As you fumble through the anesthesia drug tray, you begin to sweat. You notice that some drugs are missing. You quickly move to open the Pyxis machine but those drugs are missing, too. You swing open the heavy door to the operating room next door. Before you can speak through your mask, your colleague frames the question as a bewildered statement: “Let me guess, where’s the succinylcholine?”
Jerry A. Cohen, MD, past president of the American Society of Anesthesiologists (ASA), noted in 2012, “When I started practicing, I thought whatever drugs I needed would always be there. Now I open the drawer and occasionally something isn’t there.” In the past five years, according to the ASA, the United States has experienced shortages of an array of vital anesthetic drugs such as propofol, succinylcholine, even epinephrine.
The FDA began tracking drug shortages in 1999 in anticipation of possible manufacturing interruptions that might be caused by the Y2K computer scare. During the first year of the Drug Shortage Program (DSP), the FDA recorded shortages in the supplies of 61 different drugs. At that time, the shortages were caused by disruptions in regional distribution and often could be resolved locally.
Over time, however, the number of reported shortages has increased. By 2011, the DSP recorded shortages of 251 drugs, quadruple the number of drug shortages in 1999. And the drug shortages were no longer regional but national. Approximately 63% of shortages reported between January 2007 and June 2013 lasted an average of 340 days.
In response to the significant increase in drug shortages, the FDA required, rather than suggested, that pharmaceutical companies report all potential discontinuances of drugs used in the prevention or treatment of serious or life-threatening conditions. This included most anesthetic drugs.1
It appears the FDA’s actions have had some effect. Since implementation of mandatory reporting, the number of notifications to the FDA has risen sixfold. In response, the FDA has been able to prevent an increasing number of new national drug shortages
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