The Lilly heist and the need for e-pedigree
The astonishing theft of $75 million worth of antidepressants and other drugs through the roof of an Eli Lilly distribution warehouse in Connecticut earlier this week is just the latest and most acrobatic incident in a rash of prescription drug theft, and highlights the importance of establishing better tracking of drugs in the pharmaceutical supply chain. According to Freightwatch, a group that tracks cargo security, reported drug theft has quadrupled in the last four years. Last year, nearly $200 million worth of prescription drugs were stolen in the U.S. There were five pharma thefts in the month of February alone.
The case highlights the need for a start-to-finish, tamper-proof drug pedigree on every prescription drug that’s sold. As the Secure Pharma Supply Chain blog wrote, “the issue of pharmaceutical cargo theft energizes the need for material screening of products within the supply chain, from manufacturer to dispenser, to properly protect consumers everywhere.”
Right now, prescription drugs that go missing (through the roof or otherwise) are often exempt from having a pedigree once they reach a hospital or pharmacy because of regulatory gaps. Under current federal and state regulations, many parties are excluded from pedigree requirements – authorized distributors, for one—so a drug’s paper trail ends once it passes through their hands. Stolen drugs, which may be improperly stored or tampered with, can be sold back to authorized distributors, and pharmacies and hospitals that buy from them have no way of knowing of the risks.
Another problem is that it’s a paper trail—papers can be easily swapped forged or lost. And the documents that are required are for whole lots of drugs, making them meaningless in issues of partial-lot theft and resale we’ve seen occur (like the insulin units stolen from North Carolina cargo truck and found on Texas shelves months later.)
One solution would be to require an e-pedigree, an electronic barcode or radio tag on every bottle or package of prescription drugs, making it possible to track each stop along the supply chain from the factory to the medicine cabinet. California is the only state to have an e-pedigree requirement, but implementation of that law has been delayed till 2015. A federal e-pedigree law has been proposed by Representatives Buyer and Matheson, and would be a more sensible solution for a globalized and interstate industry.
–Kate Petersen, PostScript blogger
March 18th, 2010 at 5:05 pm
Counterfeit sellers require counterfeit buyers. Pedigree rules only work if buyers refuse to buy outside legitimate channels. How do we stop pharmacy buyers and consumers from purchasing outside of a theoretically secure supply chain?
Note that pharmacies, the presumed beneficiaries of pedigree laws, have opposed national pedigree legislation. See my 2008 post: http://www.drugchannels.net/2008/05/pharmacists-haggle-over-pedigree-costs.html
The pharmacy associations also funded a study that dramatically inflated the costs of a track-and-trace system: http://www.drugchannels.net/2008/06/accentures-track-and-trace-straw-man.html
Adam
March 16th, 2011 at 3:52 pm
[...] -Bring transparency and accountability in the supply chain, chiefly by a uniform electronic tracking system that would ID the drug and provide an unforgeable trail from supplier to pharmacy shelf (see here for more). [...]