New Packaging Addresses Risk
By Anastasia Thrift
A new color, larger font, and a tear-off paper warning label mark Baxter’s new heparin packaging, shown at right.
Baxter Healthcare Corp. (Deerfield, IL) has designed a new 10,000 units-per-milliliter heparin vial to distinguish it from the 10 units-per-milliliter concentration. The company highlighted this design, which officially launched in October 2007, as part of a new drug-safety initiative it announced December 2 at the American Society of Health-System Pharmacists’ midyear clinical meeting in Las Vegas.
“The significant input of over 100 clinicians was an integral part of the enhanced label design,” says Christopher King, medication delivery communications senior manager at Baxter. The company changed the label color from blue to black, increased the font size by 20%, printed a red warning label at the top, and added a tear-off paper, cautionary label with a collar that requires “clinician intervention prior to opening,” King says.
“The company continually evaluates packaging and labeling enhancements or changes to assist healthcare professionals in reducing the risk of medication errors,” King adds.
Errors involving heparin have recently gained attention. In December, a lawsuit for negligence in a heparin overdose case was filed against Baxter. Actor Dennis Quaid and his wife, Kimberly, filed the $50,000 product liability suit against the company after the Quaid’s newborn twins received blood-thinning medication 1000-times stronger than prescribed. The Quaids contend that the drug’s packaging led to its misuse.
According to a statement issued by the hospital, nurses at Cedars-Sinai Medical Center in Los Angeles administered doses of heparin in 10,000 units-per-milliliter strength, as opposed to the 10 units-per-milliliter strength necessary, to the Quaid twins and a third infant on November 18. Similar overdoses of the anticoagulant were reportedly the cause of death for three newborns in an Indianapolis hospital a year earlier.
The lawsuit claims that Baxter “failed to recall the 10,000 units-per-milliliter vial of heparin when it had actual knowledge that prior infant deaths had occurred as a result of medication errors.” It also claims that Baxter failed to repackage the higher-dosage vials. The three infants treated at Cedars-Sinai are reportedly at home in stable condition.
Three newborns died and three were injured in September 2006 at Methodist Hospital in Indianapolis after similar heparin overdoses. In this and the most recent case, nurses apparently reached for vials of the proper medication in a designated area, but the packages had been replaced with the higher dosage.
As of press time, Baxter had not been officially served with the suit and was unable to comment directly on it. The company maintains, however, that its product does not bear primary responsibility for such errors.
“This is not a product issue; the issue here is about improper use of a product,” King says. “Heparin is one of the most commonly used generic drugs in a hospital setting and plays a vital role in treatment of thousands of patients every day, when administered and used properly.”
The previously similar-looking labels of the two formulas came into focus at the time of the Indianapolis case. Groups such as the Institute for Safe Medication Practices (ISMP; Huntingdon Valley, PA) pointed out this potential for error. ISMP lists heparin among the top eight high-alert medications, which reportedly cause more than 31% of all medication errors. Hospital staff acknowledged responsibility in the Los Angeles case.
“This was a preventable error, involving a failure to follow our standard policies,” Michael L. Langberg, MD, Chief medical officer, Cedars-Sinai, said in a November 20 statement.
This potential lapse in close examination could be owing to the “human factor.” FDA defines human factor as the interaction of human abilities, expectations, and limitations with work environments and system design. It accounts for many medical errors.
Each year, 1.5 million medication errors occur in American hospitals, nursing homes, and outpatient clinics or surgery centers, according to the Institute of Medicine. The fatality rate of such errors is estimated at 7000 Americans per year.
The 2006 ISMP fourth-quarter recommendations report, which directly followed the Indianapolis case, made several suggestions to combat future errors. ISMP suggested that hospitals remove any products considered unsafe and have pharmacies provide the medication as prescribed; take steps to reduce the risk of confusing products with look-alike labels and/or packages; and consider the use of bar code technology when stocking and removing medications from ADCs (automated dispensing cabinets).
A recent teleconference produced by MedERRS, a for-profit subsidiary of ISMP, targeted human factors. “Spotlight on Medication Safety: Designing Safe Packaging and Labels” discussed the potential for design to correct common errors in healthcare facilities.
Another strongly urged tactic for preventing damage caused by human factors was bedside bar coding. Additionally, conference speakers said, mandatory package bar codes could create very specific rules for dosing individual patients.
“[About] 20% of hospitals have bedside coding, which helps with drug mix-up,” says Michael R. Cohen, ISMP president and author of the book Medication Errors. He adds that without bar codes, the burden falls heavily on packaging. “You can see how these could lead to mix-ups.”
Cohen referenced a recent Harvard study that examined the error rates before and after the implementation of bar codes. It showed that the rate of dispensing errors targeted for reduction by bar code technology fell by 85%. In addition, the potential adverse drug events (or dispensing errors with the potential to harm patients) rate fell by 63%.
Until bar coding becomes fully utilized by hospitals, companies such as Baxter aim to continue error prevention through their packaging. They insist that they cannot succeed, however, without aid from healthcare professionals.
“While Baxter strives to clearly differentiate its products and dosages, no amount of differentiation will replace the value of clinicians carefully reviewing and reading a drug name and dose before dispensing and administering it,” King says.