Contributed by Joanne Kelleher
The California State Board of Pharmacy voted on 3/25/08 to delay for two years the requirement that all prescription drugs be electronically tracked. This is the second delay, which is now pushed back to 1/1/2011.
The vote was a response to complaints from drug manufacturers, distributors and retail pharmacists that they could not possibly be ready by next January. And rather than violate the law, they said, they would have to stop selling drugs in California.
Pharmaceutical manufacturers told the California board that putting a unique serial number on each container would require changing their packaging lines, which would cost millions of dollars and take years. Because the companies do not know which bottles or vials would end up in California, they would have to make the change to all their lines meant for the United States.
Pharmacies and wholesalers, meanwhile, said they could not install the software and the equipment needed to read the serial numbers until they knew what systems the drug manufacturers would use.”
“Drug companies also said they wanted a uniform national system, not a different one for each state. The F.D.A. has said it would develop a standardized identification numbering system for drugs by March 2010. The California delay will potentially allow the California and federal standards to be the same.
California Delays Plan to Track Prescription Drugs
New York Times
The pace of technological development has sharply accelerated in the last 18 months, particularly for radio-frequency identification tags, the board said in a statement after meeting in San Diego. The extra time will help refine the new tracking tools.
California regulators delay prescription drug tracking
We were not surprised to see the California State Board of Pharmacy make this announcement, there is a lot of work to be done. Unfortunately, with the growing concern about drug counterfeiting and adulteration, the patients will be at prolonged risk.
There are several (dozen) issues that need to be resolved before an integrated drug tracking system can be implemented throughout the pharmaceutical industry. This delay will give the industry more time to determine how to securely communicate and store pedigree information. Although RFID tags are frequently mentioned as a tracking mechanism, they are just part of an integrated solution which will also include RFID readers to collect the data from the RFID tags, a centralized database to authenticate, verify and update with the e-pedigree data and communication protocols between all the parties.