Herold will be participating in the panel session, "E-Pedigree by 2015 - Examining the Requirements for Compliance, The Impact on the Industry, and important Next Steps." Joining her will be Andrew Van Ostrand, vice president, policy and research, Health Industry Distributors Association; Joshua Bolin, field services senior manager, National Association of Boards of Pharmacy; and Pat Anderson, senior solution architect, TAKE Supply Chain.

Efforts to comply with California's 2015 deadline may be slow, especially given the economy. But with thefts (www.rxpatrol.com) continuing and drug traffickers expanding their interests toward prescription drugs, the state of California itself continues to wage a tough battle against counterfeiting and diversion. The DEA reports that "diversion of hydrocodone products such as Vicodin, and oxycodone products such as OxyContin, continues to be a problem in California. Primary methods of diversion being reported are illegal sale and distribution by health care professionals and workers, 'doctor shopping,' forged prescriptions, employee theft, pharmacy and in-transit theft, and the Internet."

Despite rule delays and economic struggles, efforts to secure the supply chain in California and throughout the United States must continue.

California isn’t making much electronic pedigree news these days, given the delay in its law. However, the golden state has unofficially set the current pace of federal law. According to Ron Bone, senior vice president, distribution support, at McKesson, the alignment of serialization and track and trace timelines in the Buyer-Matheson bill with those in California’s law provides industry with realistic deadlines. Bone spoke at GS1 Healthcare’s Global GS1 Healthcare Conference this month in Washington, DC.

Also noteworthy is California’s willingness to allow emerging federal requirements to preempt its own.
Interestingly, Buyer stipulates that states’ pedigree laws can’t exceed the bill’s requirements. The bill includes a provision that would minimize pedigree initiation requirements for authorized distributors of record as an interim step. Bone said the bill is planned to be reintroduced to Congress this year.  

California’s law states that 50% of a manufacturer's products must be distributed with electronic pedigrees by 2015. The remaining 50% of the manufacturer's products must comply by 2016. Wholesalers and repackagers must accept and pass e-pedigrees by July 1, 2016. And pharmacies and pharmacy distribution centers must accept e-pedigrees by July 1, 2017.
 
There is preemption language that would repeal California's provisions if federal law regarding e-pedigrees is enacted. Or, if federal standards are enacted, they would take effect in California.
 
Of course, if FDA releases its own rules with earlier deadlines, pharmaceutical manufacturers may need to revise their implementation plans. Some rumors are circulating that FDA may soon release its draft regulations (or guidance) for Unique Device Identification (UDI), but FDA remains mum. UDI is highlighted in FDA’s budget: “CDRH’s Unique Device Identification (UDI) initiative is another element of the transformation effort. Upon completion of this multi-year initiative, UDI will enable CDRH to track devices, facilitate recalls, and support inventory management during terrorist attacks or natural disasters.”
 
Some have speculated that UDI could offer clues into what FDA may decide for drugs. (See the Federal story for official word from FDA).
 
California still has work to do, too. While its law includes provisions that define drop shipments, 3PLs, repackagers, manufacturers, and grandfathering for drugs already in the supply chain, the California State Board of Pharmacy still needs to develop regulations for inference. According to its latest meeting, no action on these regulations is planned for several years.

California seems pretty happy with conceding to FDA. "We commend FDA for recognizing the vital importance of unit-level tracking," writes Kenneth H. Schell, PharmD, president, California State Board of Pharmacy (BoP). Schell comments in response to FDA’s draft guidance on Standardized Numerical Identification for Prescription Drug Packages.

"While unit-level tracking also lays the foundation for case- and pallet-level tracking, it is only where aggregate tracking is rooted in unit-level tracking that substantial security (as well as recall) functionality can be assured. In this respect, the FDA Guidance mirrors the focus of the California pedigree legislation, which requires specification to a unit level. We are gratified to see this approach implemented at the federal level."

The board seems frustrated over recent cases in which it feels that item identification could have made a difference. "As is evidenced by the recent experience with Heparin, an effective recall also depends on a serialized-to-the-unit-level drug supply, that is absent now," Schell

writes. "A secure supply chain depends on an ability to reliably track and trace drug products, to prevent infiltration of counterfeit, misbranded, and/or adulterated products."

The California BoP also wants to keep pace with progress that is being made globally. "Unit-level serialization will also bring the U.S. supply chain more in line with international standards, as it is much more the practice in other countries to have patient-level serialization (as well as packaging)," Schell writes. "It is high time that the U.S. employed a similar practice standard."

But California is standing by its old friend—RFID—even though many international markets seem to prefer Data Matrix. In 2008, then-president William Powers stated that California prefers RFID technology, and Schell echoes this sentiment. "We recommend that FDA settle on RFID tags and technology as the mandated/preferred carrier," he writes. "To do so, we hope FDA takes a leadership role in also settling the question of propriety of use of RFID tags on biologic products."

California has led the country toward pedigrees much more vigorously than FDA has. Delayed in March to January 1, 2011, California’s pending mandate for electronic pedigrees has commanded continued industry attention, given the effort needed for salable-item serialization.

However, all eyes have turned recently toward the bill introduced by Senator Mark Ridley-Thomas, referred to as “SB 1307—Pharmacy E-Pedigree” on his Web site (http://dist26.casen.govoffice.com/). The bill would allow drug manufacturers to phase in serialization for electronic drug pedigrees. A draft of the bill amended in June stated that “all drug manufacturers and repackagers are strongly encouraged to serialize drug products and initiate electronic pedigrees as soon as possible, and all participants in the supply chain are encouraged to immediately ready themselves to receive and pass electronic pedigrees.”

Mandates, however, were as follows: “Before January 1, 2011, each manufacturer of a dangerous drug to be distributed in California shall designate drugs representing a minimum of 20 percent of the drugs . . . which shall be the subject of its initial phase of compliance with the January 1, 2011. Before, January 1, 2013, each manufacturer shall designate a minimum of an additional 30 percent; [and] before January 1, 2015, each manufacturer shall designate a minimum of an additional 50 percent . . .”

The most recent draft (http://www.leginfo.ca.gov/pub/07-08/bill/sen/sb_1301-1350/sb_1307_bill_20080814_amended_asm_v94.html), however, pushes the implementation date to January 1, 2015, and beyond. Before January 1, 2015, manufacturers would designate a minimum of 50% of their dangerous drug products subject to the pedigree requirements. Before January 1, 2016, manufacturers shall designate the remaining 50%. After July 1, 2016, a wholesaler or repackager would be prohibited from selling, trading, or transferring a dangerous drug without a pedigree; after July 1, 2017, a pharmacy would be prohibited from doing the same.

For his latest draft, Senator Ridley-Thomas reportedly sought input from a wide body of stakeholders. The State Board of Pharmacy supports SB 1307’s most recent amendments. Other supporters include the Healthcare Distribution Management Association as well as several major drug manufacturers (Pfizer, J&J, Bayer, etc.), pharmacists (the California Pharmacists Association and California Society of Health-System Pharmacists), and large distributors (Cardinal and McKesson).

If the bill passes the California Senate this month, it will make its way to California Governor Arnold Schwarzenegger. The governor will have until sometime in September to approve or veto the legislation. If vetoed, the deadline for electronic pedigrees will remain at January 1, 2011.

Predicting the bill’s outcome in the governor’s hands is difficult, however, given his administration's proposed (cut) amendments to the bill in May. These amendments spoke of an “accredited distribution chain” for drugs and required electronic pedigrees only from unaccredited distribution-chain entities by January 1, 2011 in an effort to limit costs passed to consumers and better target the counterfeit market. The CA BoP would have been charged with developing the standards for such accreditation. Amanda Fulkerson, spokeswoman for the Agency said the California State and Consumer Services Agency (SCSA) had said that the accredited supply chain model would have been a more reasonable program that could have been met by 2011. “We fail to see how continuing to delay [electronic pedigree rules] protects patients,” sources said in late July. Legislating pedigrees and serialization is a “federal responsibility, and we strongly urge the federal government to move forward.”

When asked about the latest amendments, SCSA said it was still reviewing them hoped a strong consumer protection component was added.

With potentially six-plus years to electronic pedigrees, should drug manufacturers refocus their efforts and delay serialization? Definitely not, says Virginia Herold, executive officer on the California State Board of Pharmacy’s electronic pedigree enforcement committee. She says that “everyone in the supply chain would like to see electronic pedigrees in place sooner, but we recognize the complexities. We hope that companies will continue to move forward with their pilots, especially those who would have been on track to comply with the 2011 deadline.”

She adds that the federal model for unique identification and track and trace will take precedence over any California law. FDA is charged with developing standards for unique identifiers by March 2010.

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