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There's Always Someone to Blame

We have heard much over the past few months about the tragic outbreak of fungal meningitis blamed for sickening 620 people across the country, including 39 who have died.  The New England Compounding Center (NECC) of Framingham, Massachusetts, produced the tainted steroids leading to the public health crisis.  As often happens after a national catastrophic event, we hear one resounding question - "Who do we blame?"

NECC supplied dozens of medicines to hospitals and doctors around the country.  The company prepared and shipped bulk orders of solutions without proof of the legally required individual prescriptions.  After the meningitis outbreak, NECC recalled its products and stopped operating amid a government investigation.  Barry Cadden, its president, stopped practicing.

Sterile compounding, the process used by NECC, must be performed in very controlled settings.  After the calamity, state and federal inspectors found that NECC used non-sterile raw ingredients and operated in unsanitary conditions.  They were caught even as they pursued aggressive company expansion while under the lax oversight of the Massachusetts State Board of Pharmacy.  But, sadly, not before 39 people had died.

All evidence shows the outbreak to be directly linked to the lack of controls at NECC; however, media coverage paints pharmacy in a negative light and creates repercussions for the entire industry.  Immediately following the outbreak, emergency regulations that tighten the oversight of all compounding pharmacies were put in place.

Traditional compounding pharmacies are intended to produce custom-made drugs for individual patients.  They work to support the needs of their local communities and have been a part of the practice of pharmacy since the beginning of the profession.  Drug manufacturers, conversely, produce drugs on a large scale like NECC produced.  State boards of pharmacy oversee compounding pharmacies; the US Food and Drug Administration monitors drug manufacturers.

As a result of the crisis, Federal regulation is being considered for all compounding pharmacies.  A new bill is being pushed forward by US Representative Edward Markey (D-Mass) supporting stronger regulations.  The National Association of Chain Drug Stores is in support of FDA and state pharmacy boards working in collaboration to identify sites that violate FDA's compounding guidelines.

The National Community Pharmacists Association has a clear stance: "The proposed legislation to create new board requirements on traditional pharmacy compounding could negatively impact both patients' access to essential medications and the community pharmacists that provide them.  As currently drafted, the legislation would create new roadblocks for patients by requiring waivers for pharmacists to make medications they have been making safely and effectively for decades."

In November hearings, congressional representatives and senators began to tackle an appropriate response to the outbreak.  In general, lawmakers from both parties criticized the FDA for not doing more to prevent the catastrophe.  FDA Commissioner Margaret Hamburg, MD, proposed creating a distinction between "traditional" compounding pharmacies and "nontraditional" compounding pharmacies, which would be required to follow rules that apply to drug manufacturers.

As of December 21st, the New England Compounding Center filed for Chapter 11 bankruptcy protection, and is currently setting up funds to compensate victims and their families.  NECC is clearly to blame - not only for the loss of 39 people, but for the potential future restrictions to the average patient needing a compounded drug.

As is typical of state and federal legislation, all will suffer because of the actions of a few.  In the end, we all are forced to absorb the blame.