Should healthcare wear a warning label?

When a recent report singled out medical mistakes as a leading cause of death and injury in this country, the moment for serious soul-searching arrived for the health care industry.

By RANDOLPH FILLMORE

© St. Petersburg Times, published February 9, 2000

Nov. 29, 1999, was Black Monday for American medicine.

That's the day the Institute of Medicine released its study "To Err is Human."

Researchers reported that 44,000 to 98,000 deaths in the United States each year are caused by medical mistakes. Perhaps the most chilling aspect of the report was not just that so many medical mistakes happen, but the revelation that they are "one of the nation's leading causes of death and injury."

Deaths from medical mistakes, said the report, exceed yearly deaths from highway accidents (43,000) and from breast cancer (42,000). The IOM's report said reducing medical mistakes will require "rigorous changes throughout the health care system, including mandatory reporting requirements."

The report set a goal of 50 percent reduction in medical errors by 2005 and recommended the implementation of a national mistake-reporting system.

Poor penmanship counts

One of the most startling findings of the IOM study was that drug dispensing errors are rampant. Mistakes occur when the notoriously bad handwriting of doctors was misread, when drug name similarities caused confusion or when drug interactions were not recognized. Medication errors alone counted for 7,000 deaths in 1993, said the report. About the same time the IOM report came out, a Texas jury found that poor handwriting on a prescription led to a 42-year-old patient's death. The doctor was ordered to pay a $225,000 judgment.

The IOM report authors, probably unaware of the jury's decision, noted in their report that "individual recklessness" was likely not to blame for the errors. Rather, they said the cause was "basic flaws in the health care system." They pointed out that similarly named drugs have caused mistakes, as has stocking patient care units in hospitals with full-strength drugs, which are toxic unless diluted.

"Efforts should be made to eliminate similar-sounding drug names as well as confusing packaging that foster mistakes," the study said.

For example, the report cited mistakes caused by confusing Celebrex (an arthritis drug), Cerebyx (an anti-seizure drug) and Celexa (an antidepressant). The report encourages the FDA to require that drug companies test-market names and identify and change names that sound confusingly similar.

"The Food and Drug Administration could be part of the solution" by offering more guidance, says Frank Murphy, CEO of St. Petersburg's BayCare Health Systems Inc., a non-profit network of health care institutions, including Bayfront Medical Center and St. Anthony's. According to Murphy, BayCare Health has "decentralized" its pharmacy operations to help guard against dispensing errors.

"We've moved the pharmacists to the patient care floors," says Murphy, who adds that BayCare Health System has a task force that defines, identifies and tracks errors, then reports them quarterly to a community board.

Local government health care organizations are taking action as well. According to Lula Williams, risk manager at the Veterans Administration's Medical Center at Bay Pines, the VA's concern about similar-sounding drug names and similar packaging led to a request to the pharmaceutical industry to change their confusing ways. When that didn't happen, the VA took its own steps.

"We put red dots on some and separated all similar-sounding and similar-looking drugs so that they are not kept side-by-side," Williams says. "We also have a systemwide computerized bar coding system, like at the supermarket checkout. Patients wear their bar code on their wrist band. This ensures the right drug for the right patient at the right time."

According to Dr. Jeff Kuch, chief of staff at the Bay Pines VAMC, the bar-coding system cut medication errors by two-thirds at a test site VAMC. The IOM noted the VA's success and agreed that computerized drug dispensing systems work.

So, if the FDA doesn't exercise control over drug names and packaging, do pharmaceutical companies police themselves and at least try to avoid confusion when naming their drugs? Naming new drugs is no easy task, it appears. Some companies routinely have "focus groups" that meet, often with physician members, to name new drugs.

"I think there is clearly an attempt not to sound like other drugs," says Dr. Maida Taylor, a Northern California physician who has participated in drug company focus groups. "But sometimes the processes go on in parallel so that company A with product A gets it all going while company B does the same in isolation. For example, a new hormone-replacement drug, "Activelle,' from Norvo Nordisk. approved last year but not yet distributed, and "Actonel,' about to be launched later this year, will be for osteoporosis and have a great potential for confusion."

Physicians don't routinely screen for drug interactions, said the report. They often add new drugs to your medicine cabinet without looking at your history.

The IOM report said that in 1998 2.5-billion prescriptions were filled in U.S. pharmacies. In Massachusetts, says the report, 2.4-million prescriptions were improperly filled. How can retail pharmacy errors be reduced? By a patient filling all his prescriptions at the same pharmacy so that computerized systems can guard against drug interactions.

"One of the best ways to reduce drug-dispensing errors at the retail pharmacy would be through updated regulations," says Marie Griffin, editor of Drugstore News. "Pharmacies are regulated by the states and not every state allows electronic prescription submission, although that could eliminate the error-prone process of deciphering a doctor's scribbles. "Is it Accutane, for acne, or Accolate for asthma?' "

Heavy workload and stress could also lead to pharmacy mistakes, Griffin says. "We recently published a report that showed pharmacists spend 20 percent of their time in administrative work and 22 percent of their time counting, pouring and labeling, tasks that could be done by well-trained technicians or technology."

According to Griffin, computerized dispensing systems would not only count more accurately than people, but also would include checks against dispensing the wrong medication.

"Pharmacists spend six years learning about drugs and how they work in the body," Griffen says. "They could be a more valuable participant in the process, especially when multiple medications are prescribed."

Will changes in reporting errors fly?

In an editorial published by the American Medical News, Dr. David Lawrence, CEO of Kaiser Permanente, says that the safety with which medical care is delivered in this country is "compromised by the delivery system . . . that is . . . fragmented and disorganized, more than 100 years old and can no longer do the job. It is obsolete."

Lone-wolfism by doctors may be a factor. Lawrence suggests doctors stop practicing alone and start copying the teamwork model used by the airline industry, an industry he says reduced fatalities by 80 percent between 1950 and 1990. Airline pilots, Lawrence says, unlike doctors, don't work alone but are part of a coordinated team.

Modeling on the airline's error-reporting system is fine, says Murphy, who feels that it will not be so easy to reduce health-care errors as land planes safely. "I respect how complicated it is to fly an airplane," Murphy says. "But if you think an airplane is complicated, try doing surgery."

The reporting system embraced by the airlines is a good model, concedes Murphy, even if the airline business is not like health care. Just after the IOM report, the Veterans Administration confessed to uncovering 3,000 medical errors in its system over an 18-month period.

As it turns out, despite the bad rap the VA has gotten for errors, its mistake record is better than that of the rest of the American health care industry. The upside to the VA's mistake plight is that its error reporting system seems to work and could serve as a model for others.

According to Kuch, the VA's record is even more positive, considering that the VA system is made up of 172 hospitals and 132 nursing homes. "In New York, it's estimated that 3.7 percent of patients become involved in a medical mistake. In Colorado it's 2.9. The VA's rate of medical mistakes per patient is three-tenths of one percent."

The authors of the IOM study noted that the rest of the nation could learn from the VA, noting its efforts at creating a Patient Safety Centers of Inquiry. Dr. Lucian Leape, a professor at the Harvard School of Public Health and a contributor to the IOM report, says that patients must "speak up" and take control of their relationship with doctors in an attempt to prevent mistakes. He encourages patients to discuss treatments and even do their own medical research on the Internet.

Leape, in a recent American Medical Association news service report, said response to the IOM report has been greater than expected.

"It's heartening. People are taking this seriously. It's now on the national agenda. It's about time," he says.

-- Randolph Fillmore is a Tampa freelancer who specializes in science and medicine. He is a regular contributor to Health Times and the Baltimore Sun.

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