There's More to the 60 Minutes Story on Heparin Errors
On March 17, 2008, CBS aired a 60 Minutes segment featuring interviews with Dennis Quaid and his wife Kimberly Buffington who shared their thoughts about the medication errors that happened to their newborn twins in November 2007. The errors involved the accidental administration of heparin withdrawn from vials (manufactured by Baxter) containing a concentration of 10,000 units/mL rather than the intended flush concentration of 10 units/mL. According to Mr. Quaid, the 1,000-fold overdoses caused bleeding in both twins, but fortunately, there are no signs of permanent harm.
Similar errors occurred in another hospital in 2006, which also attracted media coverage, particularly because three infants died as a result of the errors. (Click here for details about these errors in our September 21, 2006 and November 29, 2007 newsletters.) In response to the 2006 errors, ISMP, FDA, and Baxter issued nationwide safety alerts to healthcare providers, and Baxter redesigned the label and packaging of the 1 mL heparin vials containing 10,000 units/mL (as well as 1 mL vials of 5,000 units/mL and 1,000 units/mL strengths) to help distinguish them from vials containing lower concentrations of heparin flush solutions. However, heparin vials with the newer labels had not yet reached the hospital where the Quaid twins were being treated.
When describing the errors, the 60 Minutes segment focused primarily on the similarity of the heparin vial labels and the nurses' failure to read the labels correctly. But these types of errors involved additional human factors and system failures that were never mentioned during the segment. While CBS investigators were traveling across the US to gather background information for the feature story, staff from ISMP and other patient safety organizations shared with the investigators how these factors contributed to the errors. A few examples follow.
CBS investigators heard how confirmation bias can cause any healthcare practitioner to overlook disconfirming evidence when reading a medication label, particularly a label that looks similar to a product label the practitioner believes he is reading. That is, if two products have similar labels, the practitioner tends to see only what he thinks he should see for the intended product, missing information that signals he has selected the wrong product. Confirmation bias is particularly prevalent in cases where the correct product or strength was previously available in a designated storage area hundreds of times before the event (as were the heparin flush vials when these errors happened). Yet, the 60 Minutes segment most likely left viewers with the belief that the nurses simply didn’t bother to read the labels on the heparin vials.
Next, it was emphasized to CBS investigators that safe and reliable healthcare cannot be achieved through human vigilance alone, and that sole reliance on practitioners to read medication labels and interpret the information correctly is ill advised. Perfect performance on any task is impossible as evidenced by the safety science of human factors engineering and our own personal experiences. We cannot expect practitioners—no matter how experienced and vigilant—to be infallible. Indeed, in both the 2006 and 2007 events, multiple nurses and pharmacy technicians all made the same human error when selecting the heparin vials. Instead, we stressed the need to anticipate human fallibility and thus establish reliable systems to prevent errors or detect errors before they reach patients. As a practical example, we suggested point-of-care bar-coding systems, which we estimated could be implemented in every US hospital for less than $10 billion. But the 60 Minutes segment missed a great opportunity to promote bar-coding and other systems that improve the robustness and reliability of the medication use process.
ISMP also suggested that healthcare providers should assess whether 10,000 units/mL strength heparin vials are really needed in their organizations. In many cases, this strength of heparin can be eliminated given other available strengths (e.g., 5,000 units/mL) that may be less likely to be confused with other heparin strengths or cause harm if used in error. The decision to dispense vials of heparin rather than commercially available or pharmacy-prepared unit-dose syringes of heparin flush solutions to the neonatal intensive care unit was another underlying factor that contributed to the near-tragic errors experienced by the Quaid twins.
Another missed opportunity during the 60 Minutes segment was emphasizing the need for all healthcare providers to be proactive and learn from errors that have happened elsewhere. We provided newsletters to CBS in which mix-ups between the 10,000 units/mL and 10 units/mL vials of heparin had been described along with interventions to prevent similar events from happening in other organizations. We also shared the ISMP Quarterly Action Agenda and reviewed how the tool could be used to initiate changes before serious medication errors occurred in other facilities. With no regulatory or accrediting bodies requiring proactive risk-reduction activities in healthcare, we had hoped that 60 Minutes would seize the opportunity to promote this as a fundamental responsibility for all healthcare providers and other key stakeholders—from FDA to the pharmaceutical industry. Unfortunately, this didn’t happen.
ISMP supports an error-reduction strategy that the news segment did highlight throughout the broadcast: the need to consider a recall of products that pose a threat to patient safety. We can’t say whether 1 mL vials of 10,000 units/mL heparin with the older labeling should have been withdrawn from the market. ISMP is not in a position to measure the impact of such a withdrawal (although a current shortage of this important product exists after a heparin recall due to manufacturing concerns). At the time of the event, the potential shortage of the product could have presented greater hazards to patient safety than leaving the vial on the market until an adequate supply of the vials with new labeling and packaging were available. And to give credit where credit is due, Baxter was responsive to the need to change the label, which in itself was a considerable undertaking, from design of the label to market testing and FDA approval. While there are a growing number of exceptions, too many pharmaceutical companies remain passive, sitting tight and suggesting that “reading the label is Nursing 101,” or they believe that sending letters to healthcare practitioners to increase awareness of labeling problems suffices. Nevertheless, as we’ve said before, FDA and manufacturers should be required to conduct an assessment of the impact that withdrawing a problematic medication would have on patient safety, and take immediate action when safety calls for a withdrawal.
Media attention can often serve as a catalyst for change. Thus, we applaud 60 Minutes for bringing attention to medication errors, although we hope a more complete and balanced picture will be presented in further segments on the topic. We also thank the Quaid family for sharing their story publicly, supporting the need for changes in healthcare to promote patient safety, and challenging healthcare providers to be more transparent in regards to medical error. Although the segment’s tone implied otherwise, ISMP strongly believes that healthcare organizations are working hard to strengthen the many system weaknesses that have led to medication errors. As such, we hope the 60 Minutes segment sparks realization that the same error could happen in other healthcare organizations where therapeutic heparin and heparin flushes are used, and that action must be taken now to prevent a similar error from happening again.