It looks like a national track and trace system is going to be implemented in the U.S. sooner rather than later. Differences between what industry believes it is capable of handling and what regulators believe it must kept it out of the FDA reauthorization bill, but no one should think that put it into the deep freeze.
With the re-election of President Obama, track and trace is not going to get lost in the remaking of the FDA by a new administration. Even before the election, some supporters in Congress began testing the legislative waters to see if they can get some traction on a bill. And eventually the public is going to figure out that track and trace can prevent deaths. When it does, pressure is going to build on Congress to pass something. Politicians hate to be painted as having dropped the ball on lifesaving legislation. It just doesn't play well.
It is not that industry players don't realize this and some are making strides toward figuring out how to get it done. One organization this year ran an end-to-end pilot study that might even lower the angst level of some in the U.S. pharma supply chain. It shows that a drug can been traced from manufacturer to the end user with less time and hassle, and so probably less cost, than many have assumed.
With participation from the Veterans Health Administration and its Consolidated Mail Outpatient Pharmacy, the pilot tracked a cold-chain drug from an Abbott Laboratories ($ABT) plant to different VA hospitals for 9 months. The process even allowed the VA to link data to individual prescriptions. One participant believes it is the first cross-supply-chain pilot that has been done. On Wednesday, the key players will discuss how it worked and what they learned during a track-and-trace seminar being held in Arlington, VA, by the Healthcare Distribution Management Association.
What they found was that it is "not as daunting as you may think and it can provide huge benefits for patients," said Margot Drees, executive director of the Global Healthcare Exchange (GHX), whose technology served as the repository for the data. GHX was founded in 2000 to figure out how to use the Internet to help squeeze out inefficiencies in the pharma supply chain. It is now owned by 20 companies and organizations that represent players at every step of the process. That includes Abbott, which makes the drug that was tracked, and McKesson, which was the wholesaler in the pilot.
Starting in January, the program tracked two-packs of Abbott's Humira injectable rheumatoid arthritis drug, a product that requires temperature control throughout the supply chain. It is also a product that Abbott had already been putting serialized IDs on. Drees said they followed 23 serialized cases and 138 items from an Abbott plant to a McKesson distribution facility to delivery to the hospital. The cases were scanned at each point, and that information was fed into a database so that everyone knew where the product should be at any given point. They even instigated a "mock recall" that set off alerts, allowing the product to be intercepted midstream and keeping the VA from taking delivery of a drug that was theoretically suspect. Once drugs were delivered, the VA was even able to pull data into individual patient records.
So what was learned by the test? Drees says it is clear that in order for the system to work, some players are going to have to change some of their business processes to track serialized data and make the process seamless. Some tweaks to the technology will be needed so that extensions correspond to specific delivery locations. "Sometimes where the product is shipped can vary," Drees said. "One hospital may take delivery at a loading dock and another at a nurses station on the fourth floor."
But they also found out that the scanning process, which many players worry will add a bunch of time and so a ton of costs, didn't take that long and the speed was doubled over the life of the test.
"The scans first started at about 6 minutes, but eventually the VA got them down to 3 minutes," Drees explained. This is important because some players, particularly retail pharmacy operators, question how they can afford the resources to do all of the scanning.
Granted this was a relatively small test, involving only one product, but it got pretty granular and a lot was learned. She said a second pilot is being discussed that would use a second product and another distributor.
The most important finding of the pilot is "this isn't insurmountable, and the potential benefits outweigh the delays and the time involved," Drees said.
The industry needs to pay close attention to studies like these. At the least, a California law requiring serialization will take affect in 2015 that the industry must figure out how to comply with. It's not a matter of whether there will be a national track and trace program required, only a matter of when. -- Eric Palmer (email | Twitter)