National organization proposes a draft standard; will hold workship in May
The US Pharmacopeia the private non-profit that has legal status as a federal standards-setting body, has proposed a new standard, <1083> Good Distribution Practices—Supply Chain Integrity, which it says will be part of "the series of information chapters describing various aspects of the pharmaceutical supply chain." One previous chapter, <1079> Good Storage and Shipping Practices, is in review status within the organization.
To further discussion and standards development for <1083>, USP is holding an industry workshop on May 22-23 at its Rockville, MD, headquarters; details are available at www.usp.org. The draft chapter itself is available for review and comment* now. USP has a multistep process of allowing industry commentary and revision, then a voting process that ultimately leads to a new standard. At this point, <1083> can more properly be characterized as a narrative, providing background and history on past regulatory efforts, threats to supply chain integrity, and preferred solutions or countermeasures.
"Supply chain integrity" as USP defines it, is mostly focused on counterfeiting and theft. The customary concepts of layered security, along with serialization and tracking software, is described and recommended for securing products in the supply chain. The document notes the difference between authenticating a product (by checking its serial code against a master list), and a track-and-trace system that records each movement along a supply chain, but does not recommend one method over the other.
Meanwhile, a section on RFID tags revives an old bugaboo about the use of radio-frequency energy around fragile biopharmaceuticals—that the energy could affect those molecules’ efficacy. Numerous studies have shown no effect, but the standard says "It is too early to extend these limited results to all biopharmaceuticals, and analysts should study the effects of electromagnetic radiation on these products before using RFID tags on their primary packaging." It goes on to suggest acceptable testing parameters.
Another section provides some recommended features and practices for logistics systems (warehouses and vehicles) to counter cargo theft and other interferences with pharmaceutical distribution.
Finally, a section makes reference to rogue Internet pharmacies, and the risks they represent for selling adulterated product, or selling product without the intervention of a prescribing physician. The Verified Internet Pharmacy Practice Sites (VIPPS) program of the National Assn. of Boards of Pharmacy (NABP) is mentioned, along with a recommendation that Internet search engine companies police their databases to prevent their advertising via these search engines, and that payment processors (credit card companies) prohibit transactions involving counterfeit products.
<1083> is certainly a good start at establishing more-secure pharma supply chains; but, like much of the debate about national pedigree rules or anti-counterfeiting, it leaves unsaid who will take enforcement responsibility, or who will be held accountable for mishaps.