USP and industry group continue to tussle over vial labels and overseals

June 9, 2010
Pharmaceutical Commerce, Pharmaceutical Commerce - May/June 2010,

Industry consortium sponsors study that substantiates its claim of better patient safety with more labeling

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lly, the dispute between US Pharmacopeia (Rockville, MD) and the Consortium to Advance Patient Safety (CAPS; caps-edu.org) would seem to be a minor packaging and labeling issue: how much text to allow on caps of injection vials and similar containers. But the dispute has been going hot and heavy for over a decade, and the two sides appear to remain apart.

USP contends that only “imminent, life-threatening” information should be provided, which would exclude things like dosage strength, company logos, or even storage instructions like “keep refrigerated.” USP’s logic appears to be that unless additional information is restricted, the vial is less safe for administration.

Following a revised wording of “USP General Chapter <1> Injections, Labeling on Ferrules and Cap Overseals” USP-32, that was to have gone into effect in May, the CAPS group met with both FDA and USP and decided to sponsor a formal human-factors study of how useful labeling is. Nurses and other practitioners were studied as they completed simulated administration procedures by Dr. Anthony Andre, adjunct professor of human factors/ergonomics at San Jose State Univ. (CA). Test results shows that “less is not necessarily more” as CAPS puts it—meaning that more label information resulted in better, safer performance. Further, the USP standard would appear to exclude any anti-counterfeiting measures such as tamper-evident seals, even as other USP committees are addressing that concern.

CAPS submitted this information to USP during a comment period that ended this spring. USP’s current standard is in a proposed-final status; they could issue the standard as is, or make other revisions and subject it to a second round of review. CAPS executive director Frederick Balboni says that legal or even Congressional action is not out of the question at that point.

CAPS members include pharma companies (J&J, Allergan, Amgen), service providers (West) and industry consultants.