At some hospitals, posters on the wall in the emergency department list the drugs that are in short supply or unavailable,聽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 the problems with shortages.
The need for such workarounds probably won鈥檛 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聽have eased somewhat. The shortages have persisted despite a federal law enacted in 2012 that gave the Food and Drug Administration聽regulatory powers to respond to drug shortages, the study found.
For this ,聽which was published in the May issue of Health Affairs, researchers analyzed drug shortage data between 2001 and 2014 from the University of Utah鈥檚 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 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聽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,聽such as antibiotics; those that affect the , 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聽having trouble breathing, for example, it鈥檚 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.
鈥淎ll of a sudden you have a life-critical procedure and you鈥檙e using your second-best drug or a drug you鈥檙e less familiar with,鈥澛爏aid聽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聽solution while working in the emergency department at Yale-New Haven Hospital was the impetus for the聽study.
Patients are naturally often unaware of drug shortages in the emergency department, and there鈥檚 no data to show that substituting a preferred drug with one that a doctor is less comfortable with results in patient harm, experts say.
鈥淏ut if you extrapolate this problem over annually, I don鈥檛 see how patients couldn鈥檛 have been harmed by [substitutions],鈥� 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 contains provisions aimed at stemming these problems,聽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.
鈥淲e need more,鈥� Venkatesh said. 鈥淎t the national level, they need to provide more support around generic injectables and antibiotics, the two areas that are ripe for improvement.鈥�
The FDA continues to work closely with manufacturers to resolve shortages, said FDA spokesman Christopher Kelly.
鈥淚n the past couple of years, numbers of new shortages have gone down and that鈥檚 largely due to increased notifications by manufacturers,鈥� Kelly said in a statement. Injectable drugs 鈥渁re particularly susceptible to shortages聽and can be difficult to solve.鈥�
Changing the economics of these drugs could help, said George Washington鈥檚 Pines, noting that profit margins are thin and there鈥檚 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鈥� 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. 鈥淭he only way to mitigate current shortages and prevent future shortages from occurring is a collaborative effort,鈥� he said.
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