TRACK AND TRACE: California's Electronic Pedigree Law Delayed to 2011: Now What?
Whether or not legislation will alter the implementation path, we should take a deep breath and get back to work.
Nosco Inc. (Gurnee, IL)
A delay for the E-Pedigree deadline means more time to prepare. Develop a technology roadmap for pharmaceuticals and biologicals.
Editor’s Note: The California State Board of Pharmacy has delayed the implementation date of the state’s electronic pedigree laws from January 1, 2009, to January 1, 2011. “The board concurs that the additional two years to January 1, 2011, is, in the language of Business and Professions Code section 4163.5, ‘require[d]’ in order to effectively implement electronic technologies to track the distribution of dangerous drugs within the state,” wrote William Powers, president, California State Board of Pharmacy, in a March 25 statement. Companies cannot slow down their programs. “The additional time will simply allow for greater development and refinement of existing technical standards and greater maturity of technologies. It will also allow some time for the board to continue its partnership work with FDA on the development of federal unique identifier standards.”
Joe Tenhagen attended the March 25 California State Board of Pharmacy meeting. He shares Nosco’s advice for moving forward.
The California State Board of Pharmacy’s decision to delay the implementation of California’s electronic pedigree law to 2011 seems to have limited impact on the pharmaceutical industry’s drive to continue preparations. Many of the drug producers I’ve talked with view the delay as an opportunity to put the right system in place rather than any shorter-term solution that might need to be replaced later. Long-term solutions range from complete retrofits of packaging lines with full data integration within ERP systems, to obtaining preserialized packaging and using off-line RFID tag and 2-D bar-code verification with limited ERP integration.
Many producers believe the correct approach is to invest in RFID as the preferred data carrier and utilize 2-D bar codes for redundancy and as an exception for biologics and other unique situations. The delay provides the time to accomplish these goals and potentially avoid additional capital later.
Wholesalers also want to remain efficient in their operations. Although they will accept item-level 2-D bar coding, Nosco has found that they strongly prefer RFID in order to remove bar coding’s line-of-sight constraint. RFID’s efficiency is promising—one wholesaler handles up to 50,000 case-shipping events per day from its largest distribution points. A fully electronic system seems necessary.
In the California State Board of Pharmacy’s motion to delay, the board cited among the main reasons the level of industry preparedness, the state of proven electronic pedigree and serialization implementation, and the potential impact on patient safety should drugs became unavailable to California patients. The board commended manufacturers and wholesalers for their progress. The board feels the delay will enable a more “measured scale-up” by producers and trading partners. Board members strongly urged continued preparation to meet the 2011 date to continue gaining knowledge of the impact of electronic pedigree and serialization on organizations through pilots and scale-up. The 2011 date also more clearly coincides with FDA’s responsibilities under the Amendment Act of 2007. FDA has already issued its requests for public comment on standards and technology.
MAKING IT HAPPEN
The industry must band together to ensure interoperability. Manufacturers must understand standards and available item-level serialization options in the market today. Now 2-D serialized codes are available at the case and item level; high-frequency, ultra-high-frequency (UHF), and UHF near-field options are available at the case and item level with proven read rates in the field.
Industry infrastructure and experts are on hand to help define and implement down to the sellable unit-level package. Look for partners with expertise in serialization implementation. They should help you determine the pros and cons of 2-D and RFID options and what a technology road map can look like for case, item, or pallet serialization.
Some larger drug makers we’ve talked with need several years to enable full compliance, including retrofitting packaging lines, adding serialization to hundreds of SKUs and millions of sellable units, and updating and integrating ERP systems (in some cases, installing an ERP system). Producers know they must accelerate, even as the California law is delayed.
Once drug makers completely realize the size of the task ahead, they regret not starting sooner. They don’t see a delay as a reason to slow down. They see it as a way to more effectively organize and implement a cohesive approach with time to collaborate with trading partners. Challenges that must be addressed up front with proven products and tested expertise include:
Technical infrastructure. From light to full integration of e-pedigree and serialization data into their enterprise business systems (such as SAP), manufacturers can evolve to and beyond compliance. Drug makers can realize ROI in inventory management, track-and-trace programs, and forward and reverse logistics.
Line capabilities. Infrastructure architects must take note of other concerns. Consider the impact on packaging lines to serialize and validate products, capture data, and distribute both to electronic pedigree software and the enterprise without significant loss of line efficiencies. Evaluate benefits and trade-offs between in-line serializations versus receiving certified preserialized products.
Alternatives. Firms must identify, test, and implement alternate serialization methods to meet specific packaging configurations and biologics.
Training. It is necessary to scale up and train personnel and provide resources for full-blown integration within the operation.
Keep working on infrastructure and launching pilots, and gain as much expertise from those that may be farther down the path. The industry is preparing to scale up. Expertise, capacity, and other resources are becoming strained.
Nosco offers preserialized 2-D bar codes and RFID-enabled printed packaging with data certification produced under cGMP/ QSR-based processes.