On Friday, GlaxoSmithKline (GSK) made a depressing announcement: “A small number of Advair Diskus inhalers stolen from a GlaxoSmithKline distribution warehouse in 2009 have been found in some pharmacies.”Yikes! I guess the gray market is still alive and well.
This news should be a wake-up call to pharmaceutical manufacturers that are investing money in serialization. As I point out in Reality Check on Supply Chain Security, pedigree laws and track-and-trace technologies only work if pharmacy buyers refuse to buy outside legitimate channels and agree to authenticate (scan) an electronic tag.
Many executives at drug companies spend a lot of time worrying about technology implementation and standards, but forget to worry if anyone will actually read their bar code or RFID tag. Today's supply chain security investments will only have value if gray market buyers play by the rules.
Here are the official announcements from GSK and the FDA:
- GSK: Update to 2009 Notification of Stolen Advair Diskus Inhalers
- FDA: FDA Warns Consumers, Pharmacists, and Wholesalers Not to Use Stolen Advair Diskus Inhalers
So far, there is no public information about who sold the stolen inhalers to pharmacies, how many pharmacies purchased them, or whether pedigree was involved. We should all be very worried if the inhalers were purchased by pharmacies operating in states with rigorous pedigree laws.
I’m in favor of a national system for tracking and tracing pharmaceuticals to replace today’s crazy patchwork of inconsistent regulations. However, I’m also skeptical enough to worry that "Don't ask, don't tell" is the mantra of people who buy diverted products from unsavory resellers.
On the bright side, there is no truth to the rumors that a thief named Cobb snuck into the dreams of GSK CEO Andrew Witty to access the warehouse security codes.
Please feel free to refudiate me if I am mistaken.
I recall several off record statements from pharmaceutical retailers stating they should be exempt from state and federal pedigree laws to prevent dispensing diverted, counterfeit or illegitimate products because "they only dispense legitimate product to patients". Oh the irony! As long as retailers are in denial these breaches of the supply chain will continue to put patients at risk regardless of the steps taken by manufacturers and regulators.
ReplyDeleteI would love to find out where these were purchased. If paper pedigree was involved we all know it is only as good as the wholesaler because anyone can simple forge the document. I am strongly for RFID serialization to the unit level to mitigate this perfect example.
ReplyDeleteNoah-Contract Pharmacy Services
I'll figure out the plot of Inception before we find out who sold the stolen Advair!
ReplyDeleteRe:Inception
ReplyDeleteSaw it - loved it (I think). Here is the best analysis that I have seen so far: Never Wake Up: The Meaning and Secret of Inception.
WARNING: The link contains MAJOR SPOILERS for the movie "Inception." Do not read it until you have seen the movie for yourself.
Adam
Adam-
ReplyDeleteEver tour a secondary distribution facility?
Having been on the distribution end of the business for many years, the old adage of a leopard never changes its spots. There are people from that side of the business that have resurfaced under different company names that are most probably the culprits.
ReplyDeleteRegards,
Steve
While I am also in favor of a federal law, I cannot say that the track and trace model would have prevented this. Perhaps other alternatives - EFPIA for example - might actually be more effective in terms of preventing these drugs from actually being consumed.
ReplyDeleteTechnology can help, however if new business processes at each level are not put into place, it really can't be effective. Whether paper pedigree, ePedigree or anything else, if the dispensing pharmacy doesn't check... and that is the essential problem with the track and trace model - the smallest link in the chain is the only one with the complete record and ultimate responsibility.
There are many unsophisticated ways to put gray market items back into the supply chain. Unless a solution is applied and monitored at the unit level, it can be subverted.
ReplyDeleteI will likely be retired before there is any chance we will see a national comprehensive pedigree program. I was in college when PDMA was signed into law so history certainly supports such a timeline.
I don't see RFID as part of the final solution since the gray market for RFID is so vast. How can we secure an item with less secure tool?
In the meantime, we need to look to the less sweeping solutions.