Drug Shortages Continue Despite Federal Law to Prevent Them

Despite the enactment of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which gave the FDA new and expanded regulatory powers to respond to a tripling of national drug shortages, a new study finds that although the numbers of national drug shortages appearing each year has decreased, the overall number of national shortages remains high.

Notably, the study’s results suggest that the drug supply for many acutely and critically ill patients in the United States remains vulnerable despite federal efforts because shortages may be increasing for drugs that are used for diagnosis and management of patients in the emergency department (ED), hospital wards, and intensive care units.

National drug shortages have been reported for many of the most commonly used acute care drugs, including pain medications, sedatives, electrolyte solutions, antibiotics, antidotes and reversal agents, and medications for critical care, according to Serene I. Chen, MD, an emergency medical resident in Oakland, California, and colleagues at Yale University, where she was a medical student when the study was conducted, and University of Utah Health Care. The study, in the May 2016 issue of Health Affairs, makes estimates of national drug shortages based on reported national drug shortages from 2001 to 2014 that were collected by the University of Utah’s Drug Information Service.

The study found that although the number of new annual shortages decreased since the passage of the FDASIA, half of all drug shortages in the study period involved acute care drugs. Shortages affecting acute care drugs became increasingly frequent and prolonged compared with non-acute care drugs (median duration of shortages, 242 days versus 173 days, respectively). A reason acute care drugs are increasingly affected by shortages is because drugs used in the acute care setting are more likely to be directly injected instead of taken by mouth. It is well known that injectable drugs are more prone to manufacturing problems, and they are more likely to be underproduced or discontinued because of their low profitability.

Drug shortages are especially challenging for acute care because of the low tolerance for delays that can occur during the search for therapeutic alternatives. Emergency clinicians have expressed concerns about the problems they have finding alternative medications, which even when found, can be less effective, more costly, or associated with more adverse events than the preferred drug. Substituting drugs carries a higher risk of medication errors occurring in the ED than in non-acute settings.

The researchers state that the FDASIA represents only a temporary measure to deal with shortages for specialty drugs and has only limited effects on acute care drugs. They lament the fact that although FDASIA requires manufacturers to report new shortages, the FDA’s approach to these shortages is reactive and inadequate for dealing with acute care drugs.

The authors conclude that more broad-based interventions are needed to address the persisting problem of drug shortages and help maintain the availability of drugs that are critical for millions of patients every day. Suggestions that have been made to stabilize the supply of generic injectables include providing tax credits, rebates, or temporary market exclusivity.