The recent update on the U.S. Meningitis outbreak that was sparked when tainted medication was released by the New England Compounding Center is not positive. Officials now claim that the source of contamination could be from tainted mold which can incubate for several months. This may mean more people could be affected than originally thought. More disturbing are reports by the New York Times regarding the documented history of violations at this compounding pharmacy.
The Massachusetts Department of Health released hundreds of pages of documents on Monday detailing the violations at the NECC which date back as early as April 1999. Noteworthy, the company only began compounding drugs less than one year earlier. Essentially that means for almost the entire span of this company’s existence, they have not been fully in compliance. As we try to move forward and learn lessons from this, the urgent question then becomes: why is it that the company was shut down only after people died 13 years later? The number of meningitis outbreaks has now risen to 300. The death toll climbed to 23 just yesterday and is expected to rise.
The documents released by state officials, are more than revealing in terms of the flagrant violations happening at the pharmacy. Cited violations include: allowing doctors’ offices—repeatedly–to fax orders for medicine without specific patients’ names, prohibited by state law; not providing data on medicines’ expiration dates—repeatedly. These violations wereeventually corrected but it begs the question why allow repeated violations, ever? Wouldn’t officials recognize that if the same mistakes had to be corrected several times, it implies serious mismanagement within the pharmacy?
The documents were released by the Massachusetts officials in an effort to appease the press who is righteously asking a lot of questions right now in the wave of this wide-spread panic. The reports do provide some insight into repeated attempts to crack down on violations as well as the company’s efforts to correct them. The pharmacy, now shut down, issued this statement: “New England Compounding Center worked cooperatively with the Massachusetts Board of Registration in Pharmacy to resolve to the board’s satisfaction any issues brought to the company’s attention.”
Let’s assume that state officials were acting with exceptional care in the monitoring of the NECC. Then one wonders why when the NECC was inspected at least three times in 2004 and cited for a variety of violations, was it not shut down then? If we are to interpret—and it’s only an interpretation at this point since we don’t have access to the records from A-Z—the records indicate a lawyer for the company had pleaded for lenience. He stated that if disciplinary actions were imposed, the consequences “would be fatal to the business.” But, again in January 2006, the company and the Massachusetts Board of Registration in Pharmacy signed a consent agreement where its chief pharmacist and co-owner, Barry J. Cadden, agreed to one year’s probation. The board then agreed to delay the start of probation for one year pending two more inspections which would allow time for improvement. An outside auditor was then assigned to assure progress was made. A few months later the state-appointed inspector said the center had made progress. But, it does not appear that the center was ever placed on probation.
Certainly no one wants to see a company go bankrupt. But if states cannot handle the large workload that the monitoring of pharmacies requires—specifically compounding centers that are not subject to FDA guidelines—shouldn’t we find another method? Will it come to a point where patients must be assigned patient advocates for every drug administered from a compounding center to warn of potential associated risks?
Obviously, change has to happen at some level. If the FDA drags its feet on urgent system-wide reform, it’s likely consumers and patients will take matters into their own hands-by avoiding compounding pharmacies . Then it’s fairly likely these pharmacies will go out of business, without ever getting the benefit of a “probation” period.