Drugs and ePedigree: Does California
Portend a Coming Trend?

By R. Craig Curran

The California Board of Pharmacy has targeted January of 2009 for all prescription drugs entering the state to feature track-and-trace capabilities on their packaging. Known as the California ePedigree law, there often seem to be more questions than answers regarding compliance. The path to readiness is complex and can be overwhelming to even the most enthusiastic advocate.

As an industry, the pharmaceutical market has both a challenge and an opportunity. The challenge is to create pedigrees and mass serialize all prescription drugs. The opportunity is to provide our country with a much stronger level of patient safety and our companies with an improved supply chain, brand protection, and perhaps, at the end of the day, an ROI on the time and money invested in the process. Examining a few questions should provide a road map process to determine how to start the journey.

What is the timing for implementation of mass serialization?

The California ePedigree law, requiring mass serialization, goes into effect January 1, 2009. The wholesalers would like to have product in their system by July 2008. This does not leave much time. Even if California provides some extension, the outlook for serialization at the state and federal level is quite strong. We are all better off to get going now, learning about the technology and how to deploy it in the pharmaceutical supply chain. This doesn't mean we need to do it on each and every packaging line, nor does it mean we need to use RFID on every pharmaceutical product. What we can do is select a line or a brand and get started. Learn the RFID process and see what the benefits are to serialization for the pharmaceutical industry. More and more pilots and production have started in the last few months and activity is moving forward now quickly.

Should we use RFID or 2D?

Let's get right to a core question and something that should be answered very early in the process. RFID and 2D variable data matrix codes are both capable of providing mass serialization on pharmaceutical packaging. In fact, many pharma companies may well begin with 2D and progress towards RFID. In fact, some companies where biologics, eye care products, inhalants, and injectables are involved may determine that 2D is the best choice. In the end, though, RFID has to be given serious consideration. RFID is the only non-line-of-sight technology. For the marketplace to mass serialize the billions of products prescribed each year, using a technology that must be scanned in a line-of-sight environment is not practical. In fact, key wholesalers like Cardinal, Amerisource Bergen, and McKesson all support RFID and are working to install the systems necessary to use the technology in their distribution chain. At the present, there is about an equal number of RFID and 2D pilots and/or production beginning.

Should we deploy serialization on cartons or labels?

Both cartons and labels can accept an RFID tag or a 2D data matrix barcode. Determining which one to use is pharmaceutical manufacturer dependent. Much depends on the product and the packaging line. For instance, those products that are liquid and packaged in plastic may want to put an RFID tag on the carton, instead of the label. Other products may not even be packaged with a carton, thus requiring the RFID tag to be put under the label. Although the pharmaceutical industry started with most applications in a label format there are now numerous projects evolving where the RFID tag will be put in the carton.

What about encoding the RFID tag?

Several issues must be considered here. First, who should encode the EPC in the RFID tag? This can be done pre-serialized, meaning the RFID tags come from the packaging supplier already written with agreed upon data. Encoding can also be done on the packaging line. This is termed in-line serialization. Once again, you will find benefits to both, but there is less capital required and less time spent in the conversion of the packaging line to handle RFID if pre-serialized packaging is deployed. With a tight timeline of January 1, 2009, it may be prudent to consider pre-serialized packaging, at least to start. At the present, most of the new emerging applications are moving towards pre-serialized encoding of the EPC.

Is there an ROI for RFID?

This question has also been asked many times over the last few years. The truth is there may not be an ROI right at the start. However, we are starting to see real advantages in the market from the use of RFID, especially in the area of supply chain transformation. These include such important areas as inventory management, returns and credits, billing, etc. In fact, there are several closed loop RFID installations that are starting to see an ROI through the use of RFID for its supply chain benefits. As RFID is deployed for the purpose of patient safety and brand protection, with ePedigrees and mass serialization, it's highly likely that the ingenuity and expertise of those in the pharmaceutical market will find a way to make a legitimate ROI. In addition, as more pharmaceutical companies deploy the technology, it will also come down in cost, assisting in making an ROI on the technology.

What about an RFID solutions provider?

Getting started is tough and takes a great deal of time. The key for a pharmaceutical firm is to first appoint an internal team or leader to direct the ePedigree and mass serialization effort. Next, the team and/or the leader must select a solutions provider. There are many of these providers and the pharmaceutical manufacturer can manage this on their own, dealing with each of the suppliers separately. The team or leader can also choose to affiliate with a unified team which has all the necessary resources for deployment.

ePedigree and mass serialization, with either RFID or 2D, is a journey. The journey can be fun, interesting, and a learning experience. We will all look back down the road and marvel at what has changed in the pharmaceutical industry for patient safety, brand protection, and the supply chain as a whole when ePedigree and mass serialization are both fully implemented. We will have made the prescription drug supply chain more effective for our country and our companies.

R. Craig Curran is director, strategic initiatives at Nosco Inc. and he has more than 25 years of packaging experience in cartons and all forms of labels (pressure sensitive, glue applied, in-mold, beverage, etc.). Craig is a noted author on a variety of package printing topics and frequently speaks at industry trade conferences, and can be reached at ccurran@nosco.com.