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Three times for three lives
December 31, 2015
3 Min Read
For years, Baxter has publicized its fight against medication errors. In 2002, Baxter set an aggressive deadline for bar coding all of its injectable and IV-solution products. In 2003, the Institute for Safe Medication Practices (ISMP; Huntingdon Valley, PA) recognized Baxter along with Alaris Medical Systems and B. Braun Medical with a Cheers Award for “furthering development of smart pump technology.” Soon after, the company would promote its Enlightened HRBC technology for bar coding IV-solution bags.
With this track record, it’s hard to believe that any of the firm’s products would be involved in a medication error. But according to CNN reports, D’myia Alexander Nelson, Emmery Miller, and Thursday Dawn Jeffers, all premature newborns, died in September from heparin overdoses. Instead of receiving Hep-lock U/P (preservative-free heparin lock flush solution, USP 10 USP units per ml), they received Heparin sodium INJ injection, USP (10,000 USP units per ml). Single-dose vials of Heparin sodium INJ injection intended for adult patients were somehow loaded into a neonatal drug-dispensing cart. Nurses obtained the typically adult-dose vials and injected heparin 1000 times stronger than prescribed into the premies’ IV lines.
Baxter believed it had taken several steps to prevent such errors. According to Baxter spokeswoman Erin Gardiner, the products in question featured different-colored labels (dark blue versus light blue), different bar codes, different-colored caps (one is gray and one is bright green), and different type styles.
Gardiner says that, “Prior to these unfortunate incidents at Methodist, Baxter had not received any customer complaints about perceived similarity of labeling between Heparin and Hep-lock U/P.”
Michael R. Cohen, RPh, MS, ScD, and ISMP president, says that, “when errors like this one happen, there are always multiple factors that contribute. These particular vials are not labeled all that poorly but do look somewhat alike because they are same color, size, have same drug name, etc.”
One culprit may be “at-risk behavior,” as described in ISMP’s September 21 newsletter, Medication Safety Alert. “When the nurses requested 10-unit vials, the automated device pointed them to the 10-unit storage location,” says Cohen. “Probably a thousand times in the past, the nurses stuck their hands in that bin and got 10 units/ml. They did same thing they always did—picked it up—it must be 10, they thought. But this time it wasn’t. Shouldn’t they have read the label? They probably thought they did when they saw the automated dispensing unit screen. But they should have read the label three times.”
Human nature may be at fault. ISMP points out that, “Behavioral research shows that we are programmed to drift into unsafe habits, to lose perception of the risk attached to everyday behaviors, or mistakenly believe the risk to be justified,” it writes. “Over time, as perceptions of risk fade away, they take shortcuts and drift away from behaviors they know are safer.” For example, a nurse who takes the time to practice safe habits may be criticized. But a nurse who speeds care for several patients in one shift may be admired, and others may follow her example. “Therein lies the problem,” ISMP argues.
Perhaps at-risk behavior should just be assumed and prepared for. That’s precisely how packagers can make a difference. Packaging and labeling cues could play a role in forcing practitioners to pay attention to product differences.
About the Author(s)
Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, packaging, labeling, and regulatory issues for more than 25 years. Follow her on Twitter at @daphneallen and reach her at [email protected].
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