Pedigrees and Such
e just brought home a new dog. Her name is Ellie. She is a delightful pup with very sharp teeth. We are supposed to register her with the American Kennel Club (AKC) and we soon will. That way she will have a pedigree on some official register. I don’t know why she needs this, because we promised to have her spayed and she won’t have any heirs to pass her pedigree on to. I am sure some avid dog lovers will soon tell me why I need to register her. Meanwhile, the pharmaceutical world is trying to figure out how to keep track of every bottle of every drug that is produced. I am sure there are more of those than there are dogs, and I know the drugs have a more complicated sequence of owners than dogs do, so I will drop the comparison.
Tracking Keeping track of every bottle is a good idea. We need to know where they came from, where they have been, where they are, and where they end up. If you track the legitimate ones it is much more difficult to get illegitimate ones into the system and to the patient. California’s legislature has decided that this is a California problem that can be solved in California. I think it is a national problem that needs to be solved on a national level. It is probably really a worldwide issue that should be dealt with on a worldwide basis. After all, drugs are manufactured all over the world and are shipped all over the world. 36
George Pennebaker, Pharm.D.
We all know it will be a long time before we can get every nation where drugs are manufactured to agree on some kind of worldwide system. So what about a national system? The FDA is working on it, and they have been making some progress. However, it is not clear when they may get it done, since it does not appear that there is a time mandate they must meet.
Leading the Charge California, on the other hand, has mandated that a system be in place by 2015. For something of this magnitude that is not very far off. The California State Board of Pharmacy has been given the task and the authority needed to get a system in place.
Recently, the California state board held hearings on the subject. FDA representatives were there and presented their progress on the matter, including suggestions about some of the details. The main thing they suggested is that each manufactured or repackaged container should have its own unique identification that would have two parts. The first would be the NDC number of the product. The second would be 20 characters assigned by the manufacturer that would identify the specific package. This big number would be barcoded and could be read by any barcode reader. That all seems feasible. The numbers would all be sent by the manufacturer to some huge database where every time they are read the location would be recorded. Each purchaser would be required to read the number and send it to the database each time a