Healthcare Matters

Thanks to Thomas Kase of the Spend Matters Advisory Group for the following guest post:

By now, most of you have read about the current pharmacy disaster in the U.S. with people getting sick and dying from meningitis caused by tainted spinal steroid injections. The difficulty the CDC had in identifying, tracking and diagnosing the root cause of a problem that is killing people usually means we’re seeing just the tip of an iceberg – as the news is getting worse. Yesterday, the Wall Street Journal (Oct 9) stated that “as many as 13,000 patients may have been exposed to fungal meningitis.” And naturally, the news is being followed by the predictable call for congress to “bring certain specialized pharmacies under greater regulatory scrutiny.” Would more bureaucracy and regulatory oversight have prevented this supply chain problem?

As background – fungal meningitis – or any form of meningitis – is deadly serious. Well over 100 people are now known to have contracted the current strain and more than 10 have already died. And despite that, plus the fact that we’re dealing with what is essentially nothing more than a quality control problem, it took a full 3 months before the problem became visible.

As the current product disaster continues to snowball with deaths and more headlines piling up, it should be frustratingly clear that the traceability initiatives that have been sitting idle awaiting enactment (e.g. California’s e-pedigree law, and GTIN or Global Trade Item Numbers – ref UPC, UCC and EAN codes) should be quickly implemented rather than further debated. As a reference for those who have forgotten, Johnson & Johnson had to recall all Tylenol products nationwide almost exactly 30 years ago (in 1982) to deal with the Tylenol poisoning disaster in 1982 (aka Chicago Tylenol murders)  – at a cost of $100MM in 1982 dollars. Just imagine the lawsuits that are getting teed up at the moment. This current disaster will most assuredly bankrupt the firms involved –companies that have resisted track and trace solution investments, perhaps for good reason?

The Spend Matters PRO analysis Deadly Meningitis Outbreak – Time to Roll Out a Product Serialization Solution for Pharmacy Compounding Centers? looks deeper at how this tragedy is likely to accelerate adoption of solutions that address traceability – with specific mention of several technology vendors that already have proven track and trace solutions. The article also looks at the broader business case and how ROI should be calculated when investigating/justifying the requisite investments.

In addition, recommendations around next steps for those in pharmaceutical supply chain management are provided along with advice for procurement professionals who, in fact, do get close enough to this supply chain to share accountability. In other words, this problem reaches far beyond compounding pharmacy operations.

Check out the paper on Spend Matters Pro!

—Tom Finn