More Consistency Needed in Labeling to Reduce Medical Errors

Originally published by our sister publication Anesthesiology News

BOSTON—In a time-crunched hospital environment, a lack of consistency regarding labeling increases the risk for drug administration errors, experts warned during presentations at the 2024 Anesthesia Patient Safety Foundation (APSF) Stoelting Conference.

As more drug manufacturers enter the market, disparate recommendations and unenforced regulation pose an increasing risk.

“When I started with Fresenius Kabi 12.5 years ago, we had 60 generic manufacturer competitors within our addressable market,” said Angie Lindsey, the vice president of marketing at Fresenius Kabi USA, in Lake Zurich, Ill. “Today we have 123.”

“You think about all of those companies coming into the market, bringing vials; that’s where this variability is coming from,” she added. “We do not have specific standards we are following when we’re selecting label and cap colors for our products. New entrants are coming into the market, with more colors, more variability, making the risk for a look-alike error incredibly difficult to predict.”

When done correctly, medication labeling can reduce medication errors, help identify the correct drug and make dosing errors less likely, said Rick Botney, MD, an anesthesiologist based in Portland, Ore., and a member of the APSF Medication Safety Patient Safety Priorities Advisory Group.

Labels may also include additional important information such as the patient’s name, the medication’s route of administration and the medication’s expiration date.

“Although we know errors can still occur even when labeling is correct, it does not change the fact that labels are a necessary and important part of the error reduction process,” he said.

While standards, guidelines and statements regarding labeling exist, they often vary and typically serve different purposes.

“Standards provide the expectation that a measurement or production of an item will not vary and can therefore be trusted—that things are done in a uniform way so that outcomes do not change and are reliable,” Botney said. “In addition, standards are typically viewed as requirements, which are enforceable.”

In contrast, guidelines act as recommendations for clinical purposes and lack the authority of standards, he said. Statements provide additional guidance but typically do not have enforceable authority.

In 2004, the American Society of Anesthesiologists (ASA) published a statement on labeling of pharmaceuticals for use in anesthesiology, outlining standards for the design and use of labels.

“The gist of the statement was that the main consideration in label design was to reduce medication errors and promote safer patient care,” Botney said. “The statement also showed support for the use of medication labels that were consistent with the ASTM D4774 Standard Specification for User Applied Drug Labels in Anesthesiology.”

The ASA revised the statement in 2020, providing guidance on label content, color coding, font choices and the use of tall man lettering to visually differentiate established medication names. Other items include bar coding, text and background contrast, label material, label placement on syringes and readability in various conditions such as low light.

In 2008, “the International Organization for Standards [ISO] had published an international standard for label design, so the statement supports the use of labels consistent with both ASTM and ISO standards, as well as recommendations from the FDA and the Institute for Safe Medication Practices,” Botney said.

Complicating matters, ASTM, which has long developed and published voluntary consensus standards created with the input of over 30,000 experts from over 140 countries, withdrew its labeling standards in 2022.

“This means they are no longer available for reference by organizations such as pharmaceutical manufacturers or label producers,” he said.

In an effort to address this, APSF became a member of ASTM, and Botney has been working to get the standards reinstated and revised where necessary.

The reinstatement is necessary, Botney said, as numerous differences exist between the now-withdrawn ASTM standards and the ones released by the ISO.

One way this is reflected is through the terminology used for certain drug names, such as “succinylcholine” in the United States versus “suxamethonium,” which is used in many international locations. Additionally, D4774 identifies nine unique drug classes and provides color coding for them, whereas the ISO guidelines only identify eight drug cases.

In her presentation, Lindsey broached the topic of how regulations regarding colors used for labels and vial caps may help practically address the confusion caused by lax manufacturing regulations.

“Could standardizing color add another layer of safety to our system?” she asked.

Jeffrey M. Feldman, MD, an attending anesthesiologist in the Department of Anesthesiology and Critical Care Medicine at Children’s Hospital of Philadelphia, agreed that such an approach may be beneficial.

“The labels that we traditionally have put on syringes that we make in the operating room are color coded, and there are standards for those label colors based on drug class,” he said. “The problem is that that same color-coding process is not consistent on vial caps.”

This inconsistency, Feldman added, means that the color coding of a vial cap does not consistently confer an advantage in selecting the proper medication and contributes to the confusion of selecting the wrong vial.

“Often the colored vial cap is the first thing you see when you look in the drawer, and unless you are purposeful about reading the label, it is possible to end up using the wrong vial,” he said. “In my view, the color coding of caps currently contributes to confusion around selecting the right vial rather than making it more likely to select the right vial.”

In conclusion, Botney emphasized the importance of consistent labeling to reduce the risks commonly faced by anesthesiologists.

“Labels are important for reducing medication errors and improving medication safety, and label design matters in that endeavor,” he said. “Standards provide important guidance for label design.”

By Ethan Covey

Botney, Feldman and Lindsey reported no relevant financial disclosures.