July 10, 2016

Acute Drug Shortages Forcing Workarounds In Hospitals

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In hospitals across Connecticut and nationwide, workarounds to compensate for medication shortages are daily routines for treating patients – and health experts say it’s not about to change any time soon.

Some acute-care drugs in short supply nationally are antibiotics, antipsychotics, intravenous saline, and morphine, according to the most recent shortage list from the U.S. Food and Drug Administration.

In Connecticut, hospital officials say they are turning to alternative drugs, rationing supplies, or seeking new suppliers to work around the shortages.

At St. Francis Hospital and Medical Center in Hartford, Dr. C. Steven Wolf, chief of emergency medicine, said doctors most recently have been dealing with shortages of dextrose, used to treat dehydration and low blood sugar, as well as intravenous saline and other basic medications.

Bridgeport and Greenwich hospitals are facing shortages of antibiotics, including Cefepime, Tigecycline and Ceftin; anesthetics used in surgeries; and IV bags and saline solutions, according to Stacy Vaeth, director of corporate pharmacy services for the hospitals. That is on top of ongoing shortages of various cancer drugs, she said.

The hospitals also can’t get 150-milligram doses of amiodarone, which is used to treat irregular heart rhythms. Instead, they can get 18-millileter vials of the medication, but that is not a ready-to-administer dose, Vaeth said.

Drug shortages can be traced back to mergers or acquisitions by pharmaceutical companies.

iStock Photo.

Drug shortages can be traced back to mergers or acquisitions by pharmaceutical companies.

Hospitals sometimes go months without the medications. A recent study of drug shortages led by Yale University found that the median duration of shortages was 210 days overall, and 242 days for acute-care drugs.

“It really affects everybody,” said Wolf. “There have been times when we have not had (certain) medications. I don’t think patients have any clue that this is occurring. It definitely risks patient care.”

The situation has become so urgent that U.S. Senator Richard Blumenthal wants pharmaceutical companies subpoenaed and investigated to determine whether drug shortages are naturally occurring or being artificially created.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade group that represents branded biopharmaceutical makers, referred a reporter to a website statement regarding shortages. The statement reads, “Patient access to medicines is vital for the health of patients and the economy. The issue of drug shortages demands attention and collaboration from everyone involved in providing life-saving medicines.”

Health experts say that drug shortages have not improved in recent years, despite a law enacted in 2012 that gives the FDA broader authority and regulatory powers to react to drug shortages. The FDA, which tracks shortages, listed 58 medications as being in short supply as of July 8, but that number has topped 200 at times.

The Yale study, which used data from the University of Utah’s Drug Information Service from 2001 to 2014, found the number of drug shortages since the federal act passed has declined, but that shortages remain, more than half involving acute-care drugs, used to treat critically ill patients. Drug shortages have more than tripled in the past decade, the study said.

“Our key finding was that, up to 2012, shortages were rising for both non-acute and acute drugs,” said Dr. Arjun Venkatesh, senior author of the study and assistant professor of emergency medicine at Yale School of Medicine. But while shortages for non-acute drugs are decreasing and getting shorter, the shortages for acute drugs “are increasing and getting longer” since the 2012 law took effect, Venkatesh said.

Vaeth said drug shortages often trace back to mergers or acquisitions by pharmaceutical companies. If two drug makers that manufacture a certain medication merge, typically only one of the medications will be produced, said Vaeth.

Shortages also result from production disruptions, such as when FDA inspectors order a drug maker to suspend manufacturing over quality concerns.

“Even two weeks [of being shut down], it might take them a couple of months to bounce back from that shortage,” Vaeth said.

At Rockville General Hospital in Vernon, Steven Hurchala, director of pharmacy for the Eastern Connecticut Health Network, which owns Rockville, said that when there is a shortage of a popular medication at the hospital, “we may be able to supply an equally effective alternative. Just about all shortage alternatives provide the same positive patient outcome, but usually it may cost us more to provide that alternative.”

At St. Francis, Wolf said clinicians “scramble to find” alternatives to drugs in short supply or use different concentrations of medications. But that requires retraining staff to administer the new formulations, and “it increases the potential for errors,” he said. During prolonged shortages, hospitals may ration their supplies or seek drugs elsewhere, Wolf added.

“Hospitals will beg, borrow and steal from each other,” he said.

At Bridgeport and Greenwich hospitals, Vaeth said staff members do their best to find alternatives, with pharmacists working closely with physicians.

In 2012, the Academy of Managed Care Pharmacy surveyed pharmacy directors at hospitals, ambulatory centers and other facilities about drug shortages. Of 193 respondents, 101 said an adverse event at their site was “possibly/probably” related to shortages, two attributed patient deaths to shortages, three said shortages caused a disabling adverse event, and 46 said events requiring intervention were spurred by shortages.

Blumenthal, who helped craft the FDA Safety and Innovation Act, said a much deeper examination is needed of all pharmaceutical companies reporting shortages. In recent years, he has questioned whether drug distributors are hoarding certain medications in order to create shortages, increase prices, and make more money. It’s also possible, he said, that manufacturers of certain drugs are “colluding” to create artificial shortages to justify raising prices.

“There have to be subpoenas, investigations and document production, so that the potential antitrust violation is explored and documented, if it exists,” he said.

“Hospitals cannot forever triage. There are real health threats.”

One thought on “Acute Drug Shortages Forcing Workarounds In Hospitals

  1. If lifesaving medications cannot be adequately supplied, suspend or nullify the patent and allow the open market to fill the need. Fines are ineffective.

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