Securing the Chain of Custody in the Pharmaceutical Supply Chain

Interphex2007, New York, NY (Apr. 26)-Counterfeit medicines are of increasing concern to the pharmaceutical industry, both because of the potential health risks to patients and because of the effects on pharmaceutical companies’ businesses. While technology such as e-pedigree and radio frequency identification (RFID) represent solutions to secure the supply chain, there are challenges. Implementing an e-pedigree program can be difficult, and strategies for addressing those difficulties were shared by Sanjay Ahuja president of Reltronics Technology (Rochester, NY, www.reltronicstech.com),  in his presentation, “Security and Integrity in Chain-of-Custody Hand-off Related to Drug or E-pedigree,” at Interphex on Thursday.

Counterfeiting cost European manufacturers about EUR 1.55 billion (approx. $2.1 billion) in 2000, according to data presented by Ahuja. The US Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) estimates that fake drugs make up about 10% of the global market  with annual revenues of about $32 billion. To combat this problem, FDA is investigating new methods of securing the supply chain by implementing RFID and e-pedigree.  In 2006, an FDA Task Force recommended the implementation of RFID and instructed stakeholders in the pharmaceutical supply chain to explore the use of RFID.

Ahuja outlined the process for e-pedigree. The drug manufacturer first adds a unique package identification and product barcode and transfers information from the package into a database. The database holds information on genuine and fraudulent transactions, allowing for easy tracking of the drug along the supply chain.  Barcodes are most commonly used, although they are not specific to a single package. RFID tags are specific to a single package, and Ahuja projects that RFID use will spread rapidly.  “In eight years, we will have a very mature environment with RFID,” said Ahuja, who likened the adoption of RFID to the growth of wireless technology in the mid-1990s.  Implementing an e-pedigree program could help reduce thefts of goods, as it would allow for more effective tracking of packages.

There are, however, some obstacles to the widespread adoption of RFID. Several different companies produce RFID tags, but there are no standards for the production of those tags. Many companies were concerned about privacy and the ownership of business transaction data. Ahuja believes that the entire supply chain must be examined and an integrated network created to provide visibility into the pharmaceutical supply chain.  This integrated network should cover all aspects of the supply chain, from the manufacturer to the seller, and the information on the main database should include all information pertinent to the drug.  This includes its name, manufacturer, and expiration date as well as information regarding any transactions it has undergone and its path of travel since leaving the production line.