Out With Pedigree; In With Patient Safety

New group of injectables manufacturers tussles with USP over use of labeling ‘real estate’ on vial caps


Just as the tide is slipping out for broadbased information systems to establish drug pedigree, it is rising for preventing medication errors, especially in healthcare settings. A new association, the Consortium for the Advancement of Patient Safety (CAPS) has formed up; members come primarily from the ranks of manufacturers of injectables, including J&J, Allergan, Amgen, Merck, Pfizer and West, the injectables containers manufacturer.


The group’s primary focus in the near term, according to a news release, is a coming guideline from US Pharmacopoeia (a revision of “USP General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals,” USP-31-NF-26) to limit printing and other types of messaging on drug packages. Following a recent postponement decision by USP, the rule is scheduled to go into effect in May 2010.

USP rule-making process
Manufacturers and USP have been wrestling over this standard for many months, and in earlier versions, all the way back to 2005. Last summer, PhRMA sent a letter to USP requesting an indefinite postponement from a planned February 2009 implementation. In a statement, CAPS executive director Fred Balboni says that “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.”

Debbie Thomas, CAPS co-chair and VP, regulatory affairs, at West, says that “The Consortium fully agrees with USP's goals of patient safety, but we believe that the current standard is too restrictive.” For example, a common instruction like “Dilute before using” would be allowed, but others, like “Keep refrigerated” might not be. “USP wants to restrict messaging to "Cautionary Statements", which it interprets as ‘statements intended to prevent an imminent life-threatening situation, if the drug is used inappropriately’ but we find that too limiting,” she says.

In letters sent to PhRMA and others, USP has announced the postponement to 2010, and noted that their emphasis is on preventing usage and safety information from being obscured by logos or other materials. “There is a strong public health interest in restricting cap and overseal printing to only cautionary statements.”

Although CAPS’ actions may go no farther than getting a revision of this rule—if that—the activity points to the value of packaging information in maintaining product integrity—and reducing medication errors. Both of these goals have been identified as rationales for serialization systems in drug distribution and hospital workflows. Pedigree rules (which became ‘e-pedigree’ rules as the regulatory efforts proceeded over the past several years) have the same general goals.

More information about the consortium is available at caps-edu.org.