Cracking Down on Counterfeiting - Pharmaceutical Technology

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Cracking Down on Counterfeiting


Pharmaceutical Technology


Benefits of track-and-trace technology. Most of the remainder of the Counterfeit Drug Task Force report focuses on technology issues related to electronic track-and-trace, or e-pedigree, implementation. It also reiterates the members' belief that radio-frequency identification (RFID) "is the most promising technology for implementing track and trace in the drug supply chain and that stakeholders should move quickly to implement this technology" (1).

The report asserts a "timetable with achievable, realistic milestones is crucial to keep e-pedigree implementation on track" and sounds a warning note: "the voluntary approach that we advocated in the 2004 Task Force Report did not provide industry with enough incentives to meet FDA's deadline" of 2007 (1). Although the Task Force stopped short of recommending the agency mandate adoption of RFID, it certainly left the door open to that possibility if the industry doesn't show sufficient progress toward achieving track-and-trace goals.

The Task Force also noted the significant savings electronic track-and-trace technology can provide the supply chain "in the form of better inventory management, reduction in theft and product loss, improved recall efficiency, and reduced paperwork burdens" (1).

In addition, the Task Force noted, "RFID also has tremendous potential benefits for drug products used in public health emergencies such as a pandemic influenza or bioterrorist attack. RFID tracking could help in expeditious deployment and redeployment of medical countermeasures in times of crisis. FDA should, therefore, encourage manufacturers of these types of products to explore use of RFID" (1).

The hurdles. Unfortunately, hurdles to widespread adoption remain, including evolving standards, insufficient information about the effect of radio frequency on biologics, and the cost of implementation. Thus, the Task Force recommends that "FDA work quickly to complete its RFID Impact Study examining drugs and biologics, and publicly share the results" (1). It also suggests stakeholders "consider a phased-in approach, placing RFID tags on products most vulnerable to counterfeiting and diversion as a first step" (1), an action already underway at firms such as Pfizer (New York, NY, http://www.pfizer.com) and Purdue Pharma (Stamford, CT, http://www.pharma.com).

Remaining technical issues

Frequency. The choice of frequency for item-level tagging poses an obstacle to deployment, but isn't addressed in the report. Some pilot programs use high frequency (13.56 MHz) whereas others are experimenting with ultra-high frequency. In the end, the two options may coexist. Not only are there strong proponents for each frequency, but EPCglobal, Inc. (Brussels, Belgium, http://www.epcglobalinc.org) has organized working groups to develop the standards needed to use each frequency for item-level tagging. The use of both frequencies in the supply chain has infrastructure implications because each frequency requires its own reader. Nonetheless, at least one company has introduced a dual-frequency reader capable of capturing data from either ultra-high or high-frequency tags (universal point-of-sale reader, TAGSYS, Cambridge, MA, http://www.tagsysrfid.com). It is designed for point-of-sale applications, however, and may require modification for pedigree functions.

Mass serialization. Other hurdles to deployment include whether mass serialization (i.e., each drug package receives a unique identifier) is necessary and whether the product's national drug code (NDC) should be incorporated in the electronic product code. Mass serialization is essential, and the Task Force recommends the NDC be "closely associated with the product." It further recommends "for non-line-of-sight technology, such as RFID, the unique identifier for the product should either include an encrypted NDC number or an accessible link to the NDC number to protect privacy" (1).


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