The appearance of fake versions of the ADHD drug Adderall is raising concerns about track and trace laws and how pharmaceuticals need to be monitored to ensure public safety. The story, reported in numerous media outlets (click here), follows on a similar problem earlier this year with the appearance of counterfeit versions the drug Avastin and coincides with Congressional review on the topic of traceability and counterfeiting. The risks associated with this problem are significant as patients may unwittingly take counterfeit medicines that can do more harm than good. New FDA regulations, according to the article, could pose a danger to both sides as the government tries to balance public safety against increasing regulations that could stifle innovation.
The article states that the US House and Senate versions of the FDA re-authorization bill include language that would set up more stringent tracking of drugs to help prevent counterfeiting, but the details have yet to be set. (Citing Reuters) The FDA wants a nationwide program that includes and tracks identifiers on individual containers. The plan put up by an industry coalition would put unique serial numbers on individual drug packages but require scanning drugs only in “lots” when they get to distributors. They have argued that to expect individual tracking from truck to warehouse to distributor to pharmacies is unworkable, at least for now.
Europe will start requiring unique identifiers on all drug packages starting in 2016.
This has been an ongoing issue for the industry. California has twice postponed its ePedigree initiatives that are now slated to go into effect commencing in 2015 because of the technical challenge of tracking and tracing pharmaceuticals at the item level. Yet, as more counterfeit drugs show up on the market, consumers (and ultimately the government) will increase their pressure on the industry.
We think Intelleflex can help with the solution. Intelleflex temperature monitoring tags can store a complete record of the serial numbers of the individual items within the carton and also a secure e-Pedigree all in the tag memory. This makes it easier to associate the information about the items with the container that they’re shipped in. And, by using our readers with Zest Data Services, it’s possible to keep track of the drugs no matter where they may go and set secure waypoints at each location. To learn more about Intelleflex solutions for the pharmaceutical industry, click here. To read an Intelleflex article on serialization and inference, click here.
Senior Director of Marketing