USP's Ferrules and Caps Labeling Changes Put on Hold

This article is part of PharmTech's supplement "Injectable Drug Delivery."

Editor's Note: This article provides an update to the author's Viewpoint column, "Changes to Vial Labels May Affect Patient Safety," which ran in Pharmaceutical Technology's March 2009 issue.

The United States Pharmacopoeia (USP) has proposed revising the Labeling on Ferrules and Cap Overseals section of USP General Chapter <1> "Injections" to limit printing and other types of messaging on drug packages. The revision would limit printing to only cautionary statements on the top surface of the ferrule or cap overseal of an injectable drug product. USP Chapter <1> defines a cautionary statement as "one intended to prevent an imminent life-threatening situation if the injectable drug is used inappropriately."

Frederick J. Balboni, Jr.

The revision to USP Chapter <1> would force pharmaceutical manufacturers to abandon the use of technologies that have been implemented to improve patient safety and help combat the growing threat of drug counterfeiting. As a result, patient safety and supply-chain security may suffer.

In late July, USP decided to postpone indefinitely the implementation date for a revised Chapter <1> based on a series of meetings with the US Food and Drug Administration, the Consortium for the Advancement of Patient Safety (CAPS), and other industry representatives. As part of those meetings, CAPS made presentations to USP and FDA in February and March 2009, respectively, to clarify the pharmaceutical industry's position regarding printing on ferrules and cap overseals. Ultimately, industry feels that information printed on these drug-delivery components is critical to patient safety because the information often notes important instructions such as "Store Frozen," or "Dilute with 100 mL," which can help ensure that the patient receives the correct administration and dosage. Sometimes, corporate or drug-product logos are printed on the cap or ferrule as well to help identify the drug's authenticity.

FDA indicated in its meetings with CAPS that it would like to review data that discusses in more detail the effect the inclusion or omission of printing may have on patient safety. CAPS is currently considering studies to provide such data. A human factors engineering (HFE) analysis and study is in the works to help determine whether:

• Certain printing provides benefits that can reduce medication errors

• Certain printing can be detrimental or cause ambiguity in interpretation

• The printable surface area on the ferrules and cap overseals can be optimized.

In addition, a failure mode and effects analysis (FMEA) will examine the effect of the inclusion or elimination of printing on caps and ferrules.

Looking ahead, USP's Nomenclature Expert Committee (NOM) intends to revise the Labeling on Ferrules and Cap Overseals section based on continuing interest in advancing an optimal labeling standard that promotes safe medication use. The pharmacopeia will publish a revised proposal in the January/February 2010 Pharmacopeial Forum for public comment. The deadline for comments will be Apr. 15, 2010. (The first revision of the chapter was to be implemented in May 2010, which was a postponement from the original date of February 2009.)

The case for safe drug administration

CAPS' mission is to help reduce overall medication errors in the healthcare industry and the consortium appreciates the opportunity to dialogue with USP and FDA on this important issue. A primary means of achieving this goal is to ensure 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. We believe that USP should permit printing and embossing of instructional information intended to prevent medication errors as well as printing and embossing that helps combat drug counterfeiting.

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