As Paul Faber pointed out in his recent blog post, Walmart will soon begin applying removable RFID tags to individual items to improve inventory control and visibility inside stores. The theory is that tagging individual articles should reduce stock outs, shrinkage, and misplaced inventory while increasing labor productivity and shelf availability. 

This move toward item-level tagging may very well help push RFID to the next level in the supply chain world. I have long seen the retail store floor as being a key factor in the technology’s adoption. But I also believe that product authentication is another key driver in making the case for RFID. The vision for its role is well delineated by GS1 and its affiliate EPCGlobal.  

This vision is based on assigning a serial number at manufacturing or packaging to each item or sellable unit. This serial number must be unique across the global supply chain. It is stored in a data repository that can be updated as the item changes hands throughout the supply chain. Anyone taking custody of the item would be able to query the serial number against the repository to see if the item is registered or if there is anything suspicious about its history. This vision needs a physical data carrier to accompany each item that can store rather lengthy item-level serial numbers and be easily read throughout the supply chain.  RFID tags are a good fit for this role.

This type of authentication should help reduce counterfeiting, theft, and fraud, which are a bane to many industries. But there are few places where combating this pestilence matters more than in the pharmaceutical industry – an industry that definitely could benefit from higher visibility and security. I’ve seen estimates on worldwide annual industry losses due to counterfeit drugs as high as $75B. 

Safety is another key concern, as counterfeiting impacts the content and potency of delivered product. Mass serialization at the sellable unit level has been positioned as a tool for product authentication by legislation, regulations, and industry and standards organizations.

Brazil and Turkey are currently in the process of deploying pharmaceutical product authentication through mass serialization. Various European countries have piloted similar programs utilizing a ‘book-end’ approach with a single commissioning and authentication event. The latter occurs at the hospital or pharmacy. 

In the US, states have been addressing the problem through ePedigree laws and regulations, which focus on tracking the chain of custody. California’s ePedigree requirements – due to go into effect in 2015 – require serialization at the sellable unit level. Given the effort required to be compliant, many pharmaceutical manufacturers are already pursuing solutions to support these requirements.

RFID is not the only data carrier capable of supporting a global standard for serialization at the unit level. High density or 2-D barcodes can also be used for mass serialization. Brazil’s and Turkey’s requirements are based on GS1 DataMatrix bar code symbology. Europe also appears to be embracing the DataMatrix bar code as the foundation for pharmaceutical product authentication. 

And I have a feeling that most US-based manufacturers and distributors are looking toward 2-D bar codes rather than RFID tags as the vehicle to meet serialized ePedigree requirements.

There are certainly RFID success stories in the pharmaceutical industry. But when 2015 finally arrives, I wonder if it will still be more of a niche player in pharma than a mainstream auto-id technology. 

In a high-margin industry, a $.08 to $.10 passive tag on each sellable package shouldn’t matter that much. So I find the limited enthusiasm for RFID in pharma somewhat perplexing, especially since it provides advantages over 2-D bar codes that go beyond regulatory requirements. But I appreciate performance concerns and challenges. 

More importantly, we tend to look at RFID’s cost purely from a tag perspective. Infrastructure must also be taken into account. Image scanners and cameras are much more commonplace in the supply chain than RFID readers and software.

I’m still a believer in RFID. I think the ‘Internet of things’ will have a major impact upon the supply chain. But I’m not sure the RFID adoption rate will be going into overdrive anytime soon. I think that RFID still remains more of an evolutionary proposition than a radical transformation agent within the supply chain world – at least for the time being.

-- Tom

Additional Resources:

Documenting Distribution Operations: FDA Validation Beyond the Laboratory and Manufacturing Facility (White Paper)
http://www.tompkinsinc.com/publications/monograph/white-papers/fda.asp