Heparin error highlights risk and need for health care risk managers to take action

Mistake with Dennis Quaid's children brings attention

Heparin continues to pose a significant risk of dosage errors, and the recent tragedy involving actor Dennis Quaid's two young children has brought concern that hospitals have not taken the necessary steps to avoid this mistake even health care providers were warned about the risk a year ago. Risk managers must act now to avoid the same type of error, say medication safety experts.

Quaid recently announced that he is suing Baxter Healthcare Corp. in Deerfield, IL, the pharmaceutical company that manufactured the heparin involved in the incident. The actor's newborn twins accidentally were given 1,000 times the prescribed dose of the blood-thinning drug. Doctors at Cedars Sinai Medical Center in Los Angeles mistakenly administered the overdose of heparin after the children were admitted for a staph infection. The twins have recovered, according to statements released by the Quaid family, but they say the lawsuit is aimed at preventing the same mistake from happening to others. They are suing Baxter for more than $50,000 but had stated that they were not suing the hospital because they thought the root cause of the error is in the product's labeling.

A subsequent report from the California Department of Public Health conflicted with the hospital's initial report that the children each received one vial containing 10,000 units per milliliter of heparin instead of the common dosage of 10 units per milliliter. The report found that the children actually each received two of the vials. In a statement, Dennis Quaid and his wife denounced the Cedars-Sinai Medical Center over a "lack of candor" about the nature of the medical error.

The investigation also found the hospital did not adequately educate staff about the safe use of heparin and that nurses and pharmacy technicians did not check labels on the vials and did not keep adequate records of when it was used.

The Quaids' attorney, Susan Loggans, JD, in Chicago, issued a statement saying the lawsuit alleges that the mistake was made because the two bottles containing different doses of heparin share remarkably similar blue labels and a common shape. The Quaids decided to sue, at least in part, she says, because the risk of heparin overdose was known to the manufacturer. Three premature babies died at an Indianapolis hospital in 2006 when nurses inadvertently switched heplock with the much stronger heparin. After that incident, in a safety alert dated Feb. 6, 2007, the Food and Drug Administration and Baxter warned of the dangers of switching 10- and 10,000-unit vials of the drug. However, the company did not change the product's packaging at the time.

After the incident with the Quaid children received extensive media attention, Baxter announced that it is introducing new packaging designed to help caregivers avoid the same error. A company spokesman says Baxter is now producing heparin products with the new labeling but that health care providers still may have heparin with the old labeling in stock.

Incident highlights major risk

Michael L. Langberg, MD, chief medical officer at Cedars-Sinai Medical Center, says the Nov. 18, 2007, incident with the Quaid infants was a "preventable error, involving a failure to follow our standard policies and procedures, and there is no excuse for that to occur at Cedars-Sinai." Unfortunately, the Cedars-Sinai incident is a reminder of how such preventable errors can occur even at high-quality institutions and after explicit warnings, says Marlene R. Miller, MD, Msc, vice president of quality at the National Association of Children's Hospitals and Related Institutions in Alexandria, VA.

Heparin poses particular challenges for risk management, Miller says. Unlike many other drugs, heparin often is readily available on patient care units, and there is a higher dependency on caregivers to select the right product and dosage, she says. "That is different from many other drugs where you have to order it for the patient and there are more safeguards in place to make sure you're using the right thing," she says. "With heparin, it tends to sit around the unit more because there is such a high need for it. So it does pose this extra risk when you have multiple concentrations sitting around."

Miller says she supports the Quaids' decision to sue the manufacturer and not the hospital. While there is no denying that frontline caregivers made the actual error in administering the drug, she says they were set up for failure by the product design. "They two labels look nearly identical, with a lot of information in tiny print, and one of those tiny bits of information is the concentration," she says. "The key difference is how many zeroes you see, and you have to look closely."

Risk will continue

The similar packaging and small print put the burden on the caregiver to scrutinize each vial every time heparin is used. Miller says that is a recipe for disaster, and the heparin overdoses were practically inevitable.

"With packaging like that, you're left to rely on vigilance, and we know that fails," she says. "It's hard to be vigilant when the name of the drug is different, but when the name is the same and essentially everything is the same except the number of zeroes, that's tough."

Miller says Baxter's new packaging for heparin is encouraging, but the risk will exist as long as the old product packaging is in use. Miller advises risk managers to be proactive in reducing the risk of heparin overdoses. One option, she says, is to prohibit or sharply curtail how much heparin is stored on patient care units, making it available by request from the pharmacy as with many other drugs. That is an imperfect solution, Miller notes, because concentrated heparin is needed frequently on patient care units to flush central lines.

"So how do you make sure it's not a barrier to good care, that you can get it when you need it?" she asks. "But that is the approach that has worked with other medications like hypotonic saline, when you had very concentrated, dangerous medications. They have to be stored separately from all the low-concentration medications."

Verify how heparin is stored and used

The best, most immediate, step for a risk manager is to go for a walk around patient care units and see how heparin is stored and used, Miller says. Are there more vials than necessary in patient care areas? Is there any separation of the two concentrations? Do staff know to double-check the concentration every single time they use heparin?

Baxter is changing packaging for heparin

The primary manufacturer of heparin is changing the product packaging that has been blamed for dangerous dosing errors. Baxter Healthcare Corp. introduced the new drug safety initiative at the 2007 midyear clinical meeting of the American Society of Health-System Pharmacists.

The initiative is intended to help reduce medication errors "by creating enhanced packaging that provides additional safeguards to assist clinicians in the correct identification of critical medications," the company states. The company plans to improve packaging and labeling for many of its products, but as one of the top five high-alert medications as designated by the Institute of Safe Medication Practices, heparin is the first medication offered with the new enhanced label. The label features an increase of 20% font size, a unique color combination, and a large red cautionary tear-off label. Baxter is now producing heparin products with the improved labeling, but a spokesman points out that health care providers still may have products with the old labeling in stock.

According to the Institute of Medicine, 1.5 million Americans are injured each year from medication errors in hospitals, nursing homes, and outpatient clinics/surgery centers. An estimated 7,000 Americans die each year as a result of medication errors. Incorrect drug administration accounts for the largest proportion of harmful medication errors. High-alert medications bear a heightened risk of causing significant harm to patients when administered incorrectly or in error. Sixty percent of life-threatening or lethal errors involve intravenous (IV) drugs such as heparin.

In a statement released by the company, David Bonderud, U.S. Region president of Baxter's Medication Delivery business, says Baxter conducted multiple interviews with more than 100 pharmacists, physicians, and nurses to identify areas for improvement. The feedback received from health care professionals guided the design of the new vial packaging.

In research conducted after the three-phase development program, clinicians indicated that the new packaging design enhancements addressed the current clinical needs for safer injectable drug administration and could help reduce medication errors.

"I remember when I was a resident seeing units that had plats of 50 bottles just sitting there, wide open for anyone to grab, and then the next little plat over is the more concentrated stuff," she recalls. "I imagine there are still hospitals doing that. That would be the first step, the no-brainer, to just go see how it's used in your facility."

Miller points out that while the most notorious incidents have involved pediatrics, the risk of heparin overdose is an issue with adults also. So don't restrict your efforts to the pediatrics units. "Having both vials there in open storage, so the nurse can just grab it when you need it, is probably the most dangerous way to use heparin," Miller says. "Even if you don't sharply restrict access like with other dangerous drugs, there should be something in place like requiring a supervisor confirm the correct concentration. We can't count on one overworked nurse counting the right number of zeroes on the bottle every time."

Serious malpractice liability

A hospital making such an error with heparin would face significant potential for liability, says C. Scott Nichols, JD, an attorney with the law firm of Strasburger & Price in Houston. Though he won't comment on the specifics of the Cedars Sinai incident because he doesn't know details, Nichols says the likelihood of being sued after such an error often depends on how the hospital responds when the error is discovered.

"If they revealed the error, and then made attempts to change the process that results in this error, that is always a good start," Nichols says. "If the hospital was up front, apologetic, and eager to make amends, that could be why the family chose not to bring a lawsuit against the hospital. That is often what we see in these cases."

Cedars-Sinai appears to have avoided a lawsuit, but Nichols points out that any hospital's exposure is great when it already was aware of the potential for this error, yet it still occurs. Because there was a major alert about exactly this type of error a year ago, the patient could wield that fact effectively in court.

"Hospitals often can look back and say that the event was easy to prevent if only they had taken some simple steps, like not storing these two concentrations together, or marking the vials differently," he says. "It sounds to me like they took notice of the potential for error but didn't really change their policy. If the family had chosen to sue them, that might have been a hard to case to defend."

Sources

For more information on preventing heparin errors, contact:

  • Michael Langberg, MD, chief medical officer, Cedars-Sinai Medical Center, Los Angeles. Telephone: (310) 423-3277. E-mail: michael. langberg@cshs.org.
  • Susan Loggans, JD, Susan E. Loggans & Associates, Chicago. Telephone: (312) 201-8600. E-mail: loggans@logganslaw.com.
  • Marlene R. Miller, MD, Msc, Vice President of Quality, National Association of Children's Hospitals and Related Institutions, Alexandria, VA. Telephone: (703) 684-1355. E-mail: mmiller@nachri.org.
  • C. Scott Nichols, JD, Strasburger & Price, Houston. Telephone: (713) 951-5621. E-mail: scott.nichols@strasburger.com.