Barcode-related Safety Briefs
Drug manufacturers need to stop printing barcodes across round surfaces!
July 15, 2021
A hospital discovered a billing issue with its rabies immune globulin (human) 2 mL vial, KEDRAB (manufactured by Kamada, distributed by Kedrion Biopharma), while auditing their 340B program. They were not receiving the product at the correct 340B contract price because they had “no documented administrations” of it at the hospital. However, the hospital had frequently been reordering the product, so it clearly was being used. The pharmacy researched the problem and found numerous instances of not billing for the medication. The 340B program software links the billing of the doses administered to how much is being used. It turned out that the medication was not being charted on the medication administration record (MAR). Despite nurses thinking the product label scanned, documentation failed because the barcode on the product is printed on the label horizontally on the curve of the round vial (Figure 1), so it could not be completely read by the laser scanner.
This situation obviously creates a financial issue but also a patient safety issue since the medication is not being scanned for verification. The issue is also problematic because the dose may be repeated if another practitioner thought it had not been administered, or since the healthcare team might make incorrect decisions about patient care based on an inaccurate medication administration history.
The vial is packaged in a carton that has a scannable barcode, but nurses usually discard this after removing the vial, so it is no longer available at the bedside during administration. While not ideal, for now, this pharmacy is asking nurses to hold on to the carton to scan its barcode at the bedside before administering the product, rather than scanning the barcode on the vial. At a minimum, nurses should manually document administration on the MAR if the carton has already been discarded. The pharmacy will be reviewing reports daily to verify that the medication was charted as given, as well as billed appropriately.
ISMP has repeatedly mentioned this problem in the past with barcodes on the labels of round ampules, vials, inhaler canisters, and oral liquid bottles, including most recently in our January 16, 2020, issue (fentaNYL ampule from Hospira), in our March 11, 2021, issue (cisatracurium vial from AbbVie), and in our June 17, 2021, issue (sodium polystyrene sulfonate suspension from CMP Pharma). Linear barcodes on round ampules, vials, inhaler canisters, and oral liquid bottles should only be printed perpendicular to the curve of the container, usually along the edge of the label on one side, rather than horizontally around the curve of the container. Purchasers should avoid products with curved barcodes, when possible, if scanning technology is used during product selection and administration. The US Food and Drug Administration (FDA) should consider publishing an informative media release about this problem that is directed at drug manufacturers. The problem should also be addressed in the finalized FDA draft Guidance, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.
Cisatracurium barcode is not scannable
March 11, 2021
It will be difficult or impossible to scan the NIMBEX (cisatracurium besylate from AbbVie) vial barcode for proper medication identification. The product is packaged in a very slim, tall vial with the barcode printed horizontally, curving around the circumference of the vial (Figure 1). The curvature renders barcodes unscannable with a laser scanner. This is not the first time this particular barcode problem has been reported, so manufacturers and the US Food and Drug Administration (FDA) need to be aware as products with a horizontal barcode on a curved surface might not be considered useable in locations that depend on barcode scanning at the point of drug dispensing and/or administration. The FDA Barcode Rule requires a linear barcode that encodes the product’s National Drug Code (NDC) number (in this case, NDC 0074-4378-05). Linear barcodes on round vials should only be printed perpendicular to the curve of the vial, usually along the edge of the label on one side, rather than horizontally around the curve of the vial. Purchasers should avoid this product where barcode scanning is used during product selection.
Barcodes on curved surfaces
January 16, 2020
We have recently received several reports of significant scanning issues involving fentaNYL ampules from Hospira, because the barcode is printed on a curved surface (Figure 1). When a barcode is printed on a manufacturer’s label over a curved surface, it is likely to make a successful scan extremely difficult or impossible. The October 19, 2017, and November 2, 2017, issues of the ISMP Medication Safety Alert! included articles about unreadable barcodes with examples of other products with similar issues. ISMP has notified both the US Food and Drug Administration (FDA) and Hospira about the problem. The company is aware of the issue and is making changes to address the problem. Hospira told us that, during the first quarter of 2020, it will return the barcode on ampule products to its original location, running vertically on the side of each ampule. The new orientation will allow the barcode to be scanned more easily without problems.
Other pharmaceutical companies need to take notice. Problems like this might not be noticed during the approval process if only looking at or scanning a label printed on a flat, two-dimensional surface. The label should be tested to see how it displays and scans on the container (e.g., bottle, ampule, prefilled syringe), taking into account the shape and type of packaging.