Group Challenges Proposed Limits on Vial Labeling

Article by Erik Greb on PharmTech.com on 10 June 2010



US Pharmacopeia’s (USP’s) Nomenclature Expert Committee has proposed that printing on ferrules and cap overseals should be restricted. They felt that healthcare professionals should rely exclusively on package inserts and vial labels for information about drug products. The organization proposed limiting cap messages to a small set of drugs that pose a risk of imminent harm or death in the event of medication errors.

But this has been challenged by the Consortium for the Advancement of Patient Safety (CAPS) who described the proposal as "ambiguous and could unintentionally reduce patient safety."

CAPS hired Anthony Andre from Interface Analysis Associates and adjunct professor of human factors and ergonomics at San Jose State University, to study the relationship between patient safety and messages on ferrule and cap overseals. A literature review did not find any reported incidents of medication errors that were associated with cap messages, and it was felt that the human-factors principles found in scientific literature did not support the premises of USP’s proposal. An online survey of healthcare practitioners resulted in about 80% of respondents predicting that medication errors would increase if many of the currently allowed cap messages were prohibited and roughly 69% disagreeing with USP’s approach to making warnings more prominent for healthcare professionals.

An empirical human-factors study was carried out. 20 participants included nurses, physicians, and pharmacists who normally handle drug vials and check drugs against prescriptions had to select the correct drug from a group of drug vials, some of which had cap labels that would be prohibited by the USP proposal, and some of which did not. Participants selected drugs with cap labels more accurately and more quickly than they selected unlabelled drugs, according to the report. Participants rated the labelled drugs as easy to use more often than the unlabelled drugs.

I can't comment on whether USP or CAPS is right on the subject. But I am concerned that the CAPS study has only looked at the likelihood of error and not the risk. Some drug administration errors can be fatal and irreversible, whilst others are far more final. It could be the case that reserving this labelling for where it really matters may, as suggested, lead to more errors but may actually reduce risks.