Quality Outbreak

For my blog post I will discuss some quality issues related to the specialized pharmacies industry. The recent outbreak of meningitis and the growing number of deaths caused by contaminated steroid shots has been an obvious point for concern and improvement. Pharmaceuticals is an industry which needs to be consistent in every product they produce and really have no room for error. I feel using a Six sigma approach to quality would have avoided this situation in Massachusetts with the New England Compounding Center, the company accused of producing the tainted shots.

According to the Wall Street Journal article I read, titled “Meningitis Deaths Increase. Meningitis is an inflammation or infection of the protective membranes of the brain and spine (Dooren, 2012).”  http://online.wsj.com/article/SB10000872396390443294904578050854190916648.html?KEYWORDS=meningitis This outbreak could affect over 14,000 people and NECC is already linked to over 20 deaths caused by fungal meningitis due to contaminated shots.

The article goes on to discuss the FDA’s and CDC’s need for further regulation on the specialized pharmacies like these compounding centers. I feel using a six sigma approach to production to ensure no more than 3.4 defects per million operations. This approach to quality, while financially driven, is an excellent way to eliminate waste and improve core processes.

I’m sure if NECC was implementing a DMAIC process, they would be able to address the root cause of defects and remove the cause of defects, then further down the line control and maintain quality. However it appears NECC was not concerned with managing their quality and now could face criminal charges.

What is surprising to me is a medical company would not have stricter policies on sterile areas and managing quality of the product. A six sigma approach seems necessary for a company making drugs. According to recent reports, investigators found unclean conditions including visible black specks of fungus in steroids in what was supposed to be a sterile room.

Since the outbreak, Governor Patrick of Massachusetts has moved to revoke the licenses of the New England Compounding Center. Governor Patrick has also ordered the state pharmacy board to conduct surprise inspections and take more steps to better managing quality.

Another interesting point I found out was the company operated as a drug manufacturer by making drugs for wider use, rather than filling out patient specific prescriptions for specific doctors, which is all its license allowed.

So not only were they misusing their production means, they were also creating defective products the whole time. Situations like this show the critical need to use to better quality management practices throughout our society; healthcare and medicine especially, but also with everything really. No consumer expects to receive a faultily product.

So what can be done? Well I think hospitals can protect themselves by creating and controlling their own quality control standards for the medicine and equipment they use. Just in case something slips by the manufacturer, there will be a second line of defense to find the defect.