Medical Errors: Part 2

by Food and Drug Administration (FDA)

(Page 2 of 4)

In one case, a physician wrote a prescription for "Celexa 200 mg." Since the antidepressant drug is available in only 20 and 40 milligram doses, the doctor was called, and he corrected his prescription to the intended Celebrex 200 mg. In response to such reports, the co-marketers of Celebrex, G.D. Searle & Co., Chicago, Ill., and Pfizer Inc., New York, have undertaken an educational ad campaign to alert health professionals to the possible mix-ups.

Under FDA's authority to regulate drug labeling, the agency's new Office of Postmarketing Drug Risk Assessment evaluates medicines' brand names in an attempt to avoid sound-alike and look-alike names. If FDA considers the name of a new medical product to be potentially confusing to health professionals, the agency works with the drug company to change the product's name. FDA is developing new standards to prevent such name mix-ups, as well as to prevent confusion between similar-looking drug packaging.

Also, the agency is developing new label standards to highlight common interactions between drugs so that doctors are less likely to mistakenly prescribe dangerous combinations. And even after a drug is approved, FDA monitors its use to see if unexpected adverse events occur and whether any labeling changes are required to help avoid medication mishaps.

So where does FDA's responsibility end and the health professionals' judgment take over? "FDA must do everything within its authority to maximize the likelihood that approved products will be used correctly in the real world," says Honig. But, he notes, "We don't regulate the practice of medicine, such as the sloppy handwriting when prescribing a drug."

The real-world practice of medicine occurs within an intricate system, says Woodcock. "It's that complexity," she says, "coupled with the limitations of humans, that makes avoiding mistakes a consuming task."

Human Limitations

As its title — To Err Is Human — suggests, the IOM report supports moving away from the traditional culture of "naming, shaming, and blaming" individual health providers who make mistakes. Instead, the institute believes that preventing future errors is best achieved by designing a safer overall system.

Woodcock supports that view. Most health-care practitioners are competent professionals who are vulnerable to error simply by virtue of being human, she says. The professionalism model — "If we train people enough, they won't make a mistake, and we'll punish them if they do" — has outlived its usefulness, according to Woodcock. "People have made mistakes and been drummed out of their professions. They were the ones unfortunate enough to administer the lethal dose, but the systems were not in place to adequately support them in preventing such an error."

Some medical centers have begun using computer programs and other system supports to curtail medical mishaps by double-checking the care decisions doctors and nurses make. Even simple computer systems that use electronic prescriptions in place of handwritten ones have in some cases already paid off with substantial error reductions.

But systems, too, can fail, cautions Raymond L. Woosley, M.D., a professor and chairman of pharmacology at Georgetown University Medical Center. Woosley's example: "It's true that if you have a prescription drug with an electronic bar code on it — the right code — it can help prevent errors. But if the wrong code is on there, you may have even more errors. There will always be mistakes, though they will be different mistakes as the systems change. You've got to be ready to handle them."

Despite technological advances, preventing mistakes will always depend on the vigilance of health professionals, Woosley says. Otherwise, human carelessness can render useless the very systems designed to avert mistakes. Even among pharmacies with a computer program to highlight dangerous drug interactions, according to a study published in the Journal of the American Medical Association, one-third of pharmacists nevertheless continued to fill prescriptions for a known killer combination: the prescription antihistamine Seldane (terfenadine) with the antibiotic erythromycin. (Seldane has since been removed from the market.)

"The pharmacists would get the computer warnings and zip right on by them," Woosley says. "Or they would turn off the program entirely." Why turn off the computer program? Because, Woosley explains, it was slowing down the pharmacists when they wanted to print labels.

Health professionals "are trained to memorize everything and are rewarded for it," says the pharmacology professor. "The medical student who says, 'I don't know; I've got to look it up,' is likely to fail an exam, yet that's the one who is less likely to make an error." Woosley hopes medical students will be taught to accept their limitations and admit their mistakes. Under the current system, however, some people call that goal pie-in-the-sky.

Culture of Secrecy

Neonatologist Margaret Donahue, M.D., says the fear of being sued suppresses discussions about medical errors. "Even if a procedure is done with the best intention and skill, and it doesn't turn out the way it was supposed to, the doctor often still ends up having to pay the patient a huge settlement. It's that culture — the feeling they're going to lose no matter what they do — that keeps physicians closed among themselves."

Historically, people have looked for someone to blame when medical accidents happen, according to FDA's Woodcock. For victims and their relatives, she says, there may be some satisfaction in that. But from the perspective of fixing the problem, the secrecy that results keeps the medical community from learning what happened and how to correct the problem.

Most experts agree that mandating medical error reporting, in itself, will not surmount the hesitancy of doctors. More than 20 states currently have mandatory reporting systems, yet state officials say that underreporting persists.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.