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The ISMP Medication Safety Alert reports that in April, FDA issued pharmaceutical industry guidance, in a question and answer format, about barcode label requirements for medications (www.fda.gov/cder/guidance/7156fnl.pdf). FDA first published the barcode ruling on February 26, 2004, and April 26, 2006, was the date by which drug manufacturers were required, with few exceptions (www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm), to print a bar code on all prescription products as well as OTC items commonly used in hospitals.

The barcode rule was certainly a seminal event in the annals of patient safety. It ended a standoff that existed for many years in which: 1) manufacturers were reluctant to invest in systems to produce barcoded, unit-dose packages if hospitals weren't equipped to use bedside scanning, and 2) hospitals did not want to invest in bedside scanning systems unless most medications were available in barcoded, unit doses, as repackaging the medications internally would be costly.

More hospitals are now stepping up to the plate and implementing bedside scanning systems. But it's become evident that, while manufacturers are producing barcoded, unit-dose packages, the quality of the bar code may be poor or the bar code(s) may cause confusion.

Nurses and pharmacists have reported that some products with bar codes are difficult or impossible to scan or have other associated problems. For example, the current DURAGESIC (fentanyl) patch is imprinted with two manufacturer-applied bar codes. The uppermost one on the right identifies the drug by its national drug code (NDC); the one on the left is used for company quality control. Additionally, one hospital reported that, because nurses scanned the wrong barcode often on this and other product labels with dual bar codes, they now affix their own barcoded labels. Nurses know to scan the pharmacy-applied barcode and to disregard the company printed bar codes. Of course, having pharmacy apply a barcode introduces the risk of human error in that the wrong barccode could be applied.

ISMP is interested in reducing pharmacy repackaging and/or relabeling workloads caused by manufacturer-supplied barcodes that won't scan properly or otherwise cause confusion. Please let ISMP know (at www.ismp.org) about problem products so we can notify companies, advocate for appropriate changes, and publish information about problem drugs when appropriate.