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.
Printed with permission from U.S. Pharmacopeial Convention, USP.org.