Unreadable and Multiple Bar Codes on Packages

JUNE 24, 2018
Michael J. Gaunt, PharmD
Changes in the position and orientation of bar codes on products are resulting in scanning difficulties. The linear bar code on the Flovent HFA (fluticasone) inhaler, for example, was repositioned in a horizontal orientation around the circumference of the canister (Figure). Bending the bar code around a curved surface affects how light reflects off it, and if it is distorted in such a way, scanners cannot capture the entire bar code.



There are various types of bar codes based on the symbologies that encode data (Table).1 Although most scanners can read both linear and 2-D data matrix bar codes, some may require enabling certain bar code symbology to extract 2-D data matrix bar-code information.



Most prescription medications marketed in the United States must contain a linear bar code that encodes the appropriate National Drug Code (NDC) number on the product label, according to the 2004 Title 21 Code of Federal Regulations, section 201.25, bar-code label requirements. Certain drugs, such as low-density polyethylene ampoules (eg, albuterol, isoproterenol, and others), are exempt.

On some product labels, we may also find a 2-D data matrix bar code pursuant to the Drug Supply Chain Security Act (DSCSA).2 The DSCSA, enacted in 2013, requires a 2-D data matrix bar code on the smallest container intended for individual sale to a dispenser. A linear bar code will still be required. Although the smallest salable container is not usually a unit-dose package, some unit-dose products used at bedside are being encoded with both linear and 2-D data matrix bar codes.

The horizontal repositioning of linear bar codes, as mentioned earlier with the Flovent HFA inhaler, is likely due to the addition of a 2-D data matrix bar-code to some product labels. The presence of 2 bar codes can also lead to confusion regarding which one should be scanned.3 Alert all practitioners to the DSCSA requirement to include a 2-D data matrix bar code on certain product labels, in addition to the linear bar code to which all are accustomed. Be sure practitioners understand which bar code to scan for verification. Report any bar code scanning problems to the Institute for Safe Medication Practices (ismp.org/merp), so we can alert the manufacturer and the FDA.
 
Michael J. Gaunt, PharmD, is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition.

References
  1. Cummings J, Ratko T, Matuszewski K. Barcoding to enhance patient safety. Patient Safety & Quality Healthcare. psqh.com/sepoct05/barcodingrfid1.html. Published September/October 2005. Accessed May 10, 2018.
  2. Koppel R, Wetterneck T, Telles JL, Karsh BT. Workarounds to barcode medication administration systems: their occurrences, causes, and threats to patient safety. J Am Med Inform Assoc. 2008;15(4):408-23. doi: 10.1197/jamia.M2616.
  3. FDA. Drug supply chain security act (DSCSA). fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/defa ult.htm. Updated May 8, 2018. Accessed May 10, 2018.


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