A very small minority of all drugs used in the United States (typically about 1/2 of 1%) experience a shortage in any given year. However, the number of drug shortages recognized by the FDA has been increasing each year since 2006. Figure 1 shows trends in the total number of drug shortages and the number of shortages of sterile injectable drugs. Appendix A provides comparable information using data from the University of Utah’s drug shortage program.
Although sterile injectable drugs are a small percentage of the overall prescription drug market, they make up a disproportionate share of drugs in shortage and include critical drugs, such as oncology drugs, succinylcholine, naloxone, furosemide, and emergency syringes. In 2010, 74% of shortages involved sterile injectable drugs. In 2011, FDA is continuing to see new sterile injectable drug shortages. While sporadic shortages occur at roughly equal rates in both the branded and generic markets, the current shortage of sterile injectable drugs is concentrated in the generics industry.
While shortages of sterile injectable drugs have captured attention recently, problems in this area have been increasing since 2007. Many of the sterile injectable oncology drugs that have experienced shortages in 2010 and 2011 had also experienced shortages in 2008 or 2009.