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By Bill Swichtenberg, Senior Editor
Drug counterfeiting is on the rise throughout the world, as organized crime and individual opportunists exploit cracks in the pharmaceutical supply chain. The World Health Organization (WHO, Geneva, Switzerland) estimates that drug counterfeiting is now a $35 billion-per-year global business. If its growth continues at this pace, sales of fake pharmaceuticals may double over the next five years. We will have reached the point where one in five consumers of medicine takes a fake drug, as Pfizer’s senior vice president Robert Mallett reportedly told attendees at the Global Congress on Combating Counterfeiting and Piracy in Geneva last January.
According to WHO, counterfeit drugs only make up 1% or less of the market value in most developed countries with effective regulatory systems and market control. This relatively small group includes the U.S., the European Union, Australia, Canada, Japan and New Zealand. In many developing nations, though, a reasonable estimate would be between 10% and 30% counterfeit. And even in the U.S., the number of counterfeit drug cases is increasing; since 2005, they have involved such products as Percocet, Celebrex, Viagra, Cialis, Lipitor, Risperdal, Zyprexa and Procrit.
However, new track-and-trace technologies have proven their worth during pharma pilot tests and trials, and some systems based on RFID, barcodes, serialization and electronic pedigrees (e-pedigrees) promise to seal these pharma supply chain cracks, one by one.
In January 2006, Pfizer became one of the first drug manufacturers to implement a track-and-trace pilot program using Radio Frequency Identification (RFID) tags for Viagra. “Patient safety has been our primary driver,” said Peggy Staver, Pfizer’s director of product integrity during a recent web conference. “This is to deter and prevent counterfeiting through technology. We want authentic Pfizer product moving through a transparent supply chain.” Pfizer's installation uses software developed by Supply Scape and Systech, and tags developed by Tagsys and Alien Technologies.
Several U.S. states, the Food and Drug Administration (FDA) and even Congress are pressuring pharmaceutical companies to plug the holes in the distribution network. For example, Florida has already implemented drug pedigrees and California will require them (along with serialization) in 2009 (www.pharmamanufacturing.com/articles/2007/041.html). A drug pedigree is a record of each distribution of a prescription drug from its sale by a manufacturer through acquisition and sale by any wholesale distributor until final sale to a pharmacy or other authorized person administering or dispensing drugs. The pedigrees, the subject of much debate, are designed to prevent counterfeit drugs from entering the system.
Pedigrees can be maintained in the form of paper documentation, but experts in pharmaceutical supply chain security have long recommended that e-pedigrees be established to minimize risk. Years of development culminated this January, when the GS1 EPC global drug pedigree standard was established to codify, digitally, the processes and transactions involved in distributing pharmaceuticals.
In March, California's Board of Pharmacy formally accepted that standard as meeting its requirements. As a result, a growing number of drug manufacturers and distributors are providing e-pedigrees. SupplyScape is currently offering its e-pedigree solution to 45 pharmaceutical manufacturers and distributors---not only Pfizer, but Purdue Pharma and U.S. Oncology (Houston), which became the first oncology drug distributor to provide e-pedigrees this March. The process allows U.S. Oncology to provide e-pedigrees to affiliated physicians and manages the pedigrees in a central repository. Thus far, the company has shipped six million oncology units with e-pedigrees.
In the next quarter, AstraZeneca (York, U.K.) will implement a comprehensive system to serialize and authenticate its Nexium product down to the unit level. “Initially, we aim to adopt a ‘bookend strategy,’” says David Teale, product security director for AstraZeneca. “That is, placing tamper-evident security seals (TESS) and unique carton numbers (UCN) on each item at the time of manufacture, and working with industry bodies, other pharma companies and government agencies to move towards authenticating the product at the time of dispensing.”
The serialized authentication program for Nexium assigns unique serialized codes to each tablet blister pack via the carton (embedded on a two-dimensional data-matrix code) and the tamper seal. Once the code is assigned, it is activated, validated and entered into a database, where it can be cross-checked against all serialized codes throughout the AstraZeneca supply chain. In November 2006, the European Federation of Pharmaceutical Industries and Associations (EFPIA) endorsed serialization as the most promising solution to fight counterfeiting. It maintains it will work easily with RFID technologies when RFID matures.
Last June, the FDA’s Counterfeit Drug Task Force recommended the use of RFID to track and trace drugs through the pharmaceutical distribution chain. While the FDA did not mandate RFID, it did point to the technology as “the most promising technology for implementing electronic track and trace in the drug supply chain,” and suggested that “stakeholders move quickly to implement this technology.” However, the FDA also recognized that the goals can also be achieved by using other technologies, such as 2D barcodes. The FDA envisions a hybrid environment of electronic and paper pedigrees and the use of RFID and barcodes in the near future. Its plan to implement pedigree requirements on Dec. 1, 2006 hit a snag when a U.S. federal court granted an injunction regarding these requirements.
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