Drug Serialization and Supply-Chain Security

As regulators work to curb counterfeiting, industry finds benefits to gaining granular data about the supply chain. This article contains bonus online-exclusive material.
Jun 02, 2009
Volume 33, Issue 6

The problem of counterfeited, adulterated, and diverted drugs is on the rise, and fake pharmaceutical products are expected to account for $75 billion in 2010. The World Health Organization (WHO) estimates that counterfeits account for 1% of drugs in developed nations and up to 30% of drugs in developing areas. As counterfeiters' business grows, so does the sophistication of their techniques, creating losses for pharmaceutical companies, and jeopardizing the health and confidence of patients taking medications.

Industry concerns and challenges

Despite the growing number of counterfeits, there is confusion in industry over how, when, and even whether to implement anticounterfeiting and supply-chain security measures. This hesitation likely stems from several factors such as a low awareness of risks, the costs of deployment, and the lack of industry standards for implementing these measures. An incomplete understanding of counterfeiting risk or a reluctance to admit a problem could be a barrier in some instances, says Carla Reed, principle of the consulting group New Creed. "Part of the solution in any case is acknowledging the problem," she says. "Companies need to be proactive rather than reactive."

In many cases, early adopters of anticounterfeiting solutions did so because there was a counterfeiting problem. For example, Pfizer's (New York) problems with counterfeiters copying Viagra (sildenafil citrate) and Purdue Pharma's (Stamford, CT) similar issues with its painkiller OxyContin (oxycodone hydrochloride) led the companies to implement radio-frequency identification (RFID) to track those drugs through the supply chain.

Assessing product security across five dimensions.
"More important than the technology used is understanding the key events in the product life cycle, how the product is tracked, and what the failure points are," Reed says. To gain awareness of a potential counterfeiting risk, an assessment of a product's security can be performed (see sidebar, "Assessing product security across five dimensions" by Scott Dicks of Maxiom Group). Results of an assessment can help a company move forward with a brand-protection strategy.

Another roadblock for industry could be the lack of standards when it comes to measures such as serialization and electronic pedigree (ePedigree) requirements. From state to state in the US and in countries throughout the world, different requirements exist. The ability to closely trace products can prevent diversion and the introduction of counterfeit products into the supply chain, but technological details and best practices of how to achieve this are a work in progress for state and federal regulators.

Regulatory efforts
Under Section 913 of the Food and Drug Administration Amendments Act of 2007, the US Food and Drug Administration is working to develop standards and identify technologies that will secure the pharmaceutical supply chain. As part of that initiative, the agency released a draft guidance for industry, Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages, in January 2009, focused on developing standardized numerical identifiers (SNIs) for the smallest saleable unit of prescription drug packages (1). The draft guidance states that standards for other aspects of SNIs—for cases, pallets, or repackagers—and for track and trace, authentication, and validation are not addressed in this document but could be the subject of future guidances. The agency is expected to issue a final guidance on SNIs by March 2010.

Among the public comments on the draft guidance is input from pharmaceutical companies such as Endo Pharmaceuticals (Chadds Ford, PA), Hoffman–La Roche (Basel), Talecris Biotherapeutics Research Triangle Park, NC), Novo Nordisk (Bagsvaerd, Denmark), as well as the California State Board of Pharmacy, the Parenteral Drug Association, the Generic Pharmaceutical Association, the Biotechnology Industry Organization, and the supply-chain standards organization GS1 (2). A key concern is that FDA's recommended 8-digit SNI is too small, and that GS1's standard identifier Global Trade Item Number (GTIN), which is already in use by industry, should be adopted. In its comments, GS1 states that the GTIN is currently used to identify pharmaceutical products in 65 countries worldwide.

Some comments applauded the draft guidance for being technology neutral in terms of the data carrier used to comply, but California's board of pharmacy urged FDA to designate a data carrier, specifically, the use of RFID. Bikash Chatterjee, president and chief technology officer of the consultancy Pharmatech Associates, supports FDA's stance of not endorsing a specific technology.

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