Study: Acute care drug shortages persist, despite 2012 law

Early evidence suggests that the Food and Drug Administration Safety and Innovation Act of 2012 has reduced drug shortages overall, but not for acute care drugs, according to a study published today in Health Affairs. “Our estimates, based on reported national drug shortages from 2001 to 2014 collected by the University of Utah’s Drug Information Service, show that although the number of new annual shortages has decreased since the act’s passage, half of all drug shortages in the study period involved acute care drugs,” the authors write. “Shortages affecting acute care drugs became increasingly frequent and prolonged compared with non-acute care drugs (median duration of 242 versus 173 days, respectively). These results suggest that the drug supply for many acutely and critically ill patients in the United States remains vulnerable despite federal efforts.” The law gave FDA new and expanded regulatory powers to respond to national shortages. For example, FDA last year finalized a rule requiring all manufacturers of certain medically important prescription drugs to notify the agency of permanent discontinuances or temporary interruptions in manufacturing that are likely to disrupt the supply of the product in the United States.