At first, Karin's bleeding was infrequent and light, a minor annoyance. It came and went without pain. An athlete, she ate a healthful diet, played volleyball and often jogged six kilometres.
But when the bleeding continued, her concern grew. After she was hired by the Arthur Andersen accounting firm in 1987, she went to a clinic run by Family Health Plan, the HMO (health management organization) she'd joined. A physician's assistant took a Pap smear and sent it off to a lab owned by the Chem-Bio Corporation, which her HMO contracted with. The results came back normal.
Ten months later another Pap smear came back normal, but given Karin's symptoms, the HMO referred her to a gynecologist, who ordered a biopsy of her cervix. That, too, came back negative for cancer. Instead, the lab pathologist suspected Karin had microglandular hyperplasia, an excessive growth of cells in the cervix and usually nothing to worry about.
Four months later and after her marriage, Karin was still bleeding. Concerned, the doctor took a second biopsy and sent it, like the others, to the Chem-Bio lab. It, too, came back negative for cancer, though the pathologist did notice an abnormality.
Over the next year Karin's bleeding grew more frequent and heavier. In June 1990 she passed out after a volleyball game. She had been bleeding continuously for 21 days.
By then Karin knew something was wrong, but she felt sure her doctors were right.It couldn't be serious. "She thought she was anemic," Peter says. "She was working so much, we figured she was simply worn out."
The Smiths had just finished building a house in the suburbs for the family they hoped to have. Karin went to the HMO's clinic near her new home, where they recommended another Pap smear. The lab noticed an abnormality, so she had another biopsy, her third in two years.
Her doctor noted she had a red, irritated cervix, a potential sign of cancer. But possibly reassured by the earlier negative test results, he told Karin: Don't worry, I've seen cancer and this isn't cancer," Peter recalls.
Karin continued to feel tired most of the time. Hoping for some sort of resolution, she went to another gynecologist, who again examined her cervix. Afterwards blood poured from Karin, covering the table and spilling onto the floor. At a subsequent visit, her doctor tried to stop the bleeding by cauterizing the tissue, it didn't work.
After years of bleeding, three Pap smears and three biopsies, Karin Smith finally lost faith in her health care plan. She went to Dr. William Stewart, a highly regarded gynecologist not affiliated with her HMO, prepared to pay his fee out of her own pocket. The moment he looked at her cervix, he knew Karin was in serious trouble. He called David Hoogerland, a gynecological oncologist, who conducted a biopsy and sent it to the lab he used - not to Chem-Bio. The results were unquestionalbe: cancer.
Karin, who hoped to have children, was scheduled for a radical hysterectomy. Dr. Hoogerland found that the cancer - slow growing by nature - had penetrated her cervix and entered the lymph nodes, from which it would likely spread throughout her body.
Within weeks of Karin's diagnosis, the Smith's contacted lawyer Patrick Dunphy. Over the next 18 months, he put together a chilling picture of mismanaged care.
Testimony from Hoogerland and other physicians established that Karin had postcoital bleeding - a known warning sign of cervical cancer, and that the appearance of her cervix should have made the HMO's doctors suspicious. Yet they hadn't once mentioned her bleeding on the orders sent to the lab with the Pap smears and biopsies. A simple note would have caused the lab to examine her tests with extra care.
Karin blamed her doctors and a managed-care system that encouraged speed and impersonal treatment for condemning her to death. "Due to their gross incompetence and shameful errors, I am now dying," she testified before Congress in Feruary 1995.
In June 1993 the Smiths agreed to a $6.3 million malpractice settlement from Family Health Plan Cooperative, the Chem-Bio Corp., an HMO-affiliated doctor, two pathologists and the technician who misread her tests. But money provided small comfort. "Karin wanted her story made public," says her friend Karen Carleton. "She felt the doctors had committed a crime against her and it was being swept under the rug."
In the Fall of 1994 Smith and Dunphy asked Milwaukee County District Attorney E. Michael McCann to bring criminal charges against her doctors. McCann looked at the evidence and saw a villain, but not the villains Karin blamed. Even careful doctors, he reasoned, must rely on lab information. And numerous tests had told Karin's doctors that she did not have cancer. To McCann, it was clear that the blame rested with the Chem-Bio lab.
Betty Setum, a soft-spoken woman with a clear, direct gaze, began supervising work at the lab, which Chem-Bio had since sold, in 1990. The knowledge of what happened there haunts her. "I used to be proud of what I do," she says. "Now I don't mention it unless I'm asked."
Reading a Pap smear accurately is demanding for even the best cytotechnologists, as the technicians who do this job are called. Each slide may contain as many as 300,000 cells. When cancer is present only a few may have the darkened centre of malformed shape that can indicate the disease. It's like searching for a few odd blossoms in a roomful of flowered wallpaper.
For that reason, cytotechnologists need at least five minutes to check a Pap smear slide, according to the College of American Pathologists. The work is so painstaking that in 1992, U.S. federal law set the limit at 100 slides a day per technician, and labs must screen slides for quality control.
A few days after Setum began work at the lab, June Fricano, a freelance cytotechnologist, told her to be careful with slides whose case numbers ended in "2": Those were the ones rescreened. "My jaw hit the floor," Setum says. "Quality control is supposed to be random, if it's not, there's no point doing it."
Then in January 1991 Setum noticed a stack of 160 slides in Fricano's work area. Half had been marked with the next day's date - making it appear that she hadn't exceeded the legal limit.
Setum had the slides rescreened. One, which Fricano had marked as normal, showed clumps of ominous, dark cells. Fricano was fired.
A month later Setum took a phone call from a nearby hospital. In performing a hysterectomy on Dolores Geary - a 39-year-old mother of three who also belonged to Karin Smith's HMO - doctors had discovered advanced cervical cancer. Could Setum check Geary's previous Pap smears?
Setum examined a 1987 Pap smear from the files. "There were almost no normal cells," she says quietly. "Cancer's ugly. It's black and horrible. It was the worst slide I've ever seen." The slide had been reported as normal by June Fricano.
Fricano, it turned out, had screened almost 48,000 Pap smears in one year. For her speedy work, she was paid $2 a slide, earning as much as $96,000 at a time when top staff cytotechnologists made $33,000.
Traditionally, labs charge for each test they analyze. Under managed care, however, they agree to analyze an HMO's tests - regardless of how many - for a flat fee. In a "capitation" agreement, a lab may get paid only 75 cents per patient each month to do a variety of tests. Yet it can cost the lab from $6 to $20 to analyze just one Pap smear.
Working under such financial pressure could easily lead to bad medicine, says Dr. Franklin Elevitch of the College of American Pathlogists. A lab might pare costs by urging technicians to work too fast or by hiring the cheapest, least-experienced technicians.
R. Rupert Lipo, one of Chem-Bio's owners and its medical director, was aware that Fricano, who had an unusual arrangement of being paid by the slide, might screen up to 200 slides on some days. "She prided herself on her speed and accuracy," he said in a deposition. "She'd sit there like a machine and she'd just work like crazy."
Her mistakes were hard to detect, perhaps because she knew which slides would be rescreened for quality control. Fricano read almost all of the Chem-Bio lab's Pap smears during the years Karin Smith's and Dolores Geary's cancers were repeatedly misdiagnosed. (Neither Lipo nor Fricano would agree to be interviewed.)
On March 8, 1995, at the age of 29, Karin Smith died of a disease that shouldn't kill any woman receiving routine gynecological care. She was so thin and cold at the end that Peter would lie in her bed to warm it before she got in.
On April 7, 1995 McCann told a Milwaukee inquest jury that Karin Smith's case wasn't about malpractice. It was about a recklessness so excessive that the perpetrators work more than 42 hours a week for a six-year period and never to analyze more than 100 Pap smears a day. Neither was charged with a crime.
In the bright home that the Smiths shared, Peter is asked if he thinks Karin would be at peace with the conviction. He pauses, light-years away from the devil-may-care college student who once courted a vibrant but no-nonsense accounting major.
"Yeah, I think she would. We didn't hit a home run, but we hit a solid double. Articles about this case are on bulletin boards in every cytotech lab in the country. I truly believe something like this will not happen again."
Karin's message has been heard. But the real triumph of her cursade is that good doctors - and the rest of us - have a weapon with which to fight back. Now when a health-care provider cuts corners to save money and a patient dies, it's no longer a matter of malpractice. It could be homicide.
My comment: Surely, I hope, that everyone knows that to menstruate for more than 7 days is not normal to be bleeding for so long!
Deaths from cervical cancer have decreased 70 percent since women began getting regular Pap smears. While cases as numbing as Karin Smith's are rare, Pap-smear errors do happen. According to a recent international survey, cervical smears fail up to 30 percent of the time because of poor sampling and evaluating of results. Here's how you can improve the accuracy of your test:
At breakfast, seven-year-old Gabrielle Hundley took the first of two pills that would change her life. The new prescription that her mother, Peggie, had gotten filled at the Rite Aid in Rock Hill, S.C., was for Ritalin, a drug used to treat attention deficit-hyperactivity disorder.
In an emergency room later that day, February 21, 1995, doctors discovered that the little girl hadn't taken Ritalin at all, but a high dose of Glynase, a diabetes medication. In court the next year, the Hundleys' attorney argued that the pills were incorrectly dispensed, and contained 16 times the normal starting dose for adult diabetics, causing Gabrielle's blood-sugar level to plummet so severely that she suffered permanent brain damage. The jury awarded the Hundley family $16 million. Rite Aid is appealing the verdict.
Pharmacy transactions seem so straightforward. How often could they go awry?
While there are no definitive national statistics, there is evidence suggesting that drug-dispensing mistakes are more common than you think. In a 1997 nationwide survey conducted by the trade publication Drug Topics, 53 percent of pharmacists admitted having made errors in the preceding two months. A June 1996 survey of 3361 pharmacists in California and Oregon revealed that errors occurred at an annual rate of 324 per pharmacy---nearly one a day.
"Ten years ago, an acceptable error rate was considered one per year per pharmacy," says Ralph Vogel, president of the Guild For Professional Pharmacists, a union representing 2000 pharmacists. "What we're seeing today is the chaos that comes from understaffing and other new stresses in the pharmacy."
The pharmacy industry insists that worries over error rates are overblown. Nevertheless, many state regulations, consumer advocates and pharmacists contend that a revolution in the retail drug business is causing problems by increasing workloads.
They point to two factors: First, overall prescription volume keeps rising---up 30 percent between 1992 and 1997, accoding to IMS Health, a health care information company. second, the percentage of prescriptions paid for by insurance or HMOs has risen from 28 percent in 1991 to 60 percent in 1997. These third-party payers are imposing ever-lower reimbursement rates on pharmacies, which must churn out a high volume of prescriptions to keep profit margins up. Even the Big Four chains---Rite Aid, CVS, Eckerd and Walgreens---are affected.
Against this backdrop, too many people are taking the prescription transaction for granted. Indeed, for the past nine years, Americans responding to Gallup Polls have ranked pharmacists as the country's most honest and ethical professionals, ahead of clergy mambers. No wonder so many people assume nothing can go wrong. "I had blind faith," says Peggie Hundley.
Here's what you need to know to protect your family:
You can't rely solely on your doctor. Most physicians get only one year of formal training in medical schooling on the use of prescription drugs. And, generally, continuing education on medications is not required.
A white coat does not a pharmacist make. The burden of knowing about potentially dangerous drug reactions is one reason pharmacists must complete five or six years of academic training. Yet increasingly, the white-coated person who dispenses medicine isn't a pharmacist at all but a pharmacy technician. Depending on the state, such techs may have nothing more than a high school degree and on-the-job training.
You could get the right drug but the wrong dose.
The safety net has holes. Most pharmacies rely on computer setups that are supposed to be updated regularly with information about new drugs or new risks for existing drugs. But these systems don't always work.
Little watchdog oversight exists.
Most state boards don't require pharmacies to report dispensing errors. And national error-reporting programs such as one run by U.S. Pharmacopeia (a nonprofit gorup that sets drug-manufacturing quality standards) are voluntary.
TAKE NOTES: At your doctor's office, write down the generic and brand names of your prescribed medicine, along with its purpose and the dosage. That way you can double-check the medication the pharmacist hands you.
INFORM EVERYONE. Remind both your doctor and your pharmacist of any drug allergies you have as well as any other medications you're taking. Inlcude over-the-counter pain or cold remedies, vitamins and herbal supplements.
CHECK REFILLS. Make sure the pills are the same color and size you usually get. If they're different, assume they're wrong until a pharmacist examines them.
SHOP OFF-PEAK. Avoid getting prescriptions filled on a Monday, traditionally a pharmacy's busiest day. Call in refills a day or two ahead to lessen chances that your prescription will be filled during busy hours. If you get your presctiptions by mail, order them at least two weeks before you need a refill.
Most importantly, if you feel sick after taking a newly prescribed drug, call your physician immediately.
How to Keep Your HMO from Killing You: Join the ThirdAge Alternative Health Discussion Forum Hosted by Kyle Roderick. "As too many of us know, being insured by a health care maintenance organization (HMO) can be confusing and anxiety-inducing. This is primarily due to the wide variation in HMO plans and coverage, but also to the swift changes that HMO policies are subject to. And many plans fail to provide the care that we (and sometimes even our physicians) believe is necessary."
Do you know when HMOs were created? click here and find out. Also more on Managed Care.
In contrast, many states require pharmacists to complete an average 15 hours of continuing education each year. And there's no dearth of homework: new drugs are pouring into the market, stimulated by a 1992 program shortening the FDA's drug-approval times. In the past two years, 92 new drugs hit the market---compared with 125 approved for the previous five years.
So don't assume you would never leave your doctor's office with a problem prescription. Ruth Paxton, 44, of Dayton, Nev., trusted her doctor implicitly when she sought treatment for a sinus infection in July 1992.
Within 20 minutes of taking Ceftin, Paxton's throat began to swell, making it difficult to breathe. Swift self-treatment with an antihistamine stopped the reaction.
Nevada's board of pharmacy reprimanded Paxton's pharmacist, saying he should have warned her of the potential for allergic reaction.
As pharmacy chains face squeezes on profit margins, the use of techs is growing. Why? Techs typically earn $5 to $39 an hour for registered pharmacists.
Of course, pharmacists are supposed to check technicians' work. Failure to do so was cited as a major cause of dispensing errors by nearly a third of pharmacists in the Drug Topics survey.
Hazel Van Hattem of Crete, Ill., says there were two pharmacists and three technicians on duty on May 30, 1995, when she picked up a refill of Coumadin, a powerful blood-thinning medication, for her husband, Ernest. "At the trial, they said they couldn't be sure who filled the prescription," says Hazel, referring to her lawsuit against Kmart. Her attorney argued that whoever filled the vial did so with pills containing 5 mg. of Coumadin rather than Ernest's usual 2 mg.--an overdose that caused massive bleeding and led to his death. A jury levied an $810,000 judgment against the pharmacy. A Kmart spokesperson says the company is appealing.
Some dispensing errors can be attributed to unreasonable workloads. Three medical studies conducted over an 11-year period found a correlation between pharmacists' work-loads and error rates: "There does appear to be a greater risk of errors when a pharmacist is expected to fill more than 24 prescriptions per hour," says Elizabeth Allan Flynn of Auburn University's School of Pharmacy. Increasingly, pharmacists say, pushing beyond that rate is not unusual.
In a study reported in the Journal of the American Medical Association in 1996, Raymond Woosley, chairman of the department of pharmacology at Georgetown University Medical Center, and his colleagues presented two prescriptions for the same patient to 50 pharmacists in the Washington, D.C., area. One was for the antihistamine Seldane; the other was for the antibiotic erythromycin.
Since 1992 the FDA and the drug manufacturers have issued warnings that mixing the two drugs could be fatal. Still, 32 percent of the pharmacies filled the prescriptions. Of the 48 pharmacies using computers to flag adverse interactions, 29 percent had programs that failed to issue an alert. In some cases, Woosley says, pharmacists had shut down the systems or overridden them.
And what about the patient information leaflets stapled to prescription bags at most pharmacies? These are also designed to give added protection against drug interactions or side effects. They usually aren't prepared by pharmacists or physicians--but by commercial vendors. And they're often vague or out-of-date.
Drug chains, however, usually reuire pharmacists to submit error reports to management. But even those internal reports don't always prevent future errors.
Malvina Holloway, 59, of Mobile, Ala., received a vial filled withh Tambocor, a dangerous heart-rhythm-altering medication, rather than the breast-cancer drug Tamoxifen that her oncologist had prescribed. Holloway didn't discover the mistake until five months and two refills later.
Luckily, she did not experience any adverse reactions to the heart drug, but Holloway was distressed that her cancer treatment was delayed. She sued Harco Drugs, Inc., the regional chain where the mistake was made. Her attorney presented 233 incident reports that had been submitted to Harco management, the majority involving dispensing errors at their stores over the preceding three years. Holloway won a $255,000 jury award.
Such awards have motivated chains to improve internal procedures on error reports. But Carmen Carizone, executive director of the National Association of Boards of Pharmacy, which represents state licensing boards across the country, argues for greater oversight: "We are proposing that each individual pharmacy nbe required to report serious dispensing errors to the state board."
The ultimate responsibility of protecting himself, though, rests with the consumer. In most states, pharmacists are required by law to counsel customers about new prescriptions. Nevertheless, most customers turn down offers for a "show and tell."
Says Stephen Giroux, a pharmacist in Middleport, N.Y.. "If people understood the harm that couldbe done to them by a dispensing error, they wouldn't treat going to a pharmacy like going to a fast-food store."
Source:RD Sept/98
HOW TO PROTECT YOURSELF
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How do you convince your HMO to provide coverage that is essential to your health but may be denied? To answer this question, let's share strategic success stories about how we received optimal HMO care. Tell us how you acquired authoritative information on a medical condition, or how to keep good records of our case. Have you had HMO physicans on your side, or have you navigated the HMO system with a chronic illness?