Quaid Twin Fiasco: It’s All in the Label

November 12th, 2009. By Hunter West

This past September Hospira was approved for a heparin product that features, according to its web site, an ‘enhanced label design.’ Among the features of the label design are, “vibrant label colors to each strength, simplified text and increased font for dosing information, and differentiated warning labels”.

Sounds pretty basic. A hospital is a high-stress environment. Decisions have to be made quickly and accurately with split-second timing. Often there are parents, or loved ones in the room panicking. And while doctors and nurses are trained to focus on the task at hand and resist becoming distracted by any outside force that may take away from the direct relationship between practitioner and patient, the fact remains that people are human and things can get confusing.

Thus, the labeling of medication in such an obvious fashion as to ensure that the wrong medication, or strength is not fed to the wrong individual seems pretty obvious. In a quiet room without distraction a practitioner has the opportunity to carefully size up the vial and the label before injecting the substance into his patient.

However hospitals—and especially the ER—are far from quiet. There are a thousand-and-one things going on at once as you reach for that vial. Did I check the label? Oh, I’m sure I did. This is the right stuff…

For Kimberly and Dennis Quaid, it turned out to be the wrong stuff.

Most will remember the lawsuit the actor launched back in 2007 after their twins, born November 8^th of that year, were injected with heparin at 1000 times the recommended dose. Thomas Boone and Zoe Grace received the heparin November 18^th and were hospitalized two days later at Cedars Sinai Medical Center in Los Angeles, gravely ill.

Prior to the suit being filed a spokesperson for Baxter Healthcare Corporation told People Magazine, “this is not a product issue. The issue here is improper use of a product. Heparin is one of the most commonly used generic drugs in a hospital setting manufactured by seven companies in standard vials,” Erin Gardiner said. “It plays a vital role in the treatment of thousands of patients everyday when administered and used properly.”

However the lawsuit claimed that the vials containing 10-units-per-milliliter, and that of the 10,000-units-per-milliliter were virtually identical.

At the time the Quaid’s legal counsel said in a statement to the magazine that as many as 1.5 million medication errors occur in the United States each year.

Could it be the labeling? Are medication labels, delineating different strengths of the same product, sufficiently unique?

When students learn to drive, they are taught far more than a simple operation of the car and the rules of the road. In the era of the GPS, the cell phone, the mobile office and texting, defensive driving has been elevated to far more than just a good idea. It’s survival. In a perfect world, a driver memorizes the Department of Motor Vehicles rulebook and learns to safely pilot a car. Assuming everybody else does exactly the same thing, you should be fine and all will be right with the world.

But Pleasantville does not exist. And the smart driver not only has amassed some quality defensive driving savvy, she EXPECTS other drivers to screw up. She’s looking for the idiot to attempt a lane change while dialing somebody on the cell phone, or attempting to navigate traffic while crafting a response to the offer on the laptop on the seat beside him that simply can’t wait.

To assume everyone else is paying as close attention to the task at hand as you are, is naive.

If it is true that there are more than a million medication errors every year, then it begs the question—is product labeling contributing to the problem? That was the allegation with the Quaid lawsuit against Baxter.

While there were no actual photographs or mock-ups available on the Hospira site to demonstrate their labeling strategy for heparin, it sounds like they have the right idea. And any medication manufacturer who does not design a series of labels that takes into account the high-stress, high-drama and often confusing setting of a busy ER or hospital is not only missing the point…

They could be inadvertently contributing to the grave complications, or even to the deaths of human beings. Could labels that are brightly colored, or vials that differ in shape to the point of being ridiculous, translate to a life saved? In a panic situation, it just might.

In California back in the summer, four people were killed when the car they were driving experienced a fault with the accelerator system. The engine raced, the brakes failed and the panic-stricken occupants either did not know or were too fearful to realize that the engine could be turned off by pressing a button on the dashboard and holding it for three seconds. A good idea on paper? Sure. Doable in the driveway at a dead stop? Of course. Careening along an expressway at 120 miles an hour and heading for an intersection?

Possibly not.

Conversely, a pharmaceutical manufacturer must always assume that the medication will be dispensed and administered in the most stressful environment possible, with multiple distractions. That might be an over-compensation and may push the envelope beyond the everyday. But for most planners, the mantra is plan for the worst.

The message, then, is plan for panic and overcome it by making labels and vials foolproof in terms if identification. Panic and confusion, while the exception, will happen. And any manufacturer that doesn’t take that into account could be doing worse than a simple disservice to patients and practitioners. They could be killing people.

At least one manufacturer appears to have the right idea.

Tags: Baxter, Dennis Quaid, Heparin, Hospira

This was posted on Thursday, November 12th, 2009 at 10:21 am and is filed under Drugs/Medical, Emerging Issues . Feel free to respond, or trackback. Read our comments policy.