At some hospitals, posters on the wall in the emergency department list the drugs that are in short supply or unavailable, along with recommended alternatives.
The low-tech visual aid can save time with critically ill patients, allowing doctors to focus on caring for them rather than doing research on the fly, said Dr. Jesse Pines, a professor of emergency medicine and director of the Office for Clinical Practice Innovation at the George Washington University School of Medicine and Health Sciences, who has studied the problems with shortages.
The need for such workarounds probably won’t end anytime soon. According to a new study, shortages of many drugs that are essential in emergency care have increased in both number and duration in recent years even as shortages for drugs for non-acute or chronic care have eased somewhat. The shortages have persisted despite a federal law enacted in 2012 that gave the Food and Drug Administration regulatory powers to respond to drug shortages, the study found.
For this report, which was published in the May issue of Health Affairs, researchers analyzed drug shortage data between 2001 and 2014 from the University of Utah’s Drug Information Service, which contains all confirmed national drug shortages, according to the study. They divided the drugs into acute and non-acute categories. Acute-care drugs were those used in the emergency department for many of the urgent and severe conditions handled there and include remedies such as pain medications, heart drugs, and saline and electrolyte products.
Overall, the study found that 52 percent of the 1,929 shortages during the time period studied were for acute-care drugs. Following passage of the federal law in 2012, the number of active shortages of non-acute care drugs began to decline for the first time since 2004, but there was no corresponding dropoff in shortages of drugs that emergency departments and intensive care units rely on, the researchers reported.
Shortages of the emergency-care drugs lasted longer as well, the study found. Half of acute-care drug shortages lasted longer than 242 days, compared with 173 days for non-acute care drugs.
Seventy percent of the drugs that were difficult to get were injectable drugs, which emergency departments rely on to a much greater degree than other types of providers. The most common acute-care drugs affected were those to fight infections, such as antibiotics; those that affect the central nervous system, including painkillers and sedatives; and the drugs that suppress or stimulate the autonomic nervous system, which controls heart and breathing rates.
When patients come to the emergency department who have been seriously injured and are having trouble breathing, for example, it’s often necessary to administer drugs that sedate them and cause their muscles to relax so that emergency personnel can insert a breathing tube in the windpipe.
“All of a sudden you have a life-critical procedure and you’re using your second-best drug or a drug you’re less familiar with,” said Dr. Arjun Venkatesh, an assistant professor of emergency medicine at Yale School of Medicine and a study co-author.
Venkatesh said his own experience with recurring shortages of such basic but critical medicines as saline intravenous solution while working in the emergency department at Yale-New Haven Hospital was the impetus for the study.
Patients are naturally often unaware of drug shortages in the emergency department, and there’s no data to show that substituting a preferred drug with one that a doctor is less comfortable with results in patient harm, experts say.
“But if you extrapolate this problem over 140 million emergency department visits annually, I don’t see how patients couldn’t have been harmed by [substitutions],” said Dr. Frederick Blum, an associate professor of emergency medicine at West Virginia University School of Medicine who is a former president of the American College of Emergency Physicians.
The Food and Drug Administration Safety and Innovation Act of 2012 contains provisions aimed at stemming these problems, including requiring reporting of shortages by drug manufacturers to the FDA and expediting inspections and reviews by the FDA of alternative products and manufacturing facilities.
“We need more,” Venkatesh said. “At the national level, they need to provide more support around generic injectables and antibiotics, the two areas that are ripe for improvement.”
The FDA continues to work closely with manufacturers to resolve shortages, said FDA spokesman Christopher Kelly.
“In the past couple of years, numbers of new shortages have gone down and that’s largely due to increased notifications by manufacturers,” Kelly said in a statement. Injectable drugs “are particularly susceptible to shortages and can be difficult to solve.”
Changing the economics of these drugs could help, said George Washington’s Pines, noting that profit margins are thin and there’s not a lot of extra capacity in the system if one manufacturer stops producing a drug. The Health Affairs study suggests tax credits, rebates or temporary market exclusivity as potential strategies to improve the supply of generic injectables, among other things.
David Gaugh, senior vice president for sciences and regulatory affairs at the Generic Pharmaceutical Association, said drug makers’ efforts have helped decrease the shortages but acknowledged more is needed. He called for continued communication between regulators and generic drug manufacturers on the issues and improvements in the drug review process. “The only way to mitigate current shortages and prevent future shortages from occurring is a collaborative effort,” he said.