Senators Michael Bennet, Lamar Alexander, Richard Burr, and Tom Harkin recently released a draft bill that would enhance safety measures in the pharmaceutical supply chain throughout the entire distribution process.

Road Scholar Transport’s ShowMe feature tracks the live position of your freight, right down to the breadcrumbs. (Click Image to enlarge)
Instead of the current tracing system that is available at the lot-level, the bill would gradually build over a 10-year period a system able to trace at the unit-level, helping to eliminate contamination concerns once the products are circulated to stores and pharmacies and distributed to consumers. As Sen. Bennet explains, “Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves. In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death.” 1
The proposed bill would establish a national drug traceability system that would track individual drug bottles from the time it is manufactured to the time it is placed on store shelves for purchase.

Road Scholar Transport’s ReeferTrak system monitors your temperature-sensitive freight, providing the times the reefer was turned on/off, location history as well as current status, when the trailer door was opened/closed, and the temperature within the trailer during a specific time. (Click Image to enlarge)
In explaining the bill, the Senators stated, “It would require the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to pass transaction information, transaction history, and transaction statements, as applicable, when there is a change of ownership. Additionally, no one in the supply chain would be allowed to accept drugs if this information is not provided as part of a transaction.” 1
These requirements would help prevent thieves from stealing pharmaceuticals and selling them at cheap prices to unknowingly buyers. Such was the case in 2009 when consumers purchasing insulin from legitimate pharmacies experienced convulsions, a rise in blood sugar, and so on, uncovering that the insulin was part of a shipment that was hijacked months ago from a truck and became ineffective. 2 Out of the truckload of insulin stolen, only 2% had been recovered.
The bill would also “strengthen licensure requirements for wholesale distributors and require the FDA to keep a database of wholesale distributors that will be available to the public on the FDA website” in an effort to identify licensed wholesalers. 4
Comments on the draft may be submitted to drugdistributionsecurity@help.senate.gov by April 26th.
Do you believe that oversight of the prescription drug supply chain needs to be improved and is a uniform national drug traceability system requiring transaction information, history, and statements to be provided before acceptance of drugs in every part of the supply chain part of the solution?
2http://features.blogs.fortune.cnn.com/2011/03/31/drug-theft-goes-big/
3http://www.rxtrace.com/2012/05/the-built-in-protections-of-the-u-s-pharma-supply-chain.html/















