Analyzing the case of the New England Compounding Center: Dr. Michael Drues: How might this tragedy lead to an even bigger one!

During the fall of 2012, the New England Compounding Center (NECC) became the focus of national attention when the Framingham, MA-based company was accused of “unsafe manufacturing practices” that lead to 61 deaths and more than 749 injuries1 in patients infected with a fungus that led to a rare but deadly form of meningitis. In fact, as many as 13,000 people nationwide may have been put at risk from tainted steroid injections for chronic pain from this case alone.2 Since then, there were multiple reports in the press detailing the chronology of events leading to this tragedy cumulating in the CBS 60 Minutes investigation “Lethal Medicine,” which aired March 10, 2013.3 Unfortunately, this seems to be only the tip of the iceberg. More recently, U.S. Food and Drug Administration inspectors found dozens of potentially dangerous safety problems at 30 similar pharmacies across the country.4 But before considering a solution, we would be wise to ask why is this problem happening? What’s the root cause? As a result of the investigations, there is evidence to suggest the now-closed company experienced “technical problems” involving facility design, equipment maintenance, and sterilization practices. Even more troubling are the accusations of possible fraudulent business practices used to escape traditional regulatory protections, which exempt those making speciality prescriptions one patient at a time. This is now being referred to as the “Bart Simpson” phenomenon.5 While certainly disconcerting, these factors still do not get us to the root cause of the problem. - See more at: http://www.healthcarepackaging.com/trends-and-issues/regulatory/analyzing-case-new-england-compounding-center#sthash.q9B1tsZf.dpuf