Originally Published PMPN July 2002
Editorial
Safety in Numbers—Bar Coded Numbers, That Is
Can
bar codes save lives? FDA seems to think so. And so should you. You may be able
to pull it off much easier than you think.
Responding to the Institute of Medicine's (IOM) 1999 report that medical errors may contribute to the deaths of between 44,000 and 98,000 people each year, the agency is considering requiring bar codes on all human drug and biologic products, and possibly medical devices. In its report, IOM suggested that the healthcare industry produce bar coded unit-dose packages to reduce handling errors. FDA is taking that suggestion seriously.
"Errors related to dispensing and administration can be minimized through the use of bar codes," FDA wrote in its June 18 Federal Register notice. "If a health professional could use a scanner to compare the bar code on a human drug product to a specific patient's drug regimen, [he or she] would be able to verify the right patient is receiving the right drug, at the right dose, and at the right time."
Aware that bar coding each dose requires significant investment, FDA has called a public meeting on July 26. It plans to pose some tough questions: Should all prescription and OTC drugs, blood products, vaccines, and medical devices carry a bar code? What information should be contained in the code? Should the rule adopt a specific symbology? Can bar codes be printed with a dose-specific unique identifying number, lot number, and expiry date at the highest line speeds?
Clearly, FDA senses that mandating bar codes will shake up the industry, requiring the repackaging of many already-marketed drugs. Thankfully, it is asking such questions now, giving you the chance to shape regulation.
And some are already working on the answers. Griffin-Rutgers Company, Inc., Quint Co., and Product Identification & Processing Systems Inc. (PIPS) have printed industry-standard Universal Product Number primary identification codes and secondary attribute data in Reduced Space Symbology (RSS) with Composite Component-A on foil, coated foil, and paper-backed foil lidding to determine the code's feasibility for hospital unit-dose blisters. RSS, along with its composite component, can include product and lot codes and expiry dates in about the same space as a traditional bar code, possibly less.
For the test, Griffin-Rutgers used an in-line Metronic InPrint one-color flexographic printer; Quint produced a 0.67-in. thick Cyrel plate according to GMPs; and PIPS, a bar code service bureau, supplied the original RSS/Composite EPS files (digital bar code art). The group then used an already-marketed blister layout, obtaining one from manufacturer and repackager UDL Laboratories, which has been printing hospital unit-dose blisters with Code 128 for years.
After printing, the lid stock was sent to UDL, which ran and sealed the material with a knurled pattern. Formed packages were then sent back to PIPS, where vice president George Wright IV confirmed the bar code print quality using a TruCheck verifier from Webscan. Wright says the codes received grades A and B, depending upon the substrate area, sealing pressure, and variations in the foil. (He points out that the industry's established standard is a grade C or better.)
And, while the Uniform Code Council Inc., which wrote the symbology, prefers not to endorse a supplier, healthcare director John Roberts says the results were impressive.
Of course, such efforts may well be wasted if FDA chooses another symbology as the industry standard. Nonetheless, Griffin-Rutgers, Quint, and PIPS have shown that product and lot codes and expiry dates can be encoded without increasing package sizes.
So, why not try to save lives with a code?
Daphne Allen, Editor
Copyright ©2002 Pharmaceutical & Medical Packaging News
