Doc Or Die

An e-pedigree is an electronic, auditable chain-of-custody record for pharmaceuticals from the point of manufacture to the point of sale. Paper-based pedigrees have been required since the passage of the Federal Prescription Drug Marketing Act of 1987 (PDMA). Although the FDA requirements for e-pedigree are stalled in federal court, individual states have moved forward with enacting their own legislation for compliance.

California has spearheaded the effort by passing new laws expanding the state standards. Effective January 1, 2009, all pedigrees will be required to include a serialization number. While products are currently identified on a general level by manufacturing lot numbers, the serialization number is unique to the item-level (shipping pallet of aspirin vs. each individual bottle). This is presenting companies with new challenges in maintaining a valid pedigree as the products are transported through the supply chain. Given California's large market size, this legislation may set a precedent for other areas of the nation.

D -- data types and document types

California is requiring each saleable unit to be identified with a unique serial number. Products are currently identified by the pallet-load using the manufacturing lot number, date, and purchase order information.

O -- organizational transactions and processes

The entire supply chain is affected by this change. Each saleable unit must be identified and recorded at every stage as it moves from the supplier to the customer.

C -- context

All pharmaceutical products for sale in California are affected. Companies may choose to adopt the processes developed for all products, regardless of their destination.

U -- user types and special user requirements

Manufacturers must generate serial numbers and make each unit identifiable by any entity which will accept custody of the pharmaceuticals. The California legislation does not specify the exact form of the electronic record or the technology so the data may be stored in RFID, barcodes, or other formats.

M -- models, patterns, or standards that apply or that are needed

One possible solution is to utilize a Global Trade Identification Number (GTIN) mapped into a 96-bit encodable EPC ID number. The global standard developed by EPCglobal, ratified January 5, 2007 contains two XML schemas available: the electronic pedigree format for use with open document-based pedigree laws and the standard electronic envelope format for use in document exchange between supply chain partners.

E -- enterprises and eco systems

EPCglobal is a non-profit consortium developing standards for Electronic Product Codes.

N -- the needs (business case) driving the enterprise(s)

California has mandated January 1, 2009 compliance; companies not in compliance must leave the market. FDA mandated requirements are on hold due to pending lawsuits.

T -- technology constraints and opportunities

Besides compliance with California law, companies will have the opportunity of improving their SCM with increased visibility, velocity of data, and business intelligence. Companies can also benefit during product recalls by returning only the affected units instead of returning a seller's entire inventory.

The California deadline may be pushed back to allow companies more time to implement the new processes. There are numerous technological hurdles including capturing the serial numbers at each point in the supply chain and modifying current systems to record the data.

Yu-Tin

# posted by Document Engineering Student @ 6:50 AM