Originally Published PMPN February 2005
Track & Trace
Bringing It All Together
Today's technologies need to be closely aligned with
industry standards and regulations.
Todd Warden,
Vice President of Business Development
Markem Corp.
 |
| Todd Warden |
New technologies such as radio-frequency identification (RFID) and traceability software, combined with emerging data standards like the electronic product code (EPC) and bar code symbologies like reduced-space symbology (RSS), composite, and data matrix, are intricately tied to new FDA regulations and guidelines for unit-dose bar codes and RFID, as well as to several emerging state pedigree laws.
Industry is rapidly pushing forward to create a brand-new vision for a modern and upgraded healthcare delivery system around the world. The focus is to increase patient safety, product integrity, and operational efficiency throughout the supply chain, and as a result address significant issues plaguing the industry today. Those issues include medication errors, counterfeiting, shortages, reimportation, and the overall skyrocketing costs of healthcare.
Technology
RFID technology is not new, but it is a new concept when applied to the supply chain and is still emerging from a technology development and practical implementation perspective. The benefit of using this technology is that it can provide granular product information in a highly automated way, without requiring line-of-sight interrogation (like a bar code requires). Thus, RFID reduces human error, provides high-speed readability, and provides the potential for information written to and read from an RFID tag.
Specifically, the focus of this new RFID technology has been on the ultra-high-frequency (UHF) spectrum (860–930 MHz), although there is still discussion within the pharmaceutical industry as to whether the high-frequency (HF) spectrum (13.56 MHz) will have a role. This debate is largely driven by whether there will be interference issues or conflicts within the hospital setting, but by and large it appears that UHF will be the standard technology for tracking products throughout most of the supply chain.
In conjunction with this new enabling technology, there is a growing portfolio of traceability software products that can now gather, associate, and integrate information about products to provide capabilities to track and trace the path of products throughout the supply chain. This includes going all the way back to the specific raw materials that are associated with a particular batch of product, (where, when, and who produced it), through individual product packaging (with a unique serial number), and further association to a packed case and shipped pallet. One can imagine how powerful this information might become, especially in the case of a product recall where a specific batch may have been tainted.
These new technology developments are further strengthened by leveraging the entire existing software infrastructure that has been put into place over the past decade. Millions of dollars have been spent deploying enterprise resource planning (ERP) systems, warehouse management systems (WMS), and supply chain management (SCM) platforms. RFID technology will provide highly automated granular information that will be collected, hierarchically associated, and then integrated back into these systems to illuminate the supply chain from end to end and provide a level of visibility only previously imagined.
Regulations
While the regulatory environment has always had a major impact on the pharmaceutical industry, 2004 saw some significant findings that will greatly impact the supply chain. In March, FDA passed a regulation requiring the addition of bar codes on all unit-dose-level packaging. All drugs must have their NDC encoded in a linear bar code by April 2006. This will identify the labeler/vendor, product, and package size, and will be represented as a 10-digit bar code. This is clearly a first step toward providing a greater amount of product information and enabling a more visible supply chain as a means of ensuring greater patient safety.
In addition, FDA published new RFID guidelines in November 2004. These guidelines clearly indicate the direction that FDA is heading. The agency believes that by 2007, RFID technology can feasibly be deployed and that it will provide the best protection as a standard underlying technology for track-and-trace to combat counterfeiting. The timeline indicates that during 2005 it will focus on the mass serialization of cases and pallets for products most likely to be counterfeited with some tagging and use of RFID technology. By 2007, the year will end with virtually all packages being mass serialized and RFID technology being used and widely deployed across the entire supply chain, including all manufacturers, wholesalers, hospitals, and retailers.
Other Mandates
Additionally, some state laws are also having an impact. The Florida Pedigree Law (effective July 1, 2006) will require a pedigree paper for any given drug that documents the distribution of the product from a pharmaceutical manufacturer all the way through to the final sale by a pharmacy or other person administering or dispensing the drug (including wholesalers and repackagers). Several other states are considering similar laws, as concerns about supply chain integrity and safety have escalated.
There are also other mandates that should not be overlooked. These include those imposed by retailers (Wal-Mart, Target, etc.), food distributors (Albertsons, Tesco, etc.), and the U.S. Department of Defense to adopt RFID technologies which will also impact manufacturers, as these are major outlets for many pharmaceutical industry products.
Data Standards
Many have conceptually linked RFID and the EPC together, but they are separate developments. While RFID technology will use the EPC to store information in a standard way, the EPC is really the next evolution of the UPC (Universal Product Code, which uses 14 digits) that is so ubiquitous today. The EPC will add the additional capability of serialization and will be able to store 96 bits of information, effectively providing a unique number.
Alongside the development of the EPC, there are new bar code symbologies emerging to extend current capabilities and standards and perhaps provide a bridge to RFID technology. RSS and data matrix are the two most promising.
RSS is a linear symbol that enables use on smaller areas (i.e., in response to unit-of-dose regulations for blister packs and small packages). Data matrix is a 2-D symbology utilizing an ISO standard that allows encoding a large amount of information into a small space. Lastly, composite codes combine RSS linear technology with 2-D data matrix to provide both static and variable information (like lot and date codes) to cover a wider range of needs.
Standard Body
Collaboration
Perhaps one of the most encouraging developments in this area is the collaboration of the standard-setting bodies to truly define global standards. The Uniform Code Council (UCC) and EAN have now taken over leadership of EPC Global for the development of RFID standards as it has transitioned from the Auto-ID Center at Massachusetts Institute of Technology (MIT; Boston).
EPC Global is also taking steps to ensure that its emerging standards and protocols are consistent with other bodies like ISO. All of these activities will come together to create, it is hoped, one set of standards and protocols which will enable the entire industry to invest without the fear or expense of needing to support multiple standards.
What does it all mean?
The primary motivating factor behind the adoption of these technologies, regulations, and data standards is the ability to provide better patient safety and security of our drug supply in general. A major overhaul of the supply chain and deployment of new and modern technology would address a host of other issues plaguing the industry.
While tightly linked to safety, counterfeiting also has major business ramifications for those manufacturers most affected by this activity. It is estimated to be a $10 billion–plus per year problem and is now affecting close to an estimated 4% of the total drug supply globally. Operational efficiency should be dramatically increased with these new technologies and standards and, as a result, help decrease drug shortages and reduce costs in general.
The skyrocketing costs of healthcare in the United States have brought the cost of drugs into focus and garnered a great deal of media attention. A more-effective supply chain will enable smoother and less-costly recalls, which often cause irreparable damage to the brands that pharmaceutical companies are now spending so much time and money developing.
There are more than enough reasons for industry to respond to impending regulatory changes by adopting these new technologies and emerging standards. They will provide more-satisfied customers and improved productivity, leading to better profits in the long term.
Copyright ©2005 Pharmaceutical & Medical Packaging News
