Changes to Vial Labels May Affect Patient Safety - Pharmaceutical Technology

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Changes to Vial Labels May Affect Patient Safety
USP's revised chapter on injectables could harm anticounterfeiting efforts and drug administration.

Pharmaceutical Technology
Volume 33, Issue 3, pp. 162-161

CAPS' position

The Consortium for the Advancement of Patient Safety (CAPS) was established to help reduce overall medication errors in the healthcare industry. A primary means of achieving this goal is to make sure that pharmaceutical manufacturers have access to all available technologies and methods to mitigate the risks of medication errors. Pharmaceutical manufacturers use the ferrule and cap overseal as a platform for anticounterfeiting technology, and to display information on dosage, cold-chain management, and point-of-use administration instructions to help preserve patient safety. Limiting the type of information that can be printed or otherwise displayed on drug packaging could compromise patient safety and thwart efforts to combat drug counterfeiting. USP ‹1› is germane to pharmaceutical manufacturers based out of the US because they must meet the standard for products imported into the US.

CAPS believes USP should permit printing and embossing of instructional information intended to prevent medication errors and allow printing and embossing that helps combat drug counterfeiting. Comments on the revised chapter can be submitted to USP at

Since this article was written, CAPS and USP have engaged in collaborative dialogue to ensure that patient safety concerns are addressed with regard to printing on ferrules and cap overseals on injectable drug products. CAPS is optimistic that USP will evaluate its position on General Chapter 1 quickly so that industry has clear direction for planning product-development initiatives. In addition, the US Food and Drug Administration has agreed to meet with CAPS to discuss this important issue.

Frederick J. Balboni, Jr., is executive director of the Consortium for the Advancement of Patient Safety (CAPS),


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