Proposed USP limits on vial labelling “ambiguous and vague”, says CAPS

By Gareth Macdonald

- Last updated on GMT

Related tags: Pharmaceutical drug, Pharmacology, Drug

The Consortium for the Advancement of Patient Safety (CAPS) says research shows that USP plans to restrict printing on pharmaceutical vial ferrules and caps are “ambiguous and vague.”

The proposals in question are the United States Pharmacopoeia’s (USP) revision of its General Chapter 1 rule on “Injections,Labeling on Ferrules and Cap Overseals”​ that would limit printing and other types of messaging on drug packages.

The USP’s aim of the revisions, which are due to come into effect in May next year, is to reduce the risk of accidental misuse of such drugs by ensuring that “only cautionary statements [are] to appear on the caps and overseals​”.

In a presentation to the USP’s Nomenclature Expert Committee last month the group said that of 300 US healthcare professionals surveyed 80 per cent foresee an increase in medication errors if the new USP proposals are implemented.

CAPS, whose members include pharmaceutical firms, drug packaging manufacturers and marketing professionals, also revealed that 69 per cent of respondents disagreed with the USP approach to limit printing as a way of improving safety.

The study, conducted on CAPS’ behalf by Anthony Andre, adjunct professor of ergonomics at San Jose University, was accompanied by a literature review that the group said showed that cap messages had not been implicated in any reported medication error.

Dr Andre commented that: “The gist of the USP proposal is to restrict messages on the caps of drug vials, messages that have never been implicated in medication errors or patient deaths.

“In contrast, the science of human factors, coupled with our recent research, shows that the cap area is an underutilised and highly visible area of the drug vial that is well-suited to present key medication and warning information​.”

The findings are in keeping with repeated comments that both CAPS and other industry groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) have made since the USP first tabled the revision plans in 2008.

Matthew Heyman, USP vice president of external affairs and strategic integration, welcomed the findings telling in-Pharmatechnologist that: “USP appreciates that CAPS provided data in support of its comments on the proposed standard​.”

Heyman went on to say that because the Nomenclature Expert Committee is in the final decision-making process for this standard it would be inappropriate for USP to comment further on CAPS’ input.

Related topics: Drug Delivery, Regulations

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