changes in the strengths and dosages of drugs as well as the drugs themselves weekly. It's a very serious challenge for those in the emergency department.”

Dr. Augustine seconded that opinion, and said it is especially true for prehospital care. “We are trying to juggle among the medications, even in emergency medical services. In some cases, they just don't have any magnesium, calcium, or epinephrine. These are life-saving medications. Epipens are in such short supply that we don't have them to be purchased by people who need them for anaphylaxis.

“There are going to be some repercussions if someone does not come up with solutions,” he said.

He, Ms. Benjamin, and Joseph Hill, RPh, the director of federal legislative affairs for the American Society of Health-System Pharmacists, are looking for a short-term solution to relieve the crisis, and said more investigation needs to be undertaken to identify the long-term answers. One attempt at relieving the problem came Oct. 31 when President Obama issued an executive order directing the U.S. Food and Drug Administration to broaden its reporting of potential drug shortages, accelerate review of applications for drugs facing potential shortages, and give the Department of Justice more information about price gouging or collusion among drug manufacturers.

Mr. Hill and Ms. Benjamin stressed, however, that Congressional action will be necessary to curtail the shortages. “Since the President's executive order, a lot of companies have voluntarily increased their reporting, and the numbers of shortages are below what they were in 2011,” Ms. Benjamin said.

Mr. Hill said the country needs an early notification system where manufacturers have to notify the FDA if they experience a manufacturing or quality problem and have to shut down. “If they are discontinuing production of the product, they have to notify the FDA. One thing we hear a lot is that the manufacture of generic injectables is complex, and these problems come up,” he said. “If the FDA has the information before the shortage occurs, it can work behind the scenes to have another manufacturer ramp up production or enable an abbreviated IND [investigational new drug approval] for another manufacturer to make the product. In 2011, the FDA avoided 195 drug shortages. The early notification system is something we would like to see to encourage that.”

A generic user fee paid by the manufacturer to the FDA to review its application would also help, Mr. Hill said. That process can currently take 30 months, and the fee would allow the FDA to hire more staff to speed the application process.

A third potential solution might be collaboration between the FDA and the U.S. Drug Enforcement Administration to lift strict limits on how much of a certain drug can be manufactured, but Mr. Hill said he is not sure that can be accomplished.

Dr. Augustine meanwhile is searching for solutions that emergency physicians and EMS directors can put into place. “I'm trying to find out how to share supplies of medications to be sure we have the critical supplies and don't have to make a substitution for every drug,” he said. The Texas Medical Board for one is doing its part, saying it would take shortages into account if a physician is reported for using an expired medication.

Monitoring expiration dates can help, Dr. Augustine said. His hospital puts drugs near expiration in the hospital where they will be used more quickly, and rotates the drugs with longer shelf lives to ambulances. “If they are expired, you hope that in some period of time shortly after the medications' expiration date, you will get a new supply in, [but] we are juggling like that,” he said.

Because physicians are sometimes forced to substitute one drug for another, safety reminders are important to prevent them from over- or underdosing patients. Medical directors are also placing warnings on drugs with varying side effects, such as the many paralyzing agents that are in short supply.

Dr. Augustine said finding the long-term cause of the problem will be the ultimate solution. “The GAO said the FDA should have more power. It would be almost comical if it weren't that patients' lives are in the balance. We have the executive branch, the regulatory agencies, and the oversight agency involved, and it still keeps getting worse.”

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