ePedigree: Using the Gift of Time Wisely

The year 2011 may seem far off, but there is much to do to prepare for electronic pedigrees.
Jul 02, 2008


Arvindh Balakrishnan
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.


RUPERT KING/GETTY IMAGES
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.