Have you ever had one of those little warning icons light up
on your car’s dash and you don’t know what it means? You know that some signals require attention
right away and others can wait. The
thing is, most of the time you have to look up the icon to make that decision.
When it comes to medicines and people’s lives, there is no
substitute for being clear about a warning, and for injectable drugs the stakes
are particularly high. Beginning
December 1st, manufacturers of injectable drugs will have to comply with new
labeling standards that help ensure that important warnings — warnings that can
help prevent life-threatening situations — are obvious and clear. The standards were established by the U.S.
Pharmacopeial Convention (USP). USP is a scientific nonprofit
organization that sets standards for the identity, strength, quality, and
purity of medicines, food ingredients, and dietary supplements manufactured,
distributed and consumed worldwide. USP's mission is to improve global health
through public standards and related programs that help ensure the quality,
safety, and benefit of medicines and foods.
In short, this USP standard states that warning messages – for
example, “Warning – Paralyzing Agent” or “Dilute Before Using” – are the only
markings that should appear on ferrules and cap overseals of injectable drugs. The ferrules and cap overseals must remain
clear of any markings, including logos, except for markings intended to prevent
an imminent life-threatening situation. The
standard goes on to say that warnings must be printed in contrasting color and
clearly visible under ordinary conditions of use. Finally, products that do not require
cautionary statements should be free of information, so that those with
cautionary statements are immediately apparent.
With the new USP labeling standard, if a healthcare provider
sees a warning on a ferrule or cap overseal, he or she will know immediately
that it is a vital, possibly life-saving piece of information that must be
observed and acted upon before administering the drug to the patient.
Warning messages on ferrules and cap overseals may go a very
long way to helping practitioners protect their patients from harm.