Dennis Anthony Tribble - Comment

The attached document attempts to answer the specific questions asked to the extent that I can know those answers. The short answer is that permitting the use of 2-D bar code symbologies would answer many current issues in the use of bar codes, especially on unit-of-use packages. Many, but not all... In more general terms, it is important to know that the application of bar coding as a patient-safety initiative relies heavily on the current NDC process, which is dysfunctional. A primary driver for bar coding on pharmaceutical products was and is use of that bar code to verify that the product a nurse is about to administer is clinically correct. For that to occur, the software underneath the bar code scanner must be able to recognize the data encoded in the bar code and be able to use those data to determine whether or not the product just scanned is appropriate to be given to that patient. This, in turn, requires that there be an authoritative source of information about NDC's and bar code contents that permits such a determination. THAT S SOURCE OF INFORMATION DOES NOT EXIST. The database maintained by the FDA is updated every 6 months, but the industry provides 4-5 new NDC's into the marketplace per week. In a recent webinar on the RxNorm product, Stuart Nelson of the National Library of Medicine announced that the FDA had abandoned all pretense of knowing what NDC's were actually in the marketplace and had stopped updating their database. This places a horrific burden on the healthcare community who, having adopted Bar Code Medication Administration (BCMA) in at least 25% of their hospitals, now finds that each of those hospitals must commit considerable resource to keeping up their database of NDC's and bar codes so that their BCMA systems can work. The FDA must address this issue, along with permitting 2-D bar codes to provide a workable system.