The World Health Organization (WHO) estimates that 7-10% of all drugs sold worldwide each year are counterfeit. In addition, the Organization for Economic Co-operation and Development counted more that 1,700 pharmaceutical product security incidents last year due to counterfeiting, diversion, and theft. In today's complex supply chain that includes manufacturers; a tangled web of distributors and wholesalers; plus pharmacies, hospitals, and clinics, there is ample opportunity for malfeasance to occur, and for counterfeits to enter the market -- and ultimately, consumers' bodies. Add in the increased energy in globalization programs and the risks ratchet up. When safety assumptions go wrong, the results can be devastating, such as the death of at least 81 Americans from taking counterfeited Heparin, a blood thinner.

According to the U.S. Department of Health and Human Services, at least half of all Americans take at least one prescription drug, with one in six taking three or more medications. It's assumed by consumers that when their local pharmacist, hospital, pharmacy or other caregiver hands them their bottle of pills, what's in the bottle is what is supposed to be in the bottle and it is safe for human consumption. But can we be sure?

Proven solutions to safeguard the drug supply through electronic pedigrees-a documented and complete history of a given product's chain of custody, from the manufacturer to the point of dispensing-are available today and in use across the United States, selectively. Yet, delays in government action to arrive at a unified drug pedigree mandate limit their adoption and are dangerously increasing the risk that counterfeits in the drug supply chain could directly affect unsuspecting patients. The result is that companies who are concerned about patient safety and look to electronic pedigrees as a cornerstone in their efforts to enhance product security are left to blaze their own trail in the hopes of protecting patients.

e-Pedigrees: Systemic Security Protection and Foundation for Value Creation

Electronic pedigrees provide a comprehensive set of tools to bear on securing the legitimate supply chain. Product information such as NDC, lot number, and expiration date are gathered from the original manufacturing process and then securely linked to extensive transaction detail about the changes of possession that a drug undergoes from manufacture to final dispensation. If serialized products are shipped, these serial numbers are also incorporated into the pedigree. As a result, the e-Pedigree secures the chain of custody, preventing phony transactions and products from getting into or remaining in the legitimate supply chain.

This comprehensive nature of electronic pedigree truly provides the foundation for a systemic approach to product security. We see this in how e-Pedigree provides holistic prevention, detection, and investigation support for protecting the supply chain. Prevention by significantly raising the financial investment required for individuals who seek profit by injecting adulterated products into the legitimate supply chain. The integration of digital certificates, self-authentication capabilities, and forge-resistant data security technologies used in pedigrees initiated at the manufacturer help deter individuals by creating a chain of custody that is hard to attack or reinvent. Detection through electronic pedigree systems that identify forged pedigrees for products as they are received and analyze transaction trails to identify suspicious product flow patterns. Investigation by providing a complete, verifiable, and non-repudiated transaction trail with extensive detail on product, organizations, facilities, and related financial transactions that can be used as legal evidence.

This cross-section of product, transaction, trading partner, and financial information driven by integrated pedigree systems can also provide the basis for powerful, tightly-linked supply chain and business collaboration solutions that drive supply chain efficiencies.

Hurdles to Safeguarding the Drug Supply Chain

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