Epedigree in the Pharmaceutical Supply Chain - Pharmaceutical Technology

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Epedigree in the Pharmaceutical Supply Chain
The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.

Pharmaceutical Technology

For these reasons, the board sees RFID as more readily adaptable. RFID technology would "permit mass serialization and item-level track and trace of drug products throughout the US supply chain without requiring either: a significant disruption of present practices and a dramatic increase in processing times due to the opening of every case or container; or interference on such a large scale that mass serialization/item-level tracking mandates lose much of their salience," said the board (3).

RFID may have other advantages such as the extensibility of RFID (EPC) tags for optimizing capabilities such as by adding extra data to the tag, adding sensors for temperature, pressure, light, allowing for the distinctions between "active" (smart) and "passive" (dumb) tags, and permitting a variety of frequencies, read ranges, and sizes to be used. The board noted that there are already marketable products that incorporate RFID tags into or under labels and into or under packaging materials (3).

In addition to California, Florida enacted its own electronic pedigree requirements in 2006 that duplicate the paper-based records within an EDI (electronic data interchange) transaction (5).

As federal and state authorities evaluate ePedigree standards and technologies, industry members point to the need to unify ePedigree requirements. "Congress should pass legislation that would enable FDA to establish industry-wide implementation dates for federal pedigree standards," said Mike Rose, vice-president of supply-chain technology at Johnson & Johnson (New Brunswick, NJ) in testimony before the US Senate Committee on the Judiciary in June 2008. "The FDA should be encouraged to work with state and international regulators to develop effective, practical pedigree and track and trace standards for the United States and globally." He added that the complexity of multiple pedigree laws may result in fraudulent or counterfeit pedigrees, which underscores the need for federal standard ePedigrees (6).

The ePedigree movement reached an important milestone in 2007 with the ratification of the EPCglobal Drug Pedigree Messaging Standard. The standard provides a data format that complies with all state and federal government regulations and allows trading partners to send and receive data in a secure, interoperable manner, using existing data-transfer technologies. The standard's security mechanisms ensure that data cannot be forged without easy detection, while interoperability provisions ensure that pedigrees are understandable by all trading partners, regardless of ePedigree vendor (7).

Proposed legislative requirements for ePedigree

As the regulatory authorities access ePedigree, Congress is also taking action. Earlier this year, Reps. Steve Buyer (R-IN) and 12 additional members of the US House of Representatives introduced a bill, "Safeguarding America's Pharmaceutical Act of 2008" (H.R. 5839) to establish federal requirements for a closed-loop, track-and-trace pedigree system using item-level serialization. The bill specifies that no state or nonfederal body can establish a pedigree system separate from the federal standards (8). As of press time, the bill had been referred to the House Committee on Energy and Commerce.

In late July, the House Committee on Energy and Commerce also issued a revised discussion draft to the Food and Drug Administration Globalization Act of 2008. The revised discussion draft provides additional requirements for quality risk-management plans and for electronic statements for the chain of supply of a drug. The purpose of the discussion draft is to be provide a basis for debate on possible legislation, which is not yet introduced. The committee issued the original discussion draft in April 2008.

The revised discussion draft proposes registered establishments that are involved in the "manufacture, preparation, propagation, compounding, or processing of a drug" to provide the HHS Secretary, upon request, "an electronic statement identifying each prior sale, purchase, or trade of the drug, including each prior sale, purchase, or trade of its ingredients and raw materials." The electronic statement would include the date of the each such prior sale, purchase, or trade, the names and addresses of all parties to each such transaction, and any other information required by the Secretary by regulation (9).

Although ePedigree requirements for pharmaceutical ingredients is now only a subject of discussion, consideration on how to electronically secure the custody of a drug earlier in the supply chain to include raw materials and other pharmaceutical ingredients is of growing importance. "In order to ensure paperless compliance throughout the pharmaceutical supply chain, manufacturers need a better way to improve business processes and maintain end-to-end visibility, enable product authentication, and ensure data integrity across all transactions," says Robert Pease, director of marketing of Hubspan (Seattle, WA), a provider of on-demand integration tools and services.


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