Medical System’s Failures Can Cause a Deadly Mistake

The 47-year-old man from Concord, Calif., an 82-year-old registered nurse from Walnut Creek and another man whose identity wasn’t released never expected to die when they entered an outpatient clinic last May for a routine orthopedic procedure. They simply went in for a cortisone shot to treat pain and inflammation--a shot that, unknown to them or their doctors, was contaminated with a bacterium that causes meningitis.

Ten others were hospitalized with symptoms of meningitis and blood infections but survived. All were the victims of a medical mistake.

Medical mistakes are far more common than most people realize. Each year tens of thousands of people die from medical errors, and hundreds of thousands more have close calls, according to the Institute of Medicine, an arm of the National Institutes of Health. Mistakes are made in different ways at every level of the health care system, and the consequences are never trivial.

The problems in Contra Costa County, east of San Francisco, occurred when the Sierra SurgiCenter in Walnut Creek obtained a contaminated batch of injectable cortisone, or betamethasone, from a neighborhood pharmacy. Doc’s Pharmacy had compounded, or mixed, the drug on site. But the process was done under unsterile conditions by a pharmacy technician, according to Wendel Brunner, the county’s public health director.

Brunner said when he visited the pharmacy after owner Robert Horwitz notified him of a potential problem, “I literally couldn’t believe my eyes. I did not imagine that this material injected into spinal cords would be prepared under these conditions.”

Dr. Lucian Leape, an expert on health system safety at the Harvard School of Public Health, says the majority of medical mistakes are made by “good, well-trained people trying to do a good job.” Most mistakes, he says, arise from systemic failures that could involve a physician’s office, pharmacy, hospital or regulatory agency.

“What is the system in California for ensuring safe practices in pharmacies? What are the standards? ... “ Leape asks.

In California, in this case, the system’s safeguards didn’t appear to work. The state Board of Pharmacy, which is responsible for overseeing 6,000 pharmacies and 29,000 pharmacists, has only 19 inspectors and two supervisors. And there is no law that regulates the compounding of drugs injected into the body. The board estimates that there are 300 pharmacists in the state compounding sterile injectable drugs, but it doesn’t really know for sure because there is no requirement that pharmacists report this activity to the state.

“Clearly there wasn’t enough scrutiny or inspections by the Board of Pharmacy to address the potential for something like this happening,” says Liz West, an aide to Sen. Tom Torlakson, D-Antioch. Torlakson has sponsored a bill that requires independent pharmacies to have a special license to compound sterile injectable drugs. The bill, which would include funds of about $600,000 for the hiring of more inspectors and enforcement staff, is expected to land on the governor’s desk for his signature this week.

Meanwhile, the Board of Pharmacy has prohibited Doc’s and Horwitz from compounding medicines--at least until after a disciplinary hearing this fall. Horwitz and a spokeswoman for the Sierra SurgiCenter declined to comment on the specifics of the incident.

Outpatient surgical centers like Sierra are regulated by the California Department of Health Services, which conducts inspections on behalf of the federal government. The department is supposed to inspect these facilities at least once every three years.

“In all honesty we have not done inspections once every three years,” says Lori McLean, a field operations chief. “We try to do the ones where it has been a long time or there has been a complaint.” Until the Doc’s Pharmacy case, state officials had not inspected Sierra since 1989.

Most patients don’t know whether a local pharmacist has mixed drugs under unsanitary conditions; in short, they don’t know how unsafe the system really is.

No one is immune when it comes to medical errors.

Pete Conrad was an astronaut, the commander of the second moon landing and the third man to walk on the moon. A naval pilot, he had spent his whole life around systems built for safety. Two years ago he died in a small community hospital where he was taken after a motorcycle accident.

He died a “preventable death because of a systems failure involving diagnosis, procedures and communication,” says his widow, Nancy, who has started a nonprofit foundation that is working to improve patient safety in community hospital emergency departments.

“Chances are very good that someone in an earthquake, a fire, a car accident will be taken to a community hospital,” she says.

Medical care can be made safer, Leape says. “The real question is whether the health care system can do what needs to be done without more regulation.”

The incident in Walnut Creek suggests that someone on the outside should be minding the store.

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Trudy Lieberman is the author of “Consumer Reports Complete Guide to Health Services for Seniors” (Three Rivers Press, 2000). Write to trudyal530@aol.com. Health Matters appears on the third Monday of the month.