Using Label Technology to Encourage Safe Drug Administration

The Institute for Safe Medication Practices (ISMP) maintains a list of high-alert medications, which are those drugs that carry a heightened risk of causing significant patient harm if used in error. Midazolam, a moderate sedation agent, is on that list. Categorized as a Schedule IV controlled substance, midazolam is used to cause temporary amnesia in order to prevent patients from recalling a procedure or surgery.

Baxter Healthcare Corp. believes that distinctive labeling for Midazolam Hydrochloride injection can help clinicians address medication errors. On all of its midazolam injection products manufactured after July 1, Baxter is introducing tear-off labels that are designed to require clinical intervention prior to administration.

“The tear-off labels serve as an extra reminder,” explains Erin Gardiner, director of corporate communications, for Baxter. “We underscore the importance of reading labeling, and the tear-off feature will help encourage clinicians to do so.”

The patents-pending label technology, developed by Baxter, was first introduced for heparin, in October 2007. (Baxter recalled all of its heparin products in 2008 and has not recommercialized it.)

Midazolam is the second of Baxter’s products to be introduced with the distinctive labeling. Use of the labeling is part of Baxter’s greater initiative to fight administration errors and improve patient care in conjunction with the use of its products, Gardiner says.

Midazolam was a good candidate for such labeling, Gardiner says, because it met Baxter’s three criteria for action: it was included on the ISMP list, it could cause significant harm if used in error, and such errors could be mitigated by using enhanced labeling.

Color is also used to encourage safe administration. “Three distinct colors were used to ensure differentiation among the strengths,” says Gardiner. “There also are three distinct colors for the potency block concentrations, which was done to further enhance differentiation. Also, for reference, the colors were an extension of the original midazolam label.”

Bar coding is also employed. Midazolam has a standard GS1 Data Bar on the vial.

Reducing administration errors offers huge benefits to patients, Gardiner says. When asked whether such safety improvements can play a role in healthcare reform, she noted that Baxter is following reform efforts closely to determine Baxter’s potential role.

Baxter points out that the extra medical costs associated with treating drug-related injuries in hospitals alone conservatively amount to $3.5 billion a year, according to a report from the Institute of Medicine.

This article was originally published in PMP News's ePackage Newsletter August 4. To subscribe, click here.

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