While provisions of the Food and Drug Administration's 2012 Safety and Innovation Act have been associated with reductions in many national drug shortages, drug shortages in acute care settings like the emergency room have continued, according to a new study published in Health Affairs and covered by NPR.
For the study, researchers analyzed data on drug shortages collected between 2001 and 2014 by a drug information service at University of Utah in Salt Lake City. Researchers distinguished whether drugs where acute or non-acute. Acute drugs were medications used in the ER to treat urgent conditions — pain medications, heart drugs, saline solution and electrolyte products fell into this category. The study determined that 52 percent of the 1,929 shortages examined were acute care drugs. Researchers also found that drug shortages in the ER lasted on average 69 days longer than non-acute shortages.
While non-acute drug shortages have been in decline since the 2012 law expanding the FDA's regulatory reach, the same cannot be said of acute drug shortages, according to the study's findings.
"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," Arjun Venkatesh, MD, an assistant professor of emergency medicine at Yale School of Medicine and a study co-author, told NPR. Dr. Venkatesh also told NPR his personal experience with acute drug shortages in the ER at Yale-New Haven (Conn.) Hospital was the catalyst for the study.
There is currently no data that suggests substituting a preferred drug with one that a physician is less comfortable with results in patient harm. "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]," Frederick Blum, MD, an associate professor of emergency medicine at West Virginia University School of Medicine in Morgantown, told NPR.
The FDA is working with manufacturers to resolve shortage issues, according agency spokesman Christopher Kelly. In a statement to NPR, Mr. Kelly said injectable drugs "are particularly susceptible to shortages and can be difficult to solve."
Dr. Venkatesh said more needs to be done. "At the national level, they need to provide more support around generic injectables and antibiotics, the two areas that are ripe for improvement."