Compounding Problems at Pharmacies – Time For a Product Serialization Solution?

You have probably read about the current pharmacy disaster in the USA with people getting sick and dying from meningitis caused by tainted spinal steroid injections. The difficulty of diagnosing the illness likely means that the problem resembles the tip of an iceberg – it is getting worse by the day – the Wall Street Journal (as of Oct 9) states that "as many as 13,000 patients may have been exposed to fungal meningitis" quickly followed by the predictable legislator call for "bringing certain specialized pharmacies under greater regulatory scrutiny." The slow response by the CDC and other authorities doesn't suggest that even more bureaucracy will help this supply chain.

As background, fungal meningitis (or any form of meningitis) is deadly serious. Well over 100 people are currently known to have contracted the illness and more than 10 have already died from a quality control problem. What is really unacceptable is that it took three months for the problem to work its way through the system before it was discovered.

As the current product disaster continues to snowball with deaths and headlines piling up, it is getting clearer that the traceability initiatives waiting around the corner (e.g. California's e-pedigree law, and GTIN or Global Trade Item Numbers – ref UPC, UCC and EAN codes) should be embraced rather than avoided. 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 turn around the Tylenol poisoning (aka Chicago Tylenol murders) disaster in 1982 – at a retail value of $100MM in 1982 dollars. The lawsuits that are bound to follow the meningitis infections and deaths are almost guaranteed to bankrupt the firms involved, unless the bureaucrats get to it first.

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 technology solutions that address traceability – with specific mentions of several providers that have operational solutions that target this area. Solutions that are available now. The article also looks at the broader business case and how an ROI calculation goes beyond the immediate product area – several additional use case scenarios to consider are included.

We close with recommendations around next steps for those in pharmaceutical supply chain management – as well as other procurement professionals touching discrete products that can cause end user injuries, are susceptible to recalls, or exposed to manufacturing fraud or theft. In other words, this problem reaches far beyond compounding pharmacies.

- Thomas Kase

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