Synopsis
It is an unfortunate sign of the times that a quick scan through just about any news source will yield at least one example of an adverse drug event that was created or exacerbated, at least in part, by the alarming trend of drug shortages in the US marketplace. Stories abound of treatments delayed or cancelled, inferior drug substitutions, and desperate patients scrambling for life-saving medications. The American Hospital Association (AHA), the Institute for Safe Medication Practices (ISMP) and the American Society of Health System Pharmacists (ASHP) all have published data surrounding the impact of these product shortages on patient care, and although no definitive systematic studies are yet available, these sources all point to a wide and deepening problem that seems to have no end in sight. The FDA is reporting that the number of annual drug shortages has tripled from 61 in 2005 to 178 in 2010.1 Their data reveals that the majority of drug shortages (80%) involved sterile injectables, with oncology drugs (28%), antibiotics (13%), and electrolyte/nutrition drugs (11%) rounding out the major therapeutic classes of drugs. As the FDA concludes, “the problem of medical product shortages is complex and stems from economic, legal, regulatory, policy, and clinical decisions that are deeply interconnected.”
