Monday, February 5, 2018

A precursor of what's to come? Barcode issues are only the start...

GS1 US recently released a telling article about the current state of barcoding for DSCSA compliance (Link).  A great review and opinion from Dirk Rodgers was also released on Monday.  A highly suggested read (Link).

The crux of the study is that approx. 6.6% of all serialized barcodes evaluated by two of the largest wholesalers met expected quality requirements and DSCSA compliance.  The results of this barcoding survey, in my opinion, are staggering to say the least.   

Let's put this in perspective- imagine if the results had come back that 50% of the barcodes did not meet DSCSA compliance?   If these results held true, that means that in just 10 short months half of all products distributed in the US should be set aside for non-compliance.  That would be catastrophic to the industry.

So that fact that only 6.6% of barcodes evaluated met two of the largest wholesaler's expectations for quality and DSCSA compliance isnt just staggering- it should be a signal to the entire industry that the traditional ways of approaching serialization simply are not working. 

But what may be more interesting is-  How does the pharma industry view these survey results?   I'd love to think the majority of the industry is gravely concerned.  My fear is most are not.  My fear is many take a position of either:  A) I don't care,  B) That can't possibly apply to me because I use all of the 'leading' vendors or C) If that many are non-compliant then I'm probably in the same boat as everyone else and therefore don't need to worry about it.

It would generally be 'easy' to pin the blame for these results on CMOs/packaging sites- but doing so would miss the mark.  Non-compliance of this magnitude indicates a failure at multiple levels- this is an issue with both business and technical involvement, regulatory interpretation, requirements gathering, GS1 Standards education and, certainly, execution.    I have no doubt the majority of these implementations were fully tested/validated- which means these implementations were doomed for failure before they even started because they were being tested/validated against requirements which were already non-compliant.    

Part of this blame certainly goes back on vendors who are depended upon to be experts in this space.  Vendors at all levels should be able to recognize the issues that led to 6.6% compliance- that's not situational failure, that's systematic failure.  Even enterprise vendors, where most of my experience is rooted, are subject.  If your enterprise vendor didn't recognize these issues-  red flag.

But vendors can't be the only ones in the cross-hairs.  Whether the industry wants to admit it or not there has long been a mentality towards serialization to do as little as possible, as fast as possible for as cheap as possible.   This can't be ignored as a contributing factor.   A lack of necessary oversight and attention to detail has put the industry in the current situation and the scariest part might be- how many companies don't even know they have issues or are led to believe everything is 'OK'?

We now have a clear indicator of how well that mentality is working out for the industry.  And (sorry for the doom-and-gloom) my estimate is its only going to get worse when the focus shifts from barcoding to serialization data.   

The results from the GS1 survey are more likely to be a telling indicator rather than an unexpected blip on the industry's march towards serialization compliance. Where we go from here is in the hands of the industry-  the documentation, tools and services exist to help pharma companies get this 'right'.   Whether the industry chooses to pay attention and take the necessary steps remains to be seen.    

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