Arvindh Balakrishnan
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Electronic pedigree (ePedigree) is still coming to California, just not as soon as expected. Many in the industry breathed
a sigh of relief earlier this spring when the California Board of Pharmacy voted to delay for another two years (until Jan.
1, 2011) implementation of ePedigree requirements for tracking drugs from the manufacturer to the pharmacy. Although many
in the industry view this extra time as a gift, the delay should not signal a halt to planning. Instead, the industry should
view it as a new opportunity for regulators, distributors, manufacturers, and information technology (IT) vendors to get it
right.
The California ePedigree initiative, which will require all prescription drugs to be electronically tagged and tracked from
the manufacturer to the pharmacy, holds the potential to significantly reduce the possibility of counterfeit prescription
drugs. As all stakeholders in the process agree, success in this complex initiative will require creative and committed cooperation
on the part of all involved parties.
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IT is at the core of the initiative. Even though most pharmaceutical manufacturers are well into their ePedigree planning
process, nearly all have been reluctant or unable to execute their programs because of unanswered questions related to policy,
procedures, and technology. The way in which these significant remaining issues are resolved will shape the types of solutions
needed to ensure ePedigree compliance.
Grandfathering
How will the California board and industry address what to do with prescription drugs in the distribution pipeline as of Jan.
1, 2011? Hospitals and retailers risk spending millions of dollars replacing drugs on the shelf shipped to California before
the 2011 deadline. As such, the board is considering grandfathering as a viable solution. Grandfathering would permit transfers
without pedigree documentation for drugs transferred or acquired before the effective date of the law. The board is also reviewing
comments from industry regarding the possibility of a phased approach, which would allow manufacturers to rate their drugs
based on the risk for counterfeiting; those drugs at the highest risk would be integrated into the process first.
Inference
The California law requires that drugs be tracked at the bottle/package level. However, managing the serial number for every
individual bottle and the ePedigree associated with that bottle could be unwieldy. To improve efficiency, several pharmaceutical
organizations have suggested incorporating inference (a managed-risk business process) into the drug serialization and ePedigree
process. For example, if a manufacturer places 63 bottles of serialized bottles in a box and ships them to a distributor,
the recipient will "infer" the serial numbers being received into the system without manually scanning each individual bottle
(they would only scan the barcode on the box, or use a single radio frequency identifcation [RFID] scan at the box level).
To support this approach, the California board is considering the possibility of license-plating packages and pallets, allowing
ePedigree information, instead of individual bottles, to move with the licensed-plated shipments through the distribution
channel.
Auditing
Hand-in-hand with inference, the board must also define an audit strategy to determine which pharmacies, manufacturing and
packaging organizations, distributors, and suppliers it should audit and how often. The board also must decide whether there
should be a standard audit procedure or whether organizations with previous infractions should face more frequent audits.
The California board and other likeminded bodies must develop an efficient, manageable process that helps organizations comply
with audit procedures and ensure safety, without inflicting cumbersome tasks that could potentially interfere with productivity.
