New Haven, Conn. -- Despite federal legislation to stem shortages in the nation's drug supply, deficiencies remain for patients with acute and critical illnesses, said Yale researchers. Their study, published May 2, 2016 in the May issue of Health Affairs, points to the need for greater interventions to maintain the availability of life-saving drugs for millions of patients.
The number of drugs in short supply has more than tripled over the past decade. In 2012, the federal government passed the Food and Drug Administration Safety and Innovation Act (FDASIA), giving the FDA greater regulatory power to respond to the crisis. To assess the impact of the new legislation, a Yale-led team of researchers conducted a study of national drug shortages.
Drawing on data from the University of Utah's Drug Information Service from 2001 to 2014, the Yale team and their coauthors found that the overall number of new shortages since the FDASIA's passage appeared to decline. However, shortages remain, and more than half involve acute-care drugs used to treat critically ill patients in emergency departments (EDs), hospitals, and intensive care units.
"Our key finding was that up to 2012, shortages were rising for both non-acute and acute drugs," said Dr. Arjun Venkatesh, assistant professor of emergency medicine and senior author. But since the 2012 law, "the shortages for non-acute drugs are decreasing and getting shorter but the shortages for acute drugs are increasing and getting longer," he said.
Examples of acute-care drugs that have been in short supply include familiar and commonly used medications, from antibiotics and intravenous saline to naloxone -- a medication routinely given to individuals to reverse drug overdoses.
The researchers also found that the median duration of shortages was 210 days overall, and 242 days -- approximately eight months -- for acute-care drugs. While providers turn to alternative medications in acute and emergency situations, this practice raises the risk of medical error, said the researchers. Alternative drugs can also be less effective, more costly, and involve more side effects than the preferred drugs.
Venkatesh and his co-authors aim to call attention to the problem as a matter of policy and encourage solutions. "You could look at the passage of the law and the overall decline, and view it as a success," he noted. "That's not the case. These acute-care drugs have been ignored."
Other study authors include Serene I. Chen, Erin R. Fox, M. Kennedy Hall, Joseph S. Ross, Emily M. Bucholz, and Harlan M. Krumholz. The study was supported by the National Institutes of Health-National Heart, Lung, and Blood Institute (NHLBI) Medical Student Research Fellowship; NHLBI; the Emergency Medicine Foundation Health Policy Scholar Award; Medtronic; Johnson & Johnson; and the Centers for Medicare and Medicaid Services.
Citation: Health Affairs.